Yimei Biotech Advances in Regenerative Aesthetics with PLA and PCL-Based Injectables Following Inclusion in MIIT/NMPA 'Revealing Champions' Initiative

As the “beauty economy” continues to heat up, demand for medical aesthetics is steadily rising, and consumer expectations are becoming increasingly sophisticated—patients not only seek enhanced appearance but also desire “subtle enhancements,” raising the bar for safety, natural-looking outcomes, and long-term efficacy of aesthetic products.

Since 2021, three domestic medical aesthetic products based on regenerative materials have been successively approved for market launch. Offering more natural and longer-lasting results than hyaluronic acid, these products are driving the transition of medical aesthetic injections from the “filler era” into the “regenerative era,” catering to the urgent demands of countless beauty seekers. Consequently, 2021 has been hailed by the industry as the inaugural year of regenerative medical aesthetics, with its broad prospects for material innovation attracting a surge of capital and entrepreneurs.

BeautyOne (hereinafter referred to as “BeautyOne Tech”), a team with years of experience in innovative drug R&D, began its strategic layout in new materials and products for medical aesthetics as early as five to six years ago.

Guided by clinical medical needs, BeautyOne continuously explores the translational applications of novel biomaterials in the medical aesthetics industry. Leveraging a GMP-compliant process system and manufacturing management, the company ensures the delivery of high-quality medical aesthetic pharmaceutical and device products under stringent pharmaceutical-grade standards. Supported by a diversified R&D team specializing in novel biomaterials, medical devices, and pharmaceuticals, BeautyOne has established two key technological platforms: intelligent manufacturing of medical-grade biodegradable polymer-based pharmaceutical-device combination products, and preparation of active collagen alongside micro-nano processing. The company has successively developed a range of new subcutaneous injectable filler products, including those currently highly popular in the medical aesthetics market.Youth Rejuvenation Injections, Maiden Injections.

In recent years, the medical aesthetics industry has become a prominent sector within the “beauty economy,” maintaining sustained high market interest. According to iResearch’s *2022 China Medical Aesthetics Industry Research Report*, China’s medical aesthetics market reached RMB 217.9 billion in 2021, with a compound annual growth rate (CAGR) of 12.4%. The market size is projected to reach RMB 410.8 billion by 2025, representing a CAGR of 17.2% from 2021 to 2025, indicating that the industry is poised to sustain robust growth despite its already substantial scale.

According to a report released by Huajing Industry Research Institute, the penetration rate in mainland China is only 3.6%. Compared with the global medical aesthetics market, China’s medical aesthetics consumption penetration rate remains low, indicating substantial room for growth. It can be asserted that the domestic medical aesthetics market, which combines both medical and consumer attributes, has become a blue-ocean market with enormous potential.

It has become an industry trend for traditional pharmaceutical companies to enter the medical aesthetics sector. According to incomplete statistics, more than 30 large pharmaceutical companies have expanded their medical aesthetics product lines through various channels to capture a share of this hundred-billion-yuan blue ocean market. Notable examples include Huadong Medicine, Sihuan Pharmaceutical, Jiangsu Wuzhong, Fosun Pharma, and Yunnan Baiyao.

“Before our team entered the medical aesthetics sector, we conducted an in-depth study of the industry’s fundamental attributes. In my view, our accumulated technological achievements form the cornerstone, providing us with the confidence to develop robust products in this field. Furthermore, we must adhere to the pharmaceutical ethos of safety and efficacy, taking full responsibility for consumers,” said Niu Zhimeng, Founder and Chairman of BeautyOne.

Prior to founding BeautyOne, Niu Zhimeng worked for over two decades at multiple pharmaceutical companies in China, focusing on the research, development, and manufacturing of new drugs. This extensive experience has given him a deep understanding of the underlying technologies behind medical aesthetic drugs and devices. “For instance, the ‘Youth Restoration Injections,’ which have gained significant popularity in China’s regenerative medical aesthetics market, require the main ingredient, poly-L-lactic acid (PLLA), to be formulated into microspheres. The active pharmaceutical ingredients used to synthesize PLLA microspheres involve critical factors such as source, purity, and molecular weight design, all of which necessitate prolonged experimentation and evaluation by R&D departments. These underlying technologies are areas where we had already accumulated many years of experience and achieved high maturity in the pharmaceutical sector.”

“New compounds, new technologies, and new materials are the areas of greatest focus in pharmaceutical R&D.” Regenerative materials are novel biodegradable compounds capable of stimulating human fibroblasts to regenerate collagen. According to reports, mainstream medical aesthetic regenerative materials currently available in China include poly-L-lactic acid (PLLA) and polycaprolactone (PCL). PLLA-based “Youth Restoration Injections” and PCL-based “Girlhood Injections” have been on the international medical aesthetic market for many years. Naturally, medical-grade biodegradable polymer biomaterials represented by PLLA and PCL have become a key area of focus for BeautyOne.

Promoting the translational application of novel medical materials hinges on the integration of industry, academia, research, and clinical practice. Since its establishment, BeautyOne has maintained close collaboration with upstream and downstream sectors, including basic materials research and clinical healthcare.

