China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on 30 July 2024, the New Drug Application (NDA) for an additional indication of Methotrexate Injection (the “Product”) has been approved by the National Medical Products Administration of China (NMPA). The Product is a small-volume methotrexate injection with various strengths for the treatment of active rheumatoid arthritis (RA) in adult patients. The Group was granted a certificate of drug registration on 5 August 2024. Methotrexate is recognized internationally as the first choice first-line and anchor drug for RA. The Product is the first methotrexate prefilled injection to treat RA by subcutaneous administration in China, providing a safer, more effective, more convenient and more accurate administration scheme for RA adult patients. According to the communication with NMPA, the bridge clinical trial of the Product in China (the “Study”) aims […]
China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that on July 16, two new drug applications (NDA) for Ursofalk® (ursodeoxycholic acid oral suspension) (the “Product”), jointly applied by the Group and Dr. Falk Pharma, have been approved by the National Medical Products Administration (NMPA), covering the following indications: 1) The NDA for the treatment of liver disease associated with a condition called cystic fibrosis in children aged 1 month to 18 years has been approved, which is a rare disease. 2) The NDA for the treatment of dissolution of cholesterol gallstones in the gallbladder (the gallstones must be radiolucent, and the gallbladder function must be intact); cholestatic liver diseases (such as primary biliary cirrhosis) and biliary reflux gastritis has been approved. The application was previously included in the priority review by NMPA’s Center for Drug Evaluation (CDE) for its accordance with […]
In July 2024, China Medical System Holdings Limited (“CMS” or the “Group”) has once again been recognized for its outstanding performance and continuous progress in sustainable development. CMS was reincluded in the 2024 Sustainability Yearbook (China Edition) issued by S&P Global, a global-leading corporate sustainability assessment institution, and maintained its “AA” rating in the updated MSCI (Morgan Stanley Capital International) ESG Rating Report. Re-including in S&P Global’s Sustainability Yearbook (China Edition) The S&P Global’s 2024 Sustainability Yearbook (China Edition) has been released. With an CSA score of 51 that surpassing 91% global peers in the industry, CMS stood out among more than 1,700 evaluated Chinese companies to be reincluded in the China Yearbook, becoming one of the five selected companies in the pharmaceutical industry. Source: S&P Global Receiving “AA” once again in MSCI ESG Rating In July, MSCI has released the latest ESG rating report for CMS. The Group […]
On June 25, China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) announced the completion of dosing for the first subject in the phase III bridging trial of ruxolitinib cream (the “Product”) in atopic dermatitis (“AD”) in China. This is another substantial clinical development milestone for ruxolitinib cream in China, following the approval for Urgent Clinical Import by Hainan Medical Products Administration and approval for marketing in Macau for vitiligo. This trial is a randomized, double-blind, placebo-controlled phase III clinical trial evaluating the efficacy and safety of ruxolitinib cream in the treatment of atopic dermatitis in Chinese patients. The trial aims to provide more medical evidence to support the Product’s marketing application in China. The trial, led by Professor Shi Yuling, Vice President of Shanghai Skin Disease Hospital, will be conducted in 20 sites nationwide aiming to enroll approximately 192 atopic dermatitis patients. […]
On June 21, 2024, China Medical System Holdings Limited (“CMS”) was invited to attend the launching ceremony of the “Canteen for Elderly”, a digital meal delivery service project for elderly under the Public Welfare Program named “Hundreds, Thousands and Ten-Thousands Project (百千万工程)” . The ceremony was held in Lianping of Heyuan City, Guangdong Province. CMS responds actively to the “Hundreds, Thousands and Ten-Thousand Project”. With assistance to accelerate the progress of the “Canteen for Elderly” project in Lianping, CMS also participated in the construction of the “Public Library” project to promote the livelihood projects implementation and benefit local population. Canteen for Elderly Elderly meal delivery service is a common livelihood need of elderly people and their families. By donating through the Nanshan Charity Association,CMS participated in the construction of the “Canteen for Elderly in Lianping” project to provide the elderly with warm meals, and effectively improve their quality […]
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 […]
