China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the innovative patented drug Methylthioninium Chloride Enteric-coated Sustained-release Tablets (the “Product”) which was licensed in by the Group on 3 December 2020 from Cosmo Technologies Ltd. has been granted an approval for drug clinical trial issued on 2 August 2021 by the National Medical Products Administration of the People’s Republic of China and agreed to carry out a randomized, double-blind, placebo controlled, multi-centre clinical trial of the efficacy and safety of the Product in patients undergoing colorectal cancer screening or surveillance colonoscopy.
The Product is an oral diagnostic drug, being designed to increase the detection sensitivity of colorectal cancer/precancerous lesions (such as adenomas) by enhancing visualization of the colorectal lesions in adult patients undergoing screening or surveillance colonoscopy. The Product has been approved by the European Medicines Agency (EMA) to be commercialized in Europe under the trade name Lumeblue? in August 2020.
The Group is currently actively preparing for initiating the clinical trial of the Product.