LEPU BIO (02157.HK): Global Phase III Trial of CMG901 Meets Primary Endpoint, Significantly Improves Overall Survival of CLDN18.2-positive Advanced Gastric Cancer Patients

NewTimeSpace · 2026/07/28 13:14 · By Xuran Lin

NewTimeSpace News: Lepu Biopharma Co., Ltd. (02157.HK) announced positive top-line results from CLARITY-GASTRIC01, the global Phase III clinical trial of CMG901 (sonesitatug vedotin, AZD0901), an ADC candidate co-developed with AstraZeneca. Compared with investigator’s choice of treatment, the candidate delivered statistically significant and clinically meaningful improvement in overall survival among patients with CLDN18.2-positive advanced gastric cancer receiving second-line and later-line therapy. Its safety profile remained consistent with known data and no new safety signals were identified.

NewTimeSpace News: On 28 July 2026, Lepu Biopharma Co., Ltd. (02157.HK) issued a voluntary announcement. Positive top-line results were achieved in CLARITY-Gastric01, the global Phase III trial of CMG901 (sonesitatug vedotin, AZD0901), a Claudin 18.2 ADC candidate jointly developed by the Company and Kymabio.

Compared with investigator’s choice of treatment, the therapy demonstrated statistically significant and clinically meaningful overall survival (OS) improvement in patients with Claudin 18.2-positive advanced gastric cancer under second-line and later-line (2L+) treatment. It achieved one of the dual primary endpoints (OS in 3L+ patient population) and the key secondary endpoint (OS in 2L+ patient population). However, statistical significance was not reached for PFS assessed by BICR. The safety profile was consistent with existing findings with no new safety signals observed.

The trial was conducted across 175 centres in 19 countries. CMG901 has obtained Breakthrough Therapy Designation from CDE, as well as Orphan Drug Designation and Fast Track Designation from the FDA. In February 2023, KYM, the joint venture between Lepu Biopharma and Kymabio, out-licensed global rights of CMG901 to AstraZeneca.

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LEPU BIO 02157.HK AstraZeneca Clinical Trial