- Modern drug Methylthioninium Chloride Enteric-coated Sustained-release Tablets (Lumeblue®) is an oral diagnostic drug, authorized by China’s NMPA for enhancing visualisation of colorectal lesions in grownup sufferers present process screening or surveillance colonoscopy.
- The outcomes of the Section III medical trial in China present that the Product can considerably enhance the detection fee of non-polypoid colorectal lesions (the first endpoint of the examine), resulting in an improved detection fee of harmful lesions resembling non-polypoid adenomas (the secondary endpoint).
- The Product may be taken through the bowel preparation step, guaranteeing that colorectal staining is accomplished by the point colonoscopy is carried out. This not solely enhances the detection fee of colorectal lesions but additionally doubtlessly simplifies the colonoscopy process, making the examination extra environment friendly and bettering the screening advantages.
- As of now, CMS’s newly launched revolutionary portfolio has been expanded to five merchandise, repeatedly producing driving drive to the Group’s sustainable and wholesome improvement.
SHENZHEN, CHINA – China Medical System Holdings Restricted (the “Company”, along with its subsidiaries, the “Group” or “CMS”) is happy to announce that on 11 June 2024, the New Drug Software (NDA) of the Group’s revolutionary drug methylthioninium chloride enteric-coated sustained-release tablets (Lumeblue®) (the “Product”) has been authorized by the Nationwide Medical Merchandise Administration of China (NMPA). The drug registration certificates was obtained on 18 June 2024. The Product is indicated to enhancing visualisation of colorectal lesions in grownup sufferers present process screening or surveillance colonoscopy, and it’s the first oral methylthioninium chloride enteric-coated sustained-release tablets in China. The Group will synergize with current gastroenterology merchandise and assets to advance the commercialization and tutorial promotion associated works of the Product in an orderly method, aiming to attain nationwide large-scale medical utility as quickly as attainable in order to learn sufferers with colorectal illness.
Lumeblue® is an oral diagnostic drug that makes use of patented multi-matrix (MMX) know-how to ship energetic substances on to the colon and launch them domestically in a managed method. As an enhancer dye, the Product will increase the distinction between colorectal lesions and wholesome mucosa. The outcomes of the Section III medical trial in China present that the Product can considerably enhance the detection fee of non-polypoid colorectal lesions(the first endpoint of the examine), resulting in an improved detection fee of harmful lesions resembling non-polypoid adenomas (the secondary endpoint)[1]. As well as, the Product may be taken through the bowel preparation step, guaranteeing that colorectal staining is accomplished by the point colonoscopy is carried out. This not solely enhances the detection fee of colorectal lesions but additionally doubtlessly simplifies the colonoscopy process, making the examination extra environment friendly and bettering the screening advantages.
In keeping with the analysis and therapy knowledge of the Digestive Endoscopy Department of the Chinese language Medical Affiliation, roughly a complete of 28 million gastroenteroscopies had been accomplished nationwide in 2012, together with 5.83 million colonoscopies. In 2019, roughly 38.73 million gastroenteroscopies had been accomplished nationwide, a rise of 34.62% in contrast with 2012[2]. The Chinese language consensus of early colorectal most cancers screening recommends that individuals aged 50 to 75 years previous must be screened for colorectal most cancers no matter whether or not they have alarm signs[3]. There are roughly 400 million folks aged 50 to 75 in China in 2020[4]. With the recognition of early screening for colorectal most cancers in China, it’s anticipated to witness a substantial development of the variety of colonoscopies in China sooner or later.
The Product has been authorized by the European Medicines Company (EMA) to be commercialized within the European Union underneath the commerce identify Lumeblue in August 2020. The Group obtained an unique license for the Product from Cosmo Applied sciences Ltd, a totally owned subsidiary of Cosmo Prescribed drugs NV, on 3 December 2020.
Pushed by the twin-wheel of “Collaborative R&D and Independent R&D”, CMS has repeatedly deployed international first-in-class (FIC) and best-in-class (BIC) revolutionary merchandise guided by affected person and medical calls for. With enhancing R&D capabilities in creating differentiated revolutionary merchandise, CMS has empowered the continual transformation of scientific analysis outcomes into medical utility, repeatedly releasing the worth of innovation. As of now, CMS’s newly launched revolutionary portfolio has been expanded to five merchandise, repeatedly producing driving drive to the Group’s sustainable and wholesome improvement. Desidustat Tablets and Methotrexate Injection (rheumatoid arthritis), CMS’s revolutionary pipeline merchandise, are presently underneath NDA evaluate in China. In the meantime, over 10 revolutionary pipeline merchandise are present process medical trials in China, primarily randomized managed trials (RCT). CMS is anticipated to launch differentiated revolutionary merchandise yearly sooner or later with increased effectivity and extra controllable prices, persevering with to optimize its product portfolio and construct contemporary driving forces for the mid- to long-term improvement of the Firm.
About CMS
CMS is a platform firm linking pharmaceutical innovation and commercialization with robust product lifecycle administration functionality, devoted to offering aggressive services and products to satisfy unmet medical wants.
CMS focuses on the worldwide first-in-class (FIC) and best-in-class (BIC) revolutionary merchandise, and effectively promotes the medical analysis, improvement and commercialization of revolutionary merchandise, enabling the continual transformation of scientific analysis into medical practices to learn sufferers.
CMS deeply engages in a number of specialty therapeutic fields, and has developed confirmed commercialization capabilities, intensive networks and knowledgeable assets, leading to main tutorial and market positions for its main marketed merchandise. CMS continues to advertise the in-depth improvement of its advantageous specialty fields and broaden enterprise boundaries. Whereas strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology enterprise, CMS independently operates its dermatology and medical aesthetics enterprise, and ophthalmology enterprise, aiming to realize main positions in specialty therapeutic fields, while enhancing the size and effectivity. On the identical time, CMS has expanded its enterprise territory to the Southeast Asian market, striving to change into a “bridgehead” for international pharmaceutical firms to enter the Southeast Asian market, additional escorting the sustainable and wholesome improvement of the Group.
Reference:
- The outcomes of the Section III medical trial in China was revealed and may be discovered at: https://net.cms.internet.cn/en/2022/12/positive-results-for-china-phase-iii-clinical-trial-of-methylthioninium-chloride-enteric-coated-sustained-release-tablets/
- The analysis and therapy knowledge of the Digestive Endoscopy Department of the Chinese language Medical Affiliation
- Chinese language consensus of early colorectal most cancers screening (2019, Shanghai)，Chinese language Journal of Inner Drugs，DOI： 10.3760/cma.j.issn.0578-1426.2019.10.004
- CHINA POPULATION CENSUS YEARBOOK 2020, may be discovered at： https://www.stats.gov.cn/sj/pcsj/rkpc/7rp/zk/indexch.htm
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