A Open, Randomized, Single-dose, Comparative Bioequivalency and Safety Study of Human Recombinant Anti-tumor Necrosis Factor Alpha Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers

This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection and Adalimumab when used as a single subcutaneous injection in healthy volunteers.

Start Date27 Oct 2016

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

CTR20160687

/ CompletedNot Applicable

中国健康受试者中比较IBI303与阿达木单次皮下注射给药的生物等效性和安全性的临床研究

[Translation] A clinical study comparing the bioequivalence and safety of a single subcutaneous injection of IBI303 and adalimumab in healthy Chinese subjects

主要目的：比较IBI303和阿达木单抗在中国健康受试者中的AUC0-inf、AUClast、Cmax的生物等效性；次要目的：评价IBI303和阿达木单抗在中国健康受试者中的其他药代动力学特点、安全性和免疫原性

[Translation]

Primary objective: To compare the bioequivalence of IBI303 and adalimumab in terms of AUC0-inf, AUClast, and Cmax in Chinese healthy subjects; Secondary objective: To evaluate other pharmacokinetic characteristics, safety, and immunogenicity of IBI303 and adalimumab in Chinese healthy subjects

Start Date24 Oct 2016

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

NCT02893254

/ CompletedPhase 3

A Multicenter, Randomized, Double-blind, Parallel-controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Monoclonal Antibody Against Human Tumor Necrosis Factor-α (IBI303) Compared to Adalimumab in Patients With Active Ankylosing Spondylitis

Study of the efficacy and safety of IBI303 compared with adalimumab in adult patients with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)

Start Date22 Sep 2016

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

100 Clinical Results associated with Adalimumab biosimilar(Innovent Biologics (Suzhou) Co. Ltd.)

100 Translational Medicine associated with Adalimumab biosimilar(Innovent Biologics (Suzhou) Co. Ltd.)

100 Patents (Medical) associated with Adalimumab biosimilar(Innovent Biologics (Suzhou) Co. Ltd.)

Literatures (Medical) associated with Adalimumab biosimilar(Innovent Biologics (Suzhou) Co. Ltd.)

27 Jun 2025·MEDICINE

Comparative real-world retention rate and safety of biosimilar IBI303 versus Humira in ankylosing spondylitis: A retrospective study

Article

Author: Cao, Weiling ; Fu, Zhongchao ; Cao, Yaohua ; Cheng, Xiaogui ; Cheng, Beibei ; Liu, Jiang ; Xu, Xiayan ; Shi, Rangeng ; Zhang, Peng

Biosimilars play an important role in reducing the economic burden on patients, but the effectiveness of biosimilars in real-world is also being challenged. This study aims to evaluate Humira and IBI303 for ankylosing spondylitis (AS) by retention rate and safety through real-world data. We extracted patient information from the hospital information system of Shenzhen Luohu People’s Hospital, the time range is from May 1, 2020, to December 31, 2023, and conducted a retrospective study. The primary study outcome was the adalimumab retention rate at week 52 and it was estimated through survival analysis. We analyzed the data of 106 patients with AS. Among them, the retention rates of 38 patients using Humira at 12 weeks and 52 weeks were 0.87 (95% confidence interval [CI]: 0.81–0.92) and 0.44 (95% CI: 0.34–0.52), and in the IBI303 group were 0.90 (95% CI: 0.68–0.93) and 0.63 (95% CI: 0.57–0.69), respectively. Drug exposure every 4 weeks of first 52 weeks were 55.0 (44.2–66.7) and 55.6 (43.3–69.6) in Humira and IBI303 group, respectively. The incidence of adverse reactions was no statistically significant difference between the Humira and IBI303 groups (P > .05). However, the Humira group had significantly higher median costs in the first year than the IBI303 group (P = .004). In conclusion, in Chinese AS patients, there is no difference in retention rate and safety between generic and brand-name adalimumab in real-world use, but IBI303 is the more cost-effective choice.

