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

Zhito Finance APP News, Betta Pharmaceuticals (300558.SZ) announced that recently, the company learned that the marketing authorization application for Ensartinib Hydrochloride Capsules (hereinafter referred to as "Ensartinib") submitted by its controlling subsidiary Xcovery Holdings, Inc. (hereinafter referred to as "Xcovery") 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 positive opinion of the CHMP. Whether the marketing authorization application will be approved remains uncertain.