• The Product, a collagen product with bioactive components, is under China’s registrational clinical trial stage. After validated by clinical trials and approved for marketing, it is expected to provide a medical aesthetic solution that could achieve instant physical filling of skin defects, endogenously induce collagen fiber regeneration, and promote tissue repair, achieving safe, natural, and refined rejuvenation effects. • The Product will synergize with CMS Skinhealth’s marketed Korean hyaluronic acid product and the regenerative pipeline products, including Poly-L-lactic Acid Microparticle Filler Injection, Polycaprolactone Microsphere Gel for Injection and Calcium Hydroxylapatite Microsphere Gel for Injection, providing consumers with comprehensive aesthetic solutions. On June 7, 2024, the subsidiary of China Medical System Holdings Limited (“CMS”), a dermatology and medical aesthetic company “CMS Skinhealth” entered into an exclusive license agreement (“the license agreement”) with Shanghai Baiyiyuan Bioengineering Co., Ltd. (“Baiyiyuan Biotech”) for a light medical aesthetic injectable product, Decellularized Extracellular Matrix […]
China Medical System Holdings Limited (“CMS”) persists in showing deep concern for exceptional children and has supported the sustainable development of rehabilitation centers through donations during the past two years. Meanwhile, we have witnessed that many exceptional children successfully integrated into regular schools and received compulsory education with the help of rehabilitation training, laying a solid foundation for their future integration into society and healthy growth. With Children’s Day approaching, CMS again made donations to Shenzhen Nanshan Star Exceptional Children Rehabilitation Center and Shenzhen Nanshan Exceptional Children Care Center through Charity Association of Shenzhen Nanshan. The donation will be directly used for the procurement and renewal of teaching tools and toys in both centers, enhancing the children’s sense of gain, happiness, and security, as well as providing supports for creating good education atmosphere, encouraging outstanding teachers, and improving teaching quality. At yesterday’s event, representatives of CMS interacted […]
9th May 2024 – Can-Fite BioPharma issued a press release, which is summarized as follows: Can-Fite BioPharma Ltd announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for Namodenoson, for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), for the Company’s ongoing Phase IIb clinical study. Namodenoson is a small molecule orally bioavailable drug, targeting the A3 adenosine receptor, over-expressed on the surface of liver pathological cells in MASH but not normal cells. This potentially makes Namodenoson an ideal specific candidate for the treatment of MASH. Indeed, in a Phase IIa clinical study Namodenoson, has been shown to reduce hepatic steatosis, inflammation and fibrosis, with an excellent safety profile. Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and the IND approval by FDA will allow for the recruitment […]
When the development of a Pharma resonates with the trend of the industry, it is not hard to imagine how fast it will accelerate. Through 32 years of development, CMS has transferred through three stages to continuously build a new CMS for adapting to the external environment. From “selling” drugs when starting up a business, to “owning” drugs by purchasing products’ rights, and now to “creating” drugs via its innovation platform, every step taken by CMS is consistent with industrial development sooner or later. On its 32nd Birthday, with the landings of differentiated innovation fruits, CMS has successfully embarked on the commercialization era of innovative products, continuously building sustainable growth momentum. Persistent innovation investment and transformation bring us the great confidence to embrace “New Future, New Rise”!
On 9th May, the 21st Shenzhen Top Brand and Bay Area Top Brand Event was held grandly, and unveiled series of award lists. The “Kangzhe” brand was awarded the “Shenzhen Top Brand” and “Bay Area Top Brand.” Since 2003, the Shenzhen Top Brand event has been spearheaded by the Shenzhen Industry Association, in collaboration with relevant departments, industry associations, professional institutions, and media organizations to form an evaluation committee. It has fostered a group of Chinese brands with distinct advantages by motivating enterprises in Shenzhen to cultivate and establish esteemed brands. The “Kangzhe” brand participated in the evaluation for the first time. Leveraging its distinctive and professional brand image as well as outstanding innovation achievements, “Kangzhe” brand stood out among 428 applicants and has been awarded as “Shenzhen Top Brand (Bay Area Top Brand)” with high scores in various dimensions, including market position, industry reputation, brand value, and […]