01 Sep 2019·The Lancet. Rheumatology

IBI303, a biosimilar to adalimumab, for the treatment of patients with ankylosing spondylitis in China: a randomised, double-blind, phase 3 equivalence trial

Article

Author: Wang, Yongfu ; Wu, Lijun ; Li, Ting ; Qian, Lei ; Li, Juan ; Shuai, Zongwen ; Zheng, Shirui ; Wu, Xinjiang ; Luo, Li ; Tan, Wenfeng ; Bi, Liqi ; Zhou, Hui ; Xiao, Weiguo ; Zhou, Ling ; Xu, Huji ; Lu, Shujie ; Wang, Yanqi ; Xing, Qian ; Liu, Xu ; Wu, Jian ; Wu, Xin ; Shi, Guixiu ; Li, Hongbin ; Li, Xiaoxia ; Li, Zhijun ; Wang, Xiong ; Xiong, Yan ; Xiao, Zhengyu ; Li, Xiaomei ; Zheng, Yi ; He, Dongyi

BACKGROUND:

China approved adalimumab for the treatment of ankylosing spondylitis in 2013. However, the cost of the standard dose regimen exceeds ¥15 000 (around US$2250) per month, which is well beyond affordability for most Chinese patients. No biosimilars of adalimumab are available in China; IBI303 is a monoclonal antibody against TNFα that is currently in development. This study aimed to assess the clinical equivalence of IBI303 to adalimumab in patients with ankylosing spondylitis.

METHODS:

This phase 3, multicenter, double-blind, parallel, randomised controlled equivalence trial was done in 20 centers across China. Patients were randomly assigned in a 1:1 ratio to receive either 40 mg of IBI303 or 40 mg of adalimumab as a subcutaneous injection every 2 weeks until week 22. Patients were eligible for inclusion if they were between 18 and 65 years old, fulfilled the 1984 Modified New York Criteria for ankylosing spondylitis, were non-responders, inadequate responders, or intolerant to treatment with NSAIDs for 4 or more weeks, and had active ankylosing spondylitis defined by two or more indicators of disease severity. The investigators, site staff, patients, sponsors, and the contract research organisation were masked to treatment allocation. The primary outcome was the proportion of patients who met the Assessment of SpondyloArthritis international Society (ASAS) Response Criteria for a 20% improvement (ASAS20) at week 24 after treatment. Equivalence was established if the 95% CI of the difference in responses between groups was between -15% and 15%. Efficacy analyses were done in the full analysis population and in the per-protocol population. Safety analyses were done in all randomly assigned patients who received at least one drug dose. This trial is registered with ClinicalTrials.gov, number NCT02893254.

FINDINGS:

Between Sept 22, 2016, and May 11, 2018, 438 patients were randomly allocated either to the biosimilar IBI303 group (n=220) or the adalimumab group (n=218). In the full analysis population, 165 (75%) of 220 patients in the IBI303 group (95% CI 68·7-80·6) and 158 (72%) of 218 patients in the adalimumab group (66·0-78·3) reached the primary outcome of ASAS20 at week 24. The difference between the two groups was 2·3% with a 95% CI of -5·9 to 10·6, which fell within the pre-specified equivalence boundaries at week 24 (-15 to 15). In the per-protocol population, 163 (80%) of 203 patients in the IBI303 group reached ASAS20 at week 24 (95% CI 74·1-85·5), compared with 150 (80%) of 188 patients in the adalimumab group (73·3-85·3%). The difference between the groups was 0·6% with a 95% CI of -7·4 to 8·6%, which also fell within the pre-specified equivalence boundaries at week 24. Safety and tolerability profiles were similar between the two groups; 174 (79%) of 220 patients in the IBI303 group and 178 (82%) of 218 patients in the adalimumab group had treatment-emergent adverse events.

INTERPRETATION:

This trial showed therapeutic equivalence of IBI303 and adalimumab in the treatment of ankylosing spondylitis. The efficacy, safety, and immunogenicity of both drugs are highly similar. IBI303 could be an alternative treatment option for patients with ankylosing spondylitis in China.

FUNDING:

Innovent Biologics, National Major Scientific and Technological Special Project for "Significant New Drugs Development".

