Shanghai Jiao Tong University Licenses Breakthrough Bone Repair Patent for RMB 1 Million to Suzhou Yuezong Biotech
Recently,Shanghai Jiao Tong University issued an announcement stating its intention to assign the invention patent titled “Medical Degradable Zn-Cu-Li Ternary Alloy and Its Preparation and Applications” to Suzhou Yuezhong Biotechnology Co., Ltd., with a transaction amount of RMB 1 million.。
Suzhou Yuezong Biotechnology Co., Ltd. was established in 2011 as a technology partner of Shanghai Jiao Tong University, dedicated to the research and development, manufacturing, and marketing of innovative medical products in the field of minimally invasive surgery, providing customer-centric one-stop services.
Three Major Innovations Delivering High-Performance Medical Zinc Alloy Materials
In the field of bone repair, medical-grade biodegradable metals are gradually becoming a research hotspot due to their unique controllable in vivo degradation properties, which effectively avoid the secondary surgeries required for traditional inert implants and long-term in vivo rejection reactions. Developing high-performance medical zinc alloy materials that integrate high strength and toughness, anti-aging properties, an appropriate degradation rate, and excellent osteogenic capability is a goal pursued by scientific research teams both domestically and internationally.
Professor Yuan Guangyin’s team at Shanghai Jiao Tong University is no exception. As a leading figure in this field in China, Professor Yuan has long been dedicated to clinical research on biodegradable medical magnesium and zinc alloys, overcoming the technical challenge of achieving uniform and controllable degradation of medical magnesium alloys. The magnesium alloy bone screws developed by his team have been successfully used in multiple human clinical trials. To date, he has obtained more than 20 authorized invention patents both domestically and internationally, and has completed 12 technology transfers.
The patent involved in this transfer is precisely an innovative biodegradable Zn-Cu-Mg alloy bone repair material, with Mg uniformly distributed within the material.2Zn11and CuZn4. A thorough analysis of this patent reveals that its innovative highlights are mainly reflected in three aspects:
1. By incorporating a specific amount of magnesium (Mg), the team fully leveraged the osteogenic healing properties of magnesium ions continuously released during the degradation of zinc alloys, significantly improving the biocompatibility of medical-grade zinc alloys as bone repair materials and achieving the goal of promoting fracture healing.
2. The team’s first investigation into large Mg blocks in zinc alloys2 Zn11Addressing the issue of reduced plasticity caused by hard and brittle phases, this study proposes solutions from the perspective of preparation methods. By increasing the alloy solidification rate, employing short-duration homogenization heat treatment at intermediate temperatures, and optimizing deformation processes, the team achieved refinement of the alloy microstructure and secondary phases. This approach transformed coarse magnesium-containing secondary phases into finely dispersed distributions, resulting in degradable medical zinc alloys with excellent strength and toughness.
3. By adding Cu as an alloying element, the team not only significantly improved the thermal stability of the zinc alloy while enhancing its strength, but also avoided the alloy aging issue caused by the addition of Mg. In particular, when the Cu content is higher than that of Mg, the anti-aging effect is more pronounced.
Through a series of meticulously designed optimizations, Professor Yuan Guangyin’s team has developed this novel alloy, which boasts excellent mechanical properties, combining high strength with good ductility, while also demonstrating ideal uniform corrosion resistance, superior biocompatibility, and robust osteogenic capacity. This breakthrough provides an ideal option for load-bearing intraosseous implants, holding immense promise for clinical applications in the field of bone repair.
Intensifying Competition: Multiple Products Enter Preclinical Trials
In recent years, the field of biodegradable medical metals has witnessed a series of innovative breakthroughs. Among these, magnesium-based, zinc-based, and iron-based alloys, as the three mainstream categories of biodegradable metals, are leading the rapid development of this field.
Magnesium alloys have garnered significant attention due to their favorable biocompatibility and mechanical properties. In August 2019, a team from the National Engineering Research Center for Near-Net-Shape Forming of Light Alloys at Shanghai Jiao Tong University proposed a shape optimization design strategy based on the finite element method. This strategy was applied to vascular stents fabricated from their independently developed Mg-Nd-Zn-Zr (JDBM) alloy, which exhibits uniform degradation. Mechanical performance testing and in vivo degradation rate assessments yielded experimental results consistent with expectations.
In addition to the continuous emergence of research achievements from institutions such as Shanghai Jiao Tong University, R&D in the industry is also making constant breakthroughs.2In 2021, Sino Medical’s independently developed “Magnesium Alloy Fully Biodegradable Drug-Eluting Stent System”Through in-depth research on base raw materials, breakthrough progress has been achieved in the quality of magnesium alloy microtubes, with further improvements in tube quality and stability. The results from animal feasibility studies on magnesium alloy stents have met expected outcomes, indicating a breakthrough in the product’s core key technology—namely, the effective and stable control of the degradation rate of the magnesium alloy substrate.
Not only that,In 2023, Yi'an Technology also announced the completion of patient enrollment for the clinical trials of the world's first biodegradable pure magnesium bone screw.It is worth noting that the "magnesium bone screw" is made of high-purity magnesium with extremely low levels of other elements, thereby eliminating concerns about potential toxicity from these elements. Furthermore, this material lacks second phases typically generated by alloying elements, so there is no need to consider the uniformity of second-phase degradation or the effects of related degradation products.
Beyond Magnesium Alloys, More Composite Metal Materials Are Entering the Medical Field.
Zinc alloys exhibit a moderate degradation rate and good biocompatibility. In 2020, Tian Lei, Director of the Department of Maxillofacial Trauma at the Stomatological Hospital of Air Force Medical University, adoptedBiodegradable Zinc Alloy Cranio-Maxillofacial Internal Fixation SystemSuccessful open reduction and internal fixation of double mandibular fractures in a patient. Thereafter, the productInitiate its registrational clinical trial phase
Iron alloys exhibit favorable mechanical properties. In March 2022, the IBS bioresorbable drug-eluting coronary stent system, independently developed in China and recognized as the world’s first fully degradable iron-based bioresorbable coronary stent, successfully completed the enrollment of the first subject in its pivotal clinical study in China at Yunnan Fuwai Cardiovascular Hospital.
Previous clinical studies have preliminarily demonstrated its favorable safety and efficacy in simple primary coronary lesions. The device begins to degrade after providing effective vascular support (i.e., 3–6 months post-implantation), safely enters the final stage of degradation at approximately two years, and is ultimately harmlessly absorbed by human tissue, thereby effectively avoiding a series of long-term prognostic issues associated with permanent stent implantation.
As technology continues to advance and its applications are more widely adopted, biodegradable metal materials are poised to play a significant role in the medical field, bringing greater benefits to more patients.