Complix NV

DUBLIN, May 11, 2023 /PRNewswire/ -- The "Global Antibody Partnering Terms and Agreements 2016-2023" report has been added to ResearchAndMarkets.com's offering. The Global Antibody Partnering Terms and Agreements 2016 to 2023 report provides comprehensive understanding and unprecedented access to the antibody partnering deals and agreements entered into by the world's leading healthcare companies. The report provides a detailed understanding and analysis of how and why companies enter antibody partnering deals. The majority of deals are discovery or development stage whereby the licensee obtains a right or an option right to license the licensors antibody technology. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes. This report provides details of the latest antibody agreements announced in the healthcare sectors, covering: Antibodies Antibody-drug conjugates Monoclonal antibodies Murine mAb Chimeric mAb Humanized mAb Human aAb Polyclonal Antibodies Bispecific antibodies Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases do not. This report contains over 1900 links to online copies of actual antibody deals and contract documents as submitted to the Securities Exchange Commission by companies and their partners. Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal. The initial chapters of this report provide an orientation of antibody dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in antibody dealmaking since 2016, including details of average headline, upfront, milestone and royalty terms. Chapter 3 provides a review of the leading antibody deals since 2016. Deals are listed by headline value, signed by big pharma, most active antibody dealmaking companies. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 4 provides a comprehensive listing of the top 25 most active companies in antibody dealmaking with a brief summary followed by a comprehensive listing of antibody deals, as well as contract documents available in the public domain. Where available, each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand. Chapter 5 provides a comprehensive and detailed review of antibody partnering deals signed and announced since Jan 2016, where a contract document is available in the public domain. The chapter is organized by company A-Z, deal type (collaborative R&D, co-promotion, licensing etc), and specific therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive and detailed review of antibody partnering deals signed and announced since Jan 2016. The chapter is organized by specific antibody technology type in focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. In addition, a comprehensive appendix is provided organized by antibody partnering company A-Z, deal type definitions and Antibody partnering agreements example. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. The report also includes numerous tables and figures that illustrate the trends and activities in antibody partnering and dealmaking since 2016. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of antibody technologies and products. Key benefits Global Antibody Partnering Terms and Agreements 2016 to 2023 provides the reader with the following key benefits: In-depth understanding of antibody deal trends since 2016 Access to headline, upfront, milestone and royalty data Detailed access to actual antibody contracts enter into by the leading 25 big pharma companies Insight into the terms included in a antibody agreement, together with real world clause examples Understand the key deal terms companies have agreed in previous deals Undertake due diligence to assess suitability of your proposed deal terms for partner companies Report scope Global Antibody Partnering Terms and Agreements 2016 to 2023 is intended to provide the reader with an in-depth understanding and access to antibody trends and structure of deals entered into by leading companies worldwide. Global Antibody Partnering Terms and Agreements 2016 to 2023 includes: Trends in antibody dealmaking in the biopharma industry since 2016 Access to headline, upfront, milestone and royalty data Access to over 1900 antibody online deal records The leading antibody deals by value since 2016 Most active antibody dealmakers since 2016 The leading antibody partnering resources In Global Antibody Partnering Terms and Agreements 2016 to 2023, the available contracts are listed by: Company A-Z Headline value Stage of development at signing Deal component type Specific therapy target Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. The Global Antibody Partnering Terms and Agreements 2016 to 2023 report provides comprehensive access to available deals and contract documents for over 1900 antibody deals. Analyzing actual contract agreements allows assessment of the following: What are the precise antibody rights granted or optioned? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Companies Mentioned Ablexis Selexis Tubulis Trellis Bioscience Eucodis Bioscience Arsanis Biosciences biOasis Technologies MAB Discovery Hutchison MediPharma Beth Israel Deaconess Medical Center Hadasit Bioholdings Hadasit Medical Research Services and Development Affinita Biotech Immunitas Therapeutics Purolite Ab Initio Affinity Biosciences Velocity Pharmaceutical Development Infinity Pharmaceuticals Actinium Pharmaceuticals Adaptive Biotechnologies Curative Biotechnology VU University Amsterdam Rheonix Complix DNAtrix SillaJen Biolojic Design Kodiak Sciences ProtoKinetix Hong Kong University of Science & Technology Zenyaku Kogyo bioCSL Global Biological Standards Institute Pascal Biosciences For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

13 significant clinical milestones achieved year-to-date, including critical positive data readout events for felzartamab (TJ202/MOR202), lemzoparlimab (TJC4), uliledlimab (TJD5), and plonmarlimab (TJM2) and more milestone achievements are expected before the year-end 2021 Felzartamab (TJ202/MOR202) is on track for Biologic License Application (BLA) submission in Q4 2021 and eftansomatropin alfa (TJ101) phase 3 trial on track for completion of patient enrollment and potential commercial collaboration Growing pipeline with eight highly differentiated and clinically advanced assets in phase 2/3, followed by next generation of immuno-oncology assets, including bi-specific antibodies in phase 1 or pre-clinical stage and novel drug candidates enabled by transformative technologies for unique drug properties, e.g. AI-guided targeting, antibody by mRNA delivery, intracellular targeting and tumor-site activation Inclusion of the MSCI China All Shares Index, preparation of potential dual listing on China's STAR Market, and receiving of a high rating from the MSCI ESG assessment (the highest newly initiated rating among China -based biotech companies) Progress in building the manufacturing and commercialization capabilities as part of Company's transformation to a global biopharma I-Mab to host conference calls and webcasts on August 31, 2021. A Mandarin session conference call will be held at 7:00 a.m. ET, and an English session conference call will be held at 8:00 a.m. ET. SHANGHAI and GAITHERSBURG, Md., Aug. 31, 2021 /PRNewswire/ -- I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced financial results for the six months ended June 30, 2021, and provided key business updates. During the reporting period, I-Mab has made remarkable progress in its key business areas. Firstly, on the R&D front, the Company has rapidly advanced its globally competitive pipeline and achieved all critical clinical milestones as set in early 2021 for the key pipeline assets. More specifically, the Company had seven clinical trials initiated or soon to be initiated, achieved five key data readout events for its differentiated investigational drugs, i.e. CD38 antibody felzartamab (TJ202/MOR202), CD47 antibody lemzoparlimab (TJC4), CD73 antibody uliledlimab (TJD5), GM-CSF antibody plonmarlimab (TJM2) and novel IL-6 inhibitor olamkicept (TJ301). Furthermore, the Company has made significant progress in expanding the current pipeline through the bi-specific antibody panel, where two lead assets have advanced to clinical trials in the U.S. in early 2021, as well as the next generation of novel antibody candidates enabled by transformative technologies through collaborations. In this regard, the Company has successfully entered into five technology partnering deals to gain access to cutting-edge technologies to generate novel drug molecules with uniquely acquired drug properties, including mRNA delivery, AI-guided targeting, cell-penetrating antibody and tumor-site activation. Secondly, on the corporate development front, the Company has met all expected corporate milestones with respect to building its manufacturing facility in Hangzhou and its commercialization capabilities and preparation of the market launch of felzartamab. I-Mab is now globally connected with six sites or offices in China and two R&D facilities in the U.S. Thirdly, during the reporting period, the Company has initiated its dual listing plan for the STAR Market in China and received multiple prestigious corporate honors by the global biotech community and the capital market. The Company also made efforts to further strengthen its Board of Directors and Scientific Advisory Board with internationally reputable experts. "With the corporate focus and execution by our highly committed team, I-Mab has managed to have successfully delivered outstanding results that have exceeded our original expectations set early this year," said Dr. Jingwu Zang, Founder and Chairman of I-Mab. "We are thrilled by the achievements because many of the milestones are critical as they have provided positive and enabling clinical data needed for the further development of the key pipeline assets. Looking ahead, we will have 19 clinical trials either ongoing or soon to be initiated in both the United States and China by the end of this year, including our first BLA submission in Q4 2021. With these achievements, our pipeline is now not only innovative and globally competitive but also advanced with more assets moving towards late-stage clinical trials and BLA." "The progress we have made so far has placed us firmly on track to deliver the rest of the critical milestones and has effectively secured our overall development plan for the key assets such as felzartamab, eftansomatropin alfa, lemzoparlimab, uliledlimab, and plonmarlimab. We are very excited and confident to succeed in our journey to transition from a clinical stage biotech now to a global biopharma within the next few years," Dr. Zang concluded. Recent Pipeline Highlights and Upcoming Milestones I-Mab has completed felzartamab 3L registrational trial, enabling the Company's first BLA submission in Q4 2021, and currently manages two additional registrational trials, seven Phase 2 and eight Phase 1 clinical studies that are either ongoing or soon to be initiated in the U.S. and China. In parallel, a series of pre-clinical programs representing the next generation of innovative assets, i.e. bi-specific antibodies as well as so called "super antibodies", are under the development and some will advance towards IND application in 2022. Rapidly Advancing Clinical Development of the Late-Stage Assets for Near-Term Value Creation (1) Phase 3/pre-BLA assets Felzartamab (TJ202/MOR202): A differentiated CD38 antibody for the treatment of multiple myeloma (MM) and potentially autoantibody-mediated autoimmune diseases such as systemic lupus erythematosus (SLE). I-Mab has licensed development, manufacturing and commercialization rights for felzartamab in Greater China from MorphoSys. Felzartamab for MM third-line treatment is on track for BLA submission in Q4 2021 and MM second-line registrational trial is on track. The Company plans to submit a new IND application in Q3 2021 to explore the combination of felzartamab with