On 6 December, China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that the first prescriptions for the innovative drug Lumeblue^??(Methylthioninium Chloride Enteric-coated Sustained-release Tablets) (the “Product”) have been issued in China, which?marks?that?the first oral methylthioninium chloride?enteric-coated sustained-release tablets?in China?has officially entered clinical application. The Product is indicated for enhancing visualization of colorectal lesions in adult patients undergoing screening or surveillance colonoscopies.

Lumeblue^??is an oral diagnostic drug that uses patented multi-matrix (MMX^TM) 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)^[1].?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.

First Prescriptions for Lumeblue? (Methylthioninium Chloride Enteric-coated Sustained-release Tablets)?Issued

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^[2]. The Expert consensus on the early diagnosis and treatment of colorectal cancer in China (2023 edition)?recommends colorectal cancer screening for individuals aged 40 to 74^[3]. Based on the China Statistical Yearbook (2023), the total population of?this age group in China is 643.36 million^[4]. With the popularization of early colorectal cancer screening in China, the number of colonoscopies performed is expected to have significant growth potential?in the future. Early diagnosis and removal of lesions are crucial for prevention. Lumeblue^??provides an innovative solution for colorectal disease screening and management in response to this growing demand.

The Product has been?approved?by the European Medicines Agency (EMA) to be commercialized?in the European Union under the trade?name Lumeblue^??in August 2020. The Group?obtained an exclusive license?for?the Product from Cosmo Technologies Ltd., a fully-owned subsidiary of Cosmo Pharmaceuticals NV, on 3 December 2020. Following its approval in China in?June?2024, CMS worked collaboratively across its business segments to ensure the rapid importation of the first batch of products. The Group has also actively leveraged its existing gastroenterology portfolio and resources to orderly advance the commercialization and academic promotion of Lumeblue^?, facilitating its successful prescriptions?launch in China.

Lumeblue? (Methylthioninium Chloride Enteric-coated Sustained-release Tablets)?

With this milestone, CMS’s five innovative drugs have been successfully approved in China and fully entered clinical application.?This achievement?demonstrates the Group’s?ongoing?capability?of innovation transformation,?while?reflecting?CMS’s commitment to focusing on medical value?and fulfilling its corporate social responsibility.?Looking ahead, CMS will continue to be patients-centered, efficiently advancing the clinical development and commercialization of innovative products. The Group is dedicated to improving the accessibility and affordability of innovative drugs, benefiting a broader patient population.

References:

1. The results ofthe?Product’s?Phase III clinical trial?in China were published and are available at:?http://www.qqpokerceme.com/en/2022/12/positive-results-for-china-phase-iii-clinical-trial-of-methylthioninium-chloride-enteric-coated-sustained-release-tablets/
2. Data from the Digestive Endoscopy Branch of the Chinese Medical Association
3. Early Diagnosis and Treatment Group of the Chinese Society of Oncology. “ExpertConsensus on Early Diagnosis and Treatment of Colorectal Cancer in China (2023 Edition).” Chinese Medical Journal, 2023, 103(48): 3896– DOI: 10.3760/cma.j.cn112137-20230804-00164
4. National Bureau of Statistics. (2023). China Statistical Yearbook 2023. Retrieved from https://www.stats.gov.cn/sj/ndsj/2023/indexch.htm

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