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.

CTR20160628 / CompletedPhase 3

活动性强直性脊柱炎患者中比较IBI303和原研药阿达木单抗的疗效和安全性的随机、双盲、平行对照Ⅲ期临床研究

[Translation] A randomized, double-blind, parallel-controlled phase III clinical study comparing the efficacy and safety of IBI303 and the original drug adalimumab in patients with active ankylosing spondylitis

主要目的：比较IBI303和阿达木单抗在活动性强直性脊柱炎患者的有效性；次要目的：比较IBI303和阿达木单抗在活动性强直性脊柱炎患者的安全性和免疫原性；探索性目的：探索与试验用药疗效、安全性可能相关的药物遗传学。

[Translation]

Primary objective: To compare the efficacy of IBI303 and adalimumab in patients with active ankylosing spondylitis; Secondary objective: To compare the safety and immunogenicity of IBI303 and adalimumab in patients with active ankylosing spondylitis; Exploratory objective: To explore pharmacogenetics that may be related to the efficacy and safety of the trial drugs.

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.)

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 ; Li, Juan ; Qian, Lei ; Shuai, Zongwen ; Zheng, Shirui ; Wu, Xinjiang ; Luo, Li ; Tan, Wenfeng ; Bi, Liqi ; Zhou, Hui ; Xiao, Weiguo ; Zhou, Ling ; Xu, Huji ; Wang, Yanqi ; Xing, Qian ; Lu, Shujie ; Liu, Xu ; Wu, Jian ; Wu, Xin ; Shi, Guixiu ; Li, Hongbin ; Wang, Xiong ; Li, Zhijun ; Li, Xiaoxia ; 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 ; Li, Jia ; Wei, Yuquan ; Dai, Lei ; Liu, Junli ; Li, Chunlei ; Yang, Guoyou ; 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.

125

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

28 Jun 2024

·www.prnewswire.com

Innovent Provides Interpretation and Updates on Clinical Data from Mazdutide GLORY-1 Study and General Biomedicine Pipeline

