A Phase III,Multicenter,Randomized,Open-label,Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 With Semaglutide in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin Monotherapy or in Combination With SGLT2 Inhibitors
HRS9531, a once-weekly GLP-1 agonist from Fujian Shengdi Pharmaceutical, is being tested head-to-head against semaglutide in adults with type 2 diabetes inadequately controlled on metformin with or without SGLT2 inhibitors. The phase 3 randomized open-label trial enrolled 884 people with 52-week follow-up, measuring HbA1c change as the primary endpoint. This represents another Chinese biosimilar challenge to Novo Nordisk's semaglutide franchise, following similar efforts from BrightGene and Raynovent in the competitive GLP-1 space. The trial completed enrollment and is expected to read out by September 2026.