Clinical Trials Pipeline & In-Development

HRS-9531

also known as: HRS9531, KAI-9531

Hengrui's once-weekly GLP-1/GIP dual agonist in Phase 3 in China for obesity, with Kailera Therapeutics holding global ex-China rights since 2024; the structurally closest Chinese competitor to tirzepatide.

A once-weekly dual GLP-1 / GIP receptor agonist peptide developed by Jiangsu Hengrui Pharmaceuticals — Phase 3 in China for obesity (2024–2025) with reported ~22% weight loss at 48 weeks at top dose in Phase 2 — and licensed globally (ex-China) to Kailera Therapeutics in May 2024, where it is being developed alongside efpeglenatide as part of a Kailera GLP-1 portfolio.

Mechanism of action

Balanced dual GLP-1 / GIP receptor agonism — mechanistically the same class as tirzepatide. Lipidation provides albumin binding and weekly pharmacokinetics.

Primary uses

Obesity (Phase 3, China)
Type 2 diabetes mellitus (Phase 2)

Typical dosing

1–8 mg once weekly (subcutaneous)

Phase 2 explored 1–8 mg weekly dose range.

Regulatory status

Not approved. Phase 3 in China in obesity ongoing. Hengrui licensed global ex-China rights to Kailera Therapeutics in May 2024.

References

[manufacturer] Jiangsu Hengrui Pharmaceuticals. HRS9531 Phase 2 results press release (2024).
[manufacturer] Kailera Therapeutics. Press release: global licensing of HRS-9531 from Hengrui, May 2024.

Related peptides

Tirzepatide

A once-weekly GLP-1/GIP dual agonist that produced unprecedented weight loss in SURMOUNT trials — up to ~21% at highest dose.

VK2735

Viking's emerging dual GLP-1/GIP agonist — Phase 2 SC data in obesity reported up to ~14.7% placebo-adjusted weight loss at 13 weeks (VENTURE, 2024), with an oral-tablet Phase 2 program initiated 2024; the principal clinical challenger to tirzepatide's mechanism outside the Lilly / Novo axis.

Efpeglenatide

A weekly-to-monthly exendin-4-based GLP-1 agonist with positive Phase 3 cardiovascular outcomes (AMPLITUDE-O, 2021) — Sanofi returned the license to Hanmi in 2020; Hanmi re-partnered with Innovent in 2020 for China development and with Kailera in 2024 for global development.

Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.