SAN FRANCISCO and SUZHOU, China, June 27, 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, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, provided interpretation and updates on clinical data from Mazdutide's GLORY-1 study and its general biomedicine pipeline at an investor conference call on June 25. Continue Reading At the 2024 American Diabetes Association (ADA) Scientific Meeting, the company reported the results of its first Phase 3 clinical study (GLORY-1) on the GLP-1R/GCGR dual agonist mazdutide (Innovent R&D code: IBI362) in overweight or obese adults in China, along with the exploratory analysis results on liver fat content. During the June 25 conference call, leadership offered an in-depth interpretation of the clinical data. Innovent's Chief Financial Officer Rachel You and General Biomedicine Vice President of Clinical Development Lei Qian attended the meeting and made reports. Professor Linong Ji, MD, the principal investigator of the GLORY-1 study and Director of Peking University Diabetes Center and Director of the Department of Endocrinology and Metabolism, Peking University People's Hospital, also provided commentary. GLORY-1 is the first Phase 3 clinical study worldwide evaluating a GLP-1R/GCGR dual agonist for weight loss. The findings demonstrate significant weight reduction, robust safety, unique liver fat reduction and comprehensive improvement in metabolic indicators, confirming the distinctive advantages of mazdutide as a dual agonist targeting GLP-1R and GCGR. At the same time, Innovent is actively pursuing new development pathways, including innovative molecules that extend beyond T2D and weight management, with the aim to deliver transformative treatments in metabolic health. Mazdutide is an analogue of oxyntomodulin (OXM), a natural peptide hormone existing in humans that activates both glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), to scientifically and effectively reduce weight, increase energy expenditure, burn fat and improve liver fat metabolism. It can also achieve comprehensive metabolic benefits and improve physical health. The findings from GLORY-1 underscore mazdutide's impressive weight loss effects, safety and tolerability, and further highlight its ability to significantly reduce liver fat content and improve multiple cardiovascular metabolic risk factors. These results reaffirm the distinct advantages of new-generation of GLP-1R/GCGR dual agonists. Excellent weight loss efficacy The GLORY-1 study demonstrated mazdutide's remarkable weight loss efficacy. After 48 weeks of treatment, the mazdutide 6mg group experienced an average weight reduction of 14.3% compared to baseline. Additionally, mazdutide showed significant reductions in waist circumference, hip circumference, and neck circumference, indicating its potential in reducing body fat. Unprecedented liver benefits In addition to its exceptional weight management capabilities, mazdutide also demonstrated an 80.2% reduction in liver fat content in the GLORY-1 study, indicating improvements to liver health. Acting directly on the liver as a GLP-1R/GCGR dual agonist, mazdutide shows promise in treating metabolic-associated fatty liver disease (MAFLD) and metabolic-associated steatohepatitis (MASH), enhancing liver metabolic function and mitigating factors contributing to liver metabolic dysfunction. Significant reduction in multiple cardiovascular metabolic risk indicators The data at week 48 showed that mazdutide outperformed placebo in reducing waist circumference, systolic blood pressure, triglycerides, total cholesterol, LDL-C, blood uric acid, and ALT levels compared to baseline. Furthermore, mazdutide significantly normalized blood sugar level for participants with HbA1C≥5.7%. These findings highlight mazdutide's potential to mitigate cardiovascular metabolic risk factors and improve blood sugar management. Well tolerated and favorable safety profile Mazdutide showed excellent safety and tolerability in the GLORY-1 study, establishing itself as a safe treatment choice. Most gastrointestinal symptoms observed in the treatment group, such as nausea, vomiting, and diarrhea, were mild or moderate, with no signals indicating increased cardiovascular risk. These findings underscore mazdutide's effectiveness in weight loss and improving metabolic conditions, while also highlighting its promising safety profile, positioning it as a potential best-in-class treatment option. The marketing application for mazdutide's first weight loss indication is currently under review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). If approved, mazdutide is positioned to be a safe, effective, and comprehensive solution for chronic weight management among obese and overweight individuals in China, and could aid them to improve liver fat metabolism and address obesity-related comorbidities. Moving forward, Innovent plans to explore additional indications for mazdutide, advance the research and development of next-generation GLP-1 products, and contribute to improving the quality of life for patients with chronic diseases. Additionally, Innovent discussed its products in the cardiovascular and metabolic (CVM) field targeting various clinical needs currently in development. SINTBILO® (PCSK9) is the first and only Chinese-developed PCSK9 monoclonal antibody approved for treating hyperlipidemia. IBI128 (a new xanthine oxidase inhibitor) represents a next-generation candidate for managing gout and hyperuricemia, with ongoing Phase 3 clinical trials overseas and planned Phase 1/2 studies in China starting in 2024. IBI3016 (AGT siRNA) is an innovative siRNA therapy for hypertension, with a Phase 1 clinical trial scheduled to commence in 2024. Furthermore, several early-stage projects are poised to enter the IND stage, bolstering Innovent's strategic positioning and competitive edge in CVM. Metabolic diseases significantly affect quality of life and overall well-being. Innovent is accelerating innovation in this crucial area, dedicated to addressing unmet clinical needs and delivering safer, more effective treatments to patients. Over the next five years, Innovent plans to introduce 5-6 new metabolic products targeting diabetes, weight loss, cardiovascular conditions and other indications, aiming to establish itself as a leading research and development company in the field of cardiovascular metabolic diseases in China. Autoimmune: addressing global unmet clinical needs In the field of autoimmune, Innovent has successfully launched SULINNO® (adalimumab injection), which is approved for eight indications including rheumatoid arthritis and psoriasis and is covered under the National Reimbursement Drug List. Picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, successfully met primary and key secondary endpoints in its Phase 3 clinical study (CLEAR-1) for moderate to severe plaque psoriasis in China. CLEAR-1 is global the first Phase 3 registration study in IL-23p19 class that reported over 80% of subjects achieved PASI 90 after 16 weeks of treatment in psoriasis patients, and Innovent is preparing for a NDA submission to the CDE of NMPA. Innovent continues to explore unmet clinical needs in autoimmune diseases globally with advancements like IBI355 (CD40L), IBI356 (OX40L), IBI3002 (IL-4Rα/TSLP) and other innovative First-in-class/Best-in-class molecules targeting indications including primary Sjögren's syndrome, systemic lupus erythematosus, atopic dermatitis, asthma, and other diseases. Ophthalmology: advancing treatment standards In the field of ophthalmology, Innovent's new drug application for IBI311 Injection (recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, R&D) has been accepted for the treatment of thyroid eye disease (TED). This biologic with an innovative mechanism of action is poised to address a 60-year gap in domestic TED treatment, meeting significant clinical needs and offering effective, safe, and accessible treatment options for Chinese TED patients. In addition, Phase 3 clinical trials for IBI302 (VEGF/C) have commenced to address neovascular age-related maculopathy, with long-interval administration expected to achieve significant efficacy and potentially enhance management of geographic atrophy. Furthermore, IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) are currently in Phase 1 clinical trials to explore their differentiated clinical value. About Innovent Biologics: 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. 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 Biologics, Inc. ("Innovent" or "Company"), 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 turn out to be incorrect. SOURCE Innovent Biologics

