On January 10, the first subject has been dosed in China bridging trial of Methylthioninium Chloride Enteric-coated Sustained-release Tablets, the innovative medicine of China Medical System Holdings Limited, representing a significant progress after the product received its China IND approval in August 2021.
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. With Beijing Friendship Hospital, Capital Medical University being the leading hospital, the trial is planned to enroll 1,800 subjects and be conducted in around 20 sites nationwide. The principal investigators of the trial include leading experts in digestion fields, such as Prof. Shutian Zhang, former chairman of Chinese Society of Digestive Endoscopology and chairman of Chinese Association of Gastroenterologist & Hepatologist, and Prof. Yulan Liu, committee member and secretary-general of Chinese Society of Gastroenterology and chairman of Gastroenterology Branch of Chinese Geriatrics Society.
Methylthioninium Chloride Enteric-coated
Methylthioninium Chloride Enteric-coated Sustained-release Tablets, formulated by the proprietary MMX sustained-release technology of the Group’s partner Cosmo, is a novel oral formulation of the existing liquid colon staining dye methylene blues, which helps to improve the detection rate of colorectal cancer/precancerous lesions by enhancing visualization of the colorectal lesions in adult patients undergoing screening or surveillance colonoscopy. The product has been approved for marketing by the European Medicines Agency under the trade name Lumeblue in August2020.
Colorectal cancer is one of the most common malignant tumours in digestive system. 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. Early detection and removal of the lesions, before it spreads and advances, can significantly improve patient survival rate. While the colonoscopy is regarded as the gold standard in screening for colorectal cancer, the clinically meaningful precancerous lesions are often ignored in practice due to the procedure’s intrinsic detecting sensitivity issue. 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.