Jiangsu Hengrui Pharmaceuticals (01276): The drug registration application for HRS-7535 tablets has been accepted by the National Medical Products Administration.

Jiangsu Hengrui Pharmaceuticals (01276) announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., recently received a "Notice of Acceptance" from the National Medical Products Administration (NMPA) regarding the application for marketing authorization of HRS-7535 tablets. This application for marketing authorization is based on a pivotal Phase III clinical trial (Study Number: HRS7535-303) of HRS-7535 tablets conducted in adults with overweight or obesity. The trial was a multicenter, randomized, double-blind, placebo-controlled, parallel-designed study aimed at evaluating the efficacy, safety, and tolerability of HRS-7535 tablets at doses of 120 mg and 180 mg compared to placebo in non-diabetic participants with obesity or overweight, accompanied by at least one weight-related comorbidity. The HRS-7535-303 study was led by Professor Mu Yiming from the First Medical Center of the Chinese People's Liberation Army General Hospital, with 50 centers launched nationwide and 556 subjects randomized for enrollment. The results showed that all dosing groups of HRS-7535 tablets achieved all primary and key secondary endpoints at the 44-week treatment mark, with the 180 mg group showing an average weight loss of up to 10.9%. Furthermore, weight loss effects were sustained with continued treatment, as the average weight loss in the 180 mg group reached 11.1% by week 50, along with improvements observed in several cardiovascular and metabolic indicators. The safety and tolerability data were consistent with other reported oral GLP-1 therapies, and no new safety signals were observed, with good hepatic safety. Overweight and obesity are chronic metabolic disorders characterized by excessive overall body fat and/or abnormal fat distribution caused by a combination of genetic and environmental factors. In China, adults are currently diagnosed with overweight using the standard 24.0 kg/m BMI < 28.0 kg/m and obesity for BMI 28.0 kg/m. The primary therapeutic approaches for obesity include lifestyle interventions, anti-obesity medications, and metabolic surgical treatment. If lifestyle interventions are ineffective, combination pharmacotherapy or metabolic surgery may be considered. Among these, oral small-molecule GLP-1 receptor agonists offer convenient administration and fewer restrictions, while also avoiding injection-related reactions, potentially making them an important option in anti-obesity treatment. HRS-7535 tablets are a novel oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist that can promote insulin secretion from the pancreas and reduce glucagon secretion while slowing gastric emptying through the activation of human GLP-1R. Additionally, it can enhance satiety and suppress appetite through central mechanisms, directly reducing energy intake for the treatment of type 2 diabetes mellitus (T2DM) and weight loss. Globally, the only approved oral small-molecule GLP-1R agonist is Eli Lillys FOUNDAYO (orforglipron), which received FDA approval for marketing in April 2026. To date, the cumulative research and development investment for the HRS-7535 tablet project is approximately RMB 494.4 million (unaudited).