Apeloa Pharmaceutical's Deuterated Enzalutamide API Receives Marketing Approval for Chemical Drug Substance Application

Stock News

Oct 08

Apeloa Pharmaceutical Co.,Ltd. (000739.SZ) has announced that its wholly-owned subsidiary, Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd., recently received a Chemical Drug Substance Marketing Application Approval Notification issued by the National Medical Products Administration for deuterated enzalutamide API.

Hainaan (deuterated enzalutamide soft capsules) is a novel androgen receptor (AR) inhibitor developed by Hinova Pharmaceuticals Inc. based on its deuterated drug research and development platform. The drug was approved for marketing by the National Medical Products Administration in May 2025, subsequently included in the 2025 edition of the CSCO Prostate Cancer Diagnosis and Treatment Guidelines as a full-line recommended treatment option for mCRPC, and incorporated into the National Medical Insurance Drug Catalog in December 2025.

The receipt of the Chemical Drug Substance Marketing Application Approval Notification for deuterated enzalutamide API fully demonstrates the company's comprehensive competitiveness in research and development, production, and system assurance within its CDMO business, 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.

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(000739.SZ) has announced that its wholly-owned subsidiary, Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd., recently received a <b>Chemical Drug Substance Marketing Application Approval Notification</b> issued by the National Medical Products Administration for deuterated enzalutamide API.<br><br>Hainaan (deuterated enzalutamide soft capsules) is a novel androgen receptor (AR) inhibitor developed by Hinova Pharmaceuticals Inc. based on its deuterated drug research and development platform. 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(000739.SZ) has announced that its wholly-owned subsidiary, Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd., recently received a Chemical Drug Substance Marketing Application Approval Notification issued by the National Medical Products Administration for deuterated enzalutamide API.Hainaan (deuterated enzalutamide soft capsules) is a novel androgen receptor (AR) inhibitor developed by Hinova Pharmaceuticals Inc. based on its deuterated drug research and development platform. The drug was approved for marketing by the National Medical Products Administration in May 2025, subsequently included in the 2025 edition of the CSCO Prostate Cancer Diagnosis and Treatment Guidelines as a full-line recommended treatment option for mCRPC, and incorporated into the National Medical Insurance Drug Catalog in December 2025.The receipt of the Chemical Drug Substance Marketing Application Approval Notification for deuterated enzalutamide API fully demonstrates the company's comprehensive competitiveness in research and development, production, and system assurance within its CDMO business, and will bring a certain positive impact on the company's future operations. 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