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.)

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 ; Li, Xiaoxia ; Li, Zhijun ; Wang, Xiong ; Xiao, Zhengyu ; Xiong, Yan ; 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 ; Yang, Guoyou ; Li, Chunlei ; Liu, Junli ; 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.

01 Mar 2014·Annals of the rheumatic diseasesQ1 · MEDICINE

Efficacy and safety of adalimumab in Chinese adults with active ankylosing spondylitis: results of a randomised, controlled trial

Q1 · MEDICINE

Article

Author: Huang, Feng ; Xu, Jianhua ; Shi, Qun ; Xu, Huji ; Bao, Chunde ; Wu, Huaxiang ; Wang, Guochun ; Zhu, Ping ; Pangan, Aileen L. ; Andhivarothai, Nupun ; Anderson, Jaclyn ; Gu, Jieruo

Background and objectives:

Efficacy of adalimumab for ankylosing spondylitis (AS) has been established for Western populations but not in the Chinese population. This study is the first to evaluate the efficacy and safety of adalimumab in Chinese patients with AS.

Methods:

Chinese adults with active AS who had an inadequate response or were intolerant to ≥1 non-steroidal anti-inflammatory drugs were randomised to adalimumab 40 mg (N=229) or matching placebo (N=115) subcutaneously every other week (EOW) for 12 weeks, followed by a 12-week open-label adalimumab 40 mg EOW phase. The primary efficacy endpoint was the percentage of patients meeting the Assessment in Spondyloarthritis International Society (ASAS20) response criteria at week 12. The recently developed AS Disease Activity Score (ASDAS), as well as efficacy measures of spinal mobility, disease activity, physical function and quality of life were evaluated.

Results:

At week 12, adalimumab treatment resulted in a significantly greater percentage of ASAS20 responders than placebo (67.2% versus 30.4%, respectively; p<0.001). Differences in ASAS20 were observed as early as week 2 (42.8% vs 6.1%, respectively; p<0.001). The percentages of patients achieving ASAS40, ASAS 5/6 and ASDAS inactive disease were significantly greater with adalimumab than placebo at week 12 (all p<0.001). Tuberculosis was reported in one patient. No cases of malignancy, lymphoma, demyelinating disease or lupus-like syndrome were reported during the study.

Conclusions:

Adalimumab significantly reduced the signs and symptoms, improved physical function and quality of life of Chinese patients with active AS, and was generally safe and well tolerated in this population.

129

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

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

28 Jun 2024

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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

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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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

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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	pmqocovzai(tpkxyjqulv) = ppzjvfcofx xhuehxgqbv (nsiiiogbzl ) View more	Similar	01 Sep 2019
				Adalimumab	pmqocovzai(tpkxyjqulv) = hzvgymzuvi xhuehxgqbv (nsiiiogbzl ) View more
NCT02893254 (Pubmed \| Ann Rheum Dis)	Phase 3	Ankylosing Spondylitis	438	Adalimumab 40 mg	mkzfpxjpyf(usdleavfsw) = lyguuhlduf ecaebkpkit (uyrxzdqapa )	Positive	01 Mar 2014
				Placebo	mkzfpxjpyf(usdleavfsw) = jakmmzcwyj ecaebkpkit (uyrxzdqapa )
NCT01265823 (CTgov)	Phase 4	Plaque psoriasis	150	Adalimumab	ndbdmldrfe = ashmhflicc pxounchckm (cukevgxgow, lubhxqtxhz - ulnxelzaok) View more	-	11 Mar 2013

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