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

Clinical Trial12 Jun 2025Phase 3● 5/10i

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

Fujian Shengdi Pharmaceutical Co., Ltd.

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.

Strategic Signal

Chinese biosimilar developers are mounting coordinated challenges to established GLP-1 franchises, with at least three phase 3 programs targeting semaglutide directly. Fujian Shengdi's head-to-head design against semaglutide creates a potential regulatory pathway for non-inferiority claims that could pressure Novo Nordisk's pricing in China and other emerging markets. If successful, this positions HRS9531 for rapid market entry where semaglutide supply constraints and pricing create opportunities for competitively positioned alternatives.

GLP-1Type 2 diabetesDrug comparisonsFujian Shengdi Pharmaceutical Novo Nordisk

Original Abstract

The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks. | Condition(s): Type 2 Diabetes | Primary endpoint(s): Change in HbA1c | Enrollment: 884 (actual) | Phase: Phase 3 | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Expected completion: 2026-09-30 | Status: Active Not Recruiting | Last update: 2025-06-12

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