Betta Pharma's Ensartinib accepted by NMPA for new lung cancer indication

Betta Pharmaceuticals announced its Ensartinib Hydrochloride Capsules (trade name: Bemeina®) has been accepted by China's National Medical Products Administration (NMPA) for a new indication. This application is for adjuvant treatment for ALK-positive IB to IIIB stage non-small cell lung cancer (NSCLC) patients after surgical resection. Ensartinib, an ALK inhibitor, was initially approved in November 2020 for second-line treatment of ALK-positive NSCLC and in March 2022 for first-line treatment.

The company highlighted that Ensartinib's adjuvant therapy data, first disclosed at the 2025 European Society for Medical Oncology (ESMO) annual meeting, showed promising results. The drug demonstrated an 86.4% 2-year disease-free survival (DFS) rate and a hazard ratio (HR) of 0.20, indicating an 80% reduction in recurrence risk. The drug was also approved by the US FDA in December 2024 and by the Macau Drug Administration in June 2025.

Currently, Alectinib is the only drug approved in China for ALK-positive NSCLC adjuvant treatment. The NMPA will now review Betta Pharmaceuticals' application, with the timing and outcome of the approval, as well as future sales, remaining uncertain.