another I-Mab clinical asset as a potential first-line treatment for MM. The rationale of this combination study is strongly supported by the pre-clinical evidence. Third-line MM: The topline data of the registrational trial have met the primary and secondary endpoints. More importantly, the data have confirmed the clinical advantages of felzartamab with respect to its lower infusion-related reaction rate, shorter infusion time for out-patient administration etc. BLA submission is on track for Q4 2021. Under the leadership of Mr. Zhu, Chief Commercial Officer, the Company has assembled an integrated multi-functional team to focus on the launch readiness of felzartamab in China . . Second-line MM: Phase 3 registrational trial of felzartamab in combination with lenalidomide for second-line MM is on track. The Company expects to complete patient enrollment in September 2021 . The topline data package is expected to support a BLA submission in 2023. . The topline data package is expected to support a BLA submission in 2023. Potential first-line MM: A new IND application is planned in Q3 2021 to initiate a clinical trial for the combination of felzartamab with another I-Mab clinical asset as a potential first-line treatment for MM. SLE: in June 2021 , The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the Company's IND application to initiate Phase 1b trial of felzartamab in patients with SLE in Q4 2021. Eftansomatropin alfa (TJ101): A differentiated long-acting growth hormone for pediatric growth hormone deficiency (PGHD). Eftansomatropin alfa is the only rhGH in its proprietary fusion protein format (pure protein-based molecule) and is not chemically linked with PEG or other linkers. Its safety, tolerability, and efficacy have been well demonstrated in a phase 2 clinical trial in the EU. I-Mab has the development, manufacturing, and commercial rights of eftansomatropin alfa in China from Genexine. PGHD: in February 2021 , the first patient was dosed in Phase 3 registrational trial (TALLER) of eftansomatropin alfa as a weekly treatment for PGHD patients in China . Complete patient enrollment (N=165) is expected in early 2022 to be on track for a planned BLA submission in 2023. , the first patient was dosed in Phase 3 registrational trial (TALLER) of eftansomatropin alfa as a weekly treatment for PGHD patients in . Complete patient enrollment (N=165) is expected in early 2022 to be on track for a planned BLA submission in 2023. In parallel, the Company is under active discussions with potential commercial partners for the commercialization of eftansomatropin alfa in China . (2) Core clinical assets Lemzoparlimab (TJC4): A highly differentiated CD47 antibody being developed through a comprehensive clinical development plan for hematologic malignancies and solid tumors in China by I-Mab and globally by AbbVie. I-Mab's goal is to achieve the first registration of lemzoparlimab in its class in China and facilitate global registration in collaboration with AbbVie, which leads global development and commercialization efforts. To achieve this goal, three clinical programs of lemzoparlimab are ongoing in parallel in both the U.S. and China, which will potentially lead to one or two pivotal clinical trials in 2022. Lemzoparlimab in combination with rituximab for Non-Hodgkin's lymphoma (NHL): The clinical trial is ongoing to enroll more patients in the U.S. with additional clinical sites joining in September 2021 in China . The preliminary clinical data is promising in terms of safety and efficacy signals in patients with NHL. The clinical results have been summarized and submitted for presentation at the 2021 American Society of Hematology (ASH) Annual Meeting. The Company expects to, pending approval by the NMPA, initiate a pivotal trial in patients with NHL in 2022 in China . in . The preliminary clinical data is promising in terms of safety and efficacy signals in patients with NHL. The clinical results have been summarized and submitted for presentation at the 2021 American Society of Hematology (ASH) Annual Meeting. The Company expects to, pending approval by the NMPA, initiate a pivotal trial in patients with NHL in 2022 in . Lemzoparlimab in combination with AZA in AML and MDS: In May 2021 , the first patient was dosed in an abbreviated phase 2 combination clinical trial in patients with newly diagnosed AML or MDS in China . Patient enrollment is on track to be completed in Q4 2021. Based on the preliminary clinical efficacy signal seen in patients on the study, it is expected that this study will potentially lead to a pivotal clinical trial, pending approval by the NMPA, in 2022 in China . , the first patient was dosed in an abbreviated phase 2 combination clinical trial in patients with newly diagnosed AML or MDS in . Patient enrollment is on track to be completed in Q4 2021. Based on the preliminary clinical efficacy signal seen in patients on the study, it is expected that this study will potentially lead to a pivotal clinical trial, pending approval by the NMPA, in 2022 in . Lemzoparlimab in combination with pembrolizumab in patients with solid tumor: A phase 1b clinical trial is ongoing in the U.S. in patients with selected solid tumors. The preliminary clinical results are expected by the end of 2021 or early 2022. A "basket" clinical trial of lemzoparlimab in combination with a PD-1 antibody in patients with advanced solid tumors is expected to commence in China in Q4 2021. clinical trial is ongoing in the U.S. in patients with selected solid tumors. The preliminary clinical results are expected by the end of 2021 or early 2022. A "basket" clinical trial of lemzoparlimab in combination with a PD-1 antibody in patients with advanced solid tumors is expected to commence in in Q4 2021. Lemzoparlimab global phase 1b study, including combination with venetoclax, in patients with AML/MDS is being conducted in the U.S. by AbbVie. The study has the potential to lead to a global pivotal clinical trial where I-Mab will participate for the purpose of simultaneous registration of AML in China . Uliledlimab (TJD5): A highly differentiated CD73 antibody being developed for solid tumors. Phase 1 clinical trial conducted in the U.S. was completed and the clinical data was presented at ASCO 2021 as described below. The Company is advancing the asset in phase 2 clinical trials in both the U.S. and China in selected tumor types in an effort to demonstrate clinical proof-of-concept. In parallel, the Company is exploring a potential global partnering deal. Differentiated mechanism of action (MoA): the Company presented detailed data at the 2021 American Association for Cancer Research (AACR) Annual Meeting in April that highlighted the unique binding epitopes and structure of uliledlimab that enabled the complete CD73 enzymatic inhibition without the "hook effect," as well as pre-clinical immuno-regulatory and anti-tumor activity as a single agent and in combination with PD-(L)1 antibodies. Positive phase 1 results in patients with advanced solid tumors: the Company presented detailed U.S. phase 1 clinical data of uliledlimab in combination with atezolizumab in patients with advanced solid tumors at the 2021 ASCO Annual Meeting. The combination therapy is safe and well-tolerated with no dose-limiting toxicity. All treatment-related adverse events were either grade 1 or grade 2. Uliledlimab demonstrated a linear pharmacokinetic (PK) profile and reached full receptor occupancy on B cells at the middle and high dose levels with no "hook effect." Among the 13 efficacy-evaluable patients dosed at ≥ 10 mg/kg, three patients had complete or partial responses (objective response rate = 23%) and three had stable disease (disease control rate = 46%). The clinical activity was observed in both PD-(L)1 treatment naïve and refractory cancer patients, including one partial response patient who previously failed nivolumab. Tumor types of patients who had complete or partial responses or stable disease included ovarian clear cell carcinoma, non-small cell lung cancer, and a few other cancers. The three responders were identified as the only patients who exhibited higher co-expression of tumor CD73 and PD-L1 as compared to non-responders, indicating a correlation between higher CD73 expression and clinical activity of uliledlimab and a potential role of CD73 as a predictive biomarker to warrant further investigation. The abstract was selected as a "Top 12" research abstract at the conference. Phase 2 clinical trials: In February 2021 , the first patient was dosed in a phase 2 clinical trial of uliledlimab in combination with toripalimab (TUOYI®) in patients with advanced solid tumors in China . In parallel, a phase 2 "basket" clinical trial is expected to be initiated in patients with selected advanced solid tumors in the U.S. in Q4 2021. Plonmarlimab (TJM2): A monoclonal antibody targeting human granulocyte-macrophage colony-stimulating factor (GM-CSF), a cytokine that plays a critical role in acute and chronic inflammation. The Company recently carried out an interim analysis of its phase 2/3 clinical trial for the treatment of cytokine release syndrome (CRS) in patients with severe COVID-19 in the U.S. The results are reported below. The interim analysis showed positive preliminary results in patients who were mechanical ventilation free (MVF) at baseline (N=91). Plonmarlimab treatment resulted in a higher MVF rate (83.6% vs. 76.7%) by day 30, a lower mortality rate (4.9% vs. 13.3%) by day 30, higher recovery rates (68.9% vs. 56.7% at day 14 and 80.3% vs. 70.0% at day 30), as well as reduced time to recovery and hospitalization duration, as compared to placebo. The magnitudes of the clinical improvements are comparable to those observed with lenzilumab in a similar patient population. [1] Biomarker results were consistent with the observed clinical outcome and indicated patients treated with plonmarlimab had a reduction in plasma levels of pro-inflammatory cytokines and chemokines critically involved in CRS, including TARC, IP10, GCSF, IL10, IL6, MCP1, IL1RA, TNF-alpha but not interferon-gamma. A transient increase in Neutrophil to Lymphocyte Ratio (NLR) that is commonly associated with disease exacerbation was only observed in placebo. Plonmarlimab was well tolerated in all patients with no significant safety concerns. Biomarker results were consistent with the observed clinical outcome and indicated patients treated with plonmarlimab had a reduction in plasma levels of pro-inflammatory cytokines and chemokines critically involved in CRS, including TARC, IP10, GCSF, IL10, IL6, MCP1, IL1RA, TNF-alpha but not interferon-gamma. A transient increase in Neutrophil to Lymphocyte Ratio (NLR) that is commonly associated with disease exacerbation was only observed in placebo. Plonmarlimab was well tolerated in all patients with no significant safety concerns. The Company is now continuing the Phase 2/3 clinical study in the U.S. and has begun to explore other clinical opportunities associated with CRS in China . Efineptakin alfa (TJ107): The world's first and only long-acting recombinant human interleukin-7 ("rhIL-7"). This asset is clinically positioned as a monotherapy for the treatment of cancer patients with lymphopenia and as a combination immunotherapy with a PD-1 or PD-L1 antibody for cancer treatment. I-Mab has the development, manufacturing, and commercial rights of efineptakin alfa in Greater China from Genexine. I-Mab is accelerating the clinical development of efineptakin alfa by leveraging accumulative clinical data from multiple previous studies either as a monotherapy or in combination with checkpoint inhibitors in cancer patients, as conducted by I-Mab in China and Genexine and NeoImmuneTech in South Korea and the U.S., respectively. Efineptakin alfa clinical development in China by I-Mab: (1) A phase 1 clinical trial in China in patients with advanced solid tumors is completed