A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Study Comparing the Efficacy and Safety of HRS9531 Injection Versus Semaglutide Injection in Subjects With Obesity

Clinical Trial27 Feb 2026Phase 3● 5/10i

A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Study Comparing the Efficacy and Safety of HRS9531 Injection Versus Semaglutide Injection in Subjects With Obesity

Fujian Shengdi Pharmaceutical Co., Ltd.

HRS9531, a weekly injectable from Chinese sponsor Fujian Shengdi, is being tested head-to-head against semaglutide in 572 adults with obesity. This 52-week, open-label phase 3 trial completed enrollment and measures percentage weight change as the primary endpoint. The study represents another Chinese GLP-1 biosimilar or follow-on entering direct competition with Novo Nordisk's established semaglutide franchise in obesity. This adds to multiple Chinese developers pursuing GLP-1 programs, potentially targeting domestic and emerging markets where branded pricing creates access gaps.

Strategic Signal

Chinese GLP-1 developers are increasingly targeting head-to-head superiority trials against semaglutide rather than placebo-controlled studies, signaling confidence in their molecules and intent to compete on efficacy rather than just cost. This mirrors the broader Chinese biotech strategy of developing premium biologics for domestic and emerging markets where Novo's pricing leaves room for competition. If HRS9531 demonstrates non-inferiority or superiority to semaglutide, it could accelerate regulatory pathways in China and other Asia-Pacific markets where access to branded GLP-1s remains limited.

GLP-1Weight lossDrug comparisonsFujian Shengdi Pharmaceutical Co., Ltd.Novo Nordisk

Original Abstract

This study is a multicenter, randomized, open-label, parallel-controlled, phase III study to compare the efficacy, safety, and tolerability of HRS9531 versus semaglutide once weekly (QW) in adult subjects with obesity | Condition(s): Obesity | Primary endpoint(s): Percentage change from baseline in body weight after 52 weeks of treatment | Enrollment: 572 (actual) | Phase: Phase 3 | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Expected completion: 2027-03 | Status: Active Not Recruiting | Last update: 2026-02-27

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