China IND Application of China Medical System (867.HK)¡¯s Innovative Drug Methotrexate Pre-filled Injection was Accepted
2021-06-09 13:57

On June 9, the IND application of China Medical System¡¯s innovative drug Methotrexate Pre-filled Injection was accepted by the Center for Drug Evaluation, NMPA. Methotrexate Pre-filled Injection is available in multiple low dose formulations in a small volume and indicated for the treatment of active rheumatoid arthritis (RA) and other autoimmune diseases in adults.

Methotrexate (MTX) is internationally well accepted as the first-line gold standard medicine and anchored agent for the systemic treatment for RA. While oral MTX has poor patient compliance due to its relatively severe gastrointestinal side effects, Methotrexate Pre-filled Injection is administered subcutaneously, and shows better bioavailability, significant improvement of clinical efficacious response, and convenience of dosage management, achieving a greater balance between efficacy, safety, tolerability and compliance. The product has been approved for marketing in Europe.

RA is one of the major autoimmune diseases. As stated by the ¡°Chinese Rheumatoid Arthritis Diagnosis and Treatment Guidelines 2018¡±, the incidence of RA in Mainland China is 0.42%, with around 5 million patients in China. Currently, no MTX injection (including pre-filled products) for the treatment of RA has been marketed in China. Methotrexate Pre-filled Injection is expected to be the first MTX injection for subcutaneous administration for the treatment of RA in China, meeting the medical needs of basic treatment for RA patients.