AstraZeneca Advances Multiple Clinical Trials of CMG901 (AZD0901) in Late-Stage Solid Tumors, Announces First Patient Dosed in Phase III Study

Zhitong Finance APP reported that Kang Nuoya-B (02162) announced that in February 2023, its subsidiary KYM entered into a global exclusive license agreement with AstraZeneca for the development and commercialization of CMG901, the main product co-developed by the group and Innocube Limited (controlled by Lepu Biotechnology Co., Ltd., holding a 30% minority stake in KYM). After signing the license agreement and obtaining certain regulatory approvals for the licensing transaction, AstraZeneca was granted an exclusive global license in February 2023 to research, develop, register, manufacture, and commercialize CMG901. According to the license agreement, AstraZeneca is responsible for all costs and activities related to its further development and commercialization.

As of the date of this announcement, AstraZeneca has initiated multiple clinical studies on CMG901 (AZD0901) for the treatment of advanced solid tumors. An international multicenter Phase III study comparing AZD0901 monotherapy with investigator-selected regimens as second-line or later treatment in subjects with Claudin 18.2-expressing advanced or metastatic gastric and gastroesophageal junction adenocarcinoma was registered and disclosed on the Drug Clinical Trial Registration and Information Platform in March 2024. The first subject received the initial dosing on April 11, 2024.