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Hengrui Pharma and Kailera Therapeutics Report Positive Topline Data from Phase 3 Obesity Trial in China of Dual GLP-1/GIP Receptor Agonist HRS9531
– Mean weight loss of 19.2% at 6 mg with no plateau in 48-week Phase 3 trial – – Favorable safety profile consistent with other GLP-1-based treatments – – Hengrui to submit NDA in China; Kailera plans to evaluate both higher doses and longer duration of treatment in global clinical trials – JIANGSU, China and WALTHAM, Mass., July 15, 2025 (GLOBE NEWSWIRE) -- Hengrui Pharma (Hengrui), a global pharmaceutical company focused on scientific and technological innovation, and Kailera Therapeutics, Inc
About this update from Jiangsu Hengrui Pharmaceuticals Co., Ltd. Class A
[{"type":"image","alt":"Kailera Therapeutics, Inc.","displaySize":"","headline":null,"caption":"Kailera Therapeutics, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":169,"url":"https://media.zenfs.com/en/globenewswire.com/e0d3565801d0638c4e04d01b2e1d4aa0"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/0Jn2mPB37gXI37kJYUq7wQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTIzNztjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/e0d3565801d0638c4e04d01b2e1d4aa0","width":300,"height":169}},"lazy":false},{"type":"text","content":"– Mean weight loss of 19.2% at 6 mg with no plateau in 48-week Phase 3 trial –","length":78,"tagName":"p"},{"type":"text","content":"– Favorable safety profile consistent with other GLP-1-based treatments –","length":73,"tagName":"p"},{"type":"text","content":"– Hengrui to submit NDA in China; Kailera plans to evaluate both higher doses and longer duration of treatment in global clinical trials –","length":138,"tagName":"p"},{"type":"text","content":"JIANGSU, China and WALTHAM, Mass., July 15, 2025 (GLOBE NEWSWIRE) -- Hengrui Pharma (Hengrui), a global pharmaceutical company focused on scientific and technological innovation, and Kailera Therapeutics, Inc. (Kailera), a clinical-stage biopharmaceutical company focused on advancing a broad pipeline of next-generation therapies for the treatment of obesity, today announced positive topline data from Hengrui’s Phase 3 clinical trial (HRS9531-301) of once-weekly subcutaneous injection of HRS9531, a novel dual GLP-1/GIP receptor agonist, in individuals living with obesity or overweight in China (NCT06396429). The HRS9531-301 trial met both primary endpoints, including superior weight loss with HRS9531 (2 mg, 4 mg, and 6 mg) and greater percentage of participants achieving body weight reductions of at least 5% compared to placebo at 48 weeks. Hengrui plans to submit a New Drug Application (NDA) for chronic weight management in China, and Kailera is advancing HRS9531 as KAI-9531 to global clinical trials.","length":1016,"tagName":"p"},{"type":"text","content":"The trial enrolled 567 participants with a mean baseline body weight of 93 kg (205 lb). Based on the primary analysis (treatment policy estimand)1, participants taking HRS9531 achieved a mean weight loss of up to 17.7% (16.3% placebo-adjusted). Additionally, up to 88.0% of HRS9531-treated particip...
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