ICP-033

BEIJING--(BUSINESS WIRE)-- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced 2023 interim results as of 30 June 2023. Financial Highlights Revenue increased by 53.5% year-on-year to 377.5 million1 in the first half of 2023, compared to 246.0 million in the first half of 2022. Sales of orelabrutinib increased by 47.8% YoY to 320.7 million in the first half of 2023, compared to 217.0 million in the first half of 2022. The significant increase resulted from the continuous growth of orelabrutinib after its inclusion in the National Reimbursement Drug List (NRDL). Research and development expenses increased by 30.9% YoY to 358.1 million in the first half of 2023 from 273.5 million in the first half of 2022, primarily due to the advancement of numerous clinical trials, including global multi-center trials. Cash and cash equivalents2 reached 8.7 billion as of 30 June 2023, compared with 6.6 billion as of 30 June 2022, primarily due to the successful STAR Board listing on Sept. 21, 2022. The adjusted loss for the first half of 2023 as illustrated under Non-HKFRSs3 measures narrowed to 206.3 million. Accelerating Pipeline Development in Stage 2.0 InnoCare marked its 8th anniversary on August 18, 2023. For the past eight years, the Company has concentrated on addressing significant market needs in cancer and autoimmune diseases, establishing a comprehensive biopharmaceutical platform with robust in-house research, clinical development, manufacturing, and commercialization strengths. The flagship product, orelabrutinib, has received marketing approval in China and Singapore and has been included in China's NRDL. Additionally, the tafasitamab regimen has secured approval in Hong Kong and Bo’ao, complemented by 13 innovative drugs currently in clinical trials. In the rapid expansion of Stage 2.0, InnoCare plans to accelerate global clinical trials and research capabilities, with the goal of introducing five to six innovative drugs onto the market within three to five years. InnoCare’s innovative drug pipeline covers multiple novel targets and indications with significant market potential, including small molecule drugs, monoclonal antibodies, and bispecific antibodies for the treatment of blood tumors, autoimmune diseases, and solid tumors. Building A Leading Franchise in Hemato-Oncology With orelabrutinib (BTK inhibitor) serving as the backbone therapy and a key component of InnoCare’s extensive pipeline in hemato-oncology – including tafasitamab (anti-CD19 antibody), ICP-248 (BCL2 inhibitor), ICP-B02 (CD20xCD3 bispecific antibody), ICP-490 (CRBN E3 Ligase modulator), and potential future developments from internal and external sources – InnoCare strives to become a leading player in hemato-oncology both in China and worldwide. Orelabrutinib's exceptional safety and efficacy profiles promise synergistic benefits when combined with other pipeline drugs, such as ICP-248 (BCL2 inhibitor). InnoCare intends to address various segments, such as non-Hodgkin lymphoma (NHL), multiple myeloma (MM), and leukemia, utilizing both single and combination therapies. Particularly, InnoCare has designed a comprehensive combination therapy toolkit aimed at providing effective solutions for diffuse large B-cell lymphoma (DLBCL). Orelabrutinib Orelabrutinib was approved by the National Medical Products Administration (NMPA) for the treatment of relapsed/refractory marginal zone lymphoma (r/r MZL) in April 2023. Orelabrutinib has thus become the first and only BTK inhibitor for r/r MZL in China, which also marks orelabrutinib’s third indication approved in China. Patient enrollment of the Phase III registrational trial of orelabrutinib for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) was completed in China in the first half of 2023. The Company expects to submit the NDA in 2024. In the U.S., patient enrollment of the Phase II registrational trial for relapsed/refractory mantle cell lymphoma (r/r MCL) was completed. The Company expects to submit the NDA to the U.S. Food and Drug Administration (US FDA) in the middle of 2024. Orelabrutinib was approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with r/r MCL, which marks InnoCare’s entrance onto international commercial markets. Differentiated development strategy for DLBCL A registrational study of orelabrutinib for the first-line treatment of MCD DLBCL is ongoing in 45 cities in China. As of the data of released at the 2022 American Society of Clinical Oncology (ASCO), orelabrutinib-containing regimens demonstrated encouraging efficacy and well-tolerated safety pro patients with MCD DLBCL4. A comprehensive tool-kit including orelabrutinib, tafasitamab, ICP-B02, ICP-490 and ICP-248 offers a unique position to treat all stages of DLBCL patients with combination therapies. Tafasitamab Patient enrollment of the registrational trial of tafasitamab in combination with lenalidomide for the treatment of r/r DLBCL was completed in China. The Company expects to submit the biologics license application (BLA) in the second quarter of 2024 and anticipate BLA approval in the first half of 2025. The first prescription of tafasitamab in combination with lenalidomide was filled at the Ruijin Hainan Hospital at Bo’ao. Tafasitamab in combination with lenalidomide was approved by the Department of Health, the Hong Kong Special Administrative Region, China, which will extend to DLBCL patients in the Greater Bay Area. Final five-year results of the Phase II L-MIND study were presented at the 2023 AACR Annual Meeting and showed prolonged, durable responses in r/r DLBCL patients treated with the tafasitamab regimen. As of this announcement, tafasitamab has been included in the overseas special drug list in 23 provinces