Innovent Announces First Patient with Type 2 Diabetes Dosed in a Phase 2 Clinical Trial of IBI362 (a GLP-1R and Glucagon Receptor Dual Agonist) in China

SAN FRANCISCO and SUZHOU, China, Sept. 7, 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 with type 2 diabetes has been successfully dosed in a phase 2 clinical trial (clinicaltrials.gov, NCT04965506) of IBI362, a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist in China.

NCT04965506 is a randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of IBI362 as compared with placebo and dulaglutide in patients with type 2 diabetes in China. The primary objective of the study is to evaluate change from baseline in HbA1c level after 20-week dosing in patients with type 2 diabetes inadequately controlled with lifestyle intervention or metformin.

Professor Wenying Yang of China-Japan Friendship Hospital, primary investigator of the study, stated: "Diabetes has been a global health concern. Currently, there are many types of agents for the treatment of diabetes, and each type has its own advantages and disadvantages. Appropriate treatment plan should be determined according to the characteristics of patients. Novel antidiabetic drugs, represented by GLP-1R agonists, have additional benefits such as weight loss, cardiovascular risk reduction, and kidney protection besides effective glycemic control. IBI362 is a dual agonist of GLP-1R and GCGR, and the synergistic effect of dual agonism may achieve more significant benefits of blood glucose reduction, body weight loss, hepatic fat metabolism and potential cardiorenal improvement than GLP-1R agonists. Results from a phase Ib study of IBI362 in Chinese patients with type 2 diabetes demonstrated a favorable safety profile, tolerability and outstanding preliminary efficacy, which will be disclosed in an academic conference later this year. We have strong confidence that IBI362 will demonstrate clinical benefits in patients with type 2 diabetes in phase 2 and 3 studies."

Dr. Lei Qian, Executive Director of Medical Sciences and Strategies of Special Diseases of Innovent, stated: "Metabolic syndrome is not only the pathological basis of type 2 diabetes, but also the risk factor of its pathogenesis. IBI362, an innovative oxyntomodulin analog, can activate GLP-1R and GCGR. In addition to achieve glycemic control and induce weight loss, IBI 362 can also improve multiple metabolic parameters, including live fat content, blood pressure and lipid profiles. The results from a phase 1b study in patients with type 2 diabetes are very encouraging, based on which we will make every effort to promote the phase 2 clinical study and the early marketing of IBI362 in China, benefiting the majority of patients with type 2 diabetes."

About IBI362

Innovent entered into a licensing agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3, a dual GCGR and GLP-1R 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 Diabetes

The prevalence of diabetes among adults in China is 11.6%, of which type 2 diabetes accounts for about 90% of the total number of diabetic patients, and the number of patients is still increasing. Poor glycemic control will lead to irreversible microvascular and macrovascular complications such as decreased visual acuity, blindness, renal insufficiency, peripheral neuropathy, myocardial infarction, stroke, amputation, etc. As a latent disease with serious complications and high incidence, diabetes mellitus has seriously threatened human health. Currently, there are many treatment options for diabetes, and the development of new hypoglycemic drugs will also explore the additional benefits for diabetic patients in terms of weight loss, cardiovascular risk reduction, and renal protection in addition to effective glycemic control.

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 26 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing, 1 asset's NDA under NMPA review, sintilimab's Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 15 molecules in clinical studies.

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 and www.linkedin.com/company/innovent-biologics/.

Innovent Biologics, Inc. 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 materialise or turn out to be incorrect.

SOURCE Innovent Biologics