China Approves Innovative Methylthioninium Chloride Tablets

SHENZHEN, CHINA, June 18, 2024-- China Medical System Holdings Limited (CMS) announced the approval of their innovative drug, Methylthioninium Chloride Enteric-coated Sustained-release Tablets (Lumeblue®), by China's National Medical Products Administration (NMPA). This oral diagnostic drug is designed to enhance the visualization of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy. The approval paves the way for Lumeblue® to be used broadly across China, marking a significant milestone in colorectal diagnostics.

Phase III clinical trials conducted in China have demonstrated that Lumeblue® significantly improves the detection rate of non-polypoid colorectal lesions, which was the primary objective of the study. The drug also enhances the detection of high-risk lesions like non-polypoid adenomas, a secondary endpoint of the trial. The clinical trial outcomes suggest that Lumeblue® can make a substantial impact on colorectal cancer screening by improving the identification of dangerous lesions.

Lumeblue® is designed to be taken during the bowel preparation phase, ensuring that the colorectal staining is complete by the time the colonoscopy is performed. This not only aids in better detection of lesions but potentially simplifies the colonoscopy process itself, thereby increasing efficiency and screening benefits.

This recent approval expands CMS's innovative product portfolio to five, reinforcing the company's strategy for sustainable and healthy development. CMS plans to leverage its existing gastroenterology products and resources to promote the widespread clinical application of Lumeblue® across China. The company aims to achieve nationwide adoption swiftly, benefiting patients with colorectal diseases.

Lumeblue® uses patented multi-matrix (MMX) technology to deliver the active substances directly to the colon, where they are released in a controlled manner. By acting as an enhancer dye, Lumeblue® provides better contrast between colorectal lesions and healthy mucosa, making it easier for doctors to identify abnormal areas during a colonoscopy.

Colorectal cancer screening is crucial in China, with the Digestive Endoscopy Branch of the Chinese Medical Association reporting 38.73 million gastroenteroscopies in 2019, a 34.62% increase from 2012. The Chinese consensus on early colorectal cancer screening recommends that individuals aged 50 to 75 undergo regular screening, considering the approximately 400 million people in this age group as of 2020. With the growing emphasis on early cancer detection, the number of colonoscopies in China is expected to rise significantly in the future.

Lumeblue® has already been approved for commercialization in the European Union by the European Medicines Agency (EMA) under the trade name Lumeblue™ in August 2020. CMS acquired an exclusive license for Lumeblue® from Cosmo Technologies Ltd, a subsidiary of Cosmo Pharmaceuticals NV, in December 2020.

CMS operates on a dual-wheel strategy of "Collaborative R&D and Independent R&D," focusing on developing first-in-class (FIC) and best-in-class (BIC) innovative products. This approach has enabled CMS to transform scientific research into clinical applications effectively, continuously unveiling valuable innovations. CMS's pipeline includes products like Desidustat Tablets and Methotrexate Injection for rheumatoid arthritis, currently under NDA review in China. Additionally, over ten innovative pipeline products are undergoing clinical trials, primarily randomized controlled trials (RCT).

CMS's mission is to bridge pharmaceutical innovation and commercialization, providing competitive products and services tailored to meet unmet medical needs. By focusing on key therapeutic fields and expanding its market presence, CMS aims to maintain leading positions in its specialty areas, such as cardio-cerebrovascular, gastroenterology, dermatology, medical aesthetics, and ophthalmology. Moreover, CMS has strategically extended its operations to the Southeast Asian market, positioning itself as a gateway for global pharmaceutical companies aiming to enter this region. This expansion underscores CMS's commitment to sustainable growth and healthcare advancement.

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