China Medical System Holdings (CMS; HKG: 0867) has received approval from the National Medical Products Administration (NMPA) for an additional indication for its methotrexate injection. The drug is now approved for the treatment of active rheumatoid arthritis (RA) in adults. Methotrexate is internationally recognized as a first-line treatment and cornerstone medication for RA, with its subcutaneous administration showing superior efficacy compared to tablet forms in a bridging study conducted in China.
Originally approved for marketing in China in March of the previous year, the product was initially indicated for the treatment of severe, refractory, and disabling psoriasis in adults unresponsive to other treatment methods, including phototherapy, PUVA, and retinoic acid. It became the first subcutaneously administered methotrexate pre-filled injection in China. In July 2021, it was listed as a reference preparation in China, allowing for direct clinical application in the treatment of RA. CMS obtained the license for the drug from Germany-based Gesellschaft für klinische Spezialpräparate m.b.H in September 2020.- Flcube.com
