In February 2023, the New Drug Application（NDA）of methylthioninium chloride enteric-coated sustained-release tablets has been accepted by the National Medical Products Administration of China (NMPA). 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 subjects undergoing screening or surveillance colonoscopy, thus helps to improve the detection rate of colorectal cancer/precancerous lesions. The product has been approved for marketing in Europe.
The product obtained positive results for 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.
Colorectal cancer is one of the most common malignant tumours in digestive system with high incidence, high mortality and poor treatment outcomes. 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 Methylene Blue Enteric-coated Sustained-release Tablet to routine colonoscopy screening procedures will bring potential benefits to a broad population of patients.