with topline safety and PK/PD data submitted for the 2021 Chinese Society of Clinical Oncology (CSCO) Annual Meeting. (2) A phase 2 clinical trial in patients with GBM: In February 2021 , the first patient was dosed, and the study is on track for patient enrollment. (3) Another phase 2 clinical trial of efineptakin alfa in combination with pembrolizumab (Keytruda®) in advanced solid tumors was accepted by NMPA and will start when approved in patients with selected solid tumors, including triple-negative breast cancer (TNBC) and head and neck cancers. by I-Mab: (1) A phase 1 clinical trial in in patients with advanced solid tumors is completed with topline safety and PK/PD data submitted for the 2021 Chinese Society of Clinical Oncology (CSCO) Annual Meeting. (2) A phase 2 clinical trial in patients with GBM: In , the first patient was dosed, and the study is on track for patient enrollment. (3) Another phase 2 clinical trial of efineptakin alfa in combination with pembrolizumab (Keytruda®) in advanced solid tumors was accepted by NMPA and will start when approved in patients with selected solid tumors, including triple-negative breast cancer (TNBC) and head and neck cancers. Clinical data published by Genexine/NeoImmune Tech: (1) Triple-Negative Breast Cancer (TNBC): Data from the phase 1b /2 Keynote-899 study, presented at SITC 2020, showed that combination treatment of efineptakin alfa at 1200 ug/kg with pembrolizumab (Keytruda®) induced 27.8% ORR in patients with metastatic TNBC. (2) Glioblastoma multiforme (GBM): Interim results from the phase 1 trial (NCT03687957) in newly diagnosed patients with high-grade gliomas that had undergone chemoradiotherapy showed that absolute lymphocyte count (ALC) increased by 1.3 – 4.1 fold at week 4 in a dose-dependent manner and lasted up to 12 weeks after injection, with a one-year survival rate of 83.3% being observed so far. (3) Other clinical assets Olamkicept (TJ301): A differentiated IL-6 blocker for ulcerative colitis and other autoimmune diseases. I-Mab entered into a license agreement with Ferring Pharmaceuticals to develop and commercialize olamkicept for Greater China and South Korea in 2016. On April 23, 2021, the Company and Ferring signed a memorandum of understanding (MoU) to explore a possible collaboration to advance the development and commercialization of olamkicept in US and Canada, the European Union and Japan, if so agreed. Ulcerative colitis: in April 2021 , I-Mab reported positive topline phase 2 results for olamkicept in ulcerative colitis. The results demonstrated significantly higher clinical response rates after 12 weeks of treatment in patients receiving 600 mg olamkicept as compared with those on placebo (p=0.032). Significantly more patients in the 600 mg olamkicept group achieved clinical remission and mucosal healing than in the placebo group (p<0.001). The detailed data analysis was presented at the 2021 Digestive Disease Week (DDW) in the U.S. and the 2021 European Crohn's and Colitis Organisation (ECCO) meeting. A phase 3 clinical trial is being planned. Enoblituzumab (TJ271): A humanized B7-H3 antibody as an immuno-oncology treatment agent. As an anti-tumor agent, enoblituzumab works through a unique dual mechanism, i.e. ADCC and immune activation. Over the years, MacroGenics has generated sufficient clinical data in cancer patients, which provide a critical guidance for further clinical development of enoblituzumab in the treatment of cancers. In addition, I-Mab's in-house work is geared towards delineating the combo strategy where enoblituzumab in combination with another treatment agent achieves synergism required for increased clinical efficacy. The Company's development strategy is to move ahead with a combination therapy with pembrolizumab (Keytruda®) in selected cancer types, followed by new combo studies with other validated anti-tumor agent(s). I-Mab licensed the development, manufacturing, and commercialization rights of enoblituzumab in Greater China from MacroGenics. The Company plans to submit an IND in Q4 2021 to initiate a phase 2 clinical trial of enoblituzumab in combination with pembrolizumab (Keytruda®) in patients with selected solid tumors in China . The study is designed as a "basket" clinical trial involving NSCLC and two other selected cancer types based on the previous studies conducted by MacroGenics. TJ210: A novel monoclonal antibody targeting C5aR1 to treat cancers through myeloid-derived suppressor cells and modulation of tumor micro-environment in favor of enhanced anti-tumor immune response as a novel mechanism of action. The pre-clinical studies have provided ample scientific evidence for the role of TJ210 in the treatment of cancers. Research is continuing, through in vitro and in vivo experimental systems, to identify and validate the most effective combo partner(s) for TJ210 to guide further clinical development of TJ210. I-Mab owns the China rights from MorphoSys and co-develop the asset globally with MorphoSys. Phase 1 clinical trial in patients with relapsed or refractory advanced solid tumors by I-Mab in the U.S.: In January 2021 , the first patient was dosed, and the study is on track. , the first patient was dosed, and the study is on track. Phase 1 clinical trial in China : in January 2021 , the Company received China NMPA clearance for phase 1 clinical trial of TJ210 in patients with advanced solid tumors. I-Mab expects to commence the study in early 2022. Pipeline New-Comers as Bi-Specific Antibodies Driven by 2nd Wave Innovation and as "Super Antibodies" by 3rd Wave Innovation Through Transformative Technologies (1) Bi-Specific Antibodies The Company's bispecific antibodies are novel and designed to address the current unmet medical need in oncology where the majority of cancer patients respond poorly to checkpoint inhibitors as their tumors are often characterized as immunologically 'cold' tumor type. I-Mab's bi-specific antibodies are structurally and functionally enabled to convert immunologically resistant 'cold' tumors to immunologically responsive 'hot' tumors by targeting multiple immune pathways so as to achieve synergistic anti-tumor activities. They can be categorized into three antibody formats, namely PD-L1-based bispecific antibodies, 4-1BB-based conditional T cell engagers, and antibody-cytokine fusion or so-called immuno-cytokines. During the reporting period, two lead bi-specific antibody assets have advanced to Phase 1 clinical trials in the U.S. TJ-CD4B: A novel Claudin 18.2 and 4-1BB bispecific antibody capable of binding to tumor cells expressing Claudin 18.2, i.e., gastric cancer and pancreatic cancer cells, and stimulating intra-tumoral T cells by the 4-1BB arm designed to become functionally active only upon tumor engagement whilst silent elsewhere. Pre-clinical studies have demonstrated superior tumor-dependent immune activation with TJ-CD4B compared to 4-1BB monoclonal antibody. The anti-tumor activity is only achieved locally at the tumor site with no hepatotoxicity or systemic side effects that are commonly seen with 4-1BB monoclonal antibodies when used alone. Studies have also demonstrated a memory response that can resist tumor rechallenge for a long-lasting treatment effect. In June 2021, the first patient was dosed in a phase 1 clinical trial of TJ-CD4B in patients with advanced or metastatic solid tumors in the U.S. To accelerate its clinical development, China sites will join the dose expansion part of the study in Q1 2022, enrolling patients with gastric cancer, gastroesophageal junction carcinoma, esophageal adenocarcinoma, and pancreatic ductal adenocarcinoma. TJ-L14B: A differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon local tumor engagement. Pre-clinical animal model studies of TJ-L14B have demonstrated a superior anti-tumor effect attributable to the synergism of the two antibody arms in activating intra-tumoral T cells. The 4-1BB arm utilizes the same bispecific antibody format as in TJ-CD4B, aiming to minimize systemic toxicity as a class effect. In April 2021 , the first patient was dosed in a phase 1 clinical trial of TJ-L14B in the U.S. in patients with advanced or metastatic solid tumors. The study is on track. In addition, other novel bispecific antibodies are currently under pre-clinical development and are expected to advance to the clinical studies in 2022, including: TJ-C4GM is a fortified CD47 antibody with GM-CSF cytokine. This antibody-cytokine fusion is designed to enhance the anti-tumor effect of CD47 antibody for solid tumors by activating and converting pro-tumor M2 macrophages to anti-tumor M1 macrophages through the GM-CSF arm. TJ-L1C4 belongs to I-Mab's PD-L1 based bispecific antibody family and uses CD47 antibody as the other arm. TJ-L1I7 is an antibody-cytokine fusion protein with the anti-PDL1 antibody fused with IL-7, which is designed to increase both the number and functionality of T cells drawn to the tumor thereby turning "cold" tumor into a more immune-responsive "hot" tumor. (2) Super Antibodies Enabled by Transformative Technologies The Company recently launched a discovery initiative (the third wave innovation) to build a new portfolio of next generation of innovative drug candidates characterized as novel "super antibodies". These super antibodies are structurally different from monoclonal or bi-specific antibodies and uniquely enabled by transformative technologies such as an mRNA-based antibody, masked antibody, cell-penetrating antibody and AI-guided cytokine drugs etc. The Company has gained the access to these cutting-edge technology platforms through collaborations as described below. This growing new portfolio of novel drug candidates represents I-Mab's strong commitment to sustaining the global competitiveness of its pipeline through continued innovation and complements the existing clinical programs. In collaboration with Complix, an EU-based biotech company, to discover and develop Cell Penetrating Alphabodies (CPAB) for otherwise intractable intracellular drug targets. In collaboration with Affinity, a Shanghai -based biotech company, to discover and develop masked antibodies for targeted tumor-site activation. -based biotech company, to discover and develop masked antibodies for targeted tumor-site activation. In collaboration with Immorna, an mRNA biotech company, to discover and develop self-replicating mRNA for in vivo synthesized therapeutic biologics. synthesized therapeutic biologics. In collaboration with neoX Biotech, an AI-enabled R&D biotech company, to accelerate the R&D process of novel targets and modalities. The Company continues to drive innovation and scientific leadership in immuno-oncology globally. These collaborations are expected to be followed by additional partnering deals that are under discussion, which are designed to propel the discovery engine to drive future pipeline growth. Business Development and Partnering deals During the reporting period, the Company has completed 7 licensing and partnering deals that are geared to support the next generation of innovative assets. In addition, the Company is in discussion or business negotiation with potential partners on the following opportunities: (1) Eftansomatropin alfa (TJ101) for a commercial partnering deal with a potential partner at a term-sheet stage, for which I-Mab expects to hold MAH and share in significant sales profit; and (2) Other ongoing BD activities, focusing on in-licensing opportunities for the purpose of enriching the Company's initial commercial portfolio. In addition, the Company is exploring a potential global partnering deal with respect to uliledlimab (TJD5) where I-Mab expects to retain the Greater China rights and grant ex-China rights to a potential global partner. Transitioning from a Clinical Stage Biotech to Become a Global Biopharma I-Mab has embarked on a journey to evolve from a clinical stage biotech today to a global biopharma within