On January 4, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted priority review designation to China Medical System’s New Drug Application (NDA) for its innovative medicine Methotrexate Injection, Pre-filled Syringe (the”Product”) for the treatment of severe recalcitrant disabling psoriasis and other autoimmune diseases. This is a new step following the acceptance of the Product’s NDA in China on December 8, 2021.
Source：CDE official website
The Product is a methotrexate injection with multiple strengths in a small volume. It has been approved by European Heads of Medicines Agencies (HMA) and identified as the Reference Listed Drug by NMPA. Included in the “Urgently Needed Drug List” released by the National Health Commission on December 25, 2020, the Product is granted the priority review designation based on the grounds of “drugs urgently needed in clinical settings”, which further accelerates its registration process in China.
Once marketed, the Product 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.