The board (the “Board”) of directors (the “Directors”) of China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that on 15 February 2023, New Drug Application of the Group’s innovative patented drug methylthioninium chloride enteric-coated sustained-release tablets (“Methylthioninium Chloride Enteric-coated Sustained-release Tablets” or the “Product”) has been accepted by the National Medical Products Administration of China (NMPA).
Methylthioninium Chloride Enteric-coated Sustained-release Tablets is an oral diagnostic drug, being designed to significantly increase the detection rate of non-polypoid colorectal lesions by enhancing the visualization of the colorectal lesions in adult patients undergoing screening or surveillance colonoscopy. The Product obtained positive results of its Phase Ⅲ clinical trial in China. The primary study endpoint – the detection rate of non-polypoid colorectal lesions, defined as the proportion of subjects with at least one histologically proven nonpolypoid colorectal lesion, was 51% in the test group (the Product was given) and 41.2% in the control group (placebo was given). The difference between the two groups was statistically significant (P<0.0001). The false positive was well controlled.