the next three years. The Company has been expanding its global R&D and corporate footprint and is now globally connected with six sites or offices in China (Shanghai, Beijing, Hangzhou, Guangzhou, Lishui, and Hong Kong) and two sites in the U.S. (Maryland and San Diego). During the reporting period, the Company has made significant progress in advancing its build-up of the manufacturing facility in Hangzhou and its commercialization capability to prepare for the market launch of felzartamab, which has already started in 2021. Expanding global footprint (1) A new R&D facility is being established in San Diego, CA, in the U.S. to focus on translational medicine and biomarker research to support the clinical development of I-Mab pipeline assets in the U.S. and China. The center will also host the CMC formulation research and global alliance management. The facility will be operational in Q4 2021; (2) Opening of a new office in Guangzhou, China as a regional hub for clinical development and commercial activities, further aligning the Company's strategy with the Greater Bay Area ("GBA") initiative. These new sites complement with Company's existing facilities and are designed to facilitate its ambition to become a global biopharma. Building manufacturing capability in Hangzhou To support its growing pipeline and planned production of the upcoming commercial products, the Company has made substantial progress in the construction of a state-of-the-art GMP manufacturing facility in Hangzhou, China. The pilot plant with 3 x 2,000L production lines is on track to become operational by mid-2022. The PD laboratory is already functional to handle I-Mab's CMC projects. The commercial production facility is being constructed to accommodate up to 8 x 4,000L production lines and is on track to be operational by the end of 2023 or early 2024. The Hangzhou facility has been designed in compliance with Good Manufacturing Practice (GMP) standards adopted by the U.S. Food & Drug Administration (FDA), the China National Medical Products Administration (NMPA), and European Medicines Agency (EMA). Expanding the commercialization capability for the market launch of felzartamab and other upcoming products During the reporting period, the Company has advanced to expand the initial commercialization capability in the following four areas. (1) The key commercial strategy for I-Mab is to leverage its key pipeline products, i.e. felzartamab for multiple myeloma and lemzoparlimab for leukemia, e.g. AML and MDS, and lymphoma when combined with rituximab, to become a leader in the hematologic oncology therapeutic area in China. (2) The current expert commercial core team is being expanded to cover all commercialization functions, including regulatory, market research, market access, reimbursement, sales team etc. The team will be ready for scale up as felzartamab approaches the planned market launch. (3) An integrated multi-functional team consisting of different expertise has been assembled and working towards "preparing the organization", "preparing the market" and "preparing the product" for felzartamab. (4) There are ongoing efforts to enrich the initial product portfolio, beyond felzartamab, through in-licensing and commercial partnering opportunities. Potential deals are expected in late 2021 or early 2022. ESG Update In July 2021, I-Mab was granted a BBB rating, the highest newly initiated rating among China-based biotech companies, by the MSCI ESG assessment. In August 2021, the Company established an ESG Committee. The committee consists of Ms. Huaqiong Shen, executive director and CEO of I-Mab, and two independent directors, Mr. Chun Kwok Alan Au and Ms. Rong Shao. Mr. Chun Kwok Alan Au also chairs the committee to ensure impartiality. As the oversight body for the Company's ESG practices, the committee is responsible for supervising the ESG strategies, policies, long-term sustainability objectives and risks of the Company. In addition, the Company also set up an ESG working group to address daily ESG workflows. I-Mab's vision has been not only to bring innovative therapies to global patients and create value for its shareholders but is also committed to high corporate governance standards, diversity, green operations, sustainable development, and transparent disclosures. Looking forward, the Company will continuously improve its ESG practice and carry out new initiatives to further integrate ESG factors into its strategies and corporate values and communicate periodic progress with investors in a timely manner. Corporate Development I-Mab was added to the MSCI China All Shares Index in May 2021 , demonstrating I-Mab's growing profile and recognition among the global investor communities. , demonstrating I-Mab's growing profile and recognition among the global investor communities. To support its long-term growth, I-Mab's Board of Directors approved a preliminary proposal for the potential dual listing of the Company's newly issued shares on the Science and Technology Innovation Board of the Shanghai Stock Exchange (STAR Market). The Company is also considering equity listing on the Main Board of the Hong Kong Stock Exchange under Chapter 18A of the Hong Kong Listing Rules. I-Mab's appointment of Ms. Lan Kang as a new member of the Company's board of directors on August 31, 2021 . Ms. Kang is currently a managing director at CBC Group, where she is responsible for managing all the portfolio companies of the Group. Prior to CBC Group, she was an Executive Board Director and SVP of Fosun International and led Fosun's insurance business globally. She was also on the board of Fosun Pharma and Fosun United Health Insurance. Prior to joining Fosun, Ms. Kang was a Senior Client Partner at Korn/Ferry (KF) International. She successfully developed the Life Sciences practice for KF in mainland China , providing executive search and leadership assessment and human resources consulting to both multinational and local Chinese clients. Prior to that, Ms. Kang was a management consultant at McKinsey & Company, also focusing on the healthcare practice in China . Concurrently, Ms. Mengjiao Jiang, managing director at CBC Group, has resigned from the I-Mab Board due to CBC Group's internal transition of her roles and responsibilities. as a new member of the Company's board of directors on . Ms. Kang is currently a managing director at CBC Group, where she is responsible for managing all the portfolio companies of the Group. Prior to CBC Group, she was an Executive Board Director and SVP of Fosun International and led Fosun's insurance business globally. She was also on the board of Fosun Pharma and Fosun United Health Insurance. Prior to joining Fosun, Ms. Kang was a Senior Client Partner at Korn/Ferry (KF) International. She successfully developed the Life Sciences practice for KF in mainland , providing executive search and leadership assessment and human resources consulting to both multinational and local Chinese clients. Prior to that, Ms. Kang was a management consultant at McKinsey & Company, also focusing on the healthcare practice in . Concurrently, Ms. Mengjiao Jiang, managing director at CBC Group, has resigned from the I-Mab Board due to CBC Group's internal transition of her roles and responsibilities. I-Mab held a corporate R&D event in April 2021 , focusing on cutting-edge sector insights from industry experts and the latest progress of pipelines from management. , focusing on cutting-edge sector insights from industry experts and the latest progress of pipelines from management. I-Mab expanded the expertise of its board with the appointment of international gastrointestinal oncology expert Dr. Andrew Zhu to its Scientific Advisory Board, and Dr. Ruyi He and Professor Rong Shao to I-Mab's Board of Directors. to its Scientific Advisory Board, and Dr. and Professor Rong Shao to I-Mab's Board of Directors. I-Mab was ranked among the top companies by the leading global financial publication Institutional Investor in both the "Honored Companies" and "Best CFO" categories, according to its 2021 All-Asia Executive Team survey. I-Mab was honored with the T+ Excellent Employer award based on an assessment of best practices in areas such as technological leadership, organization and talent, and commitment to creating a diversified workplace. I-Mab was ranked as "2021 Top 50 Enterprises of Technology Power" by Frost&Sullivan and LeadLeo. I-Mab donated RMB 1 million to Henan Charity General Federation for the rescue and reconstruction of flood-hit regions in Henan Province . First-Half 2021 Financial Results Cash Position As of June 30, 2021, the Company had cash, cash equivalents, restricted cash, and short-term investments of RMB 4.8 billion (US $739.2 million), compared with RMB 4.8 billion as of December 31, 2020. Our strong cash balance provides us with adequate funding support and strategic flexibility as we transition from a clinical stage biotech to a global biopharma company over the next few years. Net Revenues Total net revenues for the six months ended June 30, 2021 were RMB 17.8 million (US $2.8 million). The total net revenues for the comparable period in 2020 were nil. Revenues generated for the six months ended June 30, 2021 solely consisted of revenues recognized in connection with I-Mab's strategic collaboration with AbbVie. Research & Development Expenses Research and development expenses for the six months ended June 30, 2021 were RMB 593.0 million (US $91.8 million), compared with RMB 442.3 million for the six months ended June 30, 2020. The increase was primarily due to increased CRO service fees to advance the Company's broad clinical and pre-clinical pipeline, especially for lemzoparlimab (TJC4), uliledlimab (TJD5), and eftansomatropin alfa (TJ101). Share-based compensation expense was RMB 112.7 million (US $17.5 million) for the six months ended June 30, 2021, compared with RMB 132.7 million for the six months ended June 30, 2020. Administrative Expenses Administrative expenses for the six months ended June 30, 2021 were RMB 451.5 million (US $69.9 million), compared with RMB 171.4 million for the six months ended June 30, 2020. The increase was primarily due to higher share-based compensation expenses in relation to management, increased professional service expenses (including expenses that were one-off in nature) and expansion in payroll and payroll-related expenses as a result of increased headcount (including new hires in preparation for product launch and commercialization). Share-based compensation expense was RMB 222.0 million (US $34.4 million) for the six months ended June 30, 2021, compared with RMB 97.1 million for the six months ended June 30, 2020. One-time expenses were RMB 69.9 million (US $10.8 million) for the six months ended June 30, 2021, compared with nil for the six months ended June 30, 2020. Net Loss Net loss for the six months ended June 30, 2021 was RMB 1,076.5 million (US $166.7 million), compared with RMB 582.9 million for the six months ended June 30, 2020. Net loss per share attributable to ordinary shareholders for the six months ended June 30, 2021 was RMB 6.38 (US $0.99), compared with RMB 4.78 for the six months ended June 30, 2020. Net loss per ADS attributable to ordinary shareholders for the six months ended June 30, 2021 was RMB 14.67 (US $2.28), compared with RMB 10.99 for the six months ended June 30, 2020. Non-GAAP Net Loss Non-GAAP adjusted net loss, which excludes share-based compensation expenses, for the six months ended June 30, 2021 was RMB 729.4 million (US $113.0 million), compared with RMB 353.1 million for the six months ended June 30, 2020. Non-GAAP adjusted net loss per share attributable to ordinary shareholders for the six months ended June 30, 2021 was RMB 4.32 (US $0.67), compared with RMB 2.90 for the six months ended June 30, 2020. Non-GAAP adjusted net loss per ADS attributable to ordinary shareholders for the six months ended June 30, 2021 was RMB 9.94 (US $1.54), compared with RMB 6.67 for the six months ended June 30, 2020. Conference Call and Webcast Information The Company's management will host conference calls to discuss the results and updates, and a Mandarin session conference call will be held at 7:00 a.m. ET, and an English session conference call will be held at 8:00 a.m. ET. The conference calls can be accessed by the following Zoom links: Mandarin Session English Session About I-Mab I-Mab (Nasdaq: IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon, commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global collaborations. The Company is on track to transition from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facilities and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong Kong and Maryland, United States. For more information, please visit and follow I-Mab on LinkedIn, Twitter and WeChat. I-Mab Forward Looking Statements This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. I-Mab may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical developments, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the SEC. