China's drug regulator has accepted a marketing authorization application for HRS-7535 tablets, an oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist developed by Jiangsu Hengrui Pharmaceutical Co. (HKEX: 01276), for long-term weight management in adults with obesity or overweight. The filing, submitted through Hengrui's subsidiary Shandong Shengdi Pharmaceutical, covers adults with a body mass index (BMI) of 28 kg/m² or above, or 24 kg/m² or above accompanied by at least one weight-related comorbidity.
The submission follows positive topline results from the Phase III HARBOR-1 trial, in which 556 adults across 50 centers in China received once-daily HRS-7535 at 120 mg or 180 mg, or placebo. All dose groups met the primary and key secondary endpoints at 44 weeks. The 180 mg group achieved mean weight loss of 10.9% at week 44, extending to 11.1% at week 50 with continued treatment. Improvements in cardiometabolic indicators were also reported. The company said safety and tolerability were consistent with other oral GLP-1 therapies, with no new safety signals and a favorable hepatic safety profile — a feature the filing highlights given the high co-prevalence of fatty liver disease in the target Chinese patient population.
One day earlier, on September 2, Hengrui disclosed that the National Medical Products Administration (NMPA) had also accepted a separate marketing application for HRS-7535 in type 2 diabetes, supported by the Phase III OUTSTAND-1 and OUTSTAND-2 trials. Across both studies, HRS-7535 reduced HbA1c by 1.40% to 1.68% across dose groups, with the 90 mg dose demonstrating superiority to dapagliflozin in OUTSTAND-2.