KEYMED BIO-B (02162.HK): Global Phase III Trial of CMG901 (AZD0901) Meets Primary Endpoint, Delivers Improved OS for 2L+ Gastric Cancer; AstraZeneca Forecasts Peak Sales of USD3-5 Billion
NewTimeSpace News: Keymed Biosciences Inc. (02162.HK) announced on 28 July that CMG901, a CLDN18.2-targeted ADC, achieved primary endpoint in its global Phase III trial and significantly improved overall survival for patients receiving second-line and later-line gastric cancer treatment. It is the first CLDN18.2 ADC demonstrating OS benefit in gastric cancer. AstraZeneca estimates the product’s peak sales to range from USD3 billion to USD5 billion. The Company reminds investors of commercialisation uncertainties.
NewTimeSpace News: On 28 July 2026, Keymed Biosciences Inc. (02162.HK) issued an announcement regarding positive top-line results from CLARITY-GASTRIC01, the global Phase III clinical trial of CMG901 (sonesitatug vedotin, AZD0901) in collaboration with AstraZeneca.
CLARITY-GASTRIC01 is a randomised, open-label, multicentre global Phase III trial conducted across 175 clinical sites in 19 countries covering North America, Europe, South America and Asia, enrolling a total of 594 subjects. Eligible participants are patients with locally advanced or metastatic gastric cancer, gastroesophageal junction adenocarcinoma or oesophageal adenocarcinoma whose tumour cells show CLDN18.2 expression in at least 25% of tumour cells regardless of staining intensity.
The trial set dual primary endpoints, namely OS for patients under third-line and later-line therapy and PFS for the overall trial population. The trial met the primary endpoint of OS in the 3L+ population as well as the key secondary endpoint of OS for all 2L+ patients. Although a trend of improvement was observed in PFS among 2L+ patients, statistical significance was not achieved.
CMG901 is the first CLDN18.2-targeted ADC to obtain clinical trial approvals in both China and the US, and the first CLDN18.2 ADC delivering proven OS benefit for this indication. Based on the encouraging trial outcomes, AstraZeneca projected peak annual sales of the product at USD3 billion to USD5 billion. The candidate has been granted Breakthrough Therapy Designation by CDE, and Orphan Drug Designation by the FDA and European Commission.
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