NDA for Additional Rheumatoid Arthritis Indication of Methotrexate Injection Approved in China

SHENZHEN, CHINA, Aug. 05, 2024 (GLOBE NEWSWIRE) -- China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on 30 July 2024, the New Drug Application (NDA) for an additional indication of Methotrexate Injection (the “Product”) has been approved by the National Medical Products Administration of China (NMPA). The Product is a small-volume methotrexate injection with various strengths for the treatment of active rheumatoid arthritis (RA) in adult patients. The Group was granted a certificate of drug registration on 5 August 2024.

Methotrexate is recognized internationally as the first choice first-line and anchor drug for RA. The Product is the first methotrexate prefilled injection to treat RA by subcutaneous administration in China, providing a safer, more effective, more convenient and more accurate administration scheme for RA adult patients.

According to the communication with NMPA, the bridge clinical trial of the Product in China (the “Study”) aims to compare the changes of DAS28-ESR score of patients with RA treated by methotrexate injection and methotrexate tablets compared with the baseline at week 12, and to judge whether the non-inferiority is established. The Study reached the preset primary endpoint, and the experimental group (given the Products) was not inferior to the control group (given methotrexate tablets). In addition, the results of secondary efficacy indicators suggest that the product has a tendency to have better efficacy than methotrexate tablets. The results also show that some of the curative effects that can be observed in the early stage of the Product are more obvious than those of methotrexate tablets, suggesting that the curative effect of the Product appears earlier. The Product has acceptable safety and tolerability, and is basically consistent with the safety characteristics observed in previous studies. No new safety risks have been found, and it has certain advantages over methotrexate tablets in terms of gastrointestinal adverse reaction^[1].

In March 2023, the Product was approved for marketing in China for the treatment of severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids. The Product was also announced as a Reference Listed Drug by NMPA. This indication has already entered into large-scale clinical application. After the approval of the additional RA indication, it can be directly applied to clinical application, which can improve the bioavailability and convenience of clinical treatment for RA patients, reduce gastrointestinal side effects. At the same time, it also reduces the burden of treatment on doctors and patients, so as to satisfy the demand for the basic gold standard drug for RA patients.