Innovent Announces First Participant Dosed in the Higher-dose Cohort of a Phase 2 Clinical Trial of Mazdutide in Chinese Adults with Obesity

ROCKVILLE, Md. and SUZHOU, China, Sept. 4, 2022 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed in the higher-dose cohort of a phase 2 clinical trial of mazdutide (R&D Code: IBI362), a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with obesity.

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

Professor Linong Ji, the principal investigator of the study, Peking University People's Hospital, stated, "Obesity is associated with a variety of chronic non-communicable diseases and is listed as one of the important risk factors affecting the disease burden. The prevalence and growth rate of obesity in China rank first in the world^[1], and drugs that can achieve effective and safe weight loss are therefore urgently needed in the clinic. Clinical studies of mazdutide in overweight or obese population have demonstrated significant efficacy on body weight loss and comprehensive metabolic improvement. Treatment of mazdutide 6.0 mg for 6 months resulted in 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 mazdutide will show even more satisfactory efficacy on body weight loss and will offer a new treatment option for participant with moderate to severe obesity."

Dr. Lei Qian, Vice President of Clinical Development at Innovent, stated, "In the Phase 2 study in Chinese participants with overweight or obesity, low-dose mazdutide showed robust efficacy on body weight loss and multiple improvement in metabolic parameters, reflecting the Best-in-Class potential of mazdutide among GLP-1 receptor agonists and co-agonists. To further extend its clinical utility, we will continue to explore the clinical benefit of mazdutide 9.0 mg in adults with obesity (BMI ≥ 30 kg/m²). The result of the phase 1 study suggests that mazdutide is the first single-agent anti-obesity molecule, among all approved or under development, that achieves a 12-week body weight loss by more than 11.5%. We hope that the higher-dose mazdutide will provide a safer, bariatric surgery-like and more accessible treatment option to patients with obesity."

About Overweight and Obesity

China has the largest obese population in the world, with obesity rate likely to increase. Obesity can lead to a range of complications or related diseases that impact life expectancy and deteriorate 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 considerable percentage of patients fail to achieve the desired weight loss goal upon lifestyle intervention due to various reasons and may require pharmacological intervention. Traditional anti-obesity drugs have limited weight-loss effects and are associated with safety issues.

About Mazdutide

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

In addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose and reducing body weight, mazdutide may also increase energy expenditure and improve hepatic fat metabolism through the activation of glucagon receptor. The treatment of metabolic diseases by activating multiple metabolism-related targets simultaneously is currently the worldwide 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 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, ophthalmology 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 34 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 7 products – TYVYT^® (sintilimab injection), BYVASDA^® (bevacizumab biosimilar injection), SULINNO^® (adalimumab biosimilar injection), HALPRYZA^® (rituximab biosimilar injection), Pemazyre^® (pemigatinib oral inhibitor) , NAILIKE (olverembatinib) and Cyramza^® (ramucirumab), 3 asset under NMPA NDA review, 4 assets in Phase 3 or pivotal clinical trials, and an additional 20 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, Sanofi, Adimab, Incyte, MD Anderson Cancer Center 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/.

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^® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre^® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau 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 under clinical study, which hasn't been approved in China.

2. Innovent does not recommend any off-label usage.

Forward-looking statement

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. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company 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

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