China Medical System Holdings (CMS; HKG: 0867) has announced that it has received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its methylthioninium enteric coated sustained-release tablets. This oral formulation is the first of its kind in China and is indicated for enhancing the visualization of colorectal lesions in adult patients during colonoscopy screening or monitoring.
Methylthioninium utilizes a multi-matrix (MMX) patent technology that enables direct delivery of the active substance to the colon with controlled release. As an enhancer dye, it improves the contrast between colorectal lesions and healthy mucosa. A Phase III study conducted in China demonstrated that methylthioninium significantly increased the detection rate of non-polypoid colorectal lesions, which was the primary endpoint, and also increased the detection rate of high-risk lesions such as non-polypoid adenomas, the secondary endpoint. The product is taken during the intestinal preparation phase to ensure colon staining is completed at the time of colonoscopy, thereby potentially simplifying the procedure and making it more efficient and effective for screening.
Methylthioninium was granted marketing authorization in the European Union in August 2020 under the trade name Lumeblue. In December 2020, CMS entered into a licensing agreement with Cosmo Pharmaceuticals NV, securing exclusive rights to the drug.- Flcube.com
