Betta Pharmaceuticals (300558.SZ): Ensartinib Hydrochloride Capsules' Marketing Authorization Application Accepted by EMA

Stock News11-28

Betta Pharmaceuticals Co., Ltd. (300558.SZ) announced that its subsidiary Xcovery received notification from the European Medicines Agency (EMA) regarding the acceptance of its marketing authorization application for Ensartinib Hydrochloride Capsules ("Ensartinib"). The application seeks approval for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Ensartinib is a novel, potent, and highly selective next-generation ALK inhibitor. Its second-line indication, targeting ALK-positive locally advanced or metastatic NSCLC patients who have progressed on or are intolerant to crizotinib, was approved by China's National Medical Products Administration (NMPA) in November 2020. Additionally, its first-line indication for ALK-positive locally advanced or metastatic NSCLC patients was approved by the NMPA in March 2022.

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