On December 6, cms (00867, hereinafter referred to as "cms" or "the company") announced that its innovative drug Leflan (methylene blue enteric-coated controlled-release tablet) has issued the country's first batch of prescriptions, officially entering clinical use. This is china's first oral methylene blue enteric-coated controlled-release tablet, used to enhance the visualization of colorectal lesions in adult patients undergoing screening or monitoring with colonoscopy.

According to information from Zhitong Finance APP, as of now, cms has successfully approved five innovative drugs in china, fully entering clinical use. These achievements fully demonstrate the company's core capability in continuously promoting the transformation of innovation as a platform-based pharmaceutical enterprise linking medical innovation and commercialization.

Company news indicates that Leflan is an oral diagnostic drug that uses patented multi-matrix (MMXTM) technology to directly deliver the active substance to the colon and control the local release, increasing the contrast between colorectal lesions and healthy mucosa. Results from china's Phase III clinical study show that the product can significantly improve the detection rate of non-polyp colorectal lesions (the primary endpoint), thereby increasing the detection rate of hazardous lesions such as non-polyp adenomas (the secondary endpoint). In addition, this product is taken during the bowel preparation phase, ensuring that colorectal staining is completed during the colonoscopy, potentially simplifying the colonoscopy procedure while simultaneously increasing the rate of detection of colorectal lesions, making the colonoscopy more efficient and enhancing screening benefits.

According to data from the Gastroenterology Endoscopy Branch of the Chinese Medical Association, approximately 28 million gastrointestinal endoscopies were completed nationwide in 2012, among which 5.83 million were colonoscopies. In 2019, approximately 38.73 million gastrointestinal endoscopies were completed nationwide, a growth of 34.62% compared to 2012. The "Expert Consensus on Early Diagnosis and Treatment of Colorectal Cancer in China (2023 Edition)" recommends the screening age range for colorectal tumors in our country to be 40-74 years. According to data from the "China Statistical Yearbook (2023)", the total population of those aged 40 to 74 in our country is 643.36 million. With the popularization of early screening for colorectal cancer in china, it is expected that the number of colonoscopies will still have significant growth potential in the future. Faced with the increasingly growing demand, the launch of Leflan provides an innovative solution for the screening and management of colorectal disease in china.

It is reported that this product was approved by the European Medicines Agency (EMA) in August 2020 for commercialization in the EU under the brand name Lumeblue. cms obtained exclusive licensing rights for the product from Cosmo Technologies Ltd., a wholly-owned subsidiary of Cosmo Pharmaceuticals NV, on December 3, 2020, and promoted its approval in china this June.

cms stated that in the future, the company will continue to adhere to a patient-centered approach, efficiently promoting the clinical development and commercialization processes of innovative products, improving the accessibility and affordability of innovative drugs, benefiting more patients.