China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the innovative drug Methotrexate Injection, Pre-filled Syringe (the “Product”), which was licensed in by the Group on 21 September 2020 from medac Gesellschaft fürklinische Spezialpraparate m.b.H (“medac”), has been granted an approval for drug clinical trial issued on 13 August 2021 by the National Medical Products Administration of the People’s Republic of China and agreed to carry out a clinical trial for adult rheumatoid arthritis (RA) indications. The trial is a non inferiority designed clinical trial comparing with methotrexate oral solid preparation, aiming to evaluate the safety and efficacy of the Product among Chinese RA patients.
The Product is a methotrexate injection with multiple low-dose formulations in a small volume, indicating for the treatment of active RA and other autoimmune diseases in adults, which has been approved for marketing by European Heads of Medicine Agencies (HMA). Methotrexate is internationally recognized as the first-line gold standard medicine for the systemic treatment for RA. Currently, no methotrexate injection (including pre-filled products) for the treatment of RA has been approved for marketing in China. The Product is expected to be the first methotrexate injection for subcutaneous administration for the treatment of RA in China, meeting the medical needs of basic treatment for RA patients.
The Group is currently actively preparing for initiatingthe clinical trial of the Product.