China Medical System Holdings Limited (CMS) has announced the first prescriptions for Lumeblue® (Methylthioninium Chloride Enteric-coated Sustained-release Tablets) have been issued in China. This marks the clinical application of the first oral methylthioninium chloride enteric-coated sustained-release tablets in China, indicated for enhancing the visualization of colorectal lesions in adult patients undergoing colonoscopies.
Lumeblue® is designed as an oral diagnostic drug that employs patented multi-matrix (MMX™) technology to ensure targeted delivery and controlled release of the active substance directly within the colon. Functioning as an enhancer dye, Lumeblue® increases the contrast between colorectal lesions and the surrounding healthy mucosa, thereby facilitating improved detection during colonoscopies.
Clinical Trial Data
Phase III clinical trial results in China demonstrated that Lumeblue® significantly improved the detection rate of non-polypoid colorectal lesions, which was the study's primary endpoint. Furthermore, the trial also showed an improved detection rate of non-polypoid adenomas, a key secondary endpoint. The convenience of administering Lumeblue® during the bowel preparation phase ensures that colorectal staining is completed by the time the colonoscopy is performed, streamlining the procedure and enhancing its efficiency.
Market and Screening Context
Data from the Digestive Endoscopy Branch of the Chinese Medical Association indicates a substantial increase in gastroenteroscopies performed nationwide, from 28 million in 2012 to 38.73 million in 2019, marking a 34.62% increase. The "Expert Consensus on Early Diagnosis and Treatment of Colorectal Cancer in China (2023 Edition)" recommends colorectal cancer screening for individuals aged 40 to 74, representing a population of 643.36 million in China, according to the China Statistical Yearbook (2023). With increased emphasis on early colorectal cancer screening, the demand for colonoscopies is expected to rise, positioning Lumeblue® as a crucial tool in early diagnosis and lesion removal.
Regulatory and Commercialization Details
Lumeblue® received approval for commercialization in the European Union from the European Medicines Agency (EMA) in August 2020. CMS secured exclusive rights to the product from Cosmo Technologies Ltd. in December 2020. Following its approval in China in June 2024, CMS has been focused on the rapid importation and commercial promotion of Lumeblue®, leveraging its gastroenterology portfolio to facilitate its successful launch.
CMS's Strategic Achievements
The successful approval and clinical application of Lumeblue® marks CMS's fifth innovative drug to achieve this milestone in China. This accomplishment underscores CMS's commitment to innovation and its focus on addressing unmet medical needs. CMS aims to continue prioritizing patient-centric approaches, advancing clinical development, and enhancing the accessibility and affordability of innovative drugs.
