Shanghai Pharmaceuticals Holding(02607): The listing application for the raw material drug Tamsulosin hydrochloride has been approved.
Shanghai Pharmaceuticals (02607) announced that recently, its subsidiary Shanghai Pharma Kangli (Changzhou) Pharmaceutical Co., Ltd. (hereinafter referred to as "Shanghai Pharma Kangli") received the "Notice of Approval of Chemical Raw Material Drug Market Application for Approval of Listing for Hydrochloride Tamsulosin Raw Materials" issued by the National Drug Administration (Certificate No.: 2026YS00102), and the drug has been approved for production.
Shanghai Pharmaceuticals Holding (02607) announced that its subsidiary Shanghai Kangli (Changzhou) Pharmaceutical Co., Ltd. (hereinafter referred to as "Shanghai Kangli") recently received the "Chemical Raw Material Drug Market Approval Notice" (Certificate No.: 2026YS00102) issued by the National Medical Products Administration for Tamsulosin Hydrochloride raw material drug, allowing the drug to be produced.
Tamsulosin hydrochloride is a third-generation highly selective long-acting 1 inhibitor, used for the treatment of benign prostatic hyperplasia (BPH). It was developed by Yamanouchi Pharmaceutical in Japan and approved for marketing by the United States Food and Drug Administration in July 1992. In July 2024, Shanghai Kangli submitted an application for registration and market approval of the drug to the National Medical Products Administration, and it was accepted. As of the date of this announcement, the company has invested approximately RMB 1.5 million in research and development expenses for this drug.
The approval of the Tamsulosin hydrochloride raw material drug market application indicates that the raw material drug meets the relevant requirements for drug registration in China and can be sold in the domestic market, while also accumulating valuable experience for the company in future applications for raw material drugs. These developments are not expected to have a significant impact on the company's current operating performance.
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