and cities in mainland China including Shanghai, Hainan province, etc. ICP-248 The Phase I dose escalation trial is underway. The preliminary results demonstrated good safety pro achieved favorable pharmacokinetic (PK) with high exposure at relatively low dose level, demonstrating differentiation from other BCL2 inhibitor. So far, four patients were dosed, and among the three patients evaluated, two achieved complete response (CR) with undetectable minimal residual disease (uMRD). The study result would potentially support combination therapy with orelabrutinib in the first line treatment of CLL/SLL, which could become an important asset for the Company’s globalization. The Company expects to submit an investigational new drug (IND) application in the U.S. within this year. ICP-248 is a novel, orally bioavailable BCL2 selective inhibitor, developed as single drug or in combination with orelabrutinib for the treatment of CLL, MCL, follicular lymphoma (FL), DLBCL and other hematological malignancies. ICP-B02 (CM355) ICP-B02 is a CD20xCD3 bispecific antibody co-developed with Keymed. In the Phase I dose escalation study, the dose escalation of intravenous infusion (IV) cohort was completed with no dose-limiting toxicities (DLTs) observed. In the meantime, the first subcutaneous (SC) cohort was completed with no DLTs observed so far. Preliminary data of both IV and SC formulations has shown good efficacy in patients with FL and DLBCL. Further registration strategy is being developed. ICP-490 ICP-490 was developed from InnoCare’s molecular glue platform for the treatment of MM and NHL. In the Phase I dose escalation study, preliminary results demonstrated immune modulation activity through the shift of peripheral T-cell subsets activation. ICP-490 shows strong potential to revolutionize MM treatment and further promise in hemato-oncology therapeutics as a mono therapy or in combination with others. Developing B-cell and T-cell Pathways in Autoimmune Diseases The Company has fortified its powerful discovery engine in the global frontier targets for the development of differentiated autoimmune therapeutics through B-cell and T-cell pathways for the purpose of providing the first-in-class or best-in-class treatments to the massive unmet medical needs with a promising market potential in global and/or regional markets. Orelabrutinib The Company has achieved proof of concept (PoC) of orelabrutinib for the treatment of primary immune thrombocytopenia purpura (ITP) and the Phase III registrational trial is ongoing in China. The latest data showed that 40% of patients met primary endpoint at 50mg. And patients with previous response to glucocorticoids (GC) or intravenous immunoglobulin (IVIG) were analyzed as a sub-group, 75.0% patients at the 50mg achieved the primary endpoint. ITP is the most common autoimmune hemorrhagic disease characterized by a decrease in peripheral blood platelet counts, resulting in an increased risk of bleeding and a decreased quality of life. The Phase IIa trial for systemic lupus erythematosus (SLE) demonstrated positive results, with remarkable SLE Responder Index (SRI)-4 response rates observed in a dose dependent manner, along with trends indicating a reduction in proteinuria levels. A Phase IIb trial has been initiated to encompass a larger population in China, and the Company expects to complete patient enrollment in the first half of 2024, and finish the interim analysis by the end of 2024. The 24-week data of orelabrutinib from the multiple sclerosis (MS) global Phase II trial is consistent with the previous reported 12-week data in terms of both efficacy and safety. The primary endpoint was achieved dose-dependently (Cmax driven) in all three active orelabrutinib treatment groups. Notably, a 92.3% relative reduction was achieved in cumulative number of new gadolinium (Gd) + T1 lesions at week 24 at 80mg QD compared to placebo arm (switched to orelabrutinib 50mg QD after Week 12). This reduction stands out as a leading efficacy indicator of efficacy when compared to other MS therapies that are approved or in developmental stages. All orelabrutinib groups achieved T1 new lesion control after 4 weeks of treatment and the effect is sustained up to 24 weeks. The 80 mg QD cohort showed the highest reduction rate of cumulative number of new lesions Gd+T1 lesions and the best for lesion control throughout 24 weeks with best safety profile, indicating its potential as a leading MS treatment therapy. The Phase II clinical trial for the treatment of neuromyelitis optica spectrum disorder (NMOSD) is ongoing in China and the Company is potentially further exploring the treatment of chronic spontaneous urticaria (CSU). ICP-332 Phase I data demonstrated a dose proportional and favorable PK profile, no observation of significant food effect, and well tolerated and good safety profile. InnoCare initiated a Phase II study of ICP-332 in atopic dermatitis (AD) with a data readout expected by the end of 2023. ICP-332 is a potent and selective TYK2 JH1 inhibitor that is being developed for the treatment of various autoimmune disorders, with 400 folds of selectivity against JAK2. According to the source of Pharma Intelligence, AD has become a major autoimmune disease with a global market potential of US$10 billion by 20305. ICP-488 InnoCare is accelerating the ongoing Phase I study of ICP-488 with psoriasis patients, and preliminary PoC is expected by the last quarter of 2023. The Phase II study for psoriasis is in preparation. In Phase I clinical trial with healthy subjects, the single ascending doses (SAD) and multiple ascending doses (MAD) have been completed with ICP-488, demonstrating a well-tolerated safety profile. Data shows that 