Innovent Reports Results of Phase 1 Clinical Study of IBI362, a Dual-Agonist of Glucagon-Like Peptide-1 and Glucagon Receptors in Overweight and Obese Chinese Participants at the 81st Scientific Sessions of the American Diabetes Association

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SAN FRANCISCO and SUZHOU, China, June 24, 2021 / PRNewswire / – Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company which develops, manufactures and markets high quality drugs for the treatment of oncology, metabolic, autoimmune and other major diseases, Announces Phase 1 Clinical Trial Results of IBI362, a Glucagon-Like Petide-1 (GLP-1), and Double Glucagon Receptor Agonist in Overweight and Obese Chinese Participants Featured in Electronic Poster to the American Diabetes Association 81st Scientific sessions.

This randomized, double-blind, placebo-controlled, multiple escalating dose study evaluated the safety, tolerability, and pharmacokinetic / pharmacodynamic characteristics of IBI362 in overweight or obese Chinese participants. Twelve participants in each of the three cohorts were randomized 2: 1 to receive 1.0-2.0-3.0 mg (cohort 1), 1.5-3.0-4.5 mg (cohort 2) or 2 , 0-4.0-6.0 mg (cohort 3) IBI362 or placebo for 12 weeks. IBI362 was well tolerated and showed a favorable safety profile. No adverse events leading to dose interruption or dose reduction of study drug were reported. No participant discontinued the study for safety reasons. No serious adverse events, hypoglycaemic events, and pancreatitis were reported. Gastrointestinal adverse events and decreased appetite were the most common adverse events. At week 12, the reductions in mean body weight from baseline were 3.80 kg (4.81%), 5.77 kg (6.40%), and 5.12 kg (6.05%) for participants receiving IBI362 in cohorts 1, 2, and 3, respectively, compared with a 0.37 kg (0.60%) increase in the number of participants receiving placebo (least-squares means using a mixed-effects model for repeated measures). Meanwhile, waist circumference, body mass index, blood pressure, and lipid profile were also improved in participants receiving IBI362.

“Obesity is a serious threat to public health with a gradual increase in the incidence. However, there is still a lack of effective therapeutic drugs for obese and overweight patients worldwide, posing a medical need. important and not satisfied. IBI362 has shown good safety, robust weight loss efficacy and multiple benefits in metabolic profile in the Phase 1 clinical study, and the preliminary clinical results are very encouraging. We hope that IBI362, as new generation of double GLP-1 and glucagon receptor agonists will show more inspiring results in the coming years. Phase 2 clinical studies in overweight or obese subjects. ” said the teacher Linong Ji of Peking University People’s Hospital and principal investigator of this study.

“IBI362 is a global innovative drug candidate. As an OXM analogue, IBI362 can confer a dual benefit of appetite suppression and energy expenditure through activation of the GLP-1 receptor (GLP-1R) and the glucagon receptor. Compared with traditional GLP-1 receptor agonists, IBI362 may not only lead to higher weight loss, but also improve the overall metabolic situation, including fatty liver disease and lipid metabolism in overweight or obese people. results suggest that IBI362 may be superior to currently available GLP-1R monoagonists for weight loss in obesity, highlighting the potential benefits of targeting multiple receptors in improving metabolic disorders. “said Dr Lei Qian, Executive Director of Medical Sciences and Special Disease Strategies at Innovent.

About obesity

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

About IBI362

Innovent has entered into a licensing agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3, a double agonist of GLP-1 and glucagon receptors, in China (IBI362). At the same time, Lilly is developing OXM3 outside China. IBI362 is a long-acting synthetic mammalian oxyntomodulin (OXM) -related peptide, which utilizes a fatty acid side chain to prolong the duration of action and allow once-weekly administration. IBI362, similar to the mechanism of OXM, is believed to exert its biological effects by activating the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR) in humans, which are believed to enhance glucose tolerance and lose weight. .

In addition to the effects of GLP-1R agonists on promoting insulin secretion, lowering blood sugar, and reducing body weight, IBI362 may also increase energy expenditure and improve hepatic fat metabolism through l activation of the glucagon receptor. Treating metabolic diseases by simultaneously activating multiple metabolic-related targets is the current global trend in drug development.

About Innovate

Inspired by the spirit of “Start with Integrity, Succeed with Action”, Innovent’s mission is to develop, manufacture and market high quality biopharmaceuticals that are affordable to ordinary people. Founded in 2011, Innovent is committed to developing, manufacturing and marketing high quality innovative drugs for the treatment of cancer, autoimmune, metabolic and other major diseases. At October 31, 2018, Innovent has been listed on the Main Board of the Hong Kong Stock Exchange Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated, multi-functional platform that includes R&D, CMC (chemistry, manufacturing and controls), clinical development and commercialization capabilities. By leveraging the platform, the company has built a strong pipeline of 24 valuable assets in cancer, metabolic diseases, autoimmune and other major therapeutic areas, with 5 products – TYVYT® (injection of sintilimab), BYVASDA® (injection of bevacizumab biosimilar), SULINNO® (injection of adalimumab biosimilar), HALPRYZA® (injection of rituximab biosimilar) and PEMAZYRE® (oral pemigatinib inhibitor) – officially approved for marketing, acceptance of the biological license application (BLA) for sintilimab in the United States, 5 active ingredients in phase 3 or pivotal clinical trials, and 14 additional molecules in clinical trials. In 2019, TYVYT® was the first PD-1 inhibitor included in the National Reimbursed Medicines List (NRDL) and the only PD-1 inhibitor included in the NRDL that year.

Innovent has built an international team with advanced talents in the development and commercialization of high-end biologic drugs, comprising 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 advance from China the biopharmaceutical industry, to improve the availability of drugs and improve the quality of life of patients. For more information, please visit: www.innoventbio.com.

Note: TYVYT® (injection of sintilimab),BYVASDA® (biosimilar injection of bevacizumab), SULINNO® (biosimilar injection of adalimumab) and HALPRYZA® (biosimilar injection of rituximab) are not approved in United States.

Forward-looking statements by Innovent Biologics, Inc.

This press release may contain certain forward-looking statements which are, by their nature, subject to important risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend” and similar expressions, with respect to Innovent, are intended to identify certain of these forward-looking statements. Innovent does not intend to regularly update these forward-looking statements.

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 guarantees 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. Therefore, actual results may differ materially from information contained in forward-looking statements due to future changes or developments in our business, Innovent’s competitive environment, and political, economic, legal and social conditions.

Innovent, the directors and employees of Innovent assume (a) no obligation to correct or update any forward-looking statements contained in this site; and (b) no responsibility for the failure of any of the forward-looking statements to materialize or to prove to be inaccurate.

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Company codes: Hong Kong: 1801, OTC-ROSE: IVBIY


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