CG MedTech (CEO Yoo Hyun-seung), a company specializing in the research and manufacture of in-body implants, announced that it has completed the clinical evaluation in China for its magnesium-based absorbable orthopedic implant “Resomet” and will begin full-scale preparations for approval by China’s National Medical Products Administration (NMPA).

This clinical evaluation was conducted with the participation of eight medical institutions in China and the entire clinical process was completed under the lead of Beijing Jishuitan Hospital. CG MedTech stated that by completing the clinical evaluation in China, it has secured evidence of the safety and clinical efficacy of Resomet in the Chinese medical environment.

Jishuitan Hospital, with more than 5,000 beds, is one of China’s leading tertiary general hospitals and a leading medical institution in the country across all orthopedic fields, including trauma, joint, and sports medicine. CG MedTech plans to accelerate its penetration of the Chinese market for Resomet by expanding its cooperation network in China around Jishuitan Hospital, which led the clinical trial.

Resomet is a next-generation orthopedic medical device designed as an absorbable implant using a magnesium material that naturally degrades in the body, thereby reducing the residual burden compared with conventional metallic implants while contributing to the bone healing process. CG MedTech has confirmed the technological competitiveness and clinical excellence of Resomet based on the Chinese clinical data.

Based on these clinical results, CG MedTech visited its Chinese business partner Buchang Pharma to discuss the preparation status for the China NMPA approval application, which is the next step after completion of the clinical trial, as well as the future direction of business promotion.

CG MedTech (formerly Innosys) signed an exclusive distribution license agreement for Resomet and follow-up products in China with Buchang Pharma in 2016. The agreement is a license contract worth a total of USD 5 million (approximately KRW 7.3 billion), and is centered on the condition of supplying products worth at least USD 3 million (approximately KRW 4.4 billion) per year to China for 14 years. Under this agreement, Buchang Pharma has served as the exclusive partner responsible for regulatory approvals and commercialization in China, and the license fee of USD 3 million has already been paid in accordance with the contract terms. The remaining license fee of USD 2 million (approximately KRW 2.9 billion) is scheduled to be paid additionally upon completion of the NMPA approval process. The latest discussions were held within the framework of the existing partnership to mutually confirm the completion of the clinical trial and to ensure the smooth progress of the NMPA approval procedures.

Buchang Pharma is a company with a hospital network and medical device distribution infrastructure across China, and has expanded its influence in the orthopedic field based on a network of major tertiary general hospitals, including Jishuitan Hospital. Using the completion of the clinical trial as a starting point, CG MedTech plans to steadily pursue NMPA approval preparations and subsequent business phases under the existing partnership, and to develop Resomet into a key strategic product in the orthopedic and sports medicine sectors in China. In the initial phase, adoption will be expanded focusing on tertiary general hospitals such as Jishuitan Hospital, and then gradually extended to regional hospitals.

Yoo Hyun-seung, CEO of CG MedTech, said, “Resomet is a product that has secured evidence of safety and clinical efficacy through the clinical evaluation in China centered on Jishuitan Hospital,” adding, “These discussions are a step to ensure the smooth progress of the approval process following the completion of the clinical trial in China, and CG MedTech will calmly prepare for entry into the Chinese market based on cooperation with its existing partner Buchang Pharma.”

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