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. Use of Non-GAAP Financial Measures To supplement its consolidated financial statements which are presented in accordance with U.S. GAAP, the Company uses adjusted net income (loss) as a non-GAAP financial measure. Adjusted net income (loss) represents net income (loss) before share-based compensation. The Company's management believes that adjusted net income (loss) facilitates better understanding of operating results and provide management with a better capability to plan and forecast future periods. For more information on the non-GAAP financial measures, please see the table captioned "Reconciliation of GAAP and Non-GAAP Results" set forth at the end of this press release. Non-GAAP information is not prepared in accordance with GAAP and may be different from non-GAAP methods of accounting and reporting used by other companies. The presentation of this additional information should not be considered a substitute for GAAP results. A limitation of using adjusted net income (loss) is that adjusted net income (loss) excludes share-based compensation expense that has been and may continue to be incurred in the future. Exchange Rate Information This announcement contains translations of certain RMB amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from Renminbi to U.S. dollars are made at a rate of RMB 6.4566 to US$1.00, the rate in effect as of June 30, 2021 published by the Federal Reserve Board. For more information, please contact: I-Mab Jielun Zhu, Chief Financial Officer E-mail: jielun.zhu@i-mabbiopharma.com Office line: +86 21 6057 8000 Gigi Feng, Chief Communications Officer E-mail: Gigi.Feng@i-mabbiopharma.com Office line: +86 21 6057 5709 Investor Inquiries: The Piacente Group, Inc. Emilie Wu E-mail: emilie@thepiacentegroup.com Office line: + 86 21 6039 8363 View original content to download multimedia: SOURCE I-Mab Company Codes: NASDAQ-NMS:IMAB

18 significant clinical milestones achieved since the Company’s IPO in January 2020, with multiple important data readouts for lemzoparlimab (TJC4), uliledlimab (TJD5) and other clinical assets expected in 2021 New drug application (NDA) submission for felzartamab (TJ202) CD38 antibody for treatment of relapsed or refractory multiple myeloma on track for 2021 Achieved corporate profitability, delivering full-year net revenues of RMB 1,542.7 million (US $236.4 million), net income per ADS of RMB 8.07 (US $1.24) on a GAAP basis and net income per ADS of RMB 17.09 (US $2.62) on a non-GAAP basis Total cash position of RMB 4.8 billion (US $734.1 million) driven by Hillhouse-led PIPE financing and AbbVie licensing payments sufficient to fund operations through 2023 Landmark global collaboration with AbbVie to develop and commercialize lemzoparlimab, a highly differentiated CD47 antibody, and potentially second generation CD47-based bi-specific antibodies New discovery initiative to expand transformational immuno-oncology pipeline Dual listing(s) in Greater China under consideration to support long-term growth I-Mab to host conference call and webcast on March 29 at 8:00 a.m. ET SHANGHAI, China and GAITHERSBURG, Md., March 29, 2021 (GLOBE NEWSWIRE) -- I-Mab (the “Company”) (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced financial results for the full year ended December 31, 2020 and provided key business updates. “In an unprecedented year marked by the global pandemic, I-Mab outperformed in delivering outstanding results to accelerate our progress towards becoming a fully-integrated global biopharma company,” said Dr. Jingwu Zang, Founder, Chairman and Director of I-Mab. “We have accomplished 18 significant clinical milestones since our IPO last year and our pipeline today has advanced to include three registrational trials with the first NDA planned later this year for a total 19 clinical trials either on-going or to be initiated in both the United States and China.” I-Mab’s globally competitive pipeline has now progressed to include 16 novel or highly differentiated assets with 11 in clinical development stages and five in the pre-clinical stage. The Company’s pre-NDA and core clinical assets of near-term value realization, including felzartamab (TJ202) and eftansomatropin alfa (TJ101), are progressing towards NDA. In addition, two highly differentiated investigational drugs, lemzoparlimab (TJC4) and uliledlimab (TJD5), have achieved critical progress as global front-runners. I-Mab’s next wave of innovative assets, epitomized by the novel bispecific antibodies TJ-L14B and TJ-CD4B, are now moving into clinical trials in the U.S. In the near-term, I-Mab will continue creating corporate value by delivering on a series of critical milestones including the planned NDA submission for felzartamab in 2021 as well as forging potential strategic global out-licensing partnerships for uliledlimab and other innovative assets and selected in-licensing partnerships to enrich its pipeline. The focused R&D effort is further complemented by the Company’s new discovery initiative to create the next generation of innovative assets through transformative platform technologies. “We are confident in our innovative R&D strength in immuno-oncology to continue advancing and upgrading our globally competitive pipeline.” Dr. Zang concluded. In addition to creating the near-term value, the Company has also made notable strides in its journey to become a global biopharmaceutical company, which include building a state-of-the-art GMP manufacturing facility in China with a pilot plant and commercial scale production lines. In parallel, I-Mab has begun to execute a commercialization plan that focuses on building a leading position in hematologic oncology in China, leveraging I-Mab’s core assets (i.e., felzartamab and lemzoparlimab) and additional key product(s) to be in-licensed. As both assets are progressing towards NDA, preparations are being made for product launch and commercialization. Our revenue stream generated from out-licensing deals grew tremendously in 2020 to make I-Mab profitable for the first time and is expected to converge with product sales revenues to be generated in a near term, projecting a promising financial outlook for the Company and its shareholders. Overview of Operations I-Mab currently has three registrational trials underway, 16 phase 1 and 2 clinical studies - either ongoing or to be initiated soon in both the U.S. and China – and five on-going pre-clinical programs in 2021. Four additional new discovery programs are set to advance to the pre-clinical development stage by the end of 2021 as a result of the new discovery initiative. I-Mab has achieved critical advancements in core clinical assets in early 2021. These achievements include the full patient enrollment for felzartamab in the third-line multiple myeloma trial, a key step for the NDA submission that is on track for late 2021, and the initiation to enroll patients for the registrational clinical trial of eftansomatropin alfa. The Company has also set forth with its accelerated clinical development plan for lemzoparlimab, aiming for NDA approval as the first CD47 antibody drug for the treatment of hematologic malignancies (such as MDS, AML and NHL) in China while continuing to advance clinical trials in solid tumors in combination with PD-1 therapy. These clinical trials are on-going in the U.S. and China with preliminary data readouts planned in Q4 2021 for the non-Hodgkin’s lymphoma (NHL) study and the solid tumor study in the U.S. The Company also plans to initiate a combination clinical trial of lemzoparlimab with felzartamab as a possible novel treatment option for relapsed and refractory and newly diagnosed MM with a potential to become first-line treatment if proven in addition to felzartamab currently being evaluated as a second-line and third-line treatment for MM. For uliledlimab, a globally competitive and differentiated CD73 antibody, the Company recently completed a phase 1 clinical study in the U.S., which demonstrated favorable safety, PK/PD and receptor occupancy profile, together with observed clinical activity of the investigational drug in cancer patients. The detailed clinical data have been submitted for presentation at ASCO 2021. In addition, a combined phase 1/2 clinical trial has been ongoing and the dose expansion part of the trial will be initiated in combination with PD-1 therapy in patients with cancers in China in 2H 2021. Already operating globally with five hubs in China and the U.S., I-Mab has plans to open a new R&D center in San Diego, CA, focusing on translational medicine and formulation research. In preparation for the market launch of its initial series of products in China, the Company is in construction of a comprehensive biologics manufacturing facility in Hangzhou, China, and is building up its commercialization capabilities. To support its long-term growth, I-Mab is actively monitoring market conditions and considering potential options for further equity listings on Greater China stock exchanges such as the STAR Market in Shanghai and the Main Board of the Hong Kong Stock Exchange under Chapter 18A of the Hong Kong Listing Rules. Recent Pipeline Highlights and Upcoming Milestones Core Clinical Assets – Global Frontrunners Lemzoparlimab (TJC4): A highly differentiated CD47 antibody being developed for oncology indications. The results of the US phase 1 clinical trial in patients with solid tumor indicate potential clinical advantages of lemzoparlimab in safety and PK with observed clinical activity, which does not require priming dose as compared to other clinical stage CD47 antibodies. Lemzoparlimab is being developed through a comprehensive clinical development plan for hematologic oncology and solid tumor in global collaboration with AbbVie. Global Collaboration with AbbVie: In September 2020, to facilitate and accelerate the global development and commercialization of lemzoparlimab, I-Mab granted AbbVie a global license valued at US$1.94 billion, including an upfront payment of US$180 million and the first milestone payment of US$20 million based on the phase 1 clinical results. I-Mab retains the rights to develop and commercialize lemzoparlimab in Mainland China, Hong Kong and Macau. We believe that this global collaboration with AbbVie will greatly facilitate the clinical development, manufacturing and commercialization of lemzoparlimab globally and in China. Hematologic malignancies: Our prioritized development goal is to achieve an accelerated approval of lemzoparlimab in China, ideally as the first CD47 antibody product in China. MDS and possibly NHL are being considered as potential first indication(s) as they hold the high probability of success for accelerated approvals. (1) With the approved