Betta Pharma's ensartinib accepted by EMA for lung cancer application

Xcovery Holdings, Inc., a subsidiary of Betta Pharmaceuticals, announced its marketing authorization application for ensartinib hydrochloride capsules has been accepted by the European Medicines Agency (EMA). The application seeks approval for ensartinib to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive.

Ensartinib, a next-generation ALK inhibitor, has already gained significant traction. It received NMPA approval in November 2020 for second-line treatment and in March 2022 for first-line treatment of ALK-positive NSCLC. In December 2024, ensartinib was approved by the US FDA, marking it as the first small-molecule lung cancer targeted innovative drug led by a Chinese enterprise to be approved in the US.

The company formally initiated the EMA marketing authorization procedure for ensartinib in February 2025. While the acceptance by the EMA is a significant step, Betta Pharmaceuticals cautions investors regarding the uncertainties associated with the review timeline, approval outcome, and subsequent sales performance. Five ALK-positive lung cancer drugs are currently approved in Europe: crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib.