China Medical System: NDA for Additional RA Indication of Methotrexate Injection Accepted in China

- The New Drug Application for an additional rheumatoid arthritis (RA) indication of Methotrexate Injection has been accepted by NMPA, which is a new milestone following the China approval for psoriasis indication of Methotrexate Injection. The Product is expected to become the first methotrexate (MTX) prefilled injection to treat RA by subcutaneous administration in China.

- The China bridge clinical trial of the Product’s RA indication reached the main endpoint; The results of secondary efficacy indicators suggest that the efficacy of the product is significantly better than that of MTX tablets or there is a trend of better. The product also has some advantages over MTX tablets in gastrointestinal safety.

- MTX is recognized internationally as the first choice first-line and anchor drug for RA. As a small-volume MTX prefilled injection with various strengths, the Product is expected to provide a safer, more effective, more convenient and more accurate administration scheme for active RA adult patients.

- Clinical development of the Group’s innovative products proceeds steadily, with innovative outcomes generated successively: 3 obtained marketing approval (Diazepam Nasal Spray, Tildrakizumab Solution for Injection, Methotrexate Injection-psoriasis indication); 2 under NDA review (Methylthioninium Chloride Enteric-coated Sustained-release Tablets and Methotrexate Injection-RA indication); over 10 registrational clinical trials are ongoing.

SHENZHEN, CHINA - China Medical System Holdings Limited ( “CMS” or the “Group”) announced that on 4 December 2023, the New Drug Application (NDA) for an additional indication of its innovative product, Methotrexate Injection (the “Product”), has been accepted by the National Medical Products Administration of China (NMPA). The Product is a small-volume methotrexate injection with various strengths, which is intended to be used to treat active rheumatoid arthritis (RA) in adult patients.

Methotrexate is recognized internationally as the first choice first-line and anchor drug for RA. The Product is expected to become 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 active 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, and to judge whether the non-inferiority is established. The Study reached the preset main endpoint, and the experimental group (given the Product) was not inferior to the control group (given methotrexate tablets). In addition, the results of secondary efficacy indicators suggest that the efficacy of the Product is significantly better than that of methotrexate tablets or there is a trend of better. 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 some advantages over methotrexate tablets in gastrointestinal safety, and no new safety risks have been found in the Study.

In March 2023, the Product, the first MTX pre-filled injection for subcutaneous administration in China, 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 in July 2021.

At present, the Product has been approved for marketing in more than 40 countries and regions around the world, including the European Union, Australia, China, etc.

The Group obtained a long-term effective and exclusive license for the Product from medac Gesellschaft für klinische Spezialpräparate m.b.H on 21 September 2020.

About CMS

CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.

CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries. While strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology business, CMS independently operates its dermatology and medical aesthetics business, and ophthalmology business, aiming to gain leading positions in specialty therapeutic fields, whilst enhancing the scale and efficiency. At the same time, CMS has expanded its business territory to the Southeast Asian market, striving to become a "bridgehead" for global pharmaceutical companies to enter the Southeast Asian market, further escorting the sustainable and healthy development of the Group.

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