Breaking news! The world's first restructured type A botulinum toxin Ru-toxin has been approved. Huadong Medicine (000963.SZ) opens a new era of botulinum toxin.

On March 27, 2026, Huadong Medicine (000963.SZ) announced the approval of a new drug. According to the announcement, its affiliate Chongqing Yuyan Pharmaceutical Co., Ltd. independently developed and owns the global intellectual property rights of the injection of recombinant Type A botulinum toxin (research code: YY001, brand name: Ruixinxin), which has been approved for marketing by the National Medical Products Administration (NMPA) for temporary improvement of moderate to severe glabellar lines in adults aged 65 and under 65 due to activity of the corrugator supercilii and/or procerus muscles. Ruixinxin has the same biological function and pharmacological efficacy as natural botulinum toxin, with advantages such as high purity, good safety, and scalable production. Huadong Medicine holds the exclusive commercial rights in the aesthetic medicine field in mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region, as well as related preferential rights and negotiation rights, through its wholly-owned subsidiary Xinkelimei Medical Technology Co., Ltd. (Hangzhou), which holds a 4.2787% stake in Chongqing Yuyan Pharmaceutical Co., Ltd. The successful approval of Ruixinxin not only demonstrates the research and development strength of Yuyan Pharmaceutical but also signifies an important achievement for Huadong Medicine as a strategic shareholder in the high-end aesthetic medicine product layout. Addressing industry pain points and ushering in a new era of recombinant botulinum toxin technology The announcement states that the approval of Ruixinxin for marketing is based on a multicenter, randomized, double-blind, placebo and positive drug parallel controlled Phase III clinical trial conducted in China to evaluate the efficacy and safety of injection of recombinant Type A botulinum toxin in the treatment of moderate to severe glabellar lines. The clinical research results show that its efficacy, safety, and immunogenicity have met the established clinical trial endpoints and have shown superior performance compared to the control drug. The mechanism and wide application of Type A botulinum toxin is well understood, but the long-term development of the industry has been constrained by two major bottlenecks. The first is the reliance on pathogenic botulinum toxin in the production process, which poses inherent biosecurity risks. The second is the low purity of active protein in the majority of Type A botulinum toxin products, which affects efficacy and safety. As the world's first recombinant Type A botulinum toxin, Ruixinxin innovates the technological route to avoid the biological security risks associated with traditional botulinum toxin production. At the same time, its innovative process ensures high purity, high specific activity, and low immunogenicity while maintaining protein activity. In the treatment of moderate to severe glabellar lines, YY001 demonstrates stable efficacy and good safety characteristics, significantly outperforming solvent efficacy, and achieving a higher composite response rate than onabotulinumtoxinA within the predetermined statistical testing framework. The research results support YY001 as a promising new choice in the treatment regimen of Type A botulinum toxin. Ruixinxin enters a botulinum toxin market with enormous potential. The Chinese botulinum toxin market is not only large in scale but also has strong growth momentum. According to data from Frost & Sullivan, the market size of botulinum toxin products in China increased from RMB 1.9 billion in 2017 to RMB 4.6 billion in 2021, with a compound annual growth rate of 25.6%. It is expected that the market size will reach RMB 39 billion by 2030. Based on the deep accumulation and channel resources in the high-end medical aesthetic market in China, Huadong Medicine will fully integrate the professional promotion capabilities in the public institution medical aesthetic field of the pharmaceutical industry and further strengthen the synergistic efficiency of the pharmaceutical commercial system. The company will systematically and comprehensively promote the market access, clinical promotion, and brand building of Ruixinxin, accelerating the realization of its maximum market value and consolidating and enhancing its leading position in the global medical aesthetic innovation field. Deepening the layout in the high-end medical aesthetic field and achieving full coverage of the core track of medical aesthetic injections and photonic fields Huadong Medicine has completed its strategic layout in the medical aesthetic field, successfully establishing a complete product matrix