As the core component of “youth-restoring injections,” poly-L-lactic acid (PLLA) is a synthetic, fully biodegradable thermoplastic aliphatic polyester that can be effectively broken down into carbon dioxide and water within the human body. In recent years, polylactic acid materials have seen widespread application and rapid development in various medical and pharmaceutical fields—including surgical sutures, controlled drug delivery systems, artificial skin, vascular stents, orthopedics, ophthalmology, and dentistry—due to their favorable plasticity and environmental friendliness. According to Zhiyan Consulting, China’s polylactic acid industry started relatively late, with market capacity building still in an accelerated phase and domestic supply capabilities remaining weak. For a long time, foreign companies have held more than 60% of the market share in China’s polylactic acid industry, with medical-grade polylactic acid becoming a critical bottleneck constraining industry development.

July 2023,The Ministry of Industry and Information Technology released the “List of Selected Units for the First Batch of the ‘Open Competition Mechanism’ for Innovation in Biomaterials.” The project “Medical Polylactic Acid Derivatives,” jointly applied for by BeautyOne as the lead entity, together with the Technical Institute of Physics and Chemistry of the Chinese Academy of Sciences, the Qingdao Institute of Bioenergy and Bioprocess Technology of the Chinese Academy of Sciences, Qingdao University of Science and Technology, Jingyu Furui Group, and Peking University First Hospital, was selected to undertake the critical task of achieving import substitution for this material.

“Upstream, we connect with universities and research institutes; downstream, we engage with hospitals and physicians. Serving as a bridge and industrialization platform, BeautyOne transforms innovative materials into market-ready products.” According to Niu Zhimeng, BeautyOne has specifically invested in establishing an R&D platform for medical-grade polymeric biomaterials and an intelligent manufacturing platform for pharmaceuticals and medical devices. To support the technological development of novel medical-grade polymeric biomaterials, the company is equipped with testing instruments such as rheometers, transdermal testers, and Malvern particle size analyzers to accurately evaluate relevant quality parameters of various new materials. Furthermore, referencing the latest technical guidelines for chemical injectable drugs, BeautyOne has established a comprehensive analytical and testing methodology for degradable aesthetic injectable filler materials. Leveraging its GMP “B+A” grade intelligent manufacturing platform for the engineering and production of novel polymeric material-based pharmaceuticals and medical devices, BeautyOne can rapidly convert new materials into new products, strictly ensuring product quality from the source of production.

“Regarding the selection of new aesthetic injection materials, our current focus is on two directions: first, regenerative collagen stimulators, including products such as Sculptra and Ellansé, which are based on poly-L-lactic acid (PLLA) and polycaprolactone (PCL), respectively, as well as other injectables with novel formulations for various indications; second, the collagen field, encompassing natural active collagen and recombinant collagen,” said Niu Zhimeng.

It has been disclosed that BeautyOne’s dermal fillers, including its “baby face” and “girl face” injectables, are currently in the clinical trial stage and have been successfully conducted at multiple Grade-A tertiary hospitals across China. In the field of collagen, BeautyOne has established an in-depth collaboration with the Center for Biomaterials at the Technical Institute of Physics and Chemistry, Chinese Academy of Sciences, to jointly build an internationally leading R&D platform for collagen technologies. A team comprising dozens of PhD holders from prestigious universities both in China and abroad is working collaboratively to advance the research and development of natural active collagen and recombinant humanized collagen.

Among these, the natural active collagen utilizes animal-derived collagen raw materials that are independently developed and manufactured. It exhibits high biological activity and strength, effectively preserves biological properties, and reduces the allergy rate associated with animal-derived products. Furthermore, targeted formulation optimization measures have been implemented to enhance its resistance to degradation in vivo. In contrast, the recombinant collagen employs full-sequence recombinant collagen raw materials that are independently developed and manufactured. Designed based on the characteristic sequences of human collagen, it includes the complete human collagen C-terminal peptide, Decorin recognition sequences, and RGD motifs, representing a technologically leading level within the industry.

“For us, the top priority is to develop safe and effective products, which aligns with our original aspiration in pharmaceutical development. Additionally, I hope that through our integrated industry-academia-research-medical practice supply chain layout, we can reduce the R&D and manufacturing costs of medical aesthetic products, thereby delivering more high-quality products that are affordable for consumers,” said Niu Zhimeng.

As the medical aesthetics industry undergoes transformation and upgrading, government authorities have intensified regulatory oversight in recent years, continuously issuing various guiding policies to rigorously rectify industry irregularities such as illegal medical aesthetic practices, unlicensed operations, and false advertising. This has provided high-tech enterprises like BeautyOne, which possess core proprietary technologies, with a “golden key” to market entry.

Xie Jianxun, General Manager of BeautyOne, stated in an interview that a favorable industry environment is more conducive to the long-term development of technology-driven enterprises. After all, medical aesthetic pharmaceuticals and medical devices differ from ordinary consumer goods; under the strict guidance of policies and regulations issued by regulatory authorities at all levels, medical aesthetic services must ultimately return to their medical essence. BeautyOne will continue to be guided by clinical value, rigorously developing high-quality medical aesthetic pharmaceuticals and medical devices in compliance with pharmaceutical and medical device requirements, thereby serving both patients seeking aesthetic improvements and physicians. Meanwhile, close collaboration between pharmaceutical/device companies and medical aesthetic institutions is the core force driving the industrial realization of new technologies and materials. Upstream and downstream enterprises need to engage in continuous joint research and development, constantly raising quality standards for products and services, and striving to provide “differentiated value” to the broad base of patients seeking aesthetic enhancements.