01 Sep 2015·International immunopharmacologyQ2 · MEDICINE

Anti-TNF-α monoclonal antibody reverses psoriasis through dual inhibition of inflammation and angiogenesis

Q2 · MEDICINE

Article

Author: Deng, Jie ; Zhang, Junfeng ; Liu, Yu ; Shi, Gang ; Xiang, Rong ; Wei, Yuquan ; Li, Jia ; Dai, Lei ; Yang, Guoyou ; Liu, Junli ; Li, Chunlei ; Su, Xiaolan ; Yu, Dechao ; Xing, Kaiyan ; Deng, Hongxin ; Cheng, Lin ; Yang, Yang ; Zhang, Shuang

Tumor necrosis factor-alpha (TNF-α) antagonists have shown remarkable efficacy in psoriasis; however, the precise mechanisms of action of TNF-α blocking agents mainly focus on their neutralizing TNF-α and its anti-inflammatory effects. In this study, we generated a humanized anti-TNF-α monoclonal antibody (IBI303) and suggested a potential mechanism of anti-TNF-α therapy for psoriasis. The results of SPR and ELISA indicated that IBI303 has a good affinity to TNF-α. In vitro, it could suppress TNF-α-induced cytotoxicity in WEHI164 cells. In vivo, administration of IBI303 to K14-VEGF transgenic mice led to a significant treatment efficiency in psoriasis in a dose-dependent manner. IHC staining and cytokines-ELISA indicated that TNF-α inhibition strongly reduced inflammatory cells infiltration and pro-inflammatory cytokines release, accompanied by suppression of inflamed dermal blood vessels. Mechanistically, in order to explain the anti-angiogenesis effect of anti-TNF-α antibody, the production of cytokine in macrophage conditional medium was measured by ELISA. The result indicated that the massive secretion of TNF-α stimulated by LPS in RAW264.7 cell supernatant was markedly neutralized in a dose-response manner by IBI303, moreover, the expression of NF-κB p65 was down-regulated. Mouse endothelial cell tube formation assay showed that anti-TNF-α could inhibit blood vessels formation directly and indirectly. Collectively, our study suggested a kind of antipsoriatic mechanism of TNF-α inhibitors that is the dual inhibition of inflammation and angiogenesis.

132

News (Medical) associated with Adalimumab biosimilar(Innovent Biologics (Suzhou) Co. Ltd.)

19 May 2025

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Innovent Released 2024 ESG Report, Underscoring Commitment to Sustainable Development and Global Innovation

