On June 12, China Medical System Holdings Limited (“CMS” or the “Group”) announced that on June 7 2023, the New Drug Application (NDA) of Diazepam Nasal Spray (the “Product”) received approval from the National Medical Products Administration of China (NMPA). The Product is the first diazepam nasal spray in China, and it is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e. seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older. The Product is a proprietary formulation of diazepam administered through the nasal mucosa, and has high bioavailability, outstanding absorbability, tolerance and reliability. Product formulation incorporates a combination of Vitamin E-based solvents and Intravail® absorption enhancer. Intravail® transmucosal absorption enhancement technology enables the non-invasive delivery of a broad range of proteins, peptides and small-molecule drugs. The results of the Product’s […]
On the June 1st, the joyous holiday for children, Shenzhen Kangzhe, a subsidiary of China Medical System Holdings Limited ( “CMS”), again made donations through Charity Association of Shenzhen Nanshan for the designated procurement of equipment, teaching tools, toys and sports equipment, etc., and scholarships granted to teachers of merits, hoping to improve teaching quality for exceptional children with autism, Down syndrome, developmental delay, attention disorder, etc. helping them to receive better rehabilitation training. During the visit, employee representatives of CMS expressed the most heartfelt Children’s Day blessings and gave gifts to the kids; They also played musical games and instruments with children, accompanying them to enjoy a happy and warm Children’s Day. CMS will continue to care for exceptional children, and let them feel the love from society with practical actions. Moreover, we will also actively carry out or participate more in public welfare activities to contribute CMS’s strength to the society.
CMS Obtained Exclusive License of a Regenerative Medical Aesthetic Product On May 30, the subsidiary of China Medical System Holdings Limited (“CMS” or the “Group”) – a dermatology and medical aesthetic company “CMS Skinhealth” entered into an exclusive license agreement with Jiangsu Xihong Biopharma Co., Ltd.(“Xihong Biopharma”) for Poly-L-lactic Acid Microparticle Filler Injection (the “Product”). In accordance with the license agreement, CMS Skinhealth obtained an exclusive license to promote, market and commercialize the Product in Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan. The exclusive license period shall begin from the date of the approval of the registration certificate of class III medical device of the Product in Mainland China and shall last until the tenth anniversary of the aforementioned date of approval. Upon the expiration of the aforementioned term, the license period may automatically be extended for another period of ten years thereafter if […]
On May 30, China Medical System Holdings Limited (“CMS” or the “Group”) announced that on 26 May 2023, the New Drug Application (NDA) of Tildrakizumab Injection under the brand name of ILUMETRI has been approved by the National Medical Products Administration of China (NMPA). ILUMETRI is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ILUMETRI is a humanized lgG1/κ monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMETRI has patents on composition and formulation in China. The results of the extended study of its Phase III clinical trial in China demonstrated that the primary efficacy assessment indicator PASI 75 response rate continued to increase over treatment time. The PASI 75 response rate reached a high level […]
On May 15, Hang Seng Indexes Company newly launched the Hang Seng Innovative Drug Index, in which CMS has been included. The purpose of setting the Hang Seng Innovative Drug Index is to reflect the performance of companies engaged in the research， development and manufacture of innovative drugs，and are listed in Hong Kong. The index uses the Constituents of the Hang Seng Composite Index as the universe. Each eligible security will be assigned with a Relevance Score according to its business exposure to the innovative drug industry. The top 40 securities with the highest Relevance Score Rank will be selected as constituents. Being included in the index reflects the capital market’s recognition of the Group’s comprehensive strength of innovative R&D. After 5 years of efficient innovative products layout, CMS has collaborated with around 20 global biotech companies and biopharma and established a differentiated innovative pipeline with 30 innovative products, mainly […]
31 years of marvelous journey The road traveled though far, it was reached with perseverance the mission though difficult, it was accomplished with persistence Values of Innovation, Integrity, Pragmatism, Perseverance, and Win-win have imprinted in the mind pf CMSer Reaching milestones one after another Establishing records of success as we grow On the 31st birthday of CMS From the snow-covered plateau to the treasured island of Taiwan From exotic Britain to Dubai, the commerce hub of Middle East …… CMSer all over the world have sent their wishes Wishing a happy 31st birthday to CMS! * Tibet Tianjin Shanxi Beijing Shanxi Chongqing Sichuan Shanghai Hainan Hunan Hongkong Macao Taiwan * CMSer from overseas photographed their sincere wishes for CMS as well * U.K. Singapore Philippines Thailand Vietnam Malaysia Indonesia Dubai * The beginning of a new year is the start of a new journey Chasing the future CMS will continue to stand at the forefront, and seek to innovate To be pragmatic and […]
