• Innovative drug Methylthioninium Chloride Enteric-coated Sustained-release Tablets (Lumeblue®) is an oral diagnostic drug, approved by China’s NMPA for enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.
• 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).
• 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.
• As of now, CMS's newly launched innovative portfolio has been expanded to 5 products, continuously generating driving force to the Group’s sustainable and healthy development.

China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to 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®) (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, and it is the first oral methylthioninium chloride enteric-coated sustained-release tablets in China. The Group will synergize with existing gastroenterology products and resources to advance the commercialization and academic promotion related works of the Product in an orderly manner, aiming to achieve nationwide large-scale clinical application as soon as possible so as to benefit patients with colorectal disease.

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)[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.

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 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[3]. There are approximately 400 million people aged 50 to 75 in China in 2020[4]. 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.

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.

Driven by the twin-wheel of "Collaborative R&D and Independent R&D", CMS has continuously deployed global first-in-class (FIC) and best-in-class (BIC) innovative products guided by patient and clinical demands. With enhancing R&D capabilities in developing differentiated innovative products, CMS has empowered the continuous transformation of scientific research outcomes into clinical application, continuously releasing the value of innovation. As of now, CMS's newly launched innovative portfolio has been expanded to 5 products, continuously generating driving force to the Group’s sustainable and healthy development. Desidustat Tablets and Methotrexate Injection (rheumatoid arthritis), CMS’s innovative pipeline products, are currently under NDA review in China. Meanwhile, over 10 innovative pipeline products are undergoing clinical trials in China, mainly randomized controlled trials (RCT). CMS is expected to launch differentiated innovative products every year in the future with higher efficiency and more controllable costs, continuing to optimize its product portfolio and build fresh driving forces for the mid- to long-term development of the Company.

About CMSCMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.

CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries. While strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology business, CMS independently operates its dermatology and medical aesthetics business, and ophthalmology business, aiming to gain leading positions in specialty therapeutic fields, whilst enhancing the scale and efficiency. At the same time, CMS has expanded its business territory to the Southeast Asian market, striving to become a "bridgehead" for global pharmaceutical companies to enter the Southeast Asian market, further escorting the sustainable and healthy development of the Group.

Reference:

1. The results of the Phase III clinical trial in China 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/
2. The diagnosis and treatment data of the Digestive Endoscopy Branch of the Chinese Medical Association
3. Chinese consensus of early colorectal cancer screening (2019, Shanghai)，Chinese Journal of Internal Medicine，DOI： 10.3760/cma.j.issn.0578-1426.2019.10.004
4. CHINA POPULATION CENSUS YEARBOOK 2020, can be found at： https://www.stats.gov.cn/sj/pcsj/rkpc/7rp/zk/indexch.htm

CMS Disclaimer and Forward-Looking StatementsThis press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.

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