江苏联环药业股份有限公司关于公司获得《药品注册证书》的公告

Core Viewpoint - Jiangsu Lianhuan Pharmaceutical Co., Ltd. has received the Drug Registration Certificate for Lidocaine Hydrochloride Gel from the National Medical Products Administration, marking a significant milestone in the company's product development and regulatory compliance [1][4]. Group 1: Drug Registration Certificate Details - The Drug Registration Certificate pertains to Lidocaine Hydrochloride Gel, which is indicated for local anesthesia during procedures requiring such intervention [1]. - The company is one of three domestic enterprises that have obtained this Drug Registration Certificate for the product [1]. - The estimated sales revenue for Lidocaine Hydrochloride Gel in national secondary hospitals and above is approximately 40.86 million yuan in 2024 [1]. Group 2: R&D Investment and Production Approval - As of the announcement date, the cumulative R&D investment for this project is approximately 7.27 million yuan (unaudited) [2]. - This is the first production license obtained by the company in 2026 [3]. Group 3: Impact on the Company - The acquisition of the Drug Registration Certificate for Lidocaine Hydrochloride Gel enhances the company's product line and is expected to improve its market competitiveness [4]. - The impact of this certificate on the company's near-term operating performance is not anticipated to be significant [4].