SAN FRANCISCO and SUZHOU, China, May 18, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces the release of its "2024 Environmental, Social and Governance (ESG) Report", highlighting the Company's strategies, actions, and achievements in sustainable development across five pillars, which include "Excellent Governance", "Enjoying Good Health", "High Quality as Key", "People First" and "Embracing Ecology". Continue Reading MSCI ESG RATING Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "As China's leading biopharmaceutical company, Innovent consistently navigates the pulse of the times with strategic foresight, forging a closed-loop system for value creation through synergistic integration of global innovation-driven strategies and sustainable development practices. We achieved an MSCI ESG rating of AAA, as the only biotech in China and one of just three globally to receive this rating. Throughout the year of 2024, we remained committed to our mission, 'to empower patients worldwide with affordable, high-quality biopharmaceuticals,' and stayed true to our original aspiration, 'Start with Integrity, Succeed through Action.' We deeply integrated social responsibility into our business practices, actively responded to the United Nations Sustainable Development Goals (SDGs), strengthened our governance structure, improved operational efficiency, advanced high-quality innovation, promoted diversity and empowerment among employees, and strived for low-carbon development. These initiatives firmly honored our commitment to sustainable growth. We have embedded ESG principles into the fabric of our organization, which enables us to continuously create multidimensional value for shareholders, employees, patients, and society." Building Enduring Excellence through Lean Governance Robust governance is the cornerstone of sustainable business development. In 2024, Innovent further refined its ESG governance framework to ensure agility in responding to global changes while maintaining steady, compliant operations. We strengthened compliance management through continuous improvement of risk management systems and the upholding of rigorous business ethics standards. Looking ahead, we are committed to building a stable and sustainable business ecosystem in collaboration with our partners. Board Diversity: added one female Executive Director, with every Board Committee now including at least one female chair or member. Compliance, anti-corruption, and business ethics training: 100% participation among Directors and employees. Supplier business ethics: 100% of suppliers signed the "Commitment to Compliance". Official ESG website: launched in 2024, underscoring the company's firm commitment to sustainable development. ESG recognition: achieved an MSCI ESG rating of AAA, the only biotech in China and one of just three globally to receive this rating. Driving Inclusive Healthcare through Innovation Bridging geographic and economic gaps through innovative therapies remains Innovent's unwavering goal. Guided by our company strategy, "To discover new medicines through innovation and deliver them through our global platforms", Innovent has solidified its oncology leadership in China, achieved multiple groundbreaking advancements in chronic disease therapies, and expanded our global impact. Out dedication to scientific progress is grounded in a strong sense of social responsibility, which extends to improving drug accessibility and affordability for patients worldwide, rural education, volunteer activities, and broader community support initiatives. Improving drug accessibility through an innovative pipeline: 15 commercialized products have benefited 5 million patients cumulatively. 3 New Drug Applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 molecules in early clinical development. Oncology and general biomedicine have become the Company's two growth engines. 6 drugs or assets granted 13 orphan drug designations, with 2 drug candidates for rare diseases in preclinical and clinical stages. SYCUME® (teprotumumab N01 injection) was launched as China's first IGF-1R antibody for the treatment of thyroid eye disease, ending a 70-year absence of treatment options and transforming care for this rare condition. Enhancing drug affordability by supporting medical insurance coverage with 6 medicines (TYVYT®, BYVASDA®, HALPRYZA®, SULINNO®, Olverembatinib, and SINTBILO®) included in China's National Reimbursement Drug List (NRDL) and 8 medicines (Pemazyre®, Cyramza®, Retsevmo®, FUCASO®, TYVYT®, DOVBLERON®, Jaypirca® and DUPERT®) included in the Catalog of Specific Drug Reimbursements under Huimin Insurance Programs. SINTBILO® became China's first domestically developed PCSK9 inhibitor included in the NRDL. Patient assistance programs have benefited over 200,000 patients, with donated medicines valued at more than RMB 3.6 Billion. Health education and public welfare programs benefited over 240,000 patients. Ongoing efforts in supporting rural education have cumulatively benefited nearly 4,000 teachers and students. Innovent volunteer teams contributed a total of 2,754 hours of community service, reflecting our long-term commitment to social responsibility. Delivering Life-Changing Quality High-quality is a foundational principle at Innovent that underpins our mission to deliver safer, more effective therapies to patients. Patient-centricity drives our adherence to internationally recognized quality standards across the entire product lifecycle, from development and manufacturing to distribution. Even in the face of complex external environments, we actively collaborate with industry partners to elevate sector-wide benchmarks and maintain a resilient, sustainable dual-sourcing supply chain. Our responsible marketing practices further prioritize transparency and the protection of patient rights. Innovent Biologics currently operates 140,000 L of total production capacity, comprising 60,000L of antibody production capacity at Suzhou manufacturing site and 80,000L of antibody and ADC production capacity at Hangzhou manufacturing site. With an additional 90,000L of capacity in plan at the Hangzhou site, the total production capacity will reach 230,000L upon full completion. All commercially operational production facilities are 100% GMP-certified. Reached 100% batch success rate in drug substance manufacturing. Maintained 100% pass rate in audits conducted by regulatory authorities and strategic partners. Established dual-source supply chains for raw materials used in self-manufactured commercial products. Conducted 122 quality audits of suppliers; delivered capacity-building training to approximately 170 suppliers; deployed over 400 personnel to provide on-site quality supervision, guidance, and training at 10 key supplier sites. Empowering Talent and Igniting Potential A thriving talent ecosystem fuels our innovation. At Innovent, we view our employees as the foundation of long-term success and are deeply committed to cultivating a fair, inclusive, and empowering workplace. We offer diverse career development pathways and a multi-tiered professional development training system tailored to different career stages. Our comprehensive compensation and benefits framework is designed to strengthen employees' sense of belonging, while enhancing our ability to attract, retain, and develop top talent. Committed to making Innovent a learning institution, we support employees in achieving both personal and professional growth. Women represent 51% of total employees and hold 44.2% of management positions. Key talent retention rate reached 96.8%. Employee satisfaction rate exceeded 98%. The "Innovent Beginning" Campus Recruitment Program offered over 2,100 job opportunities to new graduates from nearly 20 provinces. All operational production facilities are 100% ISO 45001 occupational health and safety (OH&S) certified. Safeguarding the Green Future with a Commitment to Sustainability Green development underpins Innovent's high-quality growth strategy. We are committed to eco-friendly practices that protect natural resources and ecosystems while actively contributing to global climate action. Through comprehensive climate risk assessments, we evaluate the potential operational impacts of climate change and implement measures to reduce our business activities' climate impacts. By integrating green, low-carbon principles across all aspects of our production and operations, we continue to set clear targets that drive continuous improvement in our environmental performance and contribute to a more sustainable future. 100% of operational production facilities are certified under the ISO 14001 Environmental Management System. Successfully completed one internal and one external environmental management audit to ensure ongoing compliance and system integrity. 29% reduction in energy consumption (per unit of production) compared to the previous year. Reduced fresh water use by 22% (per unit of production) compared to the previous year. Recycled a total of 51,100 tons of water, reflecting out commitment to resource conservation. Innovent Shanghai Global R&D Center was awarded LEED Gold certification by the U.S. Green Building Council (USGBC). Innovent remains firmly committed to sustainable development and global innovation. We will continue strategically consolidating our business momentum while pursuing breakthrough innovations in science. By harmonizing business success with long-term social value, Innovent is steadily progressing toward its vision of becoming a premier global biopharmaceutical company. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. 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28 Aug 2024