IND, the Company is initiating an abbreviated phase 2 clinical study of lemzoparlimab in combination with AZA in patients with AML and MDS, potentially bridging the clinical study – pending approval by the National Medical Products Administration (NMPA) - to a registrational clinical trial in patients with MDS. (2) The Company continues to enroll more patients with NHL in a combination clinical trial with rituximab (Rituxan®) in the U.S. This clinical trial includes clinical sites in China through an IMCT (international multi-center trial) mechanism in order to potentially bridge – pending approval by the NMPA - to a registrational clinical trial in NHL in China. The preliminary data readout of the NHL trial is set in Q4 2021. (3) The Company will participate in a global clinical trial to be led by AbbVie in patients with AML for registrational purposes globally by AbbVie and in China by I-Mab. Solid tumor indications: The Company will continue advancing the current cohort expansion study in the U.S., combining lemzoparlimab with pembrolizumab (Keytruda®) to evaluate the safety and efficacy in patients with NSCLC and ovarian cancer. The results of this on-going clinical study are anticipated in Q4 2021. In addition to the on-going US clinical trial, we are in preparation of an IND submission to China’s NMPA to initiate a phase 2 “basket” clinical trial in patients with advanced solid tumors in 2H 2021. Combination therapy with the existing assets for potential new treatment options: Pre-clinical data generated internally and reported by others support the hypothesis that lemzoparlimab may work additive with other immune pathways, such as the CD38 pathway for multiple myeloma, to offer significantly better treatment efficacy for oncology indications. A clinical trial will be initiated in 2H 2021 in China to evaluate safety and efficacy of combination therapy of lemzoparlimab with felzartamab as a possible novel treatment option for relapsed and refractory and newly diagnosed MM, potentially becoming first-line treatment if proven, in addition to felzartamab currently being evaluated as a second-line and third-line treatment for MM. Potential upcoming milestones: The on-going clinical trial with lemzoparlimab in combination with pembrolizumab in patients with NSCLC and ovarian cancers in the U.S. is on track to deliver preliminary results by Q4 2021. A new clinical trial of lemzoparlimab in combination with PD-1 therapy in patients with selected solid tumors will be initiated in 2H 2021 in China. An abbreviated phase 2 combination study of lemzoparlimab with AZA in untreated AML and MDS patients is planned to commence in Q2 2021 in China. Patient enrollment is expected to complete by Q4 2021. Topline results from the on-going NHL clinical study, involving both the U.S. and China clinical sites, are expected by Q4 2021. The combination study of lemzoparlimab with felzartamab in patients with MM is planned to start in 2H 2021 in China. Uliledlimab (TJD5): A highly differentiated CD73 antibody for immuno-oncology through modulation of tumor microenvironment. Uliledlimab is shown to strongly suppress tumor growth especially when combined with a PD-(L)1 inhibitor in pre-clinical studies. I-Mab has completed a phase 1 clinical trial in the U.S. with positive results for favorable safety, PK/PD, biomarker analysis and clinical activity of uliledlimab. The topline results have been submitted to ASCO 2021. Differentiated mechanism of action by uliledlimab: The Company will present the mechanistic analysis and pre-clinical data at 2021 American Association for Cancer Research (AACR) Annual Meeting. The key differentiation of uliledlimab when compared to other clinical stage antibodies of the same class is related to its novel epitope, which works through a unique intra-dimer binding mode, resulting in a complete inhibition of the enzymatic activity while avoiding the aberrant pharmacological property known as the “hook effect.” With this particular mode of action, uliledlimab has the potential to become a best-in-class CD73 antibody for its clinical advantages. Phase 1 clinical trial completed in the U.S.: The initial assessment of a phase 1 clinical study investigating uliledlimab monotherapy lead-in followed by combination with atezolizumab (Tecentriq®), in patients with solid tumors has been completed. Topline results from the study demonstrate that uliledlimab is safe and well tolerated at the dose range evaluated. The study also demonstrated favorable clinical activity of uliledlimab in patients with advanced solid tumors. I-Mab has submitted an abstract to present the topline results at 2021 ASCO annual meeting to be held in June. Continued clinical development: The Company is looking to expand the on-going clinical study of uliledlimab with a PD-1 antibody toripalimab (TUOYI®) in patients with advanced or metastatic cancers in China to further evaluate clinical efficacy of uliledlimab in a phase 2 combination clinical trial with toripalimab in selected solid tumors by a “basket” trial design in 2H 2021. Potential upcoming milestones: I-Mab has submitted an abstract to present the phase 1 topline results at the June 2021 ASCO annual meeting. The expansion study in patients with NSCLC and other selected tumors has been initiated in over 15 sites across China. The results are expected in 2022. Core Clinical Assets – Pre-NDA Products Felzartamab (TJ202): A potential highly differentiated CD38 antibody for multiple myeloma (MM) and systemic lupus erythematosus (SLE). Felzartamab is a pre-NDA product in I-Mab’s pipeline being positioned to launch in the near-term in China to cover third-line and second-line MM treatment. Its potential role as a first-line MM treatment in combination with lemzoparlimab is being explored. Multiple myeloma: Two registrational studies of felzartamab are on-going. The third-line registrational trial has completed patient enrollment. The Company is on track to submit an NDA in 2H 2021. The second-line combination therapy with lenalidomide is on track and is continuing to enroll patients. Full patient enrollment (N=291) for that trial is expected in Q3 2021. In addition, a new IND for combination trial of felzartamab with lemzoparlimab for MM will be submitted in Q2 2021 and the study will be initiated in 2H 2021 in China. This combination therapy, a possible first-line treatment if proven, has the potential to be a novel treatment option for relapsed and refractory and newly diagnosed MM. SLE: The Company is awaiting IND approval by the NMPA and a phase 1b trial in patients with SLE will be initiated 2H 2021 in China. Potential upcoming milestones: I-Mab expects to submit an NDA for felzartamab as a third-line treatment for MM to the NMPA in Q4 2021. Completion of patient enrollment of the second-line registrational study for MM is anticipated in Q3 2021. In China, a new IND for combination trial of felzartamab with lemzoparlimab as a possible novel treatment option for relapsed and refractory and newly diagnosed MM with the potential to become first-line treatment if proven will be submitted in Q2 2021 and the study will be initiated in 2H 2021. Initiation of phase 1b SLE trial is on track for 2H 2021. Eftansomatropin alfa (TJ101): A differentiated long-acting growth hormone for pediatric growth hormone deficiency (PGHD). Eftansomatropin has a product advantage as it is the only rhGH in its proprietary fusion protein format. Its safety and efficacy have been demonstrated in a phase 2 clinical trial in EU. In February 2021, I-Mab achieved the first patient dosing of a phase 3 registrational clinical trial (NCT04633057) in China to assess the clinical efficacy, safety of eftansomatropin alfa in PGHD patients as a weekly treatment. This registrational phase 3 trial (“TALLER”) will enroll 165 patients across multiple centers in China, with the primary objective of demonstrating non-inferiority of 1.2 mg/kg/week of eftansomatropin alfa administered SC, compared to Norditropin, a daily rhGH marketed in China. Potential upcoming milestones: The primary clinical data are expected to be available in Q2 2023 to support the planned NDA submission in China. Efineptakin alfa (TJ107): The world’s first long-acting recombinant human interleukin-7. This asset is positioned clinically as a monotherapy for the treatment of cancer patients with lymphopenia and as a combination immunotherapy to pair with PD-1 or PD-L1 antibody for cancer treatment: The on-going phase 1b clinical trial in China is investigating the safety, tolerability and PK/PD pro efineptakin alfa in patients with advanced solid tumors. The results of the study are expected in Q2 2021. The current clinical development plan is to evaluate the therapeutic role of efineptakin alfa (1) as a monotherapy for cancer patients with lymphopenia and (2) as a combination therapy with PD-1/PD-L1 antibody for cancers. The outcome of the studies will facilitate the development path of efineptakin alfa towards pivotal clinical trials in China. Cancers with lymphopenia. In December 2020, I-Mab initiated a phase 2 randomized, single-blind, placebo-controlled clinical trial (NCT04600817) to evaluate the safety and efficacy of efineptakin alfa in glioblastoma multiforme (GBM) patients with lymphopenia. The primary outcome of the study is the percentage of patients with an increase in the absolute lymphocyte counts and associated clinical response in relation to the treatment with efineptakin alfa. Combination therapy with PD-1/PD-L1 agents. Our partner Genexine recently released encouraging new data of a phase 1b/2 study of efineptakin alfa in combination with pembrolizumab (KEYTRUDA®) for the treatment of relapsed or refractory triple-negative breast cancer (TNBC) in terms of safety and efficacy signals. I-Mab plans to submit an IND in China in 2H 2021 to initiate a phase 2 clinical trial following a basket trial design, in which efineptakin alfa is combined with a PD-1 antibody for the treatment of selected tumor types, including TNBC. Other Clinical Assets Plonmarlimab (TJM2): A granulocyte-macrophage colony stimulating factor (GM-CSF) monoclonal antibody for the treatment of rheumatoid arthritis and CRS-related therapies: Cytokine release syndrome associated with severe COVID-19: I-Mab is conducting a phase 2 clinical trial with plonmarlimab for the treatment of cytokine release syndrome associated with severe and critically ill COVID-19 patients (NCT04341116) to potentially save lives of patients with severe COVID-19. The clinical trial has progressed to the second part, aiming to evaluate the efficacy, safety and cytokine levels following a single dose of plonmarlimab at 6 mg/kg or placebo (best supportive care) in patients with severe COVID-19. An interim analysis is planned in Q2 2021. Rheumatoid arthritis: I-Mab has initiated a phase 1b clinical study with plonmarlimab in patients with rheumatoid arthritis (RA). This trial is a multi-center, double-blind, placebo-controlled study involving about 63 patients who will receive a single dose or multiple doses of the treatment for up to eight weeks. The single dose escalation part is aimed to complete by 2H 2021. Olamkicept (TJ301): A potential highly differentiated IL-6 blocker for ulcerative colitis: I-Mab has successfully completed a phase 2 study in 91 patients with active ulcerative colitis (UC) in Greater China and South Korea (NCT03235752) and is at the final stages of data analysis. I-Mab will continue to advance the development and maximize the potential value of this differentiated drug molecule through our global partnership with Ferring. Enoblituzumab: A potential highly differentiated humanized B7-H3 antibody as an immuno-oncology treatment. I-Mab has the development and commercial rights of enoblituzumab in Greater China from MacroGenics. I-Mab plans to submit a pre-IND in Q2 2021 to initiate a phase 2 clinical trial of enoblituzumab in