YuanNang Bio, Partner of KeHui Medical, Files IPO Prospectus for World’s First Fully Degradable Bone Adhesive 'Gu-02' That Redefines Fracture Treatment

On September 9, 2025, Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine, held a press conference for the world's first "Bone Glue" major independent innovation achievement.System Disclosure of "Bone 02" Crushed Bone Adhesive Clinical Research Results.This innovative biomaterial, led by Professor Fan Shunwu and Director Lin Xianfeng's team from Sir Run Run Shaw Hospital, and jointly developed with Canwell Medical Co., Ltd. and Origo Biotechnology, can achieve precise adhesion and fixation of large and small bone fragments. It has the potential to reduce or even replace traditional metal internal fixators, bringing a disruptive innovation to treatment modalities in the orthopedic field.

As of the day of the press conference, Sir Run Run Shaw Hospital of Zhejiang University has collaborated with Zhejiang University Second Hospital, Shanghai Sixth Hospital, and other authoritative medical institutions in China to complete the enrollment for the world's first multi-center randomized controlled clinical study on adhesive treatment for comminuted fractures. Among more than 150 subjects, “Bone 02” demonstrated good safety and efficacy – no cases of infection, foreign body reaction, or loss of reduction occurred, and the postoperative rehabilitation outcomes significantly surpassed those of traditional surgery.

                 

Case of Distal Radius Fracture Treated with "Bone 02"                                                       

The first half of this year, Mr. Li (pseudonym)Comminuted fracture of the distal radius in the wrist caused by trauma。According to the traditional plan, he needs to undergo a large incision surgery to implant steel plates and screws, which not only causes significant trauma and carries the risk of tendon adhesion or nerve damage, but also requires a second surgery one year later to remove the internal fixation.

The application of "Bone02" enables "minimally invasive" treatment. Doctors add "Bone02" powder into the delivery device, connect it with a liquid-phase syringe for mixing, and then inject it through a 2-3 cm minimally invasive incision to the fracture surface, completing precise adhesion and fixation of comminuted bone fragments within 2-3 minutes.

Three-month postoperative follow-up showed that Mr. Wang's fracture had healed well, and his wrist joint function was fully restored, sparing him from the pain of a second surgery.

Traditional Treatment for Distal Radius Fractures: Metal Internal Fixation

Distal Radius Fracture "Bone 02" Treatment Method: Independent Adhesive Fixation

From "Oyster Cultivation for Foundation Stabilization" to Biomimetic Materials: Solving a Century-Old Medical Challenge

The inspiration for the development of "Bone 02" comes from the thousand-year-old wisdom of the "Oyster Cultivation for Foundation Strengthening" technique used in the construction of the Luoyang Bridge in Quanzhou during the Northern Song Dynasty — ancient craftsmen cultivated oysters beneath the bridge piers, utilizing their secretion of natural "adhesive" to resist seawater erosion, allowing the bridge to endure for a millennium. This biomimetic approach provided the team with a direction to solve the century-old medical challenge of "difficulty in fixing bone fragments in a blood environment."

Inspired by this bionic principle, the team clarified their direction. HoweverTransforming inspiration into products requires overcoming multiple barriers: First, the selection and breakthrough of materials, which involves finding composite materials that can quickly form strong adhesion in the blood environment, have excellent biocompatibility, and allow precise temperature control to avoid thermal damage to tissues. Second, innovation in manufacturing processes is essential, requiring standardized and reproducible preparation procedures to ensure ease of surgical handling and meet the practical needs of clinical applications. In terms of safety verification, strict experiments must prove the long-term stability and safe absorbability of the materials in the body.

Orthopedic Doctors at Shaw Hospital UseLive Demonstration of Porcine Bone Adhesion

Orthopedic Doctors at Shaw Hospital Test Bone Glue Adhesion by Hammering Bonded Pig Bones.

Three Major Breakthroughs Reconstruct Treatment Logic, Naming Conceals "High-Efficacy Expectations"

After more than 50 iterations of formulations and hundreds of tests and optimizations, "Bone 02" finally achieved three core breakthroughs. Through extensive animal experiments involving rats, rabbits, and dogs, the team successfully overcame key challenges such as material biotoxicity, adhesion in the blood environment, and ease of surgical operation.

Scientific research results have been achievedThree Major Core Breakthroughs——

Immediate Adhesion in Wet Environments:In the physiological environment of blood infiltration, it can still solidify quickly within 2-3 minutes, addressing the pain point of insufficient bonding strength of traditional bone cement.The maximum adhesive tensile strength can reach over 400 jin.

Convenient and Efficient Operation:Minimally invasive injection methods significantly reduce operation time, lower the difficulty of doctors' manipulation, and improve treatment efficiency.

