Desidustat

SHENZHEN, CHINA, June 18, 2024 (GLOBE NEWSWIRE) -- 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 development. China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on 11 June 2024, the New Drug Application (NDA) of the Group’s innovative drug methylthioninium chloride enteric-coated sustained-release tablets (Lumeblue®) (the “Product”) has been approved by the National Medical Products Administration of China (NMPA). The drug registration certificate was obtained on 18 June 2024. The Product is indicated to enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy, and it is the first oral methylthioninium chloride enteric-coated sustained-release tablets in China. The Group will synergize with existing gastroenterology products and resources to advance the commercialization and academic promotion related works of the Product in an orderly manner, aiming to achieve nationwide large-scale clinical application as soon as possible so as to benefit patients with colorectal disease. Lumeblue® is an oral diagnostic drug that uses patented multi-matrix (MMX) 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 (the secondary endpoint)[1]. In addition, 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. According to the diagnosis and treatment data of the Digestive Endoscopy Branch of the Chinese Medical Association, approximately a total of 28 million gastroenteroscopies were completed nationwide in 2012, including 5.83 million colonoscopies. In 2019, approximately 38.73 million gastroenteroscopies were completed nationwide, an increase of 34.62% compared with 2012[2]. The Chinese consensus of early colorectal cancer screening recommends that people aged 50 to 75 years old should be screened for colorectal cancer regardless of whether they have alarm symptoms[3]. There are approximately 400 million people aged 50 to 75 in China in 2020[4]. With the popularity of early screening for colorectal cancer in China, it is expected to witness a considerable growth of the number of colonoscopies in China in the future. The Product has been approved by the European Medicines Agency (EMA) to be commercialized in the European Union under the trade name Lumeblue™ in August 2020. The Group obtained an exclusive license for the Product from Cosmo Technologies Ltd, a fully owned subsidiary of Cosmo Pharmaceuticals NV, on 3 December 2020. Driven by the twin-wheel of "Collaborative R&D and Independent R&D", CMS has continuously deployed global first-in-class (FIC) and best-in-class (BIC) innovative products guided by patient and clinical demands. With enhancing R&D capabilities in developing differentiated innovative products, CMS has empowered the continuous transformation of scientific research outcomes into clinical application, continuously releasing the value of innovation. 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 development. Desidustat Tablets and Methotrexate Injection (rheumatoid arthritis), CMS’s innovative pipeline products, are currently under NDA review in China. Meanwhile, over 10 innovative pipeline products are undergoing clinical trials in China, mainly randomized controlled trials (RCT). CMS is expected to launch differentiated innovative products every year in the future with higher efficiency and more controllable costs, continuing to optimize its product portfolio and build fresh driving forces for the mid- to long-term development of the Company. About CMS CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs. CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients. CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries. While strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology business, CMS independently operates its dermatology and medical aesthetics business, and ophthalmology business, aiming to gain leading positions in specialty therapeutic fields, whilst enhancing the scale and efficiency. At the same time, CMS has expanded its business territory to the Southeast Asian market, striving to become a "bridgehead" for global pharmaceutical companies to enter the Southeast Asian market, further escorting the sustainable and healthy development of the Group. Reference: The results of the Phase III clinical trial in China was published and can be found at: The diagnosis and treatment data of the Digestive Endoscopy Branch of the Chinese Medical Association Chinese consensus of early colorectal cancer screening (2019, Shanghai)，Chinese Journal of Internal Medicine，DOI： 10.3760/cma.j.issn.0578-1426.2019.10.004 CHINA POPULATION CENSUS YEARBOOK 2020, can be found at： CMS Disclaimer and Forward-Looking Statements This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert. This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections. Media Contact Brand: China Medical System Holdings Ltd. Contact: CMS Investor Relations Email: ir@cms.net.cn Website: Source: China Medical System Holdings Ltd.

