China Medical System: NDA for Additional Rheumatoid Arthritis Indication of Methotrexate Injection Approved in China
SHENZHEN, CHINA – China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on 30 July 2024, the New Drug Application (NDA) for an additional indication of Methotrexate Injection (the “Product”) has been approved by the National Medical Products Administration of China (NMPA). The Product is a small-volume methotrexate injection with various strengths for the treatment of active rheumatoid arthritis (RA) in adult patients. The Group was granted a certificate of drug registration on 5 August 2024.
Methotrexate is recognized internationally as the first choice first-line and anchor drug for RA. The Product is the first methotrexate prefilled injection to treat RA by subcutaneous administration in China, provi...