combination with a PD-1 antibody in patients with certain tumors in China. The study is designed as a “basket” clinical trial involving NSCLC and two other selected cancer types based on the previous studies conducted by MacroGenics. I-Mab has plans to evaluate the therapeutic role of enoblituzumab in combination with other targeted cancer therapies as a potential front-line treatment for selected cancers. The pre-clinical work is in progress. Submission of an IND is anticipated by the end of 2021 to start the clinical study. TJ210: A novel monoclonal antibody targeting myeloid derived suppressor cells as a cancer immunotherapy through a novel mechanism of action. This asset is in clinical development through partnership with MorphoSys. Pre-clinical development update: TJ210 is a novel human antibody directed against C5aR1 derived from MorphoSys’ HuCAL Platinum® technology. The findings of pre-clinical studies in relation to characterization of unique antibody epitope, pharmacological pro anti-tumor properties of TJ210 were presented at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting. Current clinical development plan: A phase 1 clinical trial is now enrolling patients in the U.S. to evaluate the safety, tolerability and PK/PD profiles of TJ210 in cancer patients. The program is expected to further evolve into a combination clinical trial with a PD-1 antibody in selected cancer types. In addition, with the IND approved by China’s NMPA in February 2021, I-Mab expects to commence a phase 1b clinical trial in 2H 2021. The results of the clinical studies in the U.S. and China, in relation to safety, PK/PD pro biomarker analysis and early efficacy signals, as described above will facilitate the further clinical development of TJ210. Two new bi-specific antibodies have entered the clinical development stage in 2021 TJ-CD4B: A novel bi-specific antibody with the Claudin 18.2 arm as a specific tumor-engager and the 4-1BB arm as a conditional T cell activator upon tumor engagement. TJ-CD4B is a novel and tumor-dependent bi-specific antibody for the treatment of gastric and other cancers which is being developed under collaboration with ABL Bio. Our pre-clinical studies have demonstrated that TJ-CD4B is capable of binding to tumor cells expressing Claudin 18.2, i.e., gastric cancer and pancreatic cancer cells, and stimulating intra-tumoral T cells by the 4-1BB arm designed to be activated only upon tumor engagement whilst silent elsewhere. Thus, TJ-CD4B effectively maintains a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both Claudin 18.2 antibody and 4-1BB antibody while it avoids or minimizes liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. I-Mab received the IND approval by the U.S. FDA on March 27, 2021 and aims to commence a phase 1 clinical trial in Q2 2021 in patients with advanced solid tumors including gastric cancer to assess the safety, tolerability, PK/PD and preliminary treatment efficacy. In addition, I-Mab will submit a separate IND with the China NMPA in 2H 2021 by leveraging the clinical data generated from the U.S. study to commence parallel clinical development in China. TJ-L14B: A differentiated bi-specific antibody with the PD-L1 arm as a tumor-site T cell activator and the 4-1BB arm as a conditional T cell activator upon tumor engagement. Being developed jointly with ABL Bio, TJ-L14B is a differentiated PD-L1-based bi-specific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Pre-clinical tumor animal model studies of TJ-L14B have demonstrated a superior anti-tumor effect attributable to mechanistic synergism of the two antibody arms in activating intra-tumoral T cells. The 4-1BB arm utilizes the same bi-specific antibody format aimed to minimize systemic toxicity as a class effect. With the approved IND from the U.S. FDA, a phase 1 dose escalation clinical study is about to be initiated to assess the safety, tolerability, PK/PD and preliminary efficacy in patients with advanced (unresectable) or metastatic solid tumors. Pre-Clinical Assets A number of novel molecules are currently under pre-clinical development, such as: (1) TJX7, a novel monoclonal antibody directed against CXCL13 for the treatment of autoimmune diseases. I-Mab has recently concluded a pre-IND meeting with the U.S. FDA. (2) TJ-C4GM is a fortified CD47 antibody with GM-CSF attached. This antibody-cytokine fusion is designed to enhance the anti-tumor effect of CD47 antibody for solid tumors by activating and converting pro-tumor M2 macrophages to anti-tumor M1 macrophages through the GM-CSF arm. The results of the pre-clinical studies support the novel mechanism of action. (3) TJ-L1I7 is another antibody-cytokine fusion protein with the anti-PDL1 antibody fused with IL-7, which is designed to increase both the number and functionality of T cells drawn to the tumor thereby turning “cold” tumor to more immune-responsive “hot” tumor. (4) TJ-L1C4 belongs to I-Mab’s PD-L1 based bi-specific antibody family and uses CD47 antibody as the other arm. The candidate molecule is being developed at an early pre-clinical stage. Commercialization Capability In August 2020, I-Mab appointed Mr. Ivan Yifei Zhu as Chief Commercial Officer, a high-caliber commercial leader in China, to prepare for the market launch of its initial series of products in China. Our commercialization strategy is designed to build a leading hematologic oncology franchise in China through I-Mab’s unique product portfolio that includes felzartamab (TJ202) for multiple myeloma, lemzoparlimab (TJC4) for various leukemia indications and a late-stage asset/product to be in-licensed to cover lymphoma indications. This unique portfolio of the three key products enables I-Mab to have a near-complete coverage of major disease indications within the hematologic therapeutic area in China and offers an advantageous position to explore a near-cure therapeutic goal for certain hematologic oncology indications through additional drug combinations. Towards building a leading hematologic oncology franchise in China, I-Mab is laying foundations and progressing efficiently towards becoming an integrated commercial organization, encompassing market access, medical marketing, supply chain and sales teams. The initial effort of the sales organization is to focus on the launch readiness of felzartamab, the Company’s first hematologic oncology product, by targeting top academic centers and hospital networks across China where the target patient population accounting for majority of national cases is concentrated. Manufacturing Facility I-Mab has made significant progress in building a comprehensive biologics manufacturing facility in Hangzhou, China (the “Hangzhou Facility”). The Hangzhou Facility aims to have a pilot plant capacity of 2 production lines (1 line configured with 2 x 2,000L and another line with 1 x 2,000L) by 2022 and commercially progressive capacity up to 8 x 4,000L to become operational by the end of 2023. The Hangzhou Facility, when operational, will exclusively serve I-Mab’s increasing CMC and manufacturing needs for all on-going and future clinical trials in the U.S. and China and the sustained production of its planned commercial products. The Hangzhou Facility will enable the Company to control the quality and manufacturing schedules tailored to its development and commercialization needs. Importantly, it will significantly reduce our production cost burden and cost of goods as a whole. Corporate Achievements In March 2021, I-Mab reported substantial net revenues of RMB 1,542.7 million (US $236.4 million) and net income on a GAAP basis of RMB 470.9 million (US $72.2 million) for the full year of 2020, achieving corporate profitability for the first time in the Company’s history. In March 2021, I-Mab secured collaborations with Complix, an EU-based biotech company, and Affinity, a Shanghai-based biotech company, gaining access to cutting edge technology platforms to develop its next generation of novel and highly differentiated drug candidates. In December 2020, I-Mab’s American Depositary Shares (ADS) were selected for inclusion in the NASDAQ Biotechnology Index (Nasdaq: .NBI), based on a set of eligibility criteria including minimum market capitalization and average daily trading volume. In December 2020, I-Mab appointed leading Immunology and Hematology experts Dr. Chen Dong and Dr. Jun Ma to its Scientific Advisory Board. In November 2020, I-Mab received BioCentury-Bay Helix’s “Deal of the Year” award for the global strategic collaboration with AbbVie to develop and commercialize lemzoparlimab. I-Mab was also named “10 Biotechs to Know in China” by FiercePharma and listed as “50 Smartest Companies in China” by MIT Technology Review. In September 2020, I-Mab raised approximately US$418 million through a private placement by a consortium of institutional investors led by Hillhouse Capital. In September 2020, I-Mab and AbbVie entered into a strategic global collaboration to develop and commercialize lemzoparlimab (TJC4). The total upfront plus milestone payments as well as the potential value of the right of first negotiation in relation to the two additional CD47-based bi-specific antibodies amounted to US $2.94 billion, making this deal the largest cross-border out-licensing transaction from China by total value. In May 2020, I-Mab opened its Hong Kong office as a regional hub for capital markets and investor relations activities, further benefiting from the Greater Bay Area economic development initiative in the region. Full Year 2020 Financial Results Cash Position As of December 31, 2020, the Company had cash, cash equivalents, restricted cash and short-term investments of RMB 4.8 billion (US $734.1 million), compared with RMB 1.2 billion as of December 31, 2019. The current cash on hand is sufficient to fund operations through 2023, including data readouts on core clinical assets such as lemzoparlimab and uliledlimab and commercialization in China of pre-NDA assets felzartamab and efineptakin alfa. Net Revenues Total net revenues for the full year of 2020 were RMB 1,542.7 million (US $236.4 million), compared with RMB 30.0 million for the full year of 2019. The revenues generated for the full year of 2020 solely consisted of the revenues recognized in connection with the strategic collaboration with AbbVie. Research & Development Expenses Research and development expenses for the full year of 2020 were RMB 984.7 million (US $150.9 million), compared with RMB 840.4 million for the full year of 2019. The increase was primarily due to the increase in employee benefit expenses, which consist of share-based compensation and payroll expenses, to support expansion of research and development programs. Administrative Expenses Administrative expenses for the full year of 2020 were RMB 402.4 million (US $61.7 million), compared with RMB 654.6 million for the full year of 2019. The decrease was primarily due to reduced share-based compensation expenses of RMB 305.7 million (US $46.9 million). Other Income (Expenses), net Net other income for the full year of 2020 was RMB 412.9 million (US $63.3 million), compared with net other expenses of RMB 20.2 million for the full year of 2019. The change was primarily attributable to the RMB 407.6 million gain recognized as a result of the transfer of equity of I-Mab Hangzhou from I-Mab Hong Kong to a group of domestic investors in China. The equity transfer realized the fair value appreciation in the pipeline assets as well as the employment of a team of designated management and workforce. Net Income Net income for the full year of 2020 was RMB 470.9 million (US $72.2 million), compared with a loss of RMB 1,452.0 million for the full year of 2019. Net income per share attributable to ordinary shareholders for the full year of 2020 was RMB 3.51 (US $0.54), compared with net loss per share attributable to ordinary shareholders of RMB 201.19 for the full year of 2019. Net