"Science enthusiasts for beauty, good news! MaiLi Extreme has been approved domestically, Huadong Medicine (000963.SZ) makes a new breakthrough in the high-end medical beauty market."

On January 20, 2025, Huadong Medicine Co., Ltd. (000963.SZ) announced that its wholly-owned subsidiary Xin Ke Li Mei Xue (Shanghai) Medical Technology Co., Ltd. (hereinafter referred to as "Xinke Li Mei Xue Shanghai") has received the "Medical Device Registration Certificate" issued by the National Medical Products Administration (NMPA) for three types of medical devices it applied for on behalf of, including the MaiLi Extreme cross-linked hyaluronic acid sodium gel containing lidocaine for injection, and has obtained approval for listing. It is reported that the MaiLi series consists of four products, including MaiLi Precise, MaiLi Define, MaiLi Volume, and MaiLi Extreme, all of which have been launched in Europe and can be used for different parts of the face, providing a comprehensive solution for facial beauty filling for those seeking beauty. Using the OxiFree patented technology to innovate the high-end medical aesthetics filling market The announcement stated that Sinclair, a wholly-owned subsidiary of Huadong Medicine in the UK, holds the exclusive global license for the MaiLi series products. The MaiLi series products contain lidocaine, which can reduce the pain during the injection process. The innovative OxiFree patented technology used in these products can reduce the amount of cross-linking agent used, prolong the maintenance time, have excellent rheological properties, especially better filling ability, reduce the amount of product injected, and provide lasting filling effects. As the product with the highest hyaluronic acid concentration and the strongest volumizing ability in the MaiLi series products, MaiLi Extreme can instantly fill and shape after injection, rapidly improving the jaw contour of patients with retruded jaw. This product has undergone and completed a prospective, multicenter, randomized, non-therapeutic controlled, evaluator-blind, superiority clinical trial in China to evaluate the effectiveness and safety of cross-linked hyaluronic acid sodium gel containing lidocaine for chin filling, showing good filling performance and safety. The MaiLi series products mainly target the high-end market, aiming to fill the gap in the demand for high-end medical aesthetics in China. According to the blue book "Current Development Status and Future Trends of Medical Aesthetic Injection Products" published by Frost & Sullivan, non-surgical medical aesthetic projects represented by injection and photonics are more widely accepted by consumers due to their low invasiveness and quick recovery characteristics. Among them, injection projects have the advantages of strong shaping ability and visible effects, and are widely favored by the market. According to the global statistics released by The International Society of Plastic Surgery (ISAPS), hyaluronic acid is one of the most widely used and most frequently applied materials in non-surgical medical aesthetic injection projects. The global number of plastic surgeons performing hyaluronic acid injections reached 5.56 million procedures in 2023, accounting for 29.0% of all non-surgical medical aesthetic projects, with a year-on-year growth of 29.1%. According to BOC International's calculations, China's hyaluronic acid injection market is expected to reach a size of 46.6 billion yuan in 2025, with a penetration rate increasing from 1.28% in 2021 to 2.28% in 2025. This product obtained the EU CE certification in June 2020 and was launched in the European market in the first half of 2021, receiving positive feedback. In July 2024, the MaiLi series products were successfully launched in Singapore, actively exploring new markets. Therefore, the MaiLi series products have accumulated rich experience in the international market, and this approval for listing of MaiLi Extreme in China is expected to bring more facial filling solutions to beauty seekers in China. In addition, the new high-end lidocaine hyaluronic acid product MaiLi Precise completed the enrollment of all subjects in China's clinical trial on April 30, 2024. The study aimed to evaluate the effectiveness and safety of injecting MaiLi Precise in the subdermal region of the lower eyelids to correct the hollowing of the lower eyelids. MaiLi Precise is the lowest concentration of hyaluronic acid sodium in the MaiLi series, with a smaller G'(Elastic Modulus), making it more suitable for filling injections in the lower eyelids to achieve instant filling and shaping effects, rapidly improving the hollowing of the lower eyelids. Huadong Medicine expands its medical aesthetics territory further, creating a one-stop facial aesthetic solution Huadong Medicine continues to layout in the field of medical