HENGRUI PHARMA (01276.HK): NMPA accepts marketing application for oral GLP-1 weight-loss drug HRS-7535 tablets

NewTimeSpace News: On 3 September 2026, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (stock code: 01276) announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has received the acceptance notice issued by the National Medical Products Administration (NMPA) for the marketing application of HRS-7535 tablets (acceptance numbers: CXHS2600122 and CXHS2600124). The proposed indication is for long-term weight management in adults with an initial body mass index (BMI) meeting the following requirements, on the basis of diet control and increased exercise: (i) BMI ≥28kg/m² (obesity), or (ii) BMI ≥24kg/m² (overweight) accompanied by at least one weight-related comorbidity (such as hyperglycaemia, hypertension, dyslipidaemia, obstructive sleep apnoea and fatty liver).

The filing is based on a multicentre, randomised, double-blind, placebo-controlled, parallel-design pivotal Phase III clinical trial (study number: HRS-7535-303) in adults who are overweight or obese, evaluating the efficacy, safety and tolerability of HRS-7535 tablets at 120mg and 180mg versus placebo in non-diabetic participants with obesity or overweight accompanied by at least one weight-related comorbidity. The study was led by Professor Mu Yiming of the First Medical Centre of the Chinese PLA General Hospital as the principal investigator, with 50 centres initiated nationwide and 556 subjects randomised. The results showed that all dose groups of HRS-7535 tablets achieved all primary and key secondary endpoints at 44 weeks of treatment, with an average weight reduction of up to 10.9% in the 180mg group; the weight-loss effect persisted with continued treatment, with an average weight reduction of up to 11.1% in the 180mg group at week 50; improvements in multiple cardiometabolic indicators were also observed, with safety and tolerability data consistent with other reported oral GLP-1 therapies and no new safety signals identified.

HRS-7535 tablets are a novel oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist, which can promote pancreatic insulin secretion, reduce glucagon secretion and inhibit gastric emptying by activating the human GLP-1R, and can also enhance satiety and suppress appetite by affecting the central nervous system, for the treatment of type 2 diabetes mellitus (T2DM) and weight loss. Globally, the only oral small-molecule GLP-1R agonist approved to date is Lilly's FOUNDAYO (orforglipron), which received FDA approval in April 2026. As of the date of this announcement, the cumulative R&D investment in the HRS-7535 tablets project amounts to approximately RMB 494.4 million (unaudited).

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.