China Medical System
Holdings Limited (the “Company”, together with its subsidiaries, the “Group”)
is pleased to announce that the Group, through its wholly-owned subsidiary
signed a License, Collaboration and Distribution Agreement (the “License Agreement”)
with Cosmo Technologies Ltd. (“Cosmo”), a specialty pharma focusing on developing and
commercializing the products related to gastrointestinal disorders, for the innovative patented drug Methylthioninium Chloride Cosmo and any line extension thereof (the “Product”)
on 3 December 2020. The Product currently includes a drug that has been
approved by the European Medicines Agency (EMA) to be commercialized in Europe
under the trade name Lumeblue? for the
detection of lesions during colonoscopy. Based on a proprietary innovative technology of Cosmo, this oral diagnostic drug has clinically demonstrated its improvement of
diagnosis sensitivity in detecting the cancerous/precancerous lesions during colonoscopy for the screening of colorectal cancer.
In accordance with the License Agreement, the Group through its
wholly-owned subsidiary will gain an exclusive license to
develop and commercialize the Product and use the Product mark in association
with the commercialization of the Product in Mainland China, Hong
Kong Special Administrative Region, Macao Special Administrative Region and Taiwan
(the “Territory”). The License Agreement will commence on the effective
date and continue to be valid until (i) the twentieth (20th) anniversary of the
first commercial sale of the Product in the Territory, or (ii) the last
expiration date of the Product patents of Cosmo, whichever is later. Upon the expiration of the
aforementioned term, the License Agreement may be renewable for every single
period of three years thereafter as per certain conditions defined in the
License Agreement.
Through this collaboration, the Group’s products for digestive
system will be further enriched and extended upon the commercialization of the Product in
the Territory.
About
the Product
Lumeblue?（Methylene
Blue MMX, EMA approved prescription drug）
Lumeblue? is an oral diagnostic drug. The drug is designed to increase the detecting sensitivity of
colorectal cancer/precancerous lesions (such as adenomas) by enhancing visualization of the colorectal lesions
in adult patients undergoing screening or surveillance colonoscopy. It was
firstly approved in Europe on 21 August 2020, following a successful global
Phase III trial. Lumeblue? currently
has a granted formation
patent in China, valid to 2031.
Colorectal cancer is one of the most common malignant tumour in
digestive system, with a high incidence, high motality and poor progress throughout the world.
In China, there are 376,000 new cases and 191,000 deaths reported each year,
according to 2018 China Cancer Statistics Report. Prevention is better
than cure, so the detection and removal of the lesions, such as
adenomas, is critical, as survival is
significantly better when colorectal cancer is diagnosed early, before it spreads and advances.
For that reason, population-based screening for colorectal cancer is widely
recommended globally. Colonoscopy remains an important technique and is still
regarded as the gold standard in screening for colorectal cancer. Although some new
technologies have been developed in colonoscopy last few decades, the clinically
meaningful precancerous lesions are often ignored in the practice due to the
procedure’s intrinsic detecting sensitivity issue.
Lumeblue?
(Methylene Blue MMX) is a novel oral formulation of the existing liquid
colon staining dye methylene blues. The drug
is formulated by Cosmo’s proprietary MMX Technology. Taken orally, the
tablets deliver the dye in a delayed and controlled way distributing evenly through the full length of the
colon. Lumeblue? is clinically approved to improve
the detection of all lesions, including precancerous lesions, such as adenoma, in the colon during endoscopy. The potential to significantly improve the adenoma detection rate (ADR) is important and clinically meaningful, as an improved ADR is inversely
related to the risk of developing colorectal cancer and death. The
potential benefits of adding Methylene Blue MMX to routine
colonoscopy screening procedures appears clear.
About Cosmo
Cosmo is a specialty pharmaceutical company that
aims to become a global leader in the market of optimized therapies for
selected gastro-intestinal diseases. Cosmo’s proprietary clinical development
pipeline specifically addresses innovative treatments for the gastro-intestinal
tract, specifically Inflammatory Bowel Diseases (IBD), colon infections and
colon diagnosis. For additional information of Cosmo and its products please
visit its official website: www.cosmopharma.com.