On July 25, the China bridging trial of Methylthioninium Chloride Enteric-coated Sustained-release Tablets, an innovative medicine of China Medical System Holdings Limited (“CMS” or the “Group”), has completed the enrollment of all subjects. Since the first subject enrollment on January 10, the Group’s clinical research team has overcome challenges under pandemic prevention and control, and took only 6 months (including the Spring Festival Holiday) to complete the enrollment of all 1,800 subjects, which again proved the Group’s ability to efficiently enroll subjects for clinical trials.
The trial is a randomized, double-blind, placebo controlled, multi-center Phase III clinical trial, aiming to evaluate the efficacy of Methylthioninium Chloride Enteric-coated Sustained-release Tablets in improving the detection rate of histologically confirmed non-polypoid colorectal lesions in subjects undergoing colonoscopic screening or colonoscopic monitoring of colorectal neoplasms compared to placebo. The research was led by Beijing Friendship Hospital, Capital Medical University and conducted in 20 sites nationwide. The principle investigators include leading experts in gastrointestinal fields, such as Prof. Shutian Zhang and Prof. Yulan Liu.
Methylthioninium Chloride Enteric-coated Sustained-release Tablets
The product has been approved for marketing by the European Medicines Agency under the trade name Lumeblue in August 2020
Methylthioninium Chloride Enteric-coated Sustained-release Tablets is a novel oral formulation of the existing liquid colon staining dye methylene blues. Formulated by the proprietary MMX sustained-release technology of the Group’s partner Cosmo, it delivers the dye in a delayed and controlled way, distributing evenly through the full length of the colon, which enhances visualization of the colorectal lesions in adult patients undergoing screening or surveillance colonoscopy, thus to help improve the detection rate of colorectal cancer/precancerous lesions.
Colorectal cancer is one of the most common malignant tumours in digestive system, with a high incidence, high mortality and poor treatment effect. According to statistics from WHO International Agency for Research on Cancer (IARC), there were around 560,000 new cases of colorectal cancer and 290,000 deaths in China in 2020. Prevention is better than cure. Early detection and removal of the lesions can significantly improve patient survival rate, for which the colonoscopy is regarded as the gold standard in screening for colorectal cancer. However, the clinically meaningful precancerous lesions are often ignored in practice due to the procedure’s intrinsic detecting sensitivity issue, and most patients are already in the middle and late stages when they are first diagnosed. Adding Methylthioninium Chloride Enteric-coated Sustained-release Tablets to routine colonoscopy screening procedures can increase the detection sensitivity and will bring potential benefits to patients, and the market potential of the product is promising.