Recently, Hunan Warner Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") announced that its wholly-owned subsidiary, Hunan Warner Pharmaceutical Chiral Drugs Co., Ltd., has received the Notice of Approval for Marketing Application of Chemical API for Brivudine (Application No.: CYHS2160503) issued by the National Medical Products Administration (NMPA). The approval has been publicized on the "Public Disclosure of Registration Information for APIs, Pharmaceutical Excipients and Pharmaceutical Packaging Materials" platform of the Center for Drug Evaluation (CDE), NMPA. The relevant information is hereby announced as follows:
I. Certificate Information
Product Name: Brivudine
Registration No.: Y20210000804
Application Type: Marketing Application for Domestically Manufactured Chemical API
Packaging Specifications: 1kg/drum, 5kg/drum, 10kg/drum, 15kg/drum, 20kg/drum, 25kg/drum
Manufacturer: Hunan Warner Pharmaceutical Chiral Drugs Co., Ltd.
Manufacturing Address: No. 139, Tongguan Avenue, Tongguan Circular Economy Industrial Base, Wangcheng District, Changsha City, Hunan Province
Approval Conclusion: Pursuant to the Pharmaceutical Administration Law of the People's Republic of China, upon review, this product complies with relevant provisions for generic drug approval, and its production is hereby approved.
Joint Review Result with Formulations: A (Approved for use in marketed formulations)
II. Drug Information
Brivudine is a nucleoside analog that inhibits the replication of Varicella-Zoster Virus (VZV). In virus-infected cells, brivudine undergoes a series of phosphorylations. The intracellular phosphorylation process is catalyzed by viral thymidine kinase, ultimately forming brivudine triphosphate, which inhibits viral replication. This process occurs exclusively in virus-infected cells, conferring high selectivity to the antiviral activity of brivudine.