China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the tetravalent bispecific anti-VEGFA (vascular endothelial growth factor A) / ANG2 (angiopoietin 2) antibody for intravitreal injection (the “Tetravalent Bispecific Antibody Product”) has been granted an approval for drug clinical trials issued on 27 April 2023 by National Medical Products Administration of the People’s Republic of China (“China”) (NMPA) and agreed to conduct the clinical trials in neovascular age-related macular degeneration (nAMD). The Tetravalent Bispecific Antibody Product is a Class 1 Innovative Biological Product with a unique nano-antibody design bearing specific targeting VEGFA and ANG2, which can effectively inhibit abnormal neovascularization through two different pathways, for treatment of the ocular fundus neovascular diseases. The Tetravalent Bispecific Antibody Product enjoys the differentiation advantages of high affinity, strong inhibitory activity, high preparation concentration, good stability and low dosing frequency. It will provide a safer and more effective treatment option for patients with ocular fundus neovascularization, possessing important […]
Can-Fite announced that it received a positive opinion from the Committee for Medicinal Products for Human Use(CHMP) of the European Medicines Agency (EMA) with respect to the submission of a registration plan for a pivotal Phase III clinical trial for the treatment of moderate to severe psoriasis. The pivotal Phase III study and the safety of the 3 mg twice daily dose of Piclidenoson are accepted by the agency. The Company intends to initiate a prospective double-blind, placebo-controlled and randomized clinical trial with its lead product Piclidenoson aimed at demonstrating clinical safety and efficacy for the treatment of moderate to severe psoriasis sufficient to support a marketing authorization application. The agency also commented on the registration plan submitted by the Company relating to the chemistry, manufacturing, and controls (CMC), nonclinical data, and clinical pharmacology data. Can-Fite is currently submitting a comparable data package to the US Food and Drug Administration. Can-Fite recently reported topline results from its Phase III COMFORT™ study […]
On April 7th, China Medical System Holdings Limited (“CMS” or “the Group”) signed a strategic collaboration agreement with Haikou National High-tech Industrial Development Zone Management Committee (“Haikou National High-tech Zone”), and the Management Bureau of Boao Lecheng International Medical Tourism Pilot Zone (“Lecheng Pilot Zone”) to promote the introduction of the products in Lecheng and manufactured in Haikou of the Group’s international innovative drugs and medical devices. Leaders including Ni Qiang, Deputy Governor of Hainan Province and Director of the Working Committee of the Provincial Party Committee for the Free Trade Port, Liu Liwu, Director of the Hainan Provincial Ministry of Industry and Information Technology, Jia Ning, Director of the Hainan Provincial Medical Insurance Bureau and the Boao Lecheng Management Bureau, Zhu Ning, Director of the Hainan Medical Products Administration, Deng Lisong, Member of the Standing Committee of the Haikou Municipal Party Committee and Deputy Mayor, Feng Guang, Deputy Director […]
The board (the “Board”) of directors (the “Directors”) of China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that on 27 March 2023, the Group through the Company’s Southeast Asian business (“Rxilient”) companies Rxilient Biotech Pte. Ltd. (“Rxilient Biotech”) and Excellmab Pte. Ltd. (“Excellmab”) entered into a Shareholders’ Agreement (the “Shareholders’ Agreement”) with Shanghai Junshi Biosciences Co., Ltd.* (上海君實生物醫藥科技股份有限公司, “Junshi Biosciences”), pursuant to which Junshi Biosciences will subscribe for the shares newly issued by Excellmab in a non-monetary manner to obtain 40% equity interest. Subject to the fulfillment of the conditions precedent agreed under the Shareholders’ Agreement, Junshi Biosciences will substantially perform its capital contribution obligations and plans to enter into an Exclusive License Agreement (the “License Agreement”) with Excellmab in accordance with the text agreed upon by the parties at the time of entering into the Shareholders’ Agreement, granting Excellmab the […]
China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that on 24 March 2023, the New Drug Application (NDA) of Methotrexate Injection (the “Product”) has been approved by the National Medical Products Administration of China (NMPA). The Product is indicated for the treatment of severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids. In January 2022, the NDA was granted a priority review procedure as it complied with the “shortage of products with urgent clinical need” in China. Methotrexate (MTX) has anti-inflammatory, anti-proliferative and immunomodulatory effects, and is currently one of the most effective traditional drugs for the treatment of psoriasis. However, oral MTX has poor patient compliance due to relatively large gastrointestinal side effects. The Product is administered subcutaneously (this form of administration was recommended by domestic and foreign guidelines), which can increase […]
