By Fineline Cube 
China-based Betta Pharmaceuticals (SHE: 300558) announced a market approval filing in Macau for its ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor co-developed with its affiliate Xcovery. The drug is indicated for first-line treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
Ensartinib’s Approval Timeline
Ensartinib received market approval in China in March 2022 for the treatment of first-line ALK-positive locally advanced or metastatic NSCLC. This indication was included in the National Reimbursement Drug List (NRDL) in 2023. The drug also secured approval in the US in December 2024. Xcovery initiated the market filing for ensartinib with the European Medicines Agency (EMA) for the same indication in February of this year.
Clinical Development
In addition to its approved indications, ensartinib is undergoing a Phase III study in China as a postoperative adjuvant therapy for ALK-positive NSCLC.-Fineline Info & Tech