By Fineline Cube 
Betta Pharmaceuticals (SHE: 300558) announced the initiation of a market approval filing with the European Medicines Agency (EMA) for its anaplastic lymphoma kinase (ALK) inhibitor, ensartinib. The drug is under co-development with Betta affiliate Xcovery. The Chinese firm is seeking EMA approval for the drug’s use as a first-line treatment for ALK + locally advanced or metastatic non-small cell lung cancer (NSCLC).
Drug Background
Ensartinib received market approval in China in March 2022 for the treatment of first-line ALK-positive locally advanced or metastatic NSCLC. The indication was included in the National Reimbursement Drug List (NRDL) in 2023. The drug also gained approval in the US in December 2024.
EMA Filing Details
The EMA filing marks a significant step in Betta’s efforts to expand the global reach of ensartinib. The company aims to provide a new treatment option for patients with ALK + NSCLC in Europe.-Fineline Info & Tech