Methotrexate Injection, Pre-filled Syringe is administered subcutaneously (this form of administration was recommended by domestic and foreign guidelines), which can increase bioavailability, has lower side effects than oral MTX, in particular less adverse reactions in the gastrointestinal tract, and can improve patient treatment compliance and achieve a greater balance among efficacy, good safety tolerance and compliance. At the same time, the Product is available in a variety of small-capacity strengths, which are easy to use, allowing patients to self-administer medication at home under the judgment and guidance of a doctor to facilitate long-term disease management.
In March 2023, the New Drug Application (NDA) of Methotrexate Injection has been approved by the National Medical Products Administration of China (NMPA). The Product is indicated for the treatment of severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids. In January 2022, its NDA was granted a priority review procedure as it complied with the “shortage of products with urgent clinical need” in China.
Methotrexate (MTX) has anti-inflammatory, anti-proliferative and immunomodulatory effects, and is currently one of the most effective traditional drugs for the treatment of psoriasis. The incidence of psoriasis in China is about 0.47%, and the number of patients exceeds 7 million, of which more than 30% of patients have developed into moderate-to-severe disease. The Product can provide a safer, more effective, more convenient, and more accurate methotrexate dosing regimen for patients and can meet the drug needs of psoriasis patients for systemic treatment.
MTX is recognized internationally as the first choice first-line and anchor drug. Currently, there is no MTX injection approved for the treatment of RA in China.
The incidence of RA in Mainland China is 0.42%, with around 5 million patients. The Product is expected to become the first methotrexate prefilled injection for the treatment of RA by subcutaneous administration in China, fulfilling the basic medication needs of RA patients.