income per ADS attributable to ordinary shareholders for the full year of 2020 was RMB 8.07 (US $1.24), compared with net loss per ADS attributable to ordinary shareholders of RMB 462.74 for the full year of 2019. Non-GAAP Net Income Non-GAAP adjusted net income, which excludes share-based compensation expenses, for the full year of 2020 was RMB 997.1 million (US $152.8 million), compared with non-GAAP adjusted net loss of RMB 936.7 million for the full year of 2019. Non-GAAP adjusted net income per share attributable to ordinary shareholders for 2020 was RMB 7.43 (US $1.14), compared with non-GAAP adjusted net loss per share attributable to ordinary shareholders of RMB 131.39 for the full year of 2019. Non-GAAP adjusted net income per ADS attributable to ordinary shareholders for the full year of 2020 was RMB 17.09 (US $2.62), compared with non-GAAP adjusted net loss per ADS attributable to ordinary shareholders of RMB 302.20 for the full year of 2019. Conference Call and Webcast Information The Company will host a live conference call and webcast on March 29, 2020 at 8:00 a.m. ET. Participants must register in advance of the conference call. Details are as follows: Registration Link: Conference ID: 4848159 Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call. A webcast replay will be archived on the Company’s website for one year after the conclusion of the call at A telephone replay will be available approximately two hours after the conclusion of the call. To access the replay, please call +1-855-452-5696 (U.S.), +61-2-8199-0299 (International), 400-632-2162 (Mainland China), or 800-963-117 (Hong Kong). The conference ID number for the replay is 4848159. About I-Mab I-Mab (Nasdaq: IMAB) is an innovation-driven global biotech company focusing on discovery, development and near-term commercialization of novel or highly differentiated biologics in in immuno-oncology therapeutic area. The Company’s mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab’s globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company’s unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capabilities. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit and follow I-Mab on LinkedIn, Twitter and WeChat. Use of Non-GAAP Financial Measures To supplement its consolidated financial statements which are presented in accordance with U.S. GAAP, the Company uses adjusted net income (loss) as a non-GAAP financial measure. Adjusted net income (loss) represents net income (loss) before share-based compensation. The Company’s management believes that adjusted net income (loss) facilitates better understanding of operating results and provide management with a better capability to plan and forecast future periods. For more information on the non-GAAP financial measures, please see the table captioned “Reconciliation of GAAP and Non-GAAP Results” set forth at the end of this press release. Non-GAAP information is not prepared in accordance with GAAP and may be different from non-GAAP methods of accounting and reporting used by other companies. The presentation of this additional information should not be considered a substitute for GAAP results. A limitation of using adjusted net income (loss) is that adjusted net income (loss) excludes share-based compensation expense that has been and may continue to be incurred in the future. Exchange Rate Information This announcement contains translations of certain RMB amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from Renminbi to U.S. dollars are made at a rate of RMB6.5250 to US$1.00, the rate in effect as of December 31, 2020 published by the Federal Reserve Board. Safe Harbor Statement This press release contains statements that may constitute “forward-looking” statements pursuant to the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “aims,” “future,” “intends,” “plans,” “believes,” “estimates,” “likely to” and similar statements. Statements that are not historical facts, including statements about I-Mab’s beliefs, plans and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. Further information regarding these and other risks is included in I-Mab’s filings with the SEC. All information provided in this press release is as of the date of this press release, and I-Mab does not undertake any obligation to update any forward-looking statement, except as required under applicable law. For more information, please contact: I-Mab Jielun Zhu, Chief Financial Officer E-mail: jielun.zhu@i-mabbiopharma.com Office line: +86 21 6057 8000 Gigi Feng, Chief Communications Officer E-mail: Gigi.Feng@i-mabbiopharma.com Office line: +86 21 6057 5785 Investor Inquiries: The Piacente Group, Inc. Emilie Wu E-mail: emilie@thepiacentegroup.com Office line: + 86 21 6039 8363 I-MAB Consolidated Balance Sheets (All amounts in thousands, except for share and per share data, unless otherwise noted) As of December 31, 2019 2020 RMB RMB US$ Assets Current assets Cash and cash equivalents 1,137,473 4,758,778 729,315 Restricted cash 55,810 - - Accounts receivable - 130,498 20,000 Contract assets - 227,391 34,849 Short-term investments 32,000 31,530 4,832 Prepayments and other receivables 136,036 195,467 29,957 Total current assets 1,361,319 5,343,664 818,953 Property, equipment and software 30,069 25,272 3,873 Operating lease right-of-use assets 16,435 14,997 2,298 Intangible assets 148,844 120,444 18,459 Goodwill 162,574 162,574 24,916 Investment accounted for using the equity method - 664,832 101,890 Other non-current assets 18,331 2,010 308 Total assets 1,737,572 6,333,793 970,697 Liabilities, mezzanine equity and shareholders’ equity (deficit) Current liabilities Short-term borrowings 50,000 - - Accruals and other payables 273,553 560,558 85,909 Operating lease liabilities, current 6,807 8,058 1,235 Ordinary shares to be issued to Everest 258,119 - - Deferred subsidy income - 7,509 1,151 Total current liabilities 588,479 576,125 88,295 Convertible promissory notes 68,199 - - Put right liabilities - 116,006 17,779 Operating lease liabilities, non-current 7,492 5,542 849 Deferred subsidy income 3,920 - - Other non-current liabilities - 8,975 1,375 Total liabilities 668,090 706,648 108,298 Mezzanine equity Series A convertible preferred shares (US$0.0001 par value, 30,227,056 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of December 31, 2020) 687,482 - - Series B convertible preferred shares (US$0.0001 par value, 30,305,212 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of December 31, 2020) 921,243 - - Series C convertible preferred shares (US$0.0001 par value, 31,046,360 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of December 31, 2020) 1,306,633 - - Series C-1 convertible preferred shares (US$0.0001 par value, 3,857,143 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of December 31, 2020) 188,819 - - Total mezzanine equity 3,104,177 - - I-MAB Consolidated Balance Sheets (Continued) (All amounts in thousands, except for share and per share data, unless otherwise noted) As of December 31, 2019 2020 RMB RMB US$ Shareholders’ equity (deficit) Ordinary shares (US$0.0001 par value, 500,000,000 and 800,000,000 shares authorized as of December 31, 2019 and December 31, 2020, respectively; 8,363,719 and 164,888,519 shares issued and outstanding as of December 31, 2019 and December 31, 2020, respectively) 6 114 17 Additional paid-in capital 389,379 7,701,116 1,180,249 Accumulated other comprehensive income (loss) 70,127 (50,793 ) (7,784 ) Accumulated deficit (2,494,207 ) (2,023,292 ) (310,083 ) Total shareholders’ equity (deficit) (2,034,695 ) 5,627,145 862,399 Total liabilities, mezzanine equity and shareholders’ equity (deficit) 1,737,572 6,333,793 970,697 I-MAB Consolidated Statements of Comprehensive Income (Loss) (All amounts in thousands, except for share and per share data, unless otherwise noted) Year Ended December 31, 2018 2019 2020 RMB RMB RMB US$ Revenues Licensing and collaboration revenue 53,781 30,000 1,542,668 236,424 Expenses Research and development expenses (Note 1) (426,028 ) (840,415 ) (984,689 ) (150,910 ) Administrative expenses (Note 2) (66,391 ) (654,553 ) (402,409 ) (61,672 ) Income (loss) from operations (438,638 ) (1,464,968 ) 155,570 23,842 Interest income 4,597 30,570 24,228 3,713 Interest expense (11,695 ) (2,991 ) (957 ) (147 ) Other income (expenses), net (16,780 ) (20,205 ) 412,892 63,278 Equity in loss of an affiliate (Note 3) - - (108,587 ) (16,642 ) Fair value change of warrants 61,405 5,644 - - Income (loss) before income tax expense (401,111 ) (1,451,950 ) 483,146 74,044 Income tax expense (1,722 ) - (12,231 ) (1,874 ) Net income (loss) attributable to I-MAB (402,833 ) (1,451,950 ) 470,915 72,170 Deemed dividend to Series C-1 preferred shareholders at extinguishment of Series C-1 Preferred Shares - (5,283 ) - - Deemed dividend to Series B-1, B-2 and C preferred shareholders at modification of Series B-1, B-2 and C Preferred Shares - (27,768 ) - - Net income (loss) attributable to ordinary shareholders (402,833 ) (1,485,001 ) 470,915 72,170 Net income (loss) attributable to I-MAB (402,833 ) (1,451,950 ) 470,915 72,170 Other comprehensive income (loss): Foreign currency translation adjustments, net of nil tax 53,689 10,747 (120,920 ) (18,531 ) Total comprehensive income (loss) attributable to I-MAB (349,144 ) (1,441,203 ) 349,995 53,639 I-MAB Consolidated Statements of Comprehensive Income (Loss) (Continued) (All amounts in thousands, except for share and per share data, unless otherwise noted) Year Ended December 31, 2018 2019 2020 RMB RMB RMB US$ Net income (loss) attributable to ordinary shareholders (402,833 ) (1,485,001 ) 470,915 72,170 Weighted-average number of ordinary shares used in calculating net income (loss) per share - basic 6,529,092 7,381,230 134,158,824 134,158,824 Weighted-average number of ordinary shares used in calculating net income (loss) per share - diluted 6,529,092 7,381,230 157,231,652 157,231,652 Net income (loss) per share attributable to ordinary shareholders —Basic (61.70 ) (201.19 ) 3.51 0.54 —Diluted (61.70 ) (201.19 ) 3.00 0.46 Net income (loss) per ADS attributable to ordinary shareholders (Note 4) —Basic (141.91 ) (462.74 ) 8.07 1.24 —Diluted (141.91 ) (462.74 ) 6.90 1.06 Note: (1) Includes share-based compensation expense of RMB470 thousand and RMB284,431 thousand (US$43,591 thousand) for the year ended December 31, 2019 and 2020, respectively. (2) Includes share-based compensation expense of RMB514,733 thousand and RMB209,033 thousand (US$32,036 thousand) for the year ended December 31, 2019 and 2020, respectively. (3) Includes share-based compensation expense of nil and RMB32,707 thousand (US$5,013 thousand) for the year ended December 31, 2019 and 2020, respectively. (4) Each ten ADSs represents twenty-three ordinary shares. I-MAB Reconciliation of GAAP and Non-GAAP Results (All amounts in thousands, except for share and per share data, unless otherwise noted) Year ended December 31, 2018 2019 2020 RMB RMB RMB US$ GAAP net income (loss) attributable to I-MAB (402,833 ) (1,451,950 ) 470,915 72,170 Add back: Share-based compensation expense 3,520 515,203 526,171 80,640 Non-GAAP adjusted net income (loss) attributable to I-MAB (399,313 ) (936,747 ) 997,086 152,810 Non-GAAP adjusted income (loss) attributable to ordinary shareholders (399,313 ) (969,798 ) 997,086 152,810 Weighted-average number of ordinary shares used in calculating net income (loss) per share - basic 6,529,092 7,381,230 134,158,824 134,158,824 Weighted-average number of ordinary shares used in calculating net income (loss) per share - diluted 6,529,092 7,381,230 157,231,652 157,231,652 Non-GAAP adjusted income (loss) per share attributable to ordinary shareholders —Basic (61.16 ) (131.39 ) 7.43 1.14 —Diluted (61.16 ) (131.39 ) 6.34 0.97 Non-GAAP adjusted income (loss) per ADS attributable to ordinary shareholders —Basic (140.67 ) (302.20 ) 17.09 2.62 —Diluted (140.67 ) (302.20 ) 14.58 2.23