Apeloa Pharmaceutical (000739.SZ): Deuterated enzalutamide API receives approval for chemical API marketing application

Apeloa Pharmaceutical (000739.SZ) announced that recently, its wholly-owned subsidiary Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd. received the "Chemical API Marketing Application Approval Notice" for deuterated enzalutamide API issued by the National Medical Products Administration. Hainaan (deuterated enzalutamide soft capsules) is a novel androgen receptor (AR) inhibitor developed by Hinova Pharmaceuticals Inc. based on its deuterated drug R&D platform. The drug was approved for marketing by the National Medical Products Administration in May 2025, subsequently included in the 2025 CSCO Prostate Cancer Diagnosis and Treatment Guidelines as a recommended treatment regimen across all lines for mCRPC, and included in the National Reimbursement Drug List in December 2025. The receipt of the "Chemical API Marketing Application Approval Notice" for deuterated enzalutamide API fully demonstrates the company's comprehensive competitiveness in CDMO business R&D, production, and system assurance, and will bring a certain positive impact on the company's future operations; it will also effectively ensure the supply of deuterated enzalutamide API, helping partners advance product development and benefit patients.