Betta Pharmaceuticals (300558.SZ): The registration application for Enzalutamide Hydrochloride Capsules for postoperative adjuvant therapy indications has been accepted.

date
12:07 26/11/2025
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GMT Eight
Bethesda Pharmaceuticals (300558.SZ) has issued an announcement that the company has received a notice from the National Medical Products Administration (referred to as "NMPA" below)
Betta Pharmaceuticals (300558.SZ) announced that the company has received a "Notice of Acceptance" (Acceptance No.: CXHS2500142, CXHS2500143) issued by the National Medical Products Administration (NMPA) for the application of the market approval of the esainib hydrochloride capsules (trade name: Beimina, hereinafter referred to as "esainib") submitted by the company for "postoperative adjuvant therapy for patients with stage IB to IIIB non-small cell lung cancer (NSCLC) positive for anaplastic lymphoma kinase (ALK), who have previously undergone surgical resection and have been determined by a doctor to receive or not receive adjuvant chemotherapy."