China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on 4 November 2024, the New Drug Application (NDA) of ruxolitinib phosphate cream (the “ruxolitinib cream” or the “Product”) has been approved by the Pharmacy & Poisons Board of Hong Kong (PPBHK). The certificate of drug/product registration was obtained on 5 November 2024. The Product is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. About Ruxolitinib Cream Ruxolitinib cream (Opzelura®), a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, and is the first and only treatment for repigmentation approved for use in the United States[1]. Ruxolitinib cream (Opzelura®) is also approved in the […]
Recently, Healthcare Executive (“E药经理人”), in collaboration with a leading independent corporate social responsibility consulting agency in China, released the results of 2024 “Chinese Pharmaceutical Listed Companies ESG Competitiveness” series ranking. The ranking aims to recognize Chinese pharmaceutical companies that serve as benchmarks in various aspects of ESG management. By virtue of its continuous efforts in sustainable development and low-carbon initiatives, China Medical System (“CMS” or the “Group”) has been selected into the “Top 20 Chinese Pharmaceutical Listed Companies in ESG Competitiveness (Mid-cap Stocks)” ranking for three consecutive years, and has also been included in the inaugural “Top 10 Low-Carbon Pioneers of Chinese Pharmaceutical Listed Companies” ranking. As an active practitioner of the sustainable development concept, CMS steadily responds to the United Nations Sustainable Development Goals, and promotes the deep integration of ESG governance with its macro strategies and business operations. With adherence to high standards of business ethics in its operations, the Group has established a scientific and effective risk identification […]
China Medical System Holdings Limited (the “Group” or “CMS”) is pleased to announce that on 18 October, the first batch of prescriptions of ruxolitinib phosphate cream (the “ruxolitinib cream” or the “Product”) for qualified vitiligo patients were issued in the Greater Bay Area, at Zhongshan Chen Xinghai Hospital of Integrated Traditional Chinese and Western Medicine, Foshan Fosun Chancheng Hospital, and Dongguan Songshan Lake Tungwah Hospital. The Product’s new drug application (NDA) was approved by the Pharmaceutical Administration Bureau (ISAF) of Macau on 11 April 2024, and subsequently the Product was approved by the Guangdong Provincial Medical Products Administration on August 19 through the “Hong Kong and Macau Medicine and Equipment Connect” policy, which officially introduced ruxolitinib cream for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age, providing a novel treatment option for patients with relevant indication into designated medical institutions in […]
On September 27, the Shenzhen Enterprise Confederation and Shenzhen Entrepreneur Association released the “2024 Shenzhen Top 500 Enterprises” list. Shenzhen Kangzhe Pharmaceutical Co., Ltd. (“Shenzhen Kangzhe”), a wholly-owned subsidiary of China Medical System Holdings Limited (“CMS” or “the Group”), was once again made the list with honor, ranking at 149th, by virtue of its outstanding operational performance, social contributions, etc. Additionally, Shenzhen Kangzhe was also included in the “2024 Top 100 Most Efficient Enterprises of the Shenzhen Top 500” and the “2024 Top 100 Enterprises with the Highest Social Contributions of the Shenzhen Top 500.” CMS has been deeply rooted in the Chinese pharmaceutical market for over 30 years, developing into a platform company linking pharmaceutical innovation and commercialization. Shenzhen Kangzhe’s inclusion in the “Shenzhen Top 500 Enterprises” for the fourth time not only affirms the Group’s long-term strategic focus on specialty therapeutic fields and its success in providing differentiated products […]
On September 20, 2024, China Medical System (“CMS” or the “Group”) presented its innovative drug Lumeblue® (Methylthioninium Chloride Enteric-coated Sustained-release Tablets) (the “Product”) at the 24th Congress of Gastroenterology China in 2024 (“CGC 2024”). This congress brought together numerous domestic scholars and clinical experts in the field of gastroenterology to discuss key topics and advancements in gastroenterology disease research, serving as an important platform for promoting progress in the diagnosis and treatment of gastroenterology diseases in China. CMS develops innovative products with a focus on medical values and clinical needs, striving to provide effective and affordable therapeutic solutions for patients. The innovative drug Lumeblue® (Methylthioninium Chloride Enteric-coated Sustained-release Tablets) is indicated to enhance visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy, which not only enhances the detection rate of colorectal lesions but also potentially simplifies the colonoscopy procedure, making the examination more efficient and improving […]
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 […]