Yiling Bio, Led by Peking University PhD, Secures NMPA Class III Certification for Oral Regenerative Material with Orders Exceeding RMB 10 Million

In February 2024, Yiling Biotech’s independently developed and manufactured product for oral soft and hard tissue regeneration, “Bone Graft Material for Oral Use (Chenggukuai®),” obtained the Class III Medical Device Registration Certificate from the National Medical Products Administration (NMPA). This also marks Yiling Biotech’s first medical device registration certificate.

Yiling Biotech, founded in 2017, specializes in the innovative R&D and industrialization of bio-intelligent regenerative materials. Dr. Xu Lixin, Founder and CEO of Yiling Biotech, stated that this approval marks a significant breakthrough in the field of intelligent repair for hard and soft tissue defects in the oral cavity. Once launched, the product will provide consumers with better treatment options.

“The primary innovation of the approved product lies in its transformation of traditional bone grafting techniques, making the procedure more convenient and effective. It addresses certain unresolved challenges associated with first-generation bioinert materials and second-generation bioactive materials by enabling rapid induction of osteogenesis following quick bone grafting, while ensuring timely degradation of the graft material to form genuine autologous bone tissue. Through precise manufacturing control, the product meticulously preserves the natural three-dimensional porous collagen structure of animal tissues. Its strong compressive strength is sufficient to withstand mucosal pressure, providing stable spatial support for bone tissue reconstruction and promoting bone regeneration. Furthermore, it ensures excellent permeability and stability of bioactive factors within the material, thereby maximizing their biological activity in bone tissue regeneration and repair.“Dr. Xu Lixin said.”

Driven by rising health awareness among residents, an accelerating aging population, and price reductions from centralized procurement of dental implants, the dental implant market has entered a period of rapid growth. The oral bone implant materials market, closely linked to dental implants, is also poised to share in the dividends of this high-speed expansion.

Yiling Biotechnology, which has been deeply cultivating the market for dental bone implant materials, has also entered a period of growth. As of the end of 2023, its 30 invention patents and 26 utility model patents have established high technical barriers for Yiling Biotechnology.

Yiling Bio has established a robust technology reserve and product pipeline, leveraging its core technologies and manufacturing processes for the preparation of biological scaffold materials for oral soft and hard tissue regeneration.Many products are successively entering the registration phase, and it is expected that 2–3 domestic NMPA medical device registration certificates will be obtained in 2024.Regarding dental restorative materials, Yiling Biotech’s Chenggukuai® collagen-based filler for oral applications and Chenggukuai® absorbable repair membrane for oral use, which primarily target hard and soft tissue regeneration in dental implantology, also demonstrate competitive advantages on the global stage.

The newly approved “Chenggu Kuai® Collagen Filling Material for Oral Use” is a bone matrix derived from bovine cancellous bone through decellularization, defatting, and decalcification processes. Its main component is Type I collagen, which facilitates better absorption by the human body.It can specifically address the pain points of existing oral tissue regeneration materials, such as slow degradation rates, low osteogenic conversion efficiency, and risks of inflammation and immunogenicity.

This product has a wide range of clinical applications, including socket preservation after tooth extraction, filling of bone dehiscence defects, reconstruction of periodontal bone defects, and bone regeneration around implants affected by peri-implantitis. Compared with traditional products, it offers easier handling and superior moldability, significantly reducing clinical procedure time while lowering the expertise threshold required for clinicians.

Chenggu Kuai® Oral Absorbable Repair Membrane from Yiling Biotech is directly prepared from animal-derived biomembrane materials using a patented decellularization technology, without the use of any cross-linking agents, ensuring high biocompatibility. Featuring a dual-sided structure with a rough, porous surface and a smooth, dense surface, it guides bone regeneration while preventing soft tissue ingrowth into the newly formed bone tissue, providing a barrier effect for up to 12 weeks.

Chenggu Kuai® Resorbable Oral Repair Membrane has demonstrated favorable outcomes in various clinical applications, including protection of the sinus floor mucosa during maxillary sinus augmentation, alveolar bone reconstruction and periodontal regeneration procedures, treatment of peri-implantitis, and post-resection management following malignant tumor excision.

It is worth mentioning that,Yiling Biotech is committed to becoming a platform-based enterprise with comprehensive R&D and manufacturing capabilities in regenerative medicine materials and innovative implantable devices. The company is actively expanding its expertise in tissue engineering scaffold materials, decellularization, and growth factor loading—accumulated in the field of dentistry—to other medical specialties, including general surgery, neurosurgery, orthopedics, and dermatology.

Prior to founding Yiling Biotech, Dr. Xu Lixin served at Peking University School of Stomatology, where he held the positions of Secretary-General of the Implant Academic Committee at the Second Clinical Division, Director of the Implant Center at the Third Clinical Division, and Director of the First General Department. He conducted nearly 100 training courses on implant restoration across China, benefiting thousands of dental practitioners. Meanwhile, Dr. Xu is deeply committed to scientific research, having led multiple research projects related to tissue regeneration. He holds 47 invention and utility model patents, as well as 6 design patents.

Identifying patient needs in clinical practice and seeking answers through scientific research. After recognizing the growing mismatch between mainstream dental restorative materials on the market and patient needs, as well as the increasing contradiction with the operational convenience for clinicians, Dr. Li Xin Xu, who has dedicated years to researching tissue regeneration, personally embarked on an entrepreneurial journey with the goal of “developing a bio-intelligent regenerative material that is patient-friendly and easy for dentists to use.”

“Once I decided to start a business, my first thought was to find the most experienced partner in the field of regenerative materials.” Soon, Dr. Xu Lixin found a co-founder with extensive experience in the field of regenerative medicine research.

The co-founder not only possesses unique insights in the research and development of biomaterials and growth factors, but also has extensive experience in organizing and managing scientific research projects, with a thorough understanding of registration standards for Class III medical devices and the inspection and approval processes for medical device products.

Commercialization capability is a topic that no entrepreneur can avoid. Dr. Xu Lixin, who has a clinical background, believes in the principle that “diligence can make up for lack of natural ability.” While actively recruiting top-tier commercialization talent, he also engages in efficient learning to continuously refine his understanding of corporate operations and management. To date, Yiling Bio has built an elite team drawn from China’s leading research institutions and medical organizations, possessing extensive expertise in R&D, production management, regulatory registration and certification, clinical promotion, channel development, and commercial implementation.

Leveraging the founding team’s extensive experience in both clinical practice and industry, Yiling Biotech has established a tightly integrated innovation mechanism combining industry, academia, and research, in collaboration with leading experts and professors, renowned domestic medical institutions, and flagship enterprises in the dental equipment sector. This strategic alliance has significantly bolstered Yiling Biotech’s early-stage product development and subsequent market promotion.

Yiling Biotech, leveraging its integrated management system encompassing R&D, production, sales, and services, has expanded its business coverage to nearly 20 provinces and municipalities across China, including Beijing, Tianjin, and Shenzhen, with intended order values exceeding RMB 10 million. Dr. Xu Lixin shared that Yiling Biotech plans to serve 10,000 dental clinics within five years.

Since its inception, Yiling Biotech has completed three rounds of financing. In 2024, to accelerate the research and development upgrade of its core products and promote their rapid commercialization in both domestic and international markets, Yiling Biotech plans to launch a new round of financing.