Innovent Announces Results of a Phase 1 Clinical Trial of IBI362, a Glucagon-Like Peptide-1 and Glucagon Receptor Dual Agonist, in Overweight or Obese Chinese Participants at the American Diabetes Association’s 81st Scientific Sessions

SAN FRANCISCO and SUZHOU, China, June 24, 2021 / PRNewswire / – Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and markets high-quality drugs for the treatment of oncology, metabolic, autoimmune and other serious diseases, announces the results of a phase 1 clinical trial known from IBI362, a glucagon-like petide-1 (GLP-1) and glucagon receptor double agonist in overweight or obese Chinese participants, will be featured in an e-poster at the 81st Scientific Sessions of the American Diabetes Association.

This randomized, double-blind, placebo-controlled, multiple dose escalation study investigated the safety, tolerability, and pharmacokinetics / pharmacodynamics of IBI362 in overweight or obese Chinese participants. Twelve participants in each of the three cohorts were randomized 2: 1 and received 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 demonstrated a favorable safety profile. No adverse event was reported that resulted in a dose interruption or dose reduction of the study drug. No participant discontinued the study for safety reasons. No serious adverse event, hypoglycaemic event, or pancreatitis were reported. Gastrointestinal side effects and decreased appetite were the most common side effects. At Week 12, the mean body weight reductions from baseline were 3.80 kg (4.81%), 5.77 kg (6.40%), and 5.12 kg (6.05%) for participants who took IBI362 in cohorts 1, 2, and 3, respectively, compared to a 0.37 kg (0.60%) increase in participants who received placebo (least square mean using the mixed effect model for repeated measures). Meanwhile, waist circumference, body mass index, blood pressure, and lipid profile also improved in the participants who received IBI362.

“Obesity is a serious public health threat as its incidence continues to grow. However, there is still a shortage of effective therapeutic drugs for obese and overweight patients worldwide, which is a great and unmet medical need. IBI362 has shown good safety and robust weight loss efficacy and multiple metabolic profile benefits in the Phase 1 clinical trial, and the preliminary clinical results are very encouraging. We hope that IBI362 as a new generation of GLP-1 and glucagon receptor dual agonists will show further inspirational results in subsequent phase 2 clinical trials in overweight or obese patients, “said the professor Linong Ji from Peking University People’s Hospital and lead researcher on this study.

“IBI362 is a global innovative drug candidate. As an OXM analog, IBI362 can provide dual appetite suppression and energy consumption benefits by activating the GLP-1 receptor (GLP-1R) and the glucagon receptor. Compared to conventional GLP-1 – Receptor agonists, IBI362 can not only achieve greater weight loss but also improve the general metabolic situation including fatty liver and fat metabolism in overweight or obese people. These results suggest that IBI362 is the currently available GLP-1R monoagonist for weight loss in obesity might be superior, underscoring the potential benefits of targeting multiple receptors in ameliorating metabolic disorders. ” said Dr. Lei Qian, Executive Director of Medical Sciences and Strategies of Special Diseases at Innovent.

About obesity

China has the largest obese population in the world, which is showing a gradually increasing trend. Obesity can lead to a number of complications or related diseases that affect life expectancy or impair the quality of life. In severely obese patients, the incidence and mortality of cardiovascular diseases, diabetes and certain tumors increase significantly. Obesity is a chronic disease that requires long-term treatment and there is a lack of long-term effective and safe treatments. Lifestyle intervention is the first choice and basic treatment for overweight or obese patients. However, a significant number of patients may not achieve their desired weight loss goal for various reasons and may take medication. Traditional obesity drugs have limited weight loss effects and safety issues.

About IBI362

Innovent has signed a license agreement with Eli Lilly and Company (Lilly) to develop and potentially commercialize OXM3, a dual GLP-1 and glucagon receptor agonist China (IBI362). At the same time, Lilly is developing OXM3 outside China. IBI362 is a long-acting synthetic peptide related to mammalian oxyntomodulin (OXM) that uses a fatty acid side chain to extend duration of action and enable 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 is estimated to increase glucose tolerance improves and loses 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 liver lipid metabolism by activating the glucagon receptor. The treatment of metabolic diseases through the simultaneous activation of several metabolic-related targets is currently the global trend in drug development.

About innovation

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 for ordinary people. Founded in 2011, Innovent is dedicated to developing, manufacturing and marketing high quality innovative drugs for the treatment of cancer, autoimmune diseases, metabolic diseases and other serious medical conditions. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited under stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multifunctional platform that includes R&D, Chemistry, Manufacturing and Control (CMC), clinical development and commercialization. Using the platform, the company has built a solid pipeline of 24 valuable assets in cancer, metabolism, autoimmune disease and other key 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, approval of the Biologics License Application (BLA) of Sintilimab in the USA, 5 plants in phase 3 or pivotal clinical trials, and another 14 molecules in clinical trials. In 2019, TYVYT® was the first PD-1 inhibitor to be listed on the National Reimbursement Drug List (NRDL) and the only PD-1 inhibitor to be listed on the NRDL that year.

Innovent has built an international team of advanced talents in the development and commercialization of high quality biological medicines, including many global experts. The company has also entered into strategic alliances with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many employees to move forward China biopharmaceutical industries, improve drug availability and improve patient quality of life. Further information is available at: www.innoventbio.com.

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

Innovent Biologics, Inc. Forward-Looking Statements

This press release may contain certain forward-looking statements that by their nature are subject to significant risks and uncertainties. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” and similar expressions relating to Innovent are intended to identify certain forward-looking statements. Innovent does not intend to update these forward-looking statements on a regular basis.

These forward-looking statements are based on the beliefs, assumptions, expectations, estimates, projections and understandings of Innovent’s management with respect to future events at the time these statements were 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 difficult to predict. As a result, actual results could differ materially from the information contained in the forward-looking statements due to future changes or developments in our business, the competitive landscape of Innovent, and political, economic, legal and social conditions.

Innovent, the Directors and the Innovent employees undertake (a) no obligation to correct or update any forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements are incorrect or prove to be incorrect.

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Company codes: HongKong: 1801, OTC-PINK: IVBIY