aesthetics, enriching its pipeline of injection products to provide beauty seekers with a one-stop facial complete aesthetic solution. As of now, in the field of injectable fillers, in addition to the MaiLi series, Huadong Medicine owns several important products, including Ellans and Lanluma V-shaped and X-shaped regenerative fillers, botulinum toxin product YY001, achieving full coverage of the regenerative, hyaluronic acid, and botulinum toxin categories, with two or more differentiated product pipelines in each category. Ellans is one of the core products of Huadong Medicine's medical aesthetics, and its clinical layout in China is progressing smoothly. Ellans has been dubbed "the juvenile needle" for its excellent triple effect of "instant filling, long-lasting maintenance, and natural metabolism." Ellans S-type has been launched in China, being the first imported PCL high-end facial filler approved as a third-class medical device in China, and added the indication of "improving forehead contour through forehead filling" in November 2024, completing the enrollment of all subjects. Ellans M-type completed the 18-month safety follow-up in China in October 2024. Huadong Medicine's another regenerative medical aesthetic filler, Lanluma, a polylactic acid collagen stimulant.Clinical trials are also progressing rapidly. In November 2024, all subjects have been enrolled in the clinical trial of Lanluma V for improving lower jaw contour defects. Lanluma is currently the only regenerative product approved for filling in the buttocks and thighs, with CE certification in the EU obtained in 2020. So far, it has been approved for sale in 32 countries and regions worldwide.In addition, Huadong Medicine's exclusive distributor product YY001, a recombinant type A botulinum toxin for injection, used to improve moderate to severe glabellar lines, received market approval on December 31, 2024 and was accepted by the National Medical Products Administration. It is worth mentioning that YY001 is the world's first and currently the only recombinant type A botulinum toxin product that has submitted a market application. Huadong Medicine continues to advance its clinical layout of injectable filler pipelines internationally, accelerating the globalization of high-end medical aesthetics. The company's new patent ingredient dermal filler KIO021 has started clinical trials in China. KIO021 has the same ingredients as KIO015 but with different specifications. KIO015 submitted a CE certification application to the European Union in July 2024, and is expected to obtain EU CE-MDR certification in 2025. Huadong Medicine stated that KIO015 is expected to become the world's first non-animal source chitosan medical aesthetic filler. Looking at the overall product pipeline layout, Huadong Medicine has achieved full coverage of the high-end market in non-surgical medical aesthetic injection products and energy source devices globally. The product portfolio covers mainstream non-surgical medical aesthetic areas such as improving glabellar lines, facial and body fillers, thread lifting, skin management, body shaping, hair removal, intimate repairs, and more. Huadong Medicine's medical aesthetic business upholds the strategy of "global operation layout, dual-cycle business development". With an international perspective, and through forward-looking layouts, it has built a comprehensive and differentiated product matrix. The number and coverage of products both rank at the forefront of the industry, with over twenty products already on the market domestically and internationally, and more than ten global innovative products under development. By integrating diverse joint treatment methods such as "non-invasive + minimally invasive", "facial + body", "product + technology", and "injection + energy source equipment", it provides a more professional, safe, efficient, and comprehensive solution for beauty seekers, striving to be a leading provider of comprehensive medical aesthetic solutions globally. Looking ahead, Huadong Medicine will continue to focus on the global high-end medical aesthetic market with a more open and forward-looking approach, continuously improving its product pipeline, and forming an international medical aesthetic business system that integrates research and development, manufacturing, and marketing. Leveraging the global operating platform of its core subsidiary Sinclair, the company will integrate technological innovation resources to achieve global operations in medical aesthetics, continuously introducing high-tech and high-potential "medical aesthetics + beauty" products into the Chinese market, and accelerating the landing and commercialization process of international high-quality medical aesthetic products. It aims to provide a more diverse and personalized medical aesthetic service for beauty seekers worldwide.