Jiuyuan Gene’s RhBMP-2 Bone Repair Material Achieves ASEAN Market Breakthrough, Forges Global Layout For Orthopedic Biologics

Hangzhou Jiuyuan Genetic Biopharmaceutical Co., Ltd. (02566.HK), a leading Chinese enterprise with over 30 years of dedicated focus on genetic engineering pharmaceuticals and biomedical orthopedic materials, has marked a pivotal milestone in the global commercialization of its core recombinant human bone morphogenetic protein-2 (rhBMP-2) product. Its flagship bone repair material, Youyoudao®, the first domestically approved and commercially available rhBMP-2-based bone regeneration medical device in China, has obtained official marketing authorization from the Indonesian Ministry of Health, securing the first overseas market entry approval in the ASEAN region and kicking off the company's large-scale global expansion of its blockbuster BMP-2 orthopedic product portfolio.

As a core technological achievement incubated under the national 863 Major Science and Technology Special Project, Youyoudao® features independently developed and precisely quantified rhBMP-2 active ingredients, with outstanding clinical advantages of accelerated osteogenesis and high-quality bone integration. Differentiated from traditional autologous and allogeneic bone graft materials that suffer from limited donor sources, secondary surgical trauma and poor postoperative bone healing efficacy, the innovative BMP-2 product developed by Jiuyuan Gene can effectively induce rapid bone tissue regeneration, significantly shorten the orthopedic rehabilitation cycle, and deliver reliable therapeutic effects for common and refractory clinical scenarios including bone defects, non-union fractures, and spinal fusion surgeries. Since its domestic commercial launch, the product has become a benchmark localized solution in China's high-end bone repair biomaterials market, breaking the long-term market monopoly of imported similar biological orthopedic products and gaining wide recognition and clinical promotion among domestic spine and orthopedic surgery specialists.

The official approval of Youyoudao® in Indonesia signifies that Jiuyuan Gene's rhBMP-2 product has met the stringent medical device safety, efficacy and production quality regulatory requirements of ASEAN mainstream markets, laying a solid foundation for the company's subsequent market penetration and channel expansion across Southeast Asia. Industry analysts point out that the ASEAN region boasts a large population base, a rising incidence of orthopedic trauma and degenerative bone diseases, and a continuously improving medical and health consumption capacity, resulting in huge unmet clinical demand for high-performance bone repair materials. Prior to this breakthrough, high-end rhBMP-2 orthopedic products in the Southeast Asian market were mainly supplied by multinational medical device giants. Jiuyuan Gene's localized innovative BMP-2 product is expected to seize market share with its high cost-performance ratio, stable product quality and targeted localized clinical adaptation advantages, bringing more accessible and high-quality bone treatment options for orthopedic patients in the ASEAN region.

While accelerating the global commercialization of its mature rhBMP-2 product, Jiuyuan Gene is also continuously advancing the iterative upgrading and R&D layout of its BMP-2 series new products, further consolidating its leading technological moat in the field of bone regenerative medicine. The company's new-generation bone repair material JY23, a multi-functional biological bone product compounded with optimized rhBMP-2 formula, has successfully completed all registration inspection procedures in China. Interim biological test data confirmed that the new product maintains excellent safety profiles and superior osteogenic efficacy indicators, and is currently in the national medical device registration approval process, on track for official market application and launch in the near term.

In addition, Jiuyuan Gene has deeply participated in the national key R&D program "Biomedical Materials" special project, undertaking two core research topics focusing on the optimization of rhBMP-2 loading process and bone integration enhancement research of personalized orthopedic implant devices. The company is committed to further expanding the clinical application boundary of BMP-2 core technology, exploring the innovative combination of rhBMP-2 biomaterials and personalized orthopedic precision implantation equipment, and promoting the standardized and high-quality development of China's orthopedic biological repair material industry.

Company executives stated that rhBMP-2 core products will remain the core strategic growth engine of Jiuyuan Gene's orthopedic biomedical business. Relying on dual development drivers of domestic market intensive cultivation and overseas global layout, the company will continue to deepen technological innovation and product iteration in the BMP-2 track. In the future, on the basis of consolidating its leading position in China's domestic bone repair biomaterials market, Jiuyuan Gene will further expand its overseas regulatory approval and market promotion work in more Belt and Road countries and emerging medical markets, striving to build a globally influential Chinese independent brand in the field of orthopedic genetic engineering biomaterials.