On September 20, 2024, China Medical System (“CMS” or the “Group”) presented its innovative drug Lumeblue® (Methylthioninium Chloride Enteric-coated Sustained-release Tablets) (the “Product”) at the 24th Congress of Gastroenterology China in 2024 (“CGC 2024”). This congress brought together numerous domestic scholars and clinical experts in the field of gastroenterology to discuss key topics and advancements in gastroenterology disease research, serving as an important platform for promoting progress in the diagnosis and treatment of gastroenterology diseases in China.
CMS develops innovative products with a focus on medical values and clinical needs, striving to provide effective and affordable therapeutic solutions for patients. The innovative drug Lumeblue® (Methylthioninium Chloride Enteric-coated Sustained-release Tablets) is indicated to enhance visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy, which 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.
Gathering Academic Expertise to Explore New Insights in Gastroenterology Diagnosis and Treatment
More than 5,000 medical experts from the gastroenterology field across the country attended the conference, delving into new advances, technologies, and clinical practices, aiming to bring more insights and solutions in the treatment of gastroenterology diseases in China by connecting various parties. During the three-day conference, numerous scholars delivered fascinating academic reports on current key and challenging issues in gastroenterology treatment, such as early diagnosis of colorectal cancer. Participants also discussed the trends and cutting-edge techniques in gastroenterology disease screening and treatment, including advanced techniques for early cancer screening with endoscopy, further promoting progress in the field and paving the way for innovative drug development and clinical application, contributing to the “Healthy China” initiative.
CMS is dedicated to its mission of providing competitive products and services to meet unmet medical needs, and has long been deeply delved into innovative technologies related to specialty therapeutic fields such as gastroenterology. This time, CMS brought its innovative drug Lumeblue® to the conference, bringing a convenient solution to improve the detection rate of colorectal lesions in clinical practice. Subsequently, CMS will accelerate the commercialization process of Lumeblue® in China, by synergizing with existing products and resources of the gastroenterology line to advance the commercialization and academic promotion related works for Lumeblue® in an orderly manner, aiming to achieve nationwide large-scale clinical application as soon as possible to benefit patients with colorectal disease.
Expanding Clinical Applications to Offer Superior Solutions for Colorectal Screening
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[1]. 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[2]. There are approximately 400 million people aged 50 to 75 in China in 2020[3]. 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.
On June 11, 2024, the innovative drug Lumeblue® (Methylthioninium Chloride Enteric-coated Sustained-release Tablets) was approved for marketing by the National Medical Products Administration of China (NMPA), indicated to enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy, and it is the first oral methylthioninium chloride enteric-coated sustained-release tablets in China.
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)[4]. 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.
Driven by its innovation strategy of “collaborative and independent R&D”, CMS continues to connect global innovation forces, deploying first-in-class (FIC) and best-in-class (BIC) products, and advancing the clinical development and commercialization of innovative products, enabling the continuous translation of scientific research into clinical practices to benefit patients. As of now, CMS’s marketed innovative product portfolio in China has expanded into 5 products (including 6 indications). CMS has also steadily advanced the clinical development of innovative products, a total of about 10 projects have been prepared/launched for their registrational clinical trials, mainly randomized controlled trials (RCT).
The exploration of innovative drugs is a long and arduous process. CMS will continue to increase investment in innovation, delivering innovative products with higher efficiency and more controllable costs every year to accelerate the release of innovation value, aiming to bring more quality products to a wide range of clinical professionals and patients.
References:
- The diagnosis and treatment data of the Digestive Endoscopy Branch of the Chinese Medical Association
- Chinese consensus of early colorectal cancer screening (2019, Shanghai)，Chinese Journal of Internal Medicine，DOI：3760/cma.j.issn.0578-1426.2019.10.004
- CHINA POPULATION CENSUS YEARBOOK 2020, can be found at： https://www.stats.gov.cn/sj/pcsj/rkpc/7rp/zk/indexch.htm
- The results of the China Phase III clinical trial was published and can be found at: https://web.cms.net.cn/en/2022/12/positive-results-for-china-phase-iii-clinical-trial-of-methylthioninium-chloride-enteric-coated-sustained-release-tablets/
CMS Disclaimer and Forward-Looking Statements
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