Innovent Declares First Participant to be Handled in Larger-Dose Cohort of Section 2 Medical Trial of Mazdutide in Chinese language Overweight Adults

ROCKVILLE, MD. and SUZHOU, China, September 4, 2022 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and markets high-value drugs for the treatment of oncology, metabolic, autoimmune, ophthalmic and other serious diseases, announces that the first participant in the higher-dose cohort of a Phase 2 clinical trial has received Mazdutid (R&D code: IBI362), a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR ), has been successfully administered in Chinese adults with obesity.

This randomized, double-blind, placebo-controlled study (ClinicalTrials.gov, NCT04904913) was designed to evaluate the efficacy and safety of Mazdutide in overweight or obese Chinese participants. The results for the low-dose cohorts (3.0 mg, 4.5 mg and 6.0 mg) were published in June this year and the primary endpoint was met. At week 24, each dose of Mazdutid demonstrated a significant effect on body weight loss compared to placebo in a dose-dependent manner and provided participants with multiple cardiometabolic benefits; meanwhile, Mazdutide was well tolerated and the overall safety profile was similar to other drugs in the same class. In addition, Mazdutid titrated to 9 mg showed a good safety profile and a 12-week phase body weight loss of 11.7% 1b Study (ClinicalTrials.gov, NCT04440345). Based on these results, Innovent will further investigate the efficacy and safety of a higher dose (9.0 mg) of Mazdutid in obese (BMI ≥ 30 kg/m2) Chinese patients. A total of 80 participants will be enrolled and randomized in a 3:1 ratio to receive Mazdutide 9.0 mg or placebo for 24 weeks. The primary endpoint was percent change from baseline in body weight at week 24.

professor Ling JiThe study’s lead investigator, Beijing University People’s Hospital, said: “Obesity is associated with a variety of chronic non-communicable diseases and is listed as one of the important risk factors affecting disease burden. The prevalence and growth rate of obesity in China first place in the world[1], and drugs that can achieve effective and safe weight loss are therefore urgently needed in the clinic. Clinical trials of Mazdutid in overweight or obese populations have shown significant efficacy in weight loss and overall metabolic improvement. 6 months of treatment with mazdutid 6.0 mg resulted in an 11.6% body weight loss in participants in the low-dose cohorts of the Phase 2 study, demonstrating its best-in-class potential. I am confident that a 9.0 mg dose of Mazdutid will demonstrate even more satisfactory weight loss efficacy and provide a new treatment option for participants with moderate to severe obesity.”

dr Lei Qian, Vice President of Clinical Development at Innovent, stated, “In the Phase 2 study in overweight or obese Chinese participants, low-dose Mazdutid demonstrated robust weight-loss efficacy and multiple improvement in metabolic parameters, reflecting the best- In-class potential of Mazdutid among GLP-1 receptor agonists and co-agonists To further expand its clinical utility, we will further evaluate the clinical utility of Mazdutid 9.0 mg in obese (BMI ≥ 30 kg/m2) adults investigate. The result of the Phase 1 study suggests that Mazdutide is the first anti-obesity single-agent molecule among any approved or developmental to achieve greater than 11.5% 12-week body weight loss. We hope that the higher dose of Mazdutide will offer obese patients a safer, bariatric surgery-like, and more accessible treatment option.”

About overweight and obesity

China has the largest obese population in the world, with the obesity rate likely to increase. Obesity can lead to a number of complications or related diseases that affect life expectancy and reduce quality of life. In more obese patients, the incidence and mortality from cardiovascular disease, diabetes and certain tumors increase significantly. Obesity is a chronic disease that requires long-term management, and long-term effective and safe treatments are lacking. Lifestyle intervention is the first choice and basic treatment for patients who are overweight or obese. However, a significant percentage of patients fail to achieve the desired weight loss goal after lifestyle intervention for various reasons and may require pharmacologic intervention. Traditional anti-obesity drugs have a limited effect on weight loss and face safety issues.

About Mazdutide

Innovent entered into a licensing agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (aka Mazdutide), a GLP-1R and GCGR dual agonist, in China. In parallel, Lilly developed OXM3 outside China. Mazdutid is a long-acting synthetic peptide related to mammalian oxyntomodulin (OXM) that uses a fatty acid side chain to extend the duration of action and allow for once-weekly dosing. Mazdutide is believed to exert its biological effects by activating the GLP-1 receptor and glucagon receptor in humans, which improves glucose tolerance and induces weight loss by mimicking the effects of endogenous oxyntomodulin.

In addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose levels and reducing body weight, Mazdutid may also increase energy expenditure and improve hepatic lipid metabolism through glucagon receptor activation. The treatment of metabolic diseases through the simultaneous activation of several metabolically relevant targets is currently the global trend in drug development.

About Innovent

Inspired by the spirit of “Start with Integrity, Succeed through Action”, Innovent’s mission is to develop, manufacture and market high-quality biopharmaceutical products that are affordable for ordinary people. Founded in 2011, Innovent is dedicated to developing, manufacturing and marketing high-quality innovative medicines for the treatment of cancer, autoimmune diseases, metabolic diseases, ophthalmology and other serious diseases. On October 31, 2018Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited under share code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multifunctional platform that includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the Company has built a robust pipeline of 34 valuable compounds in cancer, metabolism, autoimmune diseases and other key therapeutic areas, with 7 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection) , SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), Pemazyre® (oral pemigatinib inhibitor), NAILIKE (olverembatinib) and Cyramza® (ramucirumab), 3 compounds in NMPA NDA review, 4 compounds in phase 3 or pivotal studies and an additional 20 molecules in clinical trials.

Innovent has built an international team of advanced talents in the development and commercialization of high-end biologic medicines, including many global experts. The company also has strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many people to make progress of China biopharmaceutical industry, improve drug availability and improve patient quality of life. For more information, visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

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® (oral pemigatinib inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in mainland China. Hong Kong, Macao and Taiwan.

CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in mainland China.

Disclaimer:

1. This indication is still in the clinical study, which has not yet been approved China.

2. Innovent does not recommend off-label use.

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These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, forecasts and knowledge of the Company’s management regarding future events as of the date the statements are made. These statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, some of which are beyond the Company’s control and are difficult to predict. As a result, future changes or developments in our business, the Company’s competitive environment, and political, economic, legal and social conditions could cause actual results to differ materially from those contained in the forward-looking statements.

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[1] Multidisciplinary Clinical Consensus on the Diagnosis and Management of Obesity (2021 Edition). Chinese Journal of Endocrinology and Metabolism, 2021.37(11): 959-972

SOURCE Innovent Biologics

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