Shanghai Pharmaceuticals (601607) announced on the evening of January 13 that its subsidiary, Shanghai Pharmaceutical Kangli (Changzhou) Pharmaceutical Co., Ltd., received the " Chemical Raw Material " certificate for isaconazole sulfate raw material issued by the National Medical Products Administration.The drug was officially approved for production upon receiving the "Notification of Approval for Drug Marketing Application".

The announcement indicates that isaconazole sulfate is an azole antifungal drug and a prodrug of isaconazole. After entering the body, it is rapidly converted into the active metabolite isaconazole by plasma esterases, which disrupts fungal cell membrane formation by inhibiting ergosterol biosynthesis. This drug was jointly developed by Astellas Pharma and Basellia Pharma, and was approved for marketing in the United States in 2015 for the treatment of invasive aspergillosis and mucormycosis in adults. It has been granted orphan drug status in both the European Union and the United States.

Shanghai Pharmaceuticals Kangli submitted a registration and marketing application for the drug to the National Medical Products Administration in April 2024, which was accepted. As of the date of this announcement, the company has invested approximately RMB 5.1287 million in research and development for the drug. The packaging specifications of the active pharmaceutical ingredient include 1kg/drum, 2kg/drum, 5kg/drum, and 10kg/drum, and it can be sold in the domestic market after approval.

In terms of the market, IQVIA database shows that in 2024, hospitals in mainland China purchased 304 million yuan worth of isaconazole sulfate preparations. Currently, Shanghai Disano Chemical Pharmaceutical Co., Ltd. is already a domestic manufacturer of these products.Several companies, including Limited Liability Company and Jiangxi Guoyao Co., Ltd., have established operations to produce this active pharmaceutical ingredient.

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