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华东医药子公司获医疗器械注册申请受理
Xin Lang Cai Jing· 2025-10-16 10:13
Core Viewpoint - The announcement indicates that East China Pharmaceutical's subsidiary, Xinkeli Medical Technology Co., Ltd., has received an acceptance notice from the National Medical Products Administration for the registration application of the Class III medical device "MaiLi Precise," which is a cross-linked hyaluronic acid gel containing lidocaine. This marks a significant milestone in the product's development process in the Chinese market [1] Group 1 - The registration application for MaiLi Precise has been accepted, which is a crucial step for its market entry in China [1] - The MaiLi series products are globally licensed exclusively to East China Pharmaceutical's wholly-owned subsidiary, Sinclair Pharmaceuticals Limited [1] - The recent progress is not expected to have a significant impact on the company's short-term operating performance, but the company will continue to advance the registration and sales process domestically [1]