China Medical System Holdings Limited announce that on 11 June 2024, the New Drug Application (NDA) of the Group's innovative drug methylthioninium chloride enteric-coated sustained-release tablets Lumeblue® ("Lumeblue®" or the "Product") has been approved by the National Medical Products Administration of China (NMPA). The drug registration certificate was obtained on 18 June 2024. The Product is indicated to enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.

Lumeblue® is an oral diagnostic drug that uses patented multi-matrix (MMX) technology to deliver active substances directly to the colon and release them locally in a controlled manner. As an enhancer dye, the Product increases the contrast between colorectal lesions and healthy mucosa. The results of the Phase III clinical trial in China show that the Product can significantly improve the detection rate of non-polypoid colorectal lesions (the primary endpoint of the study), leading to an improved detection rate of dangerous lesions such as non-polypoid adenomas (the secondary endpoint).

In addition, the Product can be taken during the bowel preparation step, ensuring that colorectal staining is completed by the time colonoscopy is conducted. This not only enhances the detection rate of colorectal lesions but also potentially simplifies the colonoscopy procedure, making the examination more efficient and improving the screening benefits. According to the diagnosis and treatment data of the Digestive Endoscopy Branch of the Chinese Medical Association, approximately a total of 28 million gastroenteroscopies were completed nationwide in 2012, including 5.83 million colonoscopies.

In 2019, approximately 38.73 million gastroenteroscopies were completed nationwide, an increase of 34.62% compared with 2012. The "Chinese Consensus of Early Colorectal Cancer Screening" recommends that people aged 50 to 75 years old should be screened for colorectal cancer regardless of whether they have alarm symptoms. There are approximately 400 million people aged 50 to 75 in China in 2020. With the popularity of early screening for colorectal cancer in China, it is expected to witness a considerable growth of the number of colonoscopies in China in the future.

Lumeblue® has been approved by the European Medicines Agency (EMA) to be commercialized in the European Union under the trade name LumeblueTM in August 2020. The Group obtained an exclusive license for the Product from Cosmo Technologies Ltd. on 3 December 2020. The Group will promote the commercialization of the Product in an orderly manner to benefit patients with colorectal disease at an early date.