China Medical System Holdings (CMS; HKG: 0867) has announced that the National Medical Products Administration (NMPA) has accepted another indication approval filing for its methotrexate injection. The company is now seeking NMPA approval for the use of the drug in treating active rheumatoid arthritis (RA) in adults.
Initially approved for marketing in China in March of this year for severe, refractory, and disabling psoriasis in adults unresponsive to other treatment methods, the product became the first subcutaneously administered methotrexate (MTX) pre-filled injection in the country. Listed as a reference preparation in China in July 2021, it has since gained approval in over 40 countries worldwide, including the EU and Australia.
A bridging study in China, comparing the changes in DAS28-ESR scores of RA patients treated with methotrexate injection versus methotrexate tablets against baseline, has met its pre-set primary endpoint, establishing non-inferiority. Secondary efficacy results suggest that the product’s efficacy is significantly better or shows a trend towards better efficacy than methotrexate tablets. Early therapeutic effects observed with the product are more significant than those of methotrexate tablets, indicating earlier efficacy. Additionally, the product demonstrates certain advantages in gastrointestinal safety over methotrexate tablets, with no new safety risks identified in the study.
CMS licensed the drug from Germany-based Gesellschaft für klinische Spezialpräparate m.b.H in September 2020, as stated in the press release.- Flcube.com
