China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that on 8 December 2021, New Drug Application of Methotrexate Injection, Pre-filled Syringe (the “Product”) has been accepted by the National Medical Products Administration of China (NMPA).
The Product is a methotrexate injection with multiple strengths in a small volume, indicating for the treatment of severe recalcitrant disabling psoriasis and other autoimmune diseases. The Product has been identified as the Reference Listed Drug (RLD) by NMPA and is expected to be the first methotrexate injection for subcutaneous administration for the treatment of psoriasis in China, meeting the medical needs of basic treatment for psoriasis patients. The Product had also been approved by European Heads of Medicines Agencies (HMA).