Betta Pharmaceuticals Co.,Ltd. (300558.SZ) has announced that its holding subsidiary, Xcovery Holdings, Inc., has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use regarding the marketing authorization application for ensartinib hydrochloride capsules. The committee has recommended approval of ensartinib for the treatment of adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer. This regulatory milestone marks a significant step forward in the company's international expansion efforts.

The European Commission will now make a final decision on the marketing authorization application based on the positive opinion from the committee, with the outcome still subject to uncertainty. The recommendation from the committee serves as a critical scientific assessment, but it does not guarantee final approval by the European Commission. Investors and stakeholders are advised to monitor subsequent regulatory developments closely as the company awaits the final decision on this oncology treatment.

Ensartinib, if approved, would provide an additional targeted therapy option for patients with ALK-positive advanced NSCLC in the European market. The company continues to advance its pipeline and regulatory strategies across global markets while maintaining focus on addressing unmet medical needs in oncology.