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Innovent Announces 2024 Interim Results and Business Updates

Strong commercial performance and significant pipeline milestones support sustained growth and innovation SAN FRANSISCO and SUZHOU, China, Aug. 28, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2024 interim results and major business updates. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "For the first half of 2024, our company's strategy of sustainable growth and global innovation continue executing very well: we achieved strong revenue growth, improved operational efficiency in all areas, and reached significant milestones in our late-stage pipeline to support our sustained growth. We also reported promising data readouts from early-stage assets, reinforcing our confidence in achieving global innovation and contributing to new long-term opportunities. The successful first half of 2024 has laid a solid foundation for achieving our full-year's growth. With strong commercial and financial execution, a high-value late-stage pipeline, and disciplined investments in next-generation innovation, we are well-positioned to deliver long-term value for patients, employees, shareholders and society." Enhanced operational efficiency and strong financial performance S trong revenue growth momentum: total revenue was RMB3,952.3 million in the first half of 2024, with a strong year-over-year growth of 46.3%, reflecting robust demand for our innovative portfolio and the advantage of our sustainable business model. Significantly improved financial performance: EBITDA Loss was significantly reduced, driven by strong revenue growth, enhanced operational efficiency and notable financial improvement. The gross profit margin of total revenue was 84.1%, a year-over-year increase of 1.8 percentage points The selling and marketing expenses of product revenue was 48.6%, a year-over-year decrease of 5.9 percentage points The administration and expenses of total revenue was 5.2%, a year-over-year decrease of 4.9 percentage points R&D expenses were RMB1,293.9 million; cash and short-term financial assets were RMB10,112.3 million, or approximately over USD1.4 billion, which enables us to focus on the long-term sustainable development EBITDA loss was RMB160.8 million, a notable year-over-year decrease of 39.9% Strong product revenue growth; preparing for CVM commercialization Product sales revenue reached RMB3 ,811.4 million in the first half of 2024, a strong year-over-year growth of 55.1%. Expansion of commercial portfolio into new approved products, new indications and broader NRDL coverage [1] , [2] and patient access: Eleven approved products: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, PEMAZYRE®, Olverembatinib, CYRAMZA®, Retsevmo®, FUCASO® , SINTBILO® and DUPERT® (new product, KRAS G12C inhibitor) . TYVYT® and PEMAZYRE® were newly approved in the Macau market. TYVYT® and BYVASDA® were included in the NRDL for the treatment of EGFR-mutated NSCLC. Solidify oncology leadership; in active preparation for new commercial opportunities in general biomedicine. Oncology: we strengthened our leadership with a robust product portfolio, including TYVYT® (sintilimab injection), and expanded out oncology business with a 10th product, a ROS1 inhibitor, set for approval in the second half of 2024. General biomedicines: Following the approval of the first CVM product SINTBILO® (tafolecimab injection) in 2023, we have successfully submitted three new drug applications (NDA)—two for mazdutide, targeting obesity/overweight population and T2D, and one for IBI311 (IGF-1R) for thyroid eye disease (TED). As a key strategic priority, we are steadily building our commercialization capabilities in the CVM field with systematic approaches, aiming to unlock substantial commercial opportunities and drive sustainable growth. Material innovation delivery supports strategic goals 7 new assets are in NDA review or pivotal registrational clinical trials, and 18 assets are in early-phase clinical studies Substantial milestones delivered for key late-stage assets Encouraging progress in the next wave innovation of "IO+ADC" TYVYT® (sintilimab): submitted an NDA for its eighth indication, 2L endometrial cancer (EMC). New registrational clinical trials for neoadjuvant therapy in colon cancer and perioperative therapy in NSCLC have been initiated. Additionally, we are exploring the potential of combination therapies through multiple collaborations with novel modalities. IBI310 (CTLA-4 )：initiated a Phase 3 clinical