Clinical ResultPhase 3Phase 1Drug ApprovalPhase 2

03 Jun 2024

·www.prnewswire.com

Innovent Delivers Oral Presentation of Clinical Data of A Randomized Controlled Phase 1b Study Evaluating IBI310 (Anti-CTLA-4 Monoclonal Antibody) in Combination with Sintilimab as Neoadjuvant Treatment of Colon Cancer at 2024 ASCO Annual Meeting

SAN FRANCISCO and SUZHOU, China, June 2, 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, metabolic, autoimmune, ophthalmology and other major diseases, announced that the clinical data of a randomized controlled Phase 1b study evaluating IBI310 (anti-CTLA-4 monoclonal antibody) in combination with sintilimab as neoadjuvant treatment of colon cancer was orally presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (ClinicalTrials.gov, NCT05890742). The abstract was selected for ASCO Daily News coverage. Based on the promising Phase 1b results, Innovent has opened the Phase 3 trial (Neoshot) evaluating IBI310 in combination with sintilimab as neoadjuvant treatment of colon cancer. The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has also granted Breakthrough Therapy Designation (BTD) for IBI310. Neoadjuvant treatment of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) in patients with microsatellite instability-high/mismatch repair-deficient colorectal cancer: results from a randomized, open-labeled, Phase 1b study Abstract #: 3505 In this Phase 1b study, the efficacy and safety of IBI310 in combination with sintilimab versus sintilimab as neoadjuvant therapy for resectable stage IIB-III MSI-H/dMMR colon cancer was evaluated. As of February 4, 2024, 101 pts were enrolled and randomized to receive IBI310 plus sintilimab (n=52) or sintilimab alone (n=49). For per-protocol set, the pathologic complete response (pCR) rates in IBI310 plus sintilimab arm were significantly improved than sintilimab alone arm （ 80.0% vs 47.7%, p=0.0007 ） . Treatment related adverse events (TRAEs) leading to surgery delay occurred in 2 pts (3.8%) in IBI310 plus sintilimab arm and 0 pt in sintilimab alone arm. Grade ≥3 immune-related adverse events (irAEs) occurred in 3 pts (5.8%) and in 4 pts (8.2%), respectively. IBI310 plus sintilimab did not increase safety risk compared to sintilimab alone, and did not affect the subsequent surgery. The Principal Investigator of the study, Prof. Ruihua Xu from Sun Yat-sen University Cancer Center, stated, "At present, complete (R0) resection for some stage IIB-III colon cancer patients remain a significant challenge, along with risks of extensive trauma and poor prognosis. In particular, neoadjuvant chemotherapy is not effective in MSI-H/dMMR colon cancer, and the pCR rate is only about 5%[1]. This Phase 1b study was the first randomized study to demonstrate the significant higher pCR rate of the dual immunotherapy in MSI-H/dMMR colon cancer. Neoadjuvant treatment of IBI310 in combination with sintilimab is potentially practice-changing that could reduce the preoperative staging, narrow the scope of radical resection, increase the complete resection rate, reduce the requirement of adjuvant chemotherapy and decrease the incidence of relapse, so as to improve the long-term prognosis and potentially cure the patients. The Phase 3 clinical study (Neoshot) is ongoing in China, and we look forward to positive results from this study to provide a more effective treatment option for patients with MSI-H/dMMR colon cancer." Dr. Hui Zhou, Senior Vice President of Innovent, stated, "There is a huge unmet clinical need for neoadjuvant therapy of resectable MSI-H/dMMR colon cancer in China. In this randomized, controlled Phase 1b study, IBI310 in combination with sintilimab significantly improved pCR rate than sintilimab alone in MSI-H/dMMR CRC with manageable safety profile. Based on the strong results of this study, we moved IBI310 in combination with sintilimab into Phase 3 trial (Neoshot) earlier this year, and we are looking forward to the positive results." About IBI310 IBI310 is a fully human monoclonal antibody injection independently developed by Innovent. IBI310 can specifically bind cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), thereby blocking CTLA-4 mediated T cell inhibition, promoting T cell activation and proliferation, improving tumor immune response, and achieving anti-tumor effects. About Sintilimab Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells[2]. In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for seven indications. The updated NRDL reimbursement scope for TYVYT® (sintilimab injection) includes: For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy; For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations; For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy; For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer; For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment; For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Besides, the New Drug Application ("NDA") for the combination of sintilimab and fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR or non-MSI-H tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the NMPA. In addition, two clinical studies of sintilimab have met their primary endpoints: Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma; Phase 3 study of sintilimab monotherapy as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable illnesses. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 4 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. 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. 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. 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. 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. References 1 2 Wang J, Fei K, Jing H, et al. Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451. DOI: 10.1080/19420862.2019.1654303. SOURCE Innovent Biologics

