Betta Pharmaceuticals (300558.SZ): Marketing authorization application for ensartinib hydrochloride capsules receives positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use.

Betta Pharmaceuticals (300558.SZ) announced that recently, the company was informed that the marketing authorization application for ensartinib hydrochloride capsules (hereinafter referred to as "ensartinib") submitted by Xcovery Holdings, Inc. (hereinafter referred to as "Xcovery"), a controlled subsidiary of the company, has received a positive opinion from the Committee for Medicinal Products for Human Use (hereinafter referred to as "CHMP") of the European Medicines Agency (hereinafter referred to as "EMA"). The CHMP recommends approval of ensartinib for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). The European Commission (hereinafter referred to as "EC") will make a final decision on the marketing authorization application based on the CHMP's positive opinion, and whether the marketing authorization application will be approved remains uncertain.