100 million people worldwide are affected by various types of psoriasis6. Building Competitive Drug Portfolio for Solid Tumor Treatment InnoCare strives to expand the breadth of our pipeline, covering solid tumor diseases areas, through a combination of targeted therapy and immune-oncology approaches. The Company believes the potential best-in-class molecules, ICP-192 and ICP-723, will enable us to establish a solid footprint in the field of solid tumor treatment. To benefit a broader range of patients, InnoCare’s rapidly maturing early-stage pipeline, including the cornerstone therapy ICP-189 and ICP-B05, and ICP-033 immune-oncology treatment, should enable the Company to provide competitive treatment solutions for a large array of solid tumors for both China and global patients. ICP-723 (Zurletrectinib) InnoCare is accelerating the registrational trial of zurletrectinib in China and expecting to submit NDA by end of 2024. A favorable efficacy of 80-90% ORR was observed in adult patients with various cancers carrying NTRK gene fusion who received ≥8 mg dosages. Zurletrectinib was shown to overcome acquired resistance to the first generation TRK inhibitors, bringing hope for patients who failed prior TRKi therapy. The Company is conducting clinical trial of zurletrectinib to treat pediatric patients (2 to 12 years old) and adolescent patients (12 to 18 years old) after showing good safety and efficacy in adult patients. ICP-192 (Gunagratinib) InnoCare is accelerating the registrational trial of gunagratinib in China. The latest data of gunagratinib in patients with cholangiocarcinoma (CCA) was presented at 2023 ASCO-GI7. Gunagratinib is safe and well-tolerated with high response rate (52.9%) compared to other approved FGFR inhibitors in previously treated patients with locally advanced or metastatic CCA harboring FGR2 gene fusions or rearrangements. ICP-189 InnoCare and ArriVent reached a clinical development collaboration to evaluate the anti-tumor activity and safety of the combination of InnoCare’s novel SHP2 allosteric inhibitor, ICP-189, with ArriVent’s furmonertinib in patients with advanced non-small cell lung cancer (NSCLC). NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases8. The Novel SHP2 allosteric inhibitor ICP-189 is developed for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. As of this announcement, the dosage has been escalated up to 120 mg with no DLT observed and a favorable PK pro a long half-life has been demonstrated. Preliminary efficacy was observed in ICP-189 monotherapy. One patient with cervical cancer in the 20 mg dose cohort achieved confirmed PR. ICP-B05 (CM369) Two cohorts of ICP-B05 were completed with no DLT observed. The preliminary results demonstrate favorable PK pro PD biomarker Treg depletion was observed. As the potential first-in-class, the drug is developed as a monotherapy or combined with other therapies to treat advanced solid tumors, including lung cancer, digestive tract cancer, etc. Other Corporate Development InnoCare was approved by the Hong Kong Stock Exchange to remove "B" from the stock code from May 12, 2023. This is another important milestone in the Company's development. After getting approval of commercial production, InnoCare Guangzhou quickly realized the production of orelabrutinib off the production line, which has been provided to patients in 30 provinces, including Beijing, Guangdong and Jiangsu, marking InnoCare realize the whole industry chain platform from in-house research and development to production. The Ministry of Industry and Information Technology completed the examination of fifth batch of “Technologically-advanced Small Giant” and announced the approved list of the enterprises. InnoCare was among the list with its strong innovation capabilities and market competitiveness in the biopharmaceutical sector. Dr. Jasmine, the Co-founder, Chairwoman and CEO of InnoCare, said, "In the past eight years, we have achieved series of milestones and established a solid foundation for long-term development in the future. In the next five years, we will achieve significant growth in the 2.0 stage. We will continue to benchmark with international standard, upgrade innovation, and accelerate development to launch more innovative drugs to benefit patients around the world. At the same time, we will continue to strengthen our commercialization capabilities, expand our global presence, comprehensively upgrade our capabilities in various fields, and develop InnoCare into a world-leading biopharmaceutical company.” To know more about the detailed financial data and business update of InnoCare 2023 interim results, please log in . Conference Call Information InnoCare will host a conference call at 9:30 a.m. Beijing time in Chinese and at 8:00 p.m. Beijing time in English on August 30, 2023. Participants must register in advance of the conference call. Details are as follows: For Chinese conference call, please register through the below link: For English conference call, please register through the below link: Forward-looking Statement This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. About InnoCare InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. _______________________ 1 Currency in the financial highlights refers to RMB 2 Cash and cash equivalents refer to cash and bank balance, financial assets measured at fair value through profit or loss and interest receivable. 3 Non-HKFRSs: Excluding unrealized exchange loss and share-based compensation expenses. 4 2022 ASCO Abstract 5 Pharma Intelligence 6 Progress in Epidemiological Investigation of Psoriasis, Diagnostic Theory and Practice. 2021. 银屑病相关流行病学调查进展，诊断学理论与实践。2021. 7 2023 ASCO GI Abstract 8 Cancer-free