driven by both "medical aesthetic injections + photonic energy sources," achieving high-end product full coverage in all core tracks of non-surgical medical aesthetics. Currently, through forward-looking layout, the company has created a comprehensive and differentiated product matrix, with a large number of products and coverage areas leading the industry. It currently has over 40 high-end medical aesthetic products in the field of "non-invasive + minimally invasive," with more than 20 products already launched domestically and over 10 innovative products under development globally, covering mainstream non-surgical medical aesthetic fields such as facial filling, facial cleansing, threading, skin management, body contouring, hair removal, and intimate rejuvenation. Huadong Medicine has formed a comprehensive product cluster, with a large number of products and coverage areas leading the industry and continuously enhancing its international influence. In the injection field, Huadong Medicine has achieved comprehensive coverage of three major categories: regenerative, hyaluronic acid, and botulinum toxin. It owns several important products, such as EllansYveshy, MaiLi hyaluronic acid, Lanluma and Ruixinxin botulinum toxin, all of which have been successfully launched domestically. Each category has deployed two or more differentiated pipelines, providing solid product support to meet diverse market demands and build competitive barriers. Ellans Yveshy is one of the core products of Huadong Medicine's medical aesthetic portfolio, known as the "fountain of youth" due to its excellent triple effect of "immediate filling + long-lasting maintenance + natural metabolism." Ellans Yveshy S type has been launched in China and is the first imported PCL high-end facial filler product in China to be approved for three categories of medical device certifications. The U.S. clinical trial has completed the enrollment of all subjects; Ellans Yveshy M type's China registration application was accepted by NMPA in January 2025 and is pending approval. Huadong Medicine is continuing the domestic registration process for its MaiLi series products. Clinical trials have been conducted for MaiLi Precise and MaiLi Extreme in the series. MaiLi Extreme, with the highest concentration of hyaluronic acid and the strongest filling capacity in the MaiLi series, was officially launched for commercial sales in May 2025. As the product with the lowest sodium hyaluronate concentration in the MaiLi series, the registration application for MaiLi Precise was accepted by NMPA in October 2025. Furthermore, clinical trials for Lanluma, a stimulating agent for poly-L-lactic acid collagen, another regenerative medical aesthetic filler from Huadong Medicine, are progressing rapidly. Lanluma is currently the first regenerative product globally approved for filling buttocks and thighs. The product is available in two variations, V and X types, for filling smaller areas like the face, upper arms, neck, and the chest and neck shoulder triangle region, as well as larger areas like the buttocks. Its main component, poly-L-lactic acid PLLA, is also known domestically as the "child-like needle" in the filler category. In the field of photonic energy source devices, the company has achieved full coverage of the high-end market, with domestically approved products such as CoolSnow for cryo whitening, Reillys and Lanais for radiofrequency anti-aging, and Ru Pros for pulse light radiofrequency therapy. The registration application for the all-in-one skin rejuvenation product V30 was accepted in 2025 and will further strengthen Huadong Medicine's leading position in non-surgical medical aesthetic devices after its upcoming launch. Huadong Medicine is actively advancing the clinical layout of its injection filling pipeline internationally to accelerate the global reach of high-end medical aesthetics. All 500 subjects in the Chinese clinical trial of KIO021, a new patented skin injection filler, have been enrolled. KIO021, with the same composition as KIO015 but different specifications, is currently in the technical evaluation stage of EU MDR-CE certification. The successful approval and marketing of Ruixinxin not only represent a significant milestone in Huadong Medicine's medical aesthetic field but also demonstrate the company's steadfast commitment to meeting the diverse and high-quality treatment needs of patients in China. In the future, the company will continue to leverage its global research and development vision and local commercialization capabilities to transform more cutting-edge technologies into excellent products, create long-term value, and lead the upgrade of the medical aesthetics industry in China and globally, opening a new chapter of growth.