Baoao Regeneration Medical: A Pioneer in Global First-in-Class Regenerative Medicine Products from Shaanxi

In recent years, regenerative medicine has become extremely popular.

According to Huajing Industry Research Institute, the global regenerative medicine market size reached USD 20.02 billion in 2021 and is projected to grow to USD 50.44 billion by 2025, with a compound annual growth rate (CAGR) of 25% from 2020 to 2025. Meanwhile, China’s regenerative medicine market size also reached RMB 28.5 billion in 2021, and with the continuous development of the regenerative medicine industry, it is expected to reach RMB 46.88 billion by 2025.

Moreover, it is even more encouraging that, unlike the import monopoly seen in many other high-end medical devices, there is no significant gap between domestic and international enterprises in the field of regenerative medicine. According to the "China's 2035 Development Strategy for Regenerative Biomedicine," using published papers and technical patents as indicators, China’s total volume of publications in regenerative biomedicine has ranked second only to the United States over the past decade, with its total number of related technical patent applications also ranking second globally.

And if we focus on the domestic market, various signs are indeed encouraging. From an investment and financing perspective, despite the periodic contraction of the capital market in recent years, enthusiasm for investment and financing in the regenerative medicine sector has remained undiminished. Notably, the number of Series A financing events has shown a wave-like upward trend over the past five years.

From the perspective of market competition, as regenerative medicine is still in its early stages of development overall, a stable competitive landscape has yet to emerge. In other words, opportunities remain in this market for companies at any stage of development.

Consequently, the domestic market has attracted wave after wave of enterprises to join. Among them, VCBeat has identified a “special” enterprise.

The company boasts a robust product pipeline that spans both serious medical sectors—such as ophthalmology, orthopedics, and surgery—and consumer healthcare segments, including functional skincare and oral care products. In addition to maintaining its own proprietary brands, the company leverages its technological platform to provide CDMO services. Furthermore, it utilizes its self-developed world’s first 3D skin model specifically for Asian populations to support R&D testing, marketing, and other services for cosmetics and pharmaceuticals.

It was also this company that, against the backdrop of a sluggish capital market in 2023, successfully completed a Series C financing round amounting to hundreds of millions of yuan and was recognized as one of the fifth batch of national “Specialized, Refined, Differential, and Innovative” (SRDI) Little Giants by the Ministry of Industry and Information Technology.

This enterprise is located in Xi'an, Shaanxi, and its name is Bio Regenerative.

All achievements made by Bio Regenerative are undoubtedly attributable to its core R&D team.

It is reported that Bio Regenerative has assembled an R&D team of over 150 professionals with diverse academic backgrounds in cell biology, molecular biology, materials science, and clinical medicine. The core R&D personnel possess more than 10 years of experience in medical research and development.

Some Core R&D Team Members of Bio Regenerative

Notably, Professor Jin Yan, the leader of Bio Regenerative’s core R&D team, was among the first researchers in China to conduct studies in regenerative medicine. The company’s current explorations in this field can be regarded as iterations and derivatives of his early research achievements.

Professor Jin Yan

In 1985, while pursuing his master’s and doctoral degrees in the Department of Oral Pathology at the Fourth Military Medical University (now the Air Force Medical University), Professor Jin Yan learned through literature review that human tissues, including oral tissues and other systemic organs, had a significant demand for regeneration. Determined to delve deeply into “regenerative medicine,” Professor Jin laid the foundation for what would become the starting point of China’s regenerative medicine field. Thanks to the efforts of Professor Jin and his team, China’s “tissue engineering and regenerative medicine” sector began to take shape. In 2007, the team achieved a groundbreaking milestone by securing the world’s first registration certificate for tissue-engineered products.

Since then, Professor Jin Yan and his team have achieved continuous breakthroughs in the field of regenerative medicine. In 2008, they successfully developed China’s first in vitro skin substitute testing model—the 3D reconstructed epidermal model—and achieved its industrialization. In 2011, Professor Jin served as the Chief Scientist for the National “973 Program” project on stem cell-based anti-aging research, successfully realizing clinical whole dental pulp regeneration based on stem cells, establishing a large-scale medical-grade stem cell bank, and developing stem cell therapeutic drugs. For these achievements, Professor Jin Yan was awarded the First Prize of the National Science and Technology Progress Award.

Professor Jin Yan Wins First Prize of the National Science and Technology Progress Award

Subsequently, in the field of pure tissue engineering (excluding cell-based technologies), Professor Jin Yan and his team successfully developed the first-generation tissue-engineered cornea and secured the world’s first registration certificate, making it the first artificial bio-cornea applied in clinical treatment globally. With this milestone, Bio Regenerative has now assembled its three world-class regenerative medicine scientific achievements.

