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MITRO helps Dongcheng Pharmaceutical's Sodium Fluoride[18F] Injection approved for market

2025-05-28 16:42

Recently, JYAMS PET Research & Development Ltd., a wholly-owned subsidiary of Yantai Dongcheng Pharmaceutical Group Co., Ltd., received the Drug Registration Certificate for Sodium Fluoride [18F] Injection from the National Medical Products Administration. Sodium Fluoride [18F] Injection passed the drug marketing authorization application and can now be produced and sold, officially entering the commercialization stage. MITRO Biotechnology Co., Ltd. (hereinafter referred to as "MITRO"), as an important partner in the development process, provided professional technical support for this project and undertook the non-clinical and clinical research.

MITRO congratulates on the successful approval of Sodium Fluoride [18F] Injection! Sodium Fluoride [18F] Injection is a positron emission tomography (PET) radiopharmaceutical used in bone imaging to identify areas of altered bone formation activity. The fluorine-18 [18F] ions in Sodium Fluoride [18F] Injection can exchange with the hydroxyl groups in the hydroxyapatite crystals of bone, forming fluorapatite, which is chemically adsorbed to the bone tissue. Bone uptake of fluorine-18 [18F] ions depends on local bone blood flow and bone formation activity, therefore preferentially depositing in bone tissue with high turnover rate and active remodeling, showing high concentration in both osteoblastic and osteolytic bone metastases. In the completed clinical trials, Sodium Fluoride [18F] Injection has been proven to have excellent diagnostic efficacy and good safety, allowing for earlier and more sensitive detection of bone metastases, providing more treatment strategies for clinical patients.

As a technology company that has been among the earliest to deploy nuclear medicine CRO services domestically, MITRO leverage its accumulated technology in the field of radiopharmaceutical research, provided important technical support for this approval through standardized service processes. The company's established radioisotope tracing technology platform and clinical image quantitative analysis system effectively ensured the accuracy and traceability of the research data. This cooperation further validates MITRO's capabilities in radiopharmaceutical research and development and particularly demonstrates its professional value in connecting non-clinical and clinical research in accordance with NMPA technical requirements. Making nuclear medicine benefit more lives has always been the mission and responsibility of every member of the MITRO team. In the future, we look forward to collaborating more deeply with more partners, using continuous technological innovation to support the research and development and market launch of more high-quality nuclear medicines, and improving patients' quality of life.