卫信康(603676.SH)：利多卡因丁卡因乳膏获药物临床试验批准

Core Viewpoint - Weitengkang (603676.SH) announced that its wholly-owned subsidiary, Tibet Zhongwei Chengkang Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the clinical trial of Lidocaine and Bupivacaine Cream, marking a significant step in the development of this product for local anesthesia in adult skin surgeries [1] Group 1: Clinical Trial Approval - The NMPA approved the clinical trial application for Lidocaine and Bupivacaine Cream, which was submitted on September 17, 2025, confirming compliance with drug registration requirements [1] - The cream is intended for local anesthesia on intact skin prior to adult skin surgeries [1] Group 2: Product Background - Lidocaine and Bupivacaine Cream was developed by Zars Company and received FDA approval in the United States on June 29, 2006, under the brand name Pliaglis, with a formulation containing 70mg of Lidocaine and 70mg of Bupivacaine per gram [1] - The NMPA's 31st batch of reference preparation catalog specifies that the reference preparation for this cream is the unimported original drug approved in the U.S. Orange Book and the EU, with licensed manufacturers being Taro Pharmaceuticals and Difa Cooper SPA/Galderma Laboratorium GmbH [1] - Currently, this product is not available in the domestic market [1]