It is evident that Bio Regenerative’s core R&D team has primarily ventured into the two major fields of tissue engineering and cell technology. These two domains collectively constitute the entire midstream sector of regenerative medicine (in the narrow sense). In other words, whether in tissue engineering technology, cell technology, or their cross-disciplinary applications, Bio Regenerative has not only established a presence but also achieved world-class scientific research outcomes, laying a solid foundation for subsequent technological iterations and applications.

As previously mentioned, Bio Regenerative’s products and business framework can be broadly categorized into consumer healthcare and serious medical care systems.

Among these, Bio Regenerative’s consumer healthcare products and business operations have advanced most rapidly, primarily comprising a moldable bone grafting material and an absorbable biological membrane in its dental product pipeline; its proprietary functional skincare brand, Zhanmeiya; a one-stop CDMO service platform; and cosmetic and pharmaceutical testing services within its organoid application segment.

Despite its broad product and business portfolio, Bio Regenerative is thriving across all its key sectors, including dental care, functional skincare, and organoid applications.

Let us first examine Bio Regenerative’s proud portfolio of dental restorative products. At present, Bio Regenerative has launched two product lines for dental restoration: a moldable bone graft material containing hyaluronic acid and a biofilm, both of which are first-of-their-kind in China.

Bio Regenerative's Aosu Product Pipeline

Bone repair materials (periosteum) and oral barrier membranes are primarily used for alveolar bone reconstruction in cases of insufficient bone volume during dental implantation, thereby ensuring the stability of implants post-insertion and improving the success rate of implant procedures. According to data released by the Chinese Stomatological Association, the domestic market size for oral barrier membranes was approximately RMB 1.35 billion in 2020, based on ex-factory prices.

As for bone repair powder, according to Zhongtai Securities, the market size of dental bone implant materials was approximately RMB 1.05 billion in 2018. Assuming a compound annual growth rate (CAGR) of 20%, the domestic market for dental bone implant materials would reach approximately RMB 1.5 billion in 2020.

Not only that, but with the launch of centralized procurement for dental implants, the market size for dental implants is expected to expand further, driving significant growth in the oral restorative materials market. According to Zhao Zheng, Director, Vice President, and Board Secretary of Bio Regenerative, the volume of dental implants exceeded 4 million units in 2022. It is projected that by 2025, market demand will surge to over 5.34 million grams of bone powder and 4.27 million sheets of bone membranes.

With its R&D team having long been deeply engaged in the field of oral bone regeneration, Bio Regenerative naturally seized the opportunity presented by this high-potential market and launched China’s first deproteinized natural bone composite with hyaluronic acid bone filler material (bone powder).

This product is primarily composed of 95% bovine cancellous bone granules and 5% hyaluronic acid gel, offering three major advantages: First, the added composite hyaluronic acid promotes the expression of osteogenic factors, accelerating early osteogenesis; meanwhile, the highly hydrophilic nature of hyaluronic acid facilitates rapid blood adsorption, thereby promoting tissue healing.

Second, the product employs low-temperature deproteinization technology, resulting in a bone-like structure that more closely resembles the human bone microarchitecture, thereby facilitating cell growth and promoting vascularization;

Meanwhile, through a low-temperature processing technique, Bio Regenerative retains carbonate within the inorganic components. According to relevant research findings, carbonated apatite can enhance the osteogenic activity of osteoblasts, promote the expression of osteogenesis-related genes, and augment bone resorption by osteoclasts. Following low-temperature processing, Bio Regenerative bone powder retains hydroxyapatite in a partially carbonated form, resulting in lower crystallinity that is better matched with new bone formation.

Furthermore, the product’s average specific surface area is as high as 118 m²/g.²/g, while the higher surface area and superior hydrophilicity also facilitate new bone deposition; meanwhile, the ultrastructure promotes cell adhesion, migration, and proliferation, thereby enhancing osteogenesis.

Third, to fully meet clinical needs and facilitate physician operation, the product can be further subdivided into moldable bone powder and granular bone powder. The former can be directly picked up with forceps for dry-state filling, while the latter comes with its own mixing cup, allowing for flexible shape adjustment according to the filling site while ensuring ease of use.

As for Bio Regenerative’s periosteal products, they are derived from bovine pericardium. As one of the most widely used extracellular matrix materials, bovine pericardium offers significant mechanical advantages and features dense fibrous tissue. When applied in the field of oral bone repair, it effectively acts as a barrier against soft tissue infiltration, thereby preserving the space necessary for bone growth.

Currently, Bio Regenerative’s bone grafting materials and absorbable biological membranes have both received regulatory approval. Thirty specifications of the bone grafting materials and seven specifications of the absorbable biological membranes are already listed for online procurement in all provinces except Fujian, Qinghai, Shanxi, and Liaoning. Furthermore, in May of this year, seven additional specifications of Bio Regenerative’s bone grafting materials were added, and preparatory work for their listing is now underway.

