Hengrui Pharma and U.S.-based Kailera Therapeutics announced on July 15, 2025, that their dual GLP-1/GIP receptor agonist HRS9531 injection achieved positive topline outcomes in a Phase III clinical trial (HRS9531-301) for Chinese subjects with obesity or overweight.

In the 48-week study involving 567 participants averaging 93 kg baseline weight, all HRS9531 dose groups (2mg, 4mg, 6mg) demonstrated superiority over placebo across co-primary and key secondary endpoints. Primary analysis revealed the 6mg cohort achieved 17.7% mean weight reduction (placebo-adjusted: 16.3%), with 88.0% of subjects losing ≥5% body weight and 44.4% achieving ≥20% weight loss. Supplementary analysis showed up to 19.2% mean weight reduction (placebo-adjusted: 17.7%).

The candidate exhibited favorable safety and tolerability, with predominantly mild-to-moderate gastrointestinal treatment-emergent adverse events consistent with established GLP-1 therapies. These findings align with prior Phase II data where an 8mg dose yielded 22.8% weight reduction after 36 weeks without plateauing.

Hengrui Pharma intends to submit a New Drug Application for long-term weight management in China imminently, while Kailera advances global development of the asset (designated KAI-9531) outside Greater China.

The multicenter, randomized, double-blind trial (NCT06396429) evaluated adults with obesity (BMI≥28kg/m²) or overweight (BMI≥24kg/m²) plus weight-related comorbidities. Among 531 completers, all active arms met superiority endpoints with safety profiles matching earlier observations.

Developed internally by Hengrui, HRS9531 represents a dual-receptor agonist targeting obesity and type 2 diabetes. Over 2,000 Chinese subjects have received the therapy across trials. The 2024 licensing agreement grants Kailera ex-China rights for up to $6 billion in milestones plus 19.9% equity.

Hengrui's metabolic portfolio includes four approved products and multiple clinical-stage assets: oral GLP-1 agonist HRS-7535, triple agonist HRS-4729, weekly insulin SHR-3167, and insulin/GLP-1R combo HR17031. Two candidates—long-acting insulin INS068 and SGLT2i/DPP4i/metformin combo HR20031—await regulatory review.