Biodegradable and Residue-Free:Avoid foreign body reactions and infection risks caused by metal internal fixation devices, and eliminate the need for secondary surgical trauma.

The naming of this material, "Bone 02," also contains a clever twist — inspired by the well-known "502 glue," it implies that it can achieve equally strong bonding effects in the orthopedic field, with even broader application scenarios.

Covers total body fracture repair, can be used for emergency rescue.

"‘Bone 02’ is suitable for almost all parts of the body and various sizes of fracture repairs, especially for tiny bone fragments that are difficult to fix with traditional instruments," introduced Dr. Lin Xianfeng. Its characteristics of rapid adhesion and easy operation can also be extended to special scenarios such as national defense warfare and disaster rescue in the future, securing the "golden treatment time" for fracture casualties.

Currently, the core team of "Bone 02" has applied for a Chinese invention patent with the National Intellectual Property Administration and simultaneously submitted an international PCT patent. After authoritative novelty search, it is confirmed to be novel and creative — which means that this China-original bone adhesive technology is expected to take a leading position in the global orthopedic field.

Bone Glue "Bone 02" Product Kit

From 0 to 1 and then to N

As "Bone02" demonstrates exciting and significant value in the treatment of comminuted fractures, the researchers have already set their sights on broader fields — next, the team plans to simultaneously carry out clinical trials for dental implants and minimally invasive spinal internal fixation alternatives. With the continuous expansion of clinical applications, "Bone02" is moving from a single breakthrough towards the innovation of a comprehensive treatment system.

Tracing back the source of this innovative momentum, its foundation is deeply rooted in the excellent innovative atmosphere of Sir Run Run Shaw Hospital, Zhejiang University, and the long-term scientific research commitment of the orthopedics department. With the full support of Professor Fan Shunwu, Lin Xianfeng leads a young team of post-90s and post-00s researchers in tackling original basic research and clinical transformation applications. Dozens of core patents cover major global economies such as China, the United States, the European Union, and Japan. The series of achievements directly address clinical pain points: the development of China's first PRP (Platelet-Rich Plasma) gel patch molding device certified by the National Medical Products Administration (NMPA) and the Zhejiang Provincial Medical Products Administration (Zhejiang MPA) (Zhejiang Medical Device Registration Certificate No. 20252141621), resolving the "last mile" issue for PRP clinical use; the world’s first creation of decellularized and decalcified porcine bone material that can replace human bone, solving the problem of scarce sources of bone graft materials in China, approved with a Class III Medical Device Registration Certificate from China NMPA (Registration No. 20243131263), and leading the drafting of China’s first recommended industry standard for in vitro immune evaluation of tissue engineering products.

Three years ago, this same team published the first original CNS main journal article with complete independent intellectual property rights in China's orthopedic field — "Plant-derived natural photosynthetic system enhances cell anabolism," featured in Nature magazine. The study transplanted thylakoids from spinach chloroplasts across species into mammalian cells, enabling animal cells to harness the energy of plant photosynthesis to reverse the metabolic state of diseased cells.

"The key to clinical breakthroughs lies in breaking conventional thinking," said Professor Fan Shunwu. The scientific implementation of seemingly far-fetched ideas—such as using oysters to strengthen bones and spinach to provide energy—is a microcosm of Chinese scientists aiming at the forefront of global technology, stimulating innovation vitality, and breaking through key core technologies.

Cai Xiujiang, President of Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, congratulated and fully affirmed Professor Fan Shunwu's team for successfully developing the milestone "Bone 02" bone glue. This achievement starts from clinical needs and pain points.Relying on multidisciplinary collaboration to overcome world-class challenges fully reflects the hospital's development guidelines of "differentiated development, precision minimally invasive techniques, problem-oriented approaches, and interdisciplinary integration." It stands as a model for the coordinated development of education, technology, and talent, as well as a firm practice of the "Four Orientations." He stated that the hospital will continue to support the clinical trials, transformation, and promotion of these results, advancing this "innovation from China" to benefit patients worldwide as soon as possible and make greater contributions to the cause of human health.

For a long time, Canwell Medical has adhered to the corporate mission of "Technology Serving Health," persisting in independent research and development. It has obtained 204 medical device registration certificates or filing credentials, comprehensively covering core orthopedic fields such as trauma, spine, sports medicine, joints, dental implants, and rehabilitation devices.

The company leverages its advantages in technology, talent, and platforms to deepen the "industry-university-research-medical-inspection" collaboration - working jointly with research institutes and medical institutions, achieving continuous innovative breakthroughs in orthopedics and related fields, contributing to the high-quality development of China's medical device industry.