Having reviewed Bio Regenerative’s oral care product line, we now turn to its explorations in functional skincare and organoid applications.

In the field of functional skincare, Zhao Zheng revealed in an interview that, leveraging the R&D team’s years of research in clinical dermatology and regenerative medicine, Bio Regenerative has built an innovative CDMO platform. This platform provides the tech-driven skincare industry with one-stop CDMO services, including innovative raw material and formula development, testing, registration, manufacturing, intellectual property management, and product empowerment.

Bio Regenerative's Innovative CDMO Platform

Furthermore, leveraging its proprietary regenerative technology skincare brand, Jumeiya, which is built upon two major technological platforms—intelligent targeted supramolecules and ultra-microvesicles—Bio Regenerative provides comprehensive, precision anti-aging solutions tailored to different skin types and usage scenarios. Simultaneously, it offers precise skincare regimens for various sub-health skin conditions through its six major product series.

As for the organoid application business segment, it is a service provided by Bio Regenerative to cosmetics companies and pharmaceutical enterprises based on its series of 3D skin tissue models.

Bio Regenerative: The World's First 3D Skin Model for Asians

As previously mentioned, the core R&D team at Bio Regenerative successfully developed the world’s first 3D skin model for Asians. By applying timed culture tissue engineering techniques using primary Asian skin cells, Bio Regenerative has created a skin model that closely mimics the structure and function of human skin. The company has achieved industrialized, large-scale production of this model, which can simulate human skin to replace certain animal and human clinical trials, thereby helping cosmetics and pharmaceutical companies obtain more accurate and safer data prior to product launch.

Meanwhile, in the interview, Zhao Zheng also stated that, in addition to assisting with drug and cosmetics R&D, the model can help companies conduct more scientific and persuasive product marketing campaigns. To date, Bio Regenerative has established collaborations with multiple domestic and international pharmaceutical and cosmetics-related enterprises on this business initiative.

In addition to this 3D skin tissue model for Asians, Bio Regenerative has also developed several 3D reconstructed skin models to meet diverse efficacy testing needs. For example, the 3D melanin skin model enables the evaluation of product whitening efficacy, the 3D full-thickness skin model facilitates anti-wrinkle efficacy testing, while the 3D oral epithelial model and 3D corneal epithelial model are applied to the testing of oral care products and eye care products, respectively.

Similar to its consumer healthcare product pipeline, Bio Regenerative’s serious medical product pipeline is also extensive. However, although the pipeline covers ophthalmology and surgery, Bio Regenerative has focused its efforts in the serious medical sector on sports rehabilitation.

Specifically, in the field of ophthalmology, Bio Regenerative’s second-generation artificial cornea is undergoing clinical trials at several renowned hospitals in China, including Xiangya Hospital and Tongren Hospital, in addition to the first-generation artificial cornea. In the field of surgery, Bio Regenerative has also laid out a portfolio of related repair products, such as dural substitutes.

However, in an interview, Zhao Zheng explicitly stated that sports rehabilitation would be a key area of focus for Bio Regenerative. VCBeat has learned that, at this stage, Bio Regenerative has launched China’s first product for guided cartilage regeneration and the country’s first bone hemostatic product.

Bio Regenerative Absorbable Composite Hemostatic Membrane

Among these, Bio Regenerative’s cartilage regeneration product can mimic the physiological structure of cartilage. By incorporating stem cells and cartilage-promoting growth factors, and leveraging its excellent biocompatibility and guided tissue regeneration properties, the product can “intelligently” induce bone marrow stem cells to differentiate directionally into chondrocytes. Currently, this product has completed clinical trials and is undergoing the next stage of regulatory submission.

Bio Regenerative’s bone hemostatic products feature a dual-effect procoagulant mechanism, delivering superior hemostasis without compromising healing at the site of bone injury. Currently, it is the first Class III orthopedic implantable medical device in China to enter clinical trials with dual functions of hemostasis and bone healing.

“Frankly speaking, regenerative medicine has only been in development for a little over two decades, yet it has become a high-value, high-potential sector in which nearly everyone has placed great hope. This is both surprising and gratifying. At the same time, we are ‘fortunate’ that Bio Regenerative’s core R&D team was among the first in China to devote itself to regenerative medicine research, yielding numerous scientific achievements. However, scientific accomplishments should not remain confined to the academic realm; they must be truly translated into industrial applications. Looking ahead, Bio Regenerative will continue to advance the industrialization of regenerative medicine innovations, bringing more regenerative medicine products and solutions to the industry,” summarized Zhao Zheng.