Innovent Announces First Overweight or Obese Subject Dosed in A Phase 2 Clinical Trial of IBI362 (a GLP-1 and Glucagon Receptor Dual Agonist) in China

SAN FRANCISCO and SUZHOU, China, June 15, 2021 /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 and other major diseases, today announced that the first subject has been successfully dosed in a phase 2 clinical trial (clinicaltrials.gov, NCT04904913) of IBI362, a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist in China.

NCT04904913 is a randomized, double-blind, placebo-controlled phase 2 study to assess the efficacy and safety of IBI362 in overweight or obese subjects in China. The primary objective of this study is to evaluate the change from baseline in body weight at week 24, and to recommend the optimal dose for phase 3 studies.

Professor Linong Ji from Peking University People's Hospital, the primary investigator of the study, stated: "Obesity has become a worldwide health problem and is an important cause of several chronic diseases including diabetes, cardiovascular disease, liver disease, respiratory and sleep disorders, as well as cancer. About 50% of type 2 diabetes cases, 30% of ischemic cardiovascular and cerebrovascular diseases and 10%-40% of cancers are caused by being obese or overweight. Obesity is also listed by the WHO as one of the top ten risk factors leading to disease burden. China has the largest number of overweight and obese people in the world, while there is still a lack of effective therapeutic drugs globally. The phase 1 clinical study evaluating IBI362 demonstrated a good safety profile and potential for clinically significant, weight loss and multiple metabolic benefits. We believe that IBI362 could become an important therapeutic option for obese and overweight individuals and we are excited to progress this molecule into phase 2 clinical studies ."

Dr. Qian Lei, Executive Director of Medical Sciences and Strategies of Special Diseases of Innovent, stated: "IBI362 is a global innovative drug candidate. As an oxyntomodulin analog, IBI362 can confer dual benefits of appetite suppression and energy expenditure through the activation of GLP-1R and GCGR. Compared with traditional GLP-1 receptor agonists, IBI362 may not only achieve better weight loss, but also improve the overall metabolic health by also improving fatty liver disease and lipid metabolism in overweight or obese people. As the first weekly GLP-1R/GCGR dual agonist entering clinical trials in China, we are excited to bring this innovative therapy forward through clinical trials, to quickly bring more effective treatment options to people with obesity."

About IBI362

Innovent entered into a licensing agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3, a dual Glucagon and GLP-1 receptor agonist, in China (IBI362). In parallel, Lilly is developing OXM3 outside China. IBI362 is a synthetic long-acting mammalian oxyntomodulin analog (OXM3) and is a GLP-1R and GCGR dual agonist with best-in-class potential. IBI362 utilizes a fatty acyl side chain to prolong the duration of action, allowing once-weekly dosing. As an OXM analog, the effects of IBI362 are thought to be mediated through the binding and activation of GLP-1R and GCGR. In addition to the effects of GLP-1R agonists on promoting insulin secretion, lowering blood glucose and reducing body weight, IBI362 may also increase energy expenditure and improve hepatic fat metabolism through the activation of GCGR. The treatment of metabolic diseases by activating multiple metabolism-related targets simultaneously is currently the worldwide trend in drug development.

About Obesity

China has the largest obese population in the world, which shows a gradually increasing trend. Obesity can lead to a range of complications or related diseases that impact life expectancy or lead to a decrease in quality of life. In more severely obese patients, the incidence and mortality of cardiovascular disease, diabetes, and certain tumors increase significantly. Obesity is a chronic disease that requires long-term management, and there is a lack of long-term effective and safe treatments. Lifestyle intervention is the first choice and basic treatment for patients with overweight or obesity. However, a number of patients cannot achieve the desired weight loss goal due to various reasons and may use medications. Traditional anti-obesity drugs have limited weight-loss effects and safety problems.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 24 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 4 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection) and HALPRYZA® (rituximab biosimilar injection) – officially approved for marketing in China, sintilimab's Biologics License Application (BLA) acceptance in the U.S. , 6 assets in Phase 3 or pivotal clinical trials, and an additional 14 molecules in clinical trials. In 2019, TYVYT® was the first PD-1 inhibitor included in the National Reimbursement Drug List (NRDL) and the only PD-1 inhibitor included in the NRDL in that year.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.

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