Hengrui Obesity Drug Rivals Zepbound in Late-Stage China Trial with Comparable Weight Loss Results.
PorAinvest
martes, 15 de julio de 2025, 11:18 pm ET1 min de lectura
LLY--
The trial enrolled 567 participants with an average baseline body weight of 93 kg (205 lb). HRS9531 was administered as a once-weekly subcutaneous injection at doses of 2 mg, 4 mg, and 6 mg. Participants achieved at least 5% weight loss in 88% of cases, and 44.4% achieved at least 20% weight loss. The trial met its primary endpoints, with HRS9531 showing superior weight loss compared to placebo at 48 weeks.
Most adverse events were mild to moderate and gastrointestinal-related, indicating a favorable safety profile. Hengrui is planning to submit a New Drug Application (NDA) for chronic weight management in China and is accelerating its efforts to secure market approval. Kailera Therapeutics, the U.S.-based partner, plans to evaluate both higher doses and longer treatment durations in global clinical trials.
Following the announcement, Hengrui’s stock rose up to 4% on Wednesday morning. This positive data is a significant milestone for Hengrui, positioning it to challenge global leaders in the obesity market. The growing Chinese biotech sector is increasingly disrupting the global biotech power balance, with locally-developed medications and cheaper generics poised to improve drug availability and affordability.
References:
[1] https://www.fiercebiotech.com/biotech/hengruis-glp-1gip-agonist-reports-18-weight-loss-phase-3-trial-readies-china-push
[2] https://www.bloomberg.com/news/articles/2025-07-16/hengrui-s-obesity-drug-rivals-zepbound-in-late-stage-china-trial
[3] https://www.biospace.com/drug-development/hengruis-dual-glp-1-gip-elicits-17-7-weight-loss-in-phase-iii
[4] https://www.globenewswire.com/news-release/2025/07/15/3115481/0/en/Hengrui-Pharma-and-Kailera-Therapeutics-Report-Positive-Topline-Data-from-Phase-3-Obesity-Trial-in-China-of-Dual-GLP-1-GIP-Receptor-Agonist-HRS9531.html
Jiangsu Hengrui Pharmaceuticals' obesity drug candidate has shown comparable weight loss results to Eli Lilly's Zepbound in a late-stage China trial. The drug, developed in partnership with Kailera Therapeutics, demonstrated a safety profile consistent with other GLP-1-based treatments. Hengrui is accelerating its efforts to secure market approval in China and plans to file for approval "as soon as possible." The company's stock rose up to 4% following the announcement.
Jiangsu Hengrui Pharmaceuticals has reported positive topline data from its Phase 3 clinical trial for its obesity drug candidate, HRS9531, in China. The drug, developed in partnership with Kailera Therapeutics, achieved a mean weight loss of 17.7% compared to placebo, demonstrating a safety profile consistent with other GLP-1-based treatments. This result is comparable to Eli Lilly’s blockbuster GLP-1/GIP agonist Zepbound, which showed a 20.9% reduction in body weight after 36 weeks.The trial enrolled 567 participants with an average baseline body weight of 93 kg (205 lb). HRS9531 was administered as a once-weekly subcutaneous injection at doses of 2 mg, 4 mg, and 6 mg. Participants achieved at least 5% weight loss in 88% of cases, and 44.4% achieved at least 20% weight loss. The trial met its primary endpoints, with HRS9531 showing superior weight loss compared to placebo at 48 weeks.
Most adverse events were mild to moderate and gastrointestinal-related, indicating a favorable safety profile. Hengrui is planning to submit a New Drug Application (NDA) for chronic weight management in China and is accelerating its efforts to secure market approval. Kailera Therapeutics, the U.S.-based partner, plans to evaluate both higher doses and longer treatment durations in global clinical trials.
Following the announcement, Hengrui’s stock rose up to 4% on Wednesday morning. This positive data is a significant milestone for Hengrui, positioning it to challenge global leaders in the obesity market. The growing Chinese biotech sector is increasingly disrupting the global biotech power balance, with locally-developed medications and cheaper generics poised to improve drug availability and affordability.
References:
[1] https://www.fiercebiotech.com/biotech/hengruis-glp-1gip-agonist-reports-18-weight-loss-phase-3-trial-readies-china-push
[2] https://www.bloomberg.com/news/articles/2025-07-16/hengrui-s-obesity-drug-rivals-zepbound-in-late-stage-china-trial
[3] https://www.biospace.com/drug-development/hengruis-dual-glp-1-gip-elicits-17-7-weight-loss-in-phase-iii
[4] https://www.globenewswire.com/news-release/2025/07/15/3115481/0/en/Hengrui-Pharma-and-Kailera-Therapeutics-Report-Positive-Topline-Data-from-Phase-3-Obesity-Trial-in-China-of-Dual-GLP-1-GIP-Receptor-Agonist-HRS9531.html
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