Huadong Medicine's MaiLi Precise Gets NMPA Approval as China's First Injectable for Infraorbital Hollows

Huadong Medicine's wholly-owned subsidiary Xinke Li Mei (Hangzhou) Medical Technology Co. , Ltd. applied for the Class III medical device "cross-linked sodium hyaluronate gel for injection with lidocaine" MaiLi Precise, which received the Medical Device Registration Certificate from the National Medical Products Administration (NMPA), and the registration application was approved for market. The product is intended for subcutaneous and subperiosteal injection in the infraorbital region to correct moderate to severe infraorbital hollows, making it the first injectable product approved in China for the treatment of infraorbital hollows.

The MaiLi series is a premium sodium hyaluronate gel product under Xinke Li Mei. It obtained CE certification in the EU in June 2020 and was launched in the European market in the first half of 2021. MaiLi Precise is the lowest hyaluronic acid concentration in the MaiLi series and can immediately correct infraorbital hollows after injection. A prospective, multicenter, randomized, no-treatment control, evaluator-blinded, superiority clinical trial completed in China demonstrated its good filling performance and safety.

According to data from the International Society of Aesthetic Plastic Surgery, global hyaluronic acid injection procedures exceeded 6.3 million in 2024, accounting for 30.9% of all non-surgical aesthetic procedures, up 5.2% from 2023. In the domestic market, China's hyaluronic acid injection market exceeded RMB 50 billion in 2024, with a compound annual growth rate of 22.7% from 2020 to 2024.

Huadong Medicine stated that the approval of MaiLi Precise will not have a significant impact on its current financial condition and operating results, but will have a positive effect on future performance. The company's medical aesthetics business adheres to a "global operation layout, dual-cycle business development" strategy, with multiple R&D centers and production bases worldwide, focusing on the R&D and production of aesthetic injectables and energy-based devices, with products sold to more than 80 countries.