Clinical ResultPhase 3ImmunotherapyASCOPhase 1

07 May 2024

·www.prnewswire.com

Innovent Receives NMPA Breakthrough Therapy Designation for IBI343（Anti-Claudin18.2 ADC）as Monotherapy for Advanced Gastric Cancer

SAN FRANCISCO and SUZHOU, China, May 6, 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, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI343 as monotherapy for the treatment of claudin18.2-positive advanced gastric/gastro-esophageal junction adenocarcinoma (GC) patients who have progressed after at least 2 lines of prior systematic treatments. The BTD for IBI343 was based on the data from an ongoing Phase 1 study (NCT05458219), in which favorable safety and tolerability and promising antitumor activity of IBI343 monotherapy in advanced GC patients were observed. The study results will be published at an upcoming medical conference later in 2024. Innovent is preparing for a registrational Phase 3 multi-regional clinical trial (MRCT) of IBI343 in patients with claudin18.2-positive, HER2-negative GC (G-HOPE-001, NCT06238843) to be initiated soon. Dr. Hui Zhou, Senior Vice President of Innovent, said, "GC patients tend to progress after second-line systematic therapies with poor prognosis and have only a half year of survival expectancy. They are in urgent need of effective third-line treatment options. We are glad to see the NMPA granted BTD for IBI343 monotherapy based on the PoC clinical results in GC, and we will continue to validate its efficacy and safety in the registrational MRCT trial. Innovent has a comprehensive and robust oncology pipeline, and, particularly in GC, we have PD-1 inhibitor (TYVYT®) for first-line GC treatment and anti-angiogenic drug (CYRAMZA®) for second-line GC treatment. We will further explore IBI343's potential in combination therapy as well as in other solid tumors such as pancreatic cancer." NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of an investigational drug to treat a serious disease or condition when preliminary clinical evidence indicates that the drug has demonstrated substantial improvement over current therapies. The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE, but it will also allow the sponsor to obtain timely advice and communication from the CDE to accelerate the approval and launch to address the unmet clinical need of patients at an accelerated pace. Click here for the published list of drugs that have been granted BTD by NMPA. About Gastric/ Gastroesophageal Junction Adenocarcinoma Gastric cancer is one of the most common malignant tumors in the world and is one of the leading causes of cancer-related deaths globally. The 5-year survival rate of patients with metastatic gastric cancer is less than 5%[i]. China and Japan are countries with highest incidence of gastric cancer[ii]. Currently, chemotherapy combination of fluoropyrimidine and platinum and immune checkpoint inhibitor therapy are the standard-of-care treatments for patients with advanced metastatic gastric cancer. However, systemic therapy has limited efficacy in advanced gastric cancer. In particular, the prognosis for patients with third-line or higher gastric cancer is usually poor, with fewer treatment options and shorter survival expectations. The median survival times for these patients is only about 0.5 year[iii]. Claudin, a member of the tight junction molecule family, is a key structural and functional component of epithelial tight junctions. Among them, CLDN18.2 is normally buried in the gastric mucosa, but the development of malignancy leads to disruption of tight junctions and exposure of CLDN18.2 epitopes on the membrane of tumor cells[iv]. CLDN18.2 is expressed in up to 80% of patients with gastric cancer. About IBI343 (Claudin18.2 ADC) IBI343 is an antibody-drug conjugate composed of an anti-claudin18.2 antibody, and a cytotoxic drug exatecan. As a topoisomerase I inhibitor, exatecan effectively kills tumor cells by inhibiting DNA synthesis. Binding of IBI343 to claudin18.2-expressing tumor cells results in claudin18.2-dependent internalization of IBI343. Degradation of the cleavable linker will release the drug that causes DNA damage, leading to apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring tumor cells, resulting in a strong "bystander killing effect" of IBI343. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. 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 3 new drug applications under regulatory review, 5 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. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (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. 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. References: SOURCE Innovent Biologics

