Jiangsu Xihong Biopharma Co., Ltd. (“Xihong Biopharma”) 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 Xihong Biopharma 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].
Mr. Zhang Tianming, General Manager of Xihong Biopharma, said that this approval is an important milestone for Xihong Biopharma as they continue to deepen their presence in the field of regenerative medicine materials. 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.
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. Its production workshop for regenerative 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.
This certification milestone further demonstrates our ability to produce regenerative aesthetics products of high-standard quality, which are ready to be offered to international markets. We cordially invite global partners to engage in dialogue with us, and explore strategic cooperation opportunities together.
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
