SHENZHEN, CHINA – 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.

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.

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.

About CMS

CMS 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.

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CMS Disclaimer and Forward-Looking Statements

This 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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Source: China Medical System Holdings Ltd.

1. The results of the Product’s Phase III clinical trial in China were published and are available at: https://web.cms.net.cn/en/2022/12/positive-results-for-china-phase-iii-c…
2. Data from the Digestive Endoscopy Branch of the Chinese Medical Association
3. Early Diagnosis and Treatment Group of the Chinese Society of Oncology. “Expert Consensus on Early Diagnosis and Treatment of Colorectal Cancer in China (2023 Edition).” Chinese Medical Journal, 2023, 103(48): 3896-3908. 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