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华东医药高端医美产品MaiLi Precise国内注册申请获受理
Zheng Quan Shi Bao Wang· 2025-10-16 13:01
Core Insights - Huadong Medicine has made significant progress in the medical aesthetics sector with the acceptance of its MaiLi Precise product registration by the NMPA, marking a key milestone in the development of its high-end hyaluronic acid product line in China [1][2] Company Developments - The full subsidiary, Xinkelimeixue (Hangzhou) Medical Technology Co., Ltd., received the acceptance notice for the registration of MaiLi Precise, a Class III medical device containing lidocaine [1] - The MaiLi series includes four products: MaiLi Precise, MaiLi Define, MaiLi Volume, and MaiLi Extreme, all of which are already available in Europe [1] - MaiLi Extreme, known for its high concentration of hyaluronic acid, is set to be commercially launched in China by May 2025 [1] Product Details - MaiLi Precise is the lowest concentration product in the MaiLi series, designed to provide immediate correction for under-eye hollows, demonstrating good filling performance and safety in clinical trials [2] - The hyaluronic acid market in China is experiencing rapid growth, with a market size increase from 3.1 billion yuan in 2017 to 6.3 billion yuan in 2021, and projected to reach 44.1 billion yuan by 2030, reflecting a compound annual growth rate of 24.2% from 2021 to 2030 [2] Industry Context - The medical aesthetics hyaluronic acid market is characterized by both rapid growth and intense competition, with nearly 70 approved products in the domestic market by May 2025 [2] - The unique OxiFree "oxygen-free" cross-linking technology of the MaiLi series allows for stronger support and a lighter, more flexible effect with less product usage, positioning it as a safe and effective choice for consumers [3] Strategic Direction - Medical aesthetics is a core strategic area for Huadong Medicine, which aims to enhance its brand presence and market education domestically while promoting the registration and launch of more high-end medical aesthetic products both domestically and internationally [3]
华东医药三类医疗器械MaiLi Precise注册申请获得受理
Bei Jing Shang Bao· 2025-10-16 11:41
Core Viewpoint - Huadong Medicine's subsidiary, Xinkelimeixue (Hangzhou) Medical Technology Co., Ltd., has received a Notice of Acceptance from the National Medical Products Administration (NMPA) for its Class III medical device registration application for MaiLi Precise, a cross-linked hyaluronic acid gel containing lidocaine [1] Group 1 - The MaiLi series consists of four high-end hyaluronic acid gel products: MaiLi Precise, MaiLi Define, MaiLi Volume, and MaiLi Extreme, all of which are already marketed in Europe [1] - The registration application for MaiLi Precise has been officially accepted, indicating progress in the regulatory approval process in China [1]
锚定科技制高点 华东医药旗下Sinclair欣可丽美学高端玻尿酸MaiLi Precise国内注册获受理
Quan Jing Wang· 2025-10-16 10:32
Core Viewpoint - The acceptance of the registration application for MaiLi Precise by the NMPA marks a significant milestone in the development of high-end hyaluronic acid products by East China Pharmaceutical in the Chinese market [1][4]. Group 1: Product Development and Market Position - MaiLi series is a high-end hyaluronic acid brand under East China Pharmaceutical, consisting of four products, all of which are already launched in Europe [2]. - MaiLi Precise, the product recently accepted for registration, is designed to correct under-eye hollows and has shown good filling performance and safety in clinical trials [4]. - The Chinese hyaluronic acid market is experiencing rapid growth, with a market size increase from 3.1 billion yuan in 2017 to 6.3 billion yuan in 2021, and projected to reach 44.1 billion yuan by 2030, reflecting a compound annual growth rate of 24.2% from 2021 to 2030 [4]. Group 2: Competitive Advantage and Technology - The MaiLi series avoids competition in a saturated market by leveraging its high-end brand positioning and unique OxiFree technology, which preserves long-chain hyaluronic acid and reduces the need for chemical cross-linking agents [5]. - This innovative technology allows for stronger support and a lighter, more flexible effect with less product usage, providing a safer and more effective option for consumers [5]. Group 3: Strategic Expansion and Future Outlook - East China Pharmaceutical is committed to a global operational strategy and has a comprehensive product matrix covering various aesthetic medical fields, including injectables and energy-based devices [6]. - The company is actively expanding its international market presence, with multiple products undergoing registration in regions such as the Middle East and Europe [8]. - A rich pipeline of new products is expected to launch in the coming years, including new high-end hyaluronic acid fillers and a recombinant botulinum toxin, which will further enhance the company's market position [9].
华东医药(000963.SZ):子公司收到医疗器械注册申请受理通知书
Ge Long Hui A P P· 2025-10-16 10:25
Core Viewpoint - Huadong Medicine (000963.SZ) announced that its wholly-owned subsidiary, Xinkelimeixue (Hangzhou) Medical Technology Co., Ltd., received the Acceptance Notice from the National Medical Products Administration (NMPA) for its Class III medical device registration application for lidocaine injection cross-linked hyaluronic acid gel MaiLiPrecise [1] Group 1 - The application for MaiLiPrecise has been accepted by NMPA, indicating progress in regulatory approval [1] - MaiLi series products are high-end hyaluronic acid gel products owned by Sinclair Pharmaceuticals Limited, a wholly-owned subsidiary of the company [1] - The products are developed in collaboration with Kylane Laboratoires SA, a Swiss professional medical aesthetics R&D company, in which Sinclair holds a stake [1]