China Medical System Holdings Limited (the “Group” or “CMS”) and Jiangsu Xihong Biopharma Co., Ltd. (“Xihong Biopharma”) jointly announced that on July 10, 2025, the registration certificate of the Class Ⅲ medical device, Poly-L-lactic Acid Microparticle Filler Injection (the “Product”), has been approved by the National Medical Products Administration of China (NMPA) (Medical Device Registration Certificate No. 国械注准20253131356), which marks a significant milestone for CMS in the regenerative product field, further expanding its consumer healthcare product portfolio.
Poly-L-lactic Acid Microparticle Filler Injection
The Product is approved for deep dermis and subcutaneous layer of nasolabial fold injection for the correction of moderate to severe nasolabial fold wrinkles. Its main component, Poly-L-lactic Acid (PLLA), is the high polymer material that is highly biocompatible and completely degradable, and is widely used in the fields of micro-plastic surgery, sports medicine, neurosurgery, etc., with proven safety and efficacy. PLLA gradually degrades after injection, which can effectively stimulate human body’s collagen regeneration to promote skin rejuvenation. In addition, the Product adopts patented microparticle preparation process, which turns microparticles into regular shape and uniform size, and microparticles can be evenly distributed beneath the dermis, and the Product could achieve relatively sound performance in the clinical application.
In recent years, Chinese consumers’ demand for safe, natural and personalized anti-aging solutions is increasing. Technological progress and innovative products iteration have made the regenerative products market showing strong growth resilience. According to the industry report of LeadLeo Research Institute, the market size of micro-plastic surgery injection products in China was RMB21.2 billion in 2023 and is expected to increase to RMB65.3 billion in 2028, with a 25.3% compound annual growth rate (CAGR) during the period[1]. Among all material segments, regenerative anti-aging products are in the fastest growing segment, with a 38.2% CAGR during the period, significantly exceeding growth rates of overall and other material markets [1].
Ms. Xiong Yafang, Head of CMS’s related business, stated that the Product’s core component, PLLA, can apply to multiple skin layers for light filling and skin rejuvenation, restoring youthfulness for consumers. The approval of the Product marks a new chapter for CMS of the microsphere-stimulated regenerative products, synergizing with marketed Modified Sodium Hyaluronate Filler for Injection, and pipeline products, including Polycaprolactone Microsphere Gel for Injection, Calcium Hydroxylapatite Microsphere Gel for Injection, and Decellularized Extracellular Matrix Implant, to enrich and improve the mainstream micro-plastic surgery injection product portfolio. In the future, leveraging the unique advantages of each material in our product portfolio, we will collaboratively create comprehensive and scientific facial solutions to precisely address consumers’ diverse needs. Meanwhile, supported by CMS’s extensive channel resources in the related fields, quality regenerative products will benefit more consumers as soon as possible.
Mr. Zhang Tianming, General Manager of Xihong Biopharma, said that this approval is an important milestone for Eastenova (Chengdu) Biotechnology Co., Ltd. (“Eastenova”) and Xihong Biopharma as they continue to deepen their presence in the field of regenerative medicine materials. Based on the commercialization needs of the Product, we have entered into an exclusive license agreement with our strategic partner, CMS, which is responsible for the promotion, sales, and commercialization of the Product in Greater China. Through deep cooperation with market key players such as CMS, we are able to focus more on technological innovation and product quality optimization. Centering on research and development (R&D) innovation, we will continue to strengthen the construction of cutting-edge technology platforms to enhance our R&D, modification, and preparation capabilities in polymer materials and regenerative biomaterials, and insist on developing high-quality products to meet more market demands.
About Xihong Biopharma
Xihong Biopharma was established in 2016 and is a wholly-owned subsidiary of Eastenova. Eastenova is a healthcare company engaged primarily in the R&D, manufacturing, and commercialization of regenerative medicine medical devices and foods for special medical purposes (FSMPs). The Company focus on the development, transformation, and application of regenerative medicine materials, and the R&D of FSMPs (especially specific nutritionally complete formula foods).
The production base of Xihong Biopharma is designed in accordance with China’s GMP standards, EU MDR standards, and U.S. FDA standards for medical devices, and National Food Safety Standard (GB 29923-2023) for FSMPs. Its production workshop for regenerative medicine medical devices has a combined annual production capacity of up to 10 million doses, making it one of the largest regenerative medicine material production lines in the country. At the same time, the microfluidic production line of this production base has recently started operation, making it one of the first Chinese companies in the regenerative medicine industry to commence operation of microfluidic production line.
Eastenova has been concentrating on the regenerative medicine materials field, continuously advancing our research in cutting-edge technology and developing application scenarios, strategically exploring and developing regenerative biomaterials, and have accumulated various critical technologies, including those for the R&D, modification and preparation of polymer materials and the regenerative biomaterials, and the R&D and preparation for microspheres. Eastenova possesses the capabilities of translating our technology in regenerative medicine material into mature products which meets market demands. With accumulated R&D and technology transfer capabilities, as well as commercial-scale manufacturing capabilities, the Company will be committed to providing high-quality products and solutions for the medical healthcare industry in the long haul.
About CMS
CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.
CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.
CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries, strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology/ophthalmology/ skin health businesses. Among them, the skin health business has become a leading enterprise in its field, bringing economies of scale in specialty therapeutic fields. Meanwhile, CMS continuously deepens its business development in the Southeast Asia and Middle East regions, further escorting the sustainable and healthy development.
Reference
1、LeadLeo Research Institute. (2025, April 23). 2025 China regenerative anti-aging injectable aesthetics industry overview. https://mp.weixin.qq.com/s/Rw_Ap0d0Vgc7Qrte4D-6Tw
Disclaimer and Forward-Looking Statements by Xihong Biopharma
The information in this press release prepared by Xihong Biopharma is based solely on publicly available data from the National Medical Products Administration (NMPA) and internal records of the Company. The approval of registration certificate for medical devices does not mean that the product has entered the commercial sales stage. The actual progress in market promotion, production, and sales will be influenced by multiple factors such as supply chain management, market access policies, and channel construction. In other words, obtaining the registration certificate does not directly guarantee the Company’s future revenue or profits.
This press release may contain limited forward-looking statements based on current information, involving the subsequent development and listing process of products. Such statements involve inherent risks and uncertainties, and actual results may differ significantly from expectations due to multiple factors including policy adjustments, market competition, and technological iterations. The Company is not obligated to update any forward-looking information after the release of this press release.
Disclaimer and Forward-Looking Statements by CMS
This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.
This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.