Akeso Medical Achieves Significant Breakthrough in Southeast Asian Market

On March 19, 2025, Aojing Medical Technology Co., Ltd. (hereinafter referred to as "Aojing Medical") announced that its core product BonGold™ artificial bone repair material has been approved by the Vietnamese Ministry of Health and officially entered the Vietnamese market.

Aojing Medical submitted the registration application for BonGold™ artificial bone repair material to the Vietnamese Ministry of Health in December 2024, and officially received the registration certificate (Registration Certificate No.: 2500502ĐKLH/BYT-HTTB) on March 13, 2025, with a permanent validity period. The product is classified as Class D (high-risk medical device), indicating that it has achieved high standards in terms of safety, efficacy, and quality control.

BonGold™ artificial bone repair material is a biomimetic mineralized collagen artificial bone repair material developed and produced by Allgen Medical based on its proprietary in vitro biomimetic mineralization technology. The product is highly biomimetic to human natural bone tissue in both composition and microstructure, capable of guiding bone regeneration after being implanted into the body, and can be gradually replaced by new bone tissue, demonstrating excellent bone tissue regeneration and repair capabilities.

BonGold™ artificial bone repair material is mainly used for the repair of various orthopedic bone defects without contraindications for bone grafting, including but not limited to fractures, non-unions, and bone defects. Clinical application data show that this product has significant efficacy in bone defect repair, can accelerate bone healing, reduce the occurrence of complications, and improve the quality of life of patients.

Since obtaining the Class III medical device product registration certificate from China's National Medical Products Administration in 2011, BonGold™ artificial bone repair material has achieved significant market performance both domestically and internationally. In July 2015, the product received 510(k) market clearance from the US FDA, becoming the first domestically produced artificial bone repair material to obtain such clearance. Since then, BonGold™ has successively obtained registration certificates in countries such as Malaysia (August 2024) and Indonesia (February 2025), with its influence in the international market continuously expanding.

Aojing Medical Technology Co., Ltd. was established in Beijing in 2004. In 2011, it pioneered the development of mineralized collagen biomimetic bone material with components and structure highly similar to natural human bone tissue, achieving clinical transformation and industrialization of the product. In May 2021, it successfully listed on the STAR Market (stock code: 688613). Since its establishment, Aojing Medical has focused on the research, production, sales, and service of high-end biomedical materials and related medical device products. After years of development, the company has gradually established a research and development system primarily based on collagen and its composite materials, a supply chain layout widely applied in surgeries across different departments, and a marketing network covering more than 900 hospitals nationwide.

Aojing Medical has successively launched a series of mineralized collagen artificial bone repair products, including "Gejin," "Chubei," and "Lurui." The product technology is internationally original, capable of guiding bone tissue regeneration, and ultimately being degraded and absorbed by the human body. All products have obtained China's Class III medical device product registration certificates, used for bone defect repair in orthopedics, oral or plastic surgery, and neurosurgery. The "BonGold" product has received US FDA 510(k) market access approval for use in orthopedic bone defect repair, becoming the first domestically produced artificial bone repair product in China to obtain US FDA 510(k) market access approval.

Overall, OrigiMed focuses on the field of biomedical materials and has conducted multiple high-end regenerative medicine product developments aimed at the clinical needs for repairing defects in bones and various human tissues. The research project, mineralized collagen/polyester artificial bone repair material, further optimizes the mechanical strength and degradation characteristics based on the mineralized collagen artificial bone repair material. This project has completed the clinical trial observation follow-up and obtained the clinical trial summary report.

According to the company's previous statement, other research and development projects include collagen dressing, oral guided tissue regeneration membrane, nerve conduit, artificial dura mater/spinal dura, artificial skin, and a series of high-end regenerative medical material products. These R&D projects are all steadily advancing as planned.