trial for IBI310 in combination with sintilimab as neoadjuvant therapy in treating colon cancer. IBI343 (CLDN18.2 ADC)：Phase 1b positive data readout in GC and a Phase 3 trial is in preparation. Accelerating new launch momentum in general biomedicine to unlock significant opportunities Mazdutide (GLP-1R/GCGR) : first NDA for weight management in obese or overweight populations and second NDA for T2D treatment, both under NMPA review. We plan to develop new indications, including adolescent obesity, metabolic dysfunction-associated steatohepatitis (MASH), obstructive sleep apnea (OSA), and heart failure with preserved ejection fraction (HFpEF). Teprotumumab (IGF-1R) : the NDA for TED is under NMPA review. With a longstanding lack of innovative TED treatments in China, Teprotumumab is set to be a transformative therapy for this significant unmet need once approved. Picankibart (IL-23p19) : the only IL-23p19 that reported over 80% subjects achieving ≥90% improvement in Psoriasis and Severity Index (PASI90) in 16 weeks of treatment, along with strong long-term skin clearance maintenance and quarterly dosing interval advantage. We plan to submit an NDA in the second half of 2024. IBI128 (XOI) : potential best-in-class XOI for the treatment of hyperuricemia in gout patients. It is currently undergoing overseas Phase 3 clinical trials overseas with our partner LG Chem, and we have completed patient enrollment for a Phase 2 clinical trial in China. IBI302 (VEGF/C) : Phase 3 study initiated for the treatment of nAMD, following stable and robust visual benefit observed with an extended dosing interval and potential macular atrophy inhibition in two Phase 2 studies. Abundant early-stage pipeline to support long-term growth and global ambition Encouraging data readouts from multiple oncology assets in Phase 1 studies, eyeing most difficult-to-treat cancers IBI363 (PD-1/IL-2 α -bias ) : preliminary positive signals in multiple IO-failed/cold tumor types; further investigations across different rumor types are ongoing; a Phase 2 clinical trial in the U.S. has been initiated. IBI343 (CLDN18.2 ADC) : encouraging positive signal in pancreatic cancer, with FDA fast track designation granted. Plans are underway for a clinical trial in the U.S. IBI389 (CLDN18.2/CD3) : encouraging and differentiated signals in GC and PDAC in Phase 1 studies; Phase 1b study is continuing. Multiple programs ongoing including IBI3003 (GPRC5D/BCMA/CD3), IBI115 (DLL3/CD3); IBI3004 (DR5/CEA); IBI3001 (EGFR/B7H3 ADC), IBI130 (TROP2 ADC), IBI133 (HER3 ADC) Develop next-generation general biomedicine programs to improve chronic disease treatment IBI3016 （ AGT siRNA ） : a new-generation siRNA drug candidate, entered into a Phase 1 clinical trial for hypertension. IBI355 (CD40L), IBI356 (OX40L) and IBI3002 (IL-4R α / TSLP) : innovative autoimmune molecules entered into first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases. IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) : both are in the Phase 1 stage to explore the potential differentiation clinical values versus existing therapy. Research innovation published in high-impact scientific journals and medical conferences, such as: AACR, ASCO, ESMO GI and ESMO plenary for oncology pipeline innovation, including 10+ oral presentations ADA, APAO, ICE, CSE for general biomedicine pipeline material progress, such as mazdutide and teprotumumab Facilitates and Manufacturing capacity adhering to high-standard quality: Shanghai R&D center (medical) is newly operational in August 2024 First manufacturing site: 60,000L antibody production capacity and ADC production lines in operation Second manufacturing site: first phase of 80,000L completed construction to secure CDMO business Devoted to responsible business practices and enhancing ESG management practices We remain committed to sustainable development, corporate responsibility and ethical business practices. We newly launched our ESG website to enhance our efforts in sustainability, corporate responsibility and ethical business conduct. The new platform highlights our initiatives, policies and performance in key ESG areas, including "Excellent Governance", "Enjoying Good Health", "Ensuring High-Quality Products", "Empowering Employees", and "Embracing Ecology". Innovent is graded 'A' level in MSCI ESG rating, ranking at the forefront of the biotechnology industry. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 11 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or is otherwise inaccurate. SOURCE Innovent Biologics

