Huadong Medicine's MaiLi Precise dermal filler accepted for NMPA review

Huadong Medicine's wholly-owned subsidiary, Zhejiang Huadong Medicine Medical Technology Co., Ltd., announced that its application for the registration of MaiLi Precise, a cross-linked sodium hyaluronate gel for injection containing lidocaine, has been accepted by the National Medical Products Administration (NMPA). This Class III medical device application marks a key milestone for the product in the Chinese market.

MaiLi Precise is part of the MaiLi series, a range of premium hyaluronic acid dermal fillers from Sinclair Pharmaceuticals Limited, Huadong Medicine's UK-based wholly-owned subsidiary. The MaiLi series, which includes four products (Precise, Define, Volume, and Extreme), received CE certification in June 2020 and launched in Europe in the first half of 2021. The products incorporate an innovative OxiFree® patented technology and lidocaine for pain reduction during injection.

The company stated that this registration progress will not significantly impact its recent operating performance. The NMPA's acceptance initiates a technical review process, and subsequent approval will allow for production and sales. Huadong Medicine will continue to advance its research and development and registration efforts in China, cautioning investors about uncertainties in regulatory approval timelines and future market competition.