Completion of First Subject Dosing in China Phase III Bridging Trial of China Medical System (867.HK)’s Innovative Medicine Methotrexate Injection, Pre-filled Syringe for RA Indication

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On April 12, China Medical System Holdings Limited completed the first subject dosing in China Phase III bridging trial of its innovative medicine Methotrexate Injection, Pre-filled Syringe for adult rheumatoid arthritis (RA) indication. This is another significant progress following the product’s IND approval for RA indication in China, in August 2021.

This study is a randomized, open, active-controlled, multi-center Phase III bridging trial, aiming to compare the efficacy and safety between Methotrexate Injection, Pre-filled Syringe and methotrexate tablets in the treatment of RA patients. With Peking Union Medical College Hospital, Chinese Academy of Medical Sciences being the leading hospital, the study is planned to enroll 140 subjects and will be conducted in around 17 sites nationwide. Prof. Xiaofeng Zeng, the former chairman of Chinese Rheumatology Association of Chinese Medical Association and the president of Rheumatology and Immunology Physicians Committee of Chinese Medical Doctor Association, served as the principal investigator of the leading hospital and will lead domestic leading rheumatology experts to carry out this study.

Methotrexate Injection, Pre-filled Syringe

Methotrexate Injection, Pre-filled Syringe is Methotrexate (MTX) injection with multiple strengths in a small volume. It is administered subcutaneously, and shows lower adverse effect profile (with less gastrointestinal adverse effect) compared with oral application of MTX. The product also has advantages of relatively high bioavailability, improvement of clinical efficacious response, flexible dosage management and operation convenience, achieving a greater balance of efficacy, safety, tolerability and compliance. The product has been approved for marketing in Europe.

RA is one of the major autoimmune diseases. As stated in the “Chinese Rheumatoid Arthritis Diagnosis and Treatment Guidelines 2021”, the incidence of RA in Mainland China is 0.42%, with around 5 million patients. MTX is internationally well accepted as the first-line gold standard and anchor medicine for the systemic treatment for RA, but there is currently no MTX injection approved for the treatment of RA in China. Methotrexate Injection, Pre-filled Syringe is expected to be the first MTX pre-filled injection for subcutaneous administration for the treatment of RA in China, fulfilling the basic medication needs of RA patients.