China IND Application of China Medical System (867.HK)'s Innovative Drug Methylene Blue Enteric-Coated Sustained-Release Tablet Was Accepted

On June 1 , the IND application of China Medical System's blockbuster innovative drug Methylene Blue Enteric-coated Sustained-release Tablet was accepted by the Center for Drug Evaluation, NMPA. Methylene Blue Enteric-coated Sustained-release Tablet is an oral diagnostic drug, 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.

Methylene Blue Enteric-coated Sustained-release Tablet is a novel oral formulation of the existing liquid colon staining dye methylene blues. Formulated by the proprietary MMX Technology of Cosmo, the Group's partner, the tablets deliver the dye in a sustained and controlled way, distributing evenly through the full length of the colon. The product has been approved for marketing by the European Medicines Agency under the trade name Lumebluesup>TM/sup> in August 2020, and its pivotal clinical data supporting the approval in Europe has demonstrated that the product can improve the detection of colorectal cancer/precancerous lesions during colonoscopy.

Colorectal cancer is one of the most common malignant tumours in digestive system. China reported 376,000 new cases and 191,000 deaths each year, according to 2018 China Cancer Statistics Report. 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, and the market potential of the product is promising.