西藏卫信康医药股份有限公司 关于子公司获得药物临床试验批准通知书的公告

Core Viewpoint - The company, Tibet Weixin Kang Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of Lidocaine and Dicaine Cream, which is intended for local anesthesia in adult skin surgeries [1][2]. Drug Basic Information - Drug Name: Lidocaine and Dicaine Cream - Dosage Form: Cream - Specification: Each gram contains 70mg of Lidocaine and 70mg of Dicaine - Application: Clinical trial approval - Acceptance Number: CYHL2500168 - Approval Conclusion: The clinical trial application meets the requirements for drug registration and is approved for use in local anesthesia for intact skin prior to adult skin surgeries [1]. Other Relevant Information - The drug was developed by Zars Company and was approved by the FDA in the U.S. on June 29, 2006, under the brand name Pliaglis [2]. - Currently, there are no domestic listings for this product, but four companies have received clinical trial approvals: Jiangsu Yingke Biological Pharmaceutical Co., Ltd., Zhejiang Funuo Pharmaceutical Co., Ltd., Beijing Nobot Biological Technology Co., Ltd., and Kedi Biopharmaceuticals (Wuxi) Co., Ltd. [2]. - The company has invested approximately RMB 8.9453 million in the research and development of this drug as of October 2025 [3]. - The total sales amount for similar products, including Compound Lidocaine Cream and Dapiprazole Cream, in urban public hospitals and county-level public hospitals in China was approximately RMB 422 million in 2024 [3].