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卫信康(603676.SH):利多卡因丁卡因乳膏获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-12-03 08:00
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 for the clinical trial of Lidocaine and Bupivacaine Cream [1] Group 1 - The approved product, Lidocaine and Bupivacaine Cream, was developed by Zars Company and was approved by the FDA in the United States on June 29, 2006, under the brand name Pliaglis [1] - The cream contains 70mg of Lidocaine and 70mg of Bupivacaine per gram [1]
卫信康:利多卡因丁卡因乳膏获药物临床试验批准
Zhi Tong Cai Jing· 2025-12-03 07:51
Core Viewpoint - Weixingkang (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 Dicaine Cream, which is intended for local anesthesia in adult skin surgeries [1] Group 1 - The clinical trial application for Lidocaine and Dicaine Cream was accepted on September 17, 2025, and meets the requirements for drug registration [1] - The cream was developed by Zars Company and was approved by the FDA in the United States on June 29, 2006, under the brand name Pliaglis, containing 70mg of Lidocaine and 70mg of Dicaine per gram [1] - The NMPA's 31st batch of reference preparation directory identifies the reference preparation for Lidocaine and Dicaine Cream as the unimported original drug listed in the US Orange Book and the EU, with the license holders being Taro Pharmaceuticals and Difa Cooper SPA/Galderma Laboratorium GmbH [1] Group 2 - Currently, there are no domestic listings for this product in China [1]
卫信康:子公司获得药物临床试验批准通知书
Xin Lang Cai Jing· 2025-12-03 07:41
Core Viewpoint - The announcement indicates that the company's wholly-owned subsidiary, Tibet Zhongwei Chengkang, has received approval from the National Medical Products Administration for the clinical trial of Lidocaine and Bupivacaine Cream, which is a significant development for the company in expanding its product portfolio in the pharmaceutical market [1] Group 1: Product Development - The 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 [1] - The cream contains 70mg of Lidocaine and 70mg of Bupivacaine per gram [1] - Currently, there are no domestic listings for this product in China [1] Group 2: Regulatory Approval - The National Medical Products Administration has included the Lidocaine and Bupivacaine Cream in the 31st batch of reference preparation directory, confirming its status as a reference preparation for unimported original drugs listed in the US Orange Book and the EU [1] - The licensed manufacturers for the reference preparation are Taro Pharmaceuticals and Difa Cooper SPA/Galderma Laboratorium GmbH [1]