SPH Receives Registration Certificate for Methotrexate for Injection
2024-05-14 · SPH-BIOCAD (HK) Limited · original sphchina.com ↗
Shanghai, May 14, 2024—Shanghai SPH Rare Disease Pharmaceutical Co., Ltd. (SPH RD), a wholly-owned subsidiary of Shanghai Pharmaceuticals Holding Co., Ltd. (SPH), recently received a “Drug Registration Certificate” (No. 2024S00758) for its Methotrexate for Injection from China’s National Medical Products Administration (NMPA). Methotrexate is an inhibitor of dihydrofolate reductase (DHFR), the enzyme that reduces dihydrofolic acid to tetrahydrofolic acid. It may disrupt thymidylate and purine synthesis to prevent cell division. The drug is mainly used in the treatment of acute leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, villous diseases (choriocarcinoma, invasive hydatid mole and hydatid mole), breast cancer, and urothelial carcinoma. In China, generic drugs approved for marketing and subject to new registration classification stand to receive greater state support for Medicare and institutional procurement. This certificate will give the medicine a competitive advantage in the market and build SPH’s track record of generic drug applications.
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