Hengrui Pharmaceutical (01276): The drug marketing license application for HRS-7535 tablets was accepted by the State Drug Administration

Zhitong Finance App News, Hengrui Pharmaceutical (01276) issued an announcement. Recently, Shandong Shengdi Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”), received the “Notice of Acceptance” issued by the China Drug Administration (hereinafter referred to as the “State Drug Administration”), and the company's drug marketing license application for HRS-7535 tablets was accepted by the State Drug Administration.

This listing is based on a multi-center, randomized, double-blind, placebo-controlled, parallel-designed key phase III clinical trial of HRS-7535 tablets in adult overweight or obese patients (study number: HRS7535-303) to evaluate the efficacy, safety, and tolerability of HRS-7535 tablets 120 mg and 180 mg compared to placebo in treating obesity or overweight non-diabetic participants with at least 1 weight-related illness.

Professor Mu Yiming of the First Medical Center of the Chinese People's Liberation Army General Hospital was the main researcher in the HRS-7535-303 study. A total of 50 centers were launched nationwide, and 556 subjects were randomly enrolled. Research results showed that all dosage groups of HRS-7535 tablets reached all major endpoints and key secondary endpoints during 44 weeks of treatment, with an average weight loss of 10.9% in the 180mg group; the weight loss effect continued. At the 50th week, the 180mg group lost an average weight loss of 11.1%; at the same time, improvements in several cardiovascular metabolic indicators were observed. The safety and tolerability data were consistent with other reported oral GLP-1 treatments. No new safety signals were observed, and liver safety was good.

Overweight and obesity are chronic metabolic diseases caused by a combination of factors such as excessive total body fat content and/or increased local fat content and abnormal distribution. China currently uses 24.0 kg/m2 ≤ BMI<28.0 kg/m2 and BMI ≥28.0 kg/m2 to diagnose overweight and obesity in adults, respectively. Major treatments for obesity include lifestyle interventions, weight loss medications, and metabolic surgery. Combined medication or metabolic surgery may be considered when lifestyle interventions are not effective. Among them, oral small-molecule GLP-1 receptor agonists are convenient to administer, have few dosage restrictions, and can also avoid injection site reactions caused by injectable preparations, so they are expected to be an important choice in weight loss drug treatment.

HRS-7535 tablets are a novel oral small molecule glucagon-like peptide-1 receptor (GLP-1R) agonist. It can not only promote pancreatic insulin secretion, reduce glucagon secretion, and inhibit gastric emptying by activating human GLP-1R, but also enhance satiety and suppress appetite by directly reducing energy intake by influencing central mechanisms to treat type 2 diabetes (T2DM) and lose weight. Only Eli Lilly's FOUNDAYO (orforglipron), the global oral small molecule GLP1R agonist, was approved for marketing by the FDA in April 2026. Up to now, the total R&D investment for HRS-7535 film-related projects is about 494.4 million yuan (unaudited).