China Medical System: First Prescriptions for Innovative Drug Lumeblue® Issued in 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 (MMXTM) 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 […]

China Medical System Gained Exclusive Commercialization Right of Class 1 Innovative Drug Targeting Gout and Hyperuricemia

China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on 2 December 2024, the Group through a wholly-owned subsidiary of the Company entered into an Exclusive Commercialization Agreement (the “Agreement”) with Atom Therapeutics Co., Ltd (hereinafter referred to as “Atom Therapeutics”, formerly named as “Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.”) of class 1 innovative drug ABP-671 for the treatment of gout and hyperuricemia (the “Product”). In accordance with the Agreement, the Group is entitled to an exclusive commercialization right of the Product in Mainland China, Hong Kong Special Administrative Region and Macao Special Administrative Region. The term of cooperation commences on the effective date of the Agreement and extends for ten years from the date the Product is first approved for market launch in Mainland China (the “Authorization Term”). Upon the expiration of the Authorization Term, it may be automatically renewed for an additional ten years, […]

IND Approval: CMS’s Self-developed Innovative Drug Dual Agonist of Glucagon-like Peptide-1 Receptor/Glucagon Receptor CMS-D005 is Approved for Drug Clinical Trials

China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that innovative drug CMS-D005 injection (“CMS-D005”) self-developed by the Group has been granted approval for drug clinical trials by National Medical Products Administration of the People’s Republic of China (“NMPA”) on 27 November 2024. The NMPA grants the Group consent to conduct a clinical trial to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CMS-D005 in healthy and overweight/obese adult subjects in China.   CMS-D005   CMS-D005 is a highly active and selective dual agonist of glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR). Activating glucagon-like peptide-1 (GLP-1) can reduce food intake through central appetite suppression and inhibit gastric emptying to increase satiety to achieve weight loss. Activating GLP-1R can enhance secretion of glucose-dependent insulin and inhibit secretion of glucagon to lower blood glucagon[1], while activating glucagon (GCG) can promote fat catabolism and enhance fat loss, […]

China Medical System: New Drug Application of Ruxolitinib Phosphate Cream for Vitiligo Approved in Hong Kong

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 […]

China Medical System Included in the “Top 20 Chinese Pharmaceutical Listed Companies in ESG Competitiveness” for Three Consecutive Years, with New Honor of the “Top 10 Low-Carbon Pioneers”

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：First Ruxolitinib Cream’s Prescriptions for Vitiligo Issued in the Greater Bay Area

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 […]

CMS’s Subsidiary Shenzhen Kangzhe Listed in “Shenzhen Top 500 Enterprises” for Four Consecutive Years

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 […]

China Medical System Presented its Innovative Drug Lumeblue® at the 2024 Congress of Gastroenterology China

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 […]

Financial Performance Increased HoH, Entering “New Product Era” Successfully丨CMS(867.HK)2024 Interim Performance Report in One Picture

China Medical System: NDA for Additional Rheumatoid Arthritis Indication of Methotrexate Injection Approved in China

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: Ursodeoxycholic Acid Oral Suspension Approved for Marketing in China, Enhancing Accessibility of Medications for Pediatric and Rare Diseases

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 […]

China Medical System Reincluded in S&P Global Sustainability Yearbook (China Edition) and Maintained MSCI ESG “AA” Rating

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 […]