Phase 1Phase 3Financial StatementPhase 2Fast Track

02 Aug 2024

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Innovent and SanegeneBio Announce First Participant Dosed in a Phase 1 Clinical Trial of IBI3016 (AGT siRNA)

SAN FRANSCISO and SUZHOU, China, Aug. 1, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, and Sanegene Bio USA Inc. (SanegeneBio) today announced the first participant has been successfully dosed in a Phase 1 First-in-Human (FIH) clinical trial of IBI3016. IBI3016 (SanegeneBio's R&D code: SGB-3908) is an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. Preclinical studies have demonstrated that IBI3016 significantly reduces serum AGT protein levels and associated biomarkers (ANG I, ANG II) in hypertensive cynomolgus monkeys, resulting in marked and sustained blood pressure reduction without observed safety concerns such as hypotension. IBI3016 is developed using SanegeneBio's next-generation proprietary siRNA technology platform, which enhances drug potency and durability while maintaining favorable safety and tolerability profiles. In December 2023, Innovent and Sanegene Bio entered into a strategic collaboration to co-develop IBI3016. Innovent also maintains an exclusive option to license the future development, manufacturing and commercialization rights of IBI3016. This FIH study (NCT06501586) is a Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (SAD) of IBI3016 in healthy volunteers and patients with mild hypertension, aiming to support the further clinical development of IBI3016. Dr. Lei Qian, Vice President of Clinical Development at Innovent Biologics, stated: "siRNA therapies, due to their long-acting effects and stable efficacy, hold tremendous potential in the management of chronic diseases, particularly in the cardiovascular and metabolic (CVM) therapeutic areas, where long-term disease control and management are critical. Leveraging SanegeneBio's strengths in siRNA drug development and Innovent's clinical development expertise in CVM diseases, we have efficiently advanced IBI3016 into the clinic. We are committed to a rigorous, science-driven clinical development strategy and will work closely with SanegeneBio to advance the clinical development of IBI3016 with high quality and efficiency, and the hope to bring this innovative treatment to a wide range of hypertension patients as well as other potential disease areas." Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical Development at SanegeneBio, stated: "Hypertension represents a significant unmet clinical need globally. IBI3016, as a transformative RNAi therapy, has demonstrated superior drug activity, sustained efficacy, and favorable safety and tolerability profiles in preclinical studies. The rapid initiation and progress of the Phase 1 study of IBI3016 would not have been possible without the strong support from the research center at Peking University Third Hospital, as well as the collaborative efforts of the clinical teams at Innovent and Sanegene. We look forward to continued close collaboration with Innovent as we diligently execute the clinical development plan for IBI3016 and achieve positive outcomes. Our ultimate goal is to fully realize the therapeutic potential of IBI3016, offering a more effective, safer, and patient-friendly treatment option for individuals with hypertension." About Hypertension Hypertension is a common chronic disease that currently affects over 1 billion people worldwide. It not only increases the risk of cardiovascular and cerebrovascular diseases while also potentially leading to complications such as kidney damage and impaired vision. With the aging population and the prevalence of risk factors such as obesity, lack of physical exercise, and unhealthy diet, the prevalence of hypertension is increasing globally. Effective anti-hypertension treatments exist, but they have some drawbacks. For example, patients must take anti-hypertension drugs daily, and because hypertension often has mild or no noticeable symptoms, it can lead to poor medication adherence. Poor compliance has become a major challenge in the treatment of hypertension, with less than 20% of hypertension patients achieving long-term effective control[i]. To address this challenge in hypertension treatment, siRNA drugs offer an alternative solution by directly reducing AGT expression. These drugs provide long-lasting effects, good safety, and high compliance, making them a promising option for better treatment and long-term benefits for patients. About IBI3016 (AGT siRNA) IBI3016 (SanegeneBio's R&D code: SGB-3908) is an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. Preclinical studies have demonstrated that IBI3016 significantly reduces serum AGT protein levels and associated biomarkers (ANG I, ANG II) in hypertensive cynomolgus monkeys, resulting in marked and sustained blood pressure reduction without observed safety concerns such as hypotension. IBI3016 is developed using SanegeneBio's next-generation proprietary siRNA technology platform, which enhances drug potency and durability while maintaining favorable safety and tolerability profiles. In December 2023, Innovent and SanegeneBio entered into a strategic collaboration to co-develop IBI3016. Innovent also maintains an exclusive option to license the future development, manufacturing and commercialization rights of IBI3016. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 10 products in the market. It has 4 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, 'Start with Integrity, Succeed through Action,' Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Note: TYVYT® (sintilimab injection) is not an approved product in the United States. BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States. TYVYT® (sintilimab injection, Innovent) BYVASDA® (bevacizumab biosimilar injection, Innovent) HALPRYZA® (rituximab biosimilar injection, Innovent) SULINNO® (adalimumab biosimilar injection, Innovent) Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan. CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Retsevmo® (selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Disclaimer: Innovent does not recommend any off-label usage. About SanegeneBio SanegeneBio is an emerging RNAi-based company developing innovative RNA interference (RNAi) therapeutics driven by the cutting-edge delivery technology. Founded in 2021, SanegeneBio was led by a team of industry-leading experts and has operations in both the US and China. Since its incorporation, SanegeneBio has successfully established proprietary chemical modification platform, hepatic and extrahepatic delivery platforms, enabling tissue-specific delivery of a wide range of RNA therapeutics to efficiently knock down disease-causing genes. Our fast-growing RNAi portfolio covers a broad range of therapeutic areas including cardiovascular and metabolic diseases, immunology-related diseases, and nervous system diseases. Among them, our first RNAi drug has entered into the clinical stage, and several pipelines are in progress simultaneously. SanegeneBio is committed to developing transformational RNAi medicines through striving for scientific innovation to address unmet medical needs worldwide and change the lives of patients and families. Innovent's Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Reference SOURCE Innovent Biologics