Phase 1Breakthrough TherapyPhase 3Phase 2Clinical Result

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

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

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

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02893254 (Literature) Manual	Phase 3	Ankylosing Spondylitis	438	Adalimumab-IBI303	hrfahrhacr(snmordznlu) = uggsljhyme xrjsbsjcgy (rypzynicxn ) View more	Similar	01 Sep 2019
				Adalimumab	hrfahrhacr(snmordznlu) = lwqzvalhpc xrjsbsjcgy (rypzynicxn ) View more
NCT02893254 (not provided, Pubmed)	Phase 3	Ankylosing Spondylitis	438	IBI303	ojeibqayxz(ussnixxdiv) = hkhplzfngy gktvlzefcw (mnicfjobxy, 68.7 - 80.6)	Positive	01 Sep 2019
				Adalimumab	ojeibqayxz(ussnixxdiv) = ylizjhilyv gktvlzefcw (mnicfjobxy, 66.0 - 78.3)
Phase III Study (ACR2018)	Phase 3	Ankylosing Spondylitis	438	IBI303	rtuqpfhptq(njjpqdtkrr) = tfuxrgstpt sqnebibyjx (kokgnfejcj )	Positive	23 Oct 2018
				Adalimumab	rtuqpfhptq(njjpqdtkrr) = pyzwhiypts sqnebibyjx (kokgnfejcj )
NCT02196701 (CLEAR, CTgov)	Phase 3	Psoriasis	46	MTX+ADA (Primary Sub-optimal Responders - ADA + MTX)	pmwoilielj(rnprabouhr) = jrkbtxueyx zldqumcemq (suusywtbsg, pzieansztr - syurzvhfcf) View more	-	19 Mar 2018
				MTX+ADA (Secondary Sub-optimal Responders - ADA + MTX)	pmwoilielj(rnprabouhr) = ovorqbqfwl zldqumcemq (suusywtbsg, zyjtwdsfoh - akbkjjxpsg) View more
NCT02893254 (Pubmed \| Ann Rheum Dis)	Phase 3	Ankylosing Spondylitis	438	Adalimumab 40 mg	erzsawdepj(nyszigygrt) = ngigcplljd ebtnvlfbwt (evtffaxdvz )	Positive	01 Mar 2014
				Placebo	erzsawdepj(nyszigygrt) = kkjxfmlhol ebtnvlfbwt (evtffaxdvz )
NCT01265823 (CTgov)	Phase 4	Plaque psoriasis	150	Adalimumab	dnehpwvrqi(kfadcdlkti) = ntpnmgimfg nenjlpsoxr (xyjpumyiea, icifxecpze - jgdyjojzvv) View more	-	11 Mar 2013
NCT00195650 (DE020, CTgov)	Phase 3	Rheumatoid Arthritis	846	Adalimumab	hbzapkqbyg(puultzysdg) = qxkhrmjmip gapgcxxlhe (jkhzgjnzoi, rwvqeakwbv - yqynyyvpfi) View more	-	31 Jul 2012
NCT00667355 (CTgov)	Phase 3	Ankylosing Spondylitis	41	adalimumab	fhskhckcfo(mfwtdbblxh) = qcjakdydml syggktmuja (zczfcblvyy, gsaviyfdpz - jparmeghxd) View more	-	11 Aug 2010

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