Wei Xinkang (603676.SH): Lidocaine tincaine cream approved for drug clinical trials

Zhitong Finance App News, Wei Xinkang (603676.SH) issued an announcement. Recently, the company's wholly-owned subsidiary, Tibet Zhongwei Chengkang Pharmaceutical Co., Ltd. (hereinafter referred to as “Tibet Zhongwei Chengkang”) received the approval and issuance of the “Drug Clinical Trial Approval Notice” for lidocaine tinocaine cream from the State Drug Administration (hereinafter referred to as the “State Drug Administration”). After review, the clinical trial application for lidocaine lactinocaine cream accepted on September 17, 2025 met the relevant requirements for drug registration and agreed that this product can be used for topical anesthesia on complete skin before adult skin surgery bed testing.

Lidocaine tincaine cream was developed by Zars and approved by the US FDA on June 29, 2006. The product name is Pliaglis. The specification is 70 mg of lidocaine and 70 mg of tetracaine per g. The 31st batch of reference formulations published by the China Drug Administration clearly states that the reference preparation for lidocaine tinocaine cream is an unimported original research drug marketed in the US Orange Book and the European Union. The licensees are Taro Pharms and Difa Cooper Spa/Galderma Laboratorium GmbH, respectively. Up to now, this product has not been marketed domestically.