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 Lumeblue<sup>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