Phase 1License out/inDrug Approval

100 Deals associated with Adalimumab biosimilar(Innovent Biologics (Suzhou) Co. Ltd.)

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KEGG	Wiki	ATC	Drug Bank
-	-	L04AB04	-

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Approved

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Indication	Country/Location	Organization	Date
Crohn Disease	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Jun 2022
Pediatric Crohn's Disease	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Jun 2022
Ankylosing Spondylitis	China	Innovent Biologics (Suzhou) Co. Ltd.	02 Sep 2020
Polyarticular Juvenile Idiopathic Arthritis	China	Innovent Biologics (Suzhou) Co. Ltd.	02 Sep 2020
Psoriasis	China	Innovent Biologics (Suzhou) Co. Ltd.	02 Sep 2020
Rheumatoid Arthritis	China	Innovent Biologics (Suzhou) Co. Ltd.	02 Sep 2020
Uveitis	China	Innovent Biologics (Suzhou) Co. Ltd.	02 Sep 2020

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 3	-	Innovent Biologics (Suzhou) Co. Ltd.	22 Sep 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02893254 (Literature \| Pubmed \| Lancet Rheumatol) Manual	Phase 3	Ankylosing Spondylitis	438	Adalimumab-IBI303	ffjzfirbsv(ptwmnlgeel) = omhsgfmfyt hzzwjuxrxy (pxrmjavvqv ) View more	Similar	01 Sep 2019
				Adalimumab	ffjzfirbsv(ptwmnlgeel) = mcwetdptsx hzzwjuxrxy (pxrmjavvqv ) View more
ACR2018	Phase 3	Ankylosing Spondylitis	438	IBI303	uecseacqvh(mweffymbux) = wuzibnatdz fcqcjfodmc (wbnbguognp )	Positive	23 Oct 2018
				Adalimumab	uecseacqvh(mweffymbux) = twaxfrrkmw fcqcjfodmc (wbnbguognp )
NCT02893254 (Pubmed \| Ann Rheum Dis)	Phase 3	Ankylosing Spondylitis	438	Adalimumab 40 mg	xfcknuztua(jtzrripdfk) = tfxbebqfxs kpwkxuczcf (gquumsefqb )	Positive	01 Mar 2014
				Placebo	xfcknuztua(jtzrripdfk) = cfhknxfdsi kpwkxuczcf (gquumsefqb )

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