本周药品注册受理数据，分门别类呈现，一目了然。(5.13-5.19）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号BCM347口溶膜博志研新泰州药物技术有限公司2.2CXHS2400043BCM347口溶膜博志研新泰州药物技术有限公司2.2CXHS2400042新药临床申请药品名称企业注册分类受理号ZL-82片成都赜灵生物医药科技有限公司1CXHL2400510ZL-82片成都赜灵生物医药科技有限公司1CXHL2400509ZL-82片成都赜灵生物医药科技有限公司1CXHL2400508NTQ5082胶囊南京正大天晴制药有限公司1CXHL2400499NTQ5082胶囊南京正大天晴制药有限公司1CXHL2400498KY-001上海栖臻医药科技有限公司1CXHL2400507KY-001上海栖臻医药科技有限公司1CXHL2400506CS060304片凯思凯迪(上海)医药科技有限公司1CXHL2400496CS060304片凯思凯迪(上海)医药科技有限公司1CXHL2400495CS060304片凯思凯迪(上海)医药科技有限公司1CXHL2400494CS060304片凯思凯迪(上海)医药科技有限公司1CXHL2400493CPU-216片中国药科大学1CXHL2400497HSK39004吸入混悬液西藏海思科制药有限公司1CXHL2400489HSK39004吸入混悬液西藏海思科制药有限公司1CXHL2400488HTMC0658片上海壹典医药科技开发有限公司1CXHL2400485HTMC0658片上海壹典医药科技开发有限公司1CXHL2400484ABSK043胶囊上海和誉生物医药科技有限公司1CXHL2400483ABSK061胶囊上海和誉生物医药科技有限公司1CXHL2400482ABSK061胶囊上海和誉生物医药科技有限公司1CXHL2400481ABSK061胶囊上海和誉生物医药科技有限公司1CXHL2400480APH01727片广州一品红制药有限公司1CXHL2400478APH01727片广州一品红制药有限公司1CXHL2400477APH01727片广州一品红制药有限公司1CXHL2400476APH01727片广州一品红制药有限公司1CXHL2400475APH01727片广州一品红制药有限公司1CXHL2400474注射用RFUS-250宜昌人福药业有限责任公司1CXHL2400491注射用RFUS-250宜昌人福药业有限责任公司1CXHL2400490APH01727片广州一品红制药有限公司1CXHL2400473D3S-001胶囊德昇济医药(无锡)有限公司1CXHL2400472D3S-001胶囊德昇济医药(无锡)有限公司1CXHL2400471HDM3010杭州中美华东制药有限公司2.1CXHL2400486SL001四川省三星堆制药有限公司2.2CXHL2400511利拉鲁肽注射液浙江和泽医药科技股份有限公司2.2CXHL2400487XZ126山东新时代药业有限公司2.2CXHL2400479恩那度司他片深圳信立泰药业股份有限公司2.4CXHL2400505恩那度司他片深圳信立泰药业股份有限公司2.4CXHL2400504恩那度司他片深圳信立泰药业股份有限公司2.4CXHL2400503恩那度司他片深圳信立泰药业股份有限公司2.4CXHL2400502恩那度司他片深圳信立泰药业股份有限公司2.4CXHL2400501恩那度司他片深圳信立泰药业股份有限公司2.4CXHL2400500甲磺酸伏美替尼片上海艾力斯医药科技股份有限公司2.4CXHL2400492重组带状疱疹疫苗(CHO细胞)远大赛威信生命科学(南京)有限公司1.3CXSL2400311重组带状疱疹疫苗(CHO细胞)远大赛威信生命科学(南京)有限公司1.3CXSL2400310PM1032注射液普米斯生物技术(珠海)有限公司1CXSL2400330IBI3004信达生物制药(苏州)有限公司1CXSL2400324注射用重组WNV-HCD86四川安可康生物医药有限公司1CXSL2400329注射用重组WNV-HCD86四川安可康生物医药有限公司1CXSL2400328注射用重组WNV-HCD86四川安可康生物医药有限公司1CXSL2400327注射用重组WNV-HCD86四川安可康生物医药有限公司1CXSL2400326注射用重组WNV-HCD86四川安可康生物医药有限公司1CXSL2400325VPD/FC01001 注射液微能生命科技集团有限公司1CXSL2400323IASO-782注射液上海驯鹿生物技术有限公司1CXSL2400322注射用SHR-A1921苏州盛迪亚生物医药有限公司1CXSL2400317RC148注射液荣昌生物制药(烟台)股份有限公司1CXSL2400320FS-8002注射液华普生物技术(河北)股份有限公司1CXSL2400319注射用RC88荣昌生物制药(烟台)股份有限公司1CXSL2400318注射用BA1302山东博安生物技术股份有限公司1CXSL2400321IBI3003信达生物制药(苏州)有限公司1CXSL2400313注射用YK012益科思特(北京)医药科技发展有限公司1CXSL2400312SCT650C 注射液神州细胞工程有限公司1CXSL2400316WGc-043 注射液成都威斯津生物医药科技有限公司1CXSL2400315WGc-043 注射液成都威斯津生物医药科技有限公司1CXSL2400314仿制药申请药品名称企业注册分类受理号葡萄糖酸钙氯化钠注射液石家庄四药有限公司3CYHS2401493乙酰半胱氨酸注射液湖南华纳大药厂股份有限公司3CYHS2401507乌苯美司胶囊西安万隆制药股份有限公司3CYHS2401505洛索洛芬钠口服溶液合肥诚志生物制药有限公司3CYHS2401502利格列汀二甲双胍缓释片湖北广辰药业有限公司3CYHS2401498利格列汀二甲双胍缓释片湖北广辰药业有限公司3CYHS2401497丁酸氯维地平注射用乳剂齐鲁制药(海南)有限公司3CYHS2401496复方聚乙二醇(3350)电解质散湖北莱康医疗技术有限公司3CYHS2401489布美他尼注射液四川奥邦古得药业有限公司3CYHS2401480盐酸纳美芬注射液海南爱科制药有限公司3CYHS2401479重酒石酸间羟胺注射液广州惠沣德生物技术有限公司3CYHS2401477二甲双胍格列本脲片通化万通药业股份有限公司3CYHS2401476二甲双胍格列本脲片通化万通药业股份有限公司3CYHS2401475二羟丙茶碱注射液峨眉山通惠制药有限公司3CYHS2401474帕拉米韦注射液浙江康吉尔药业有限公司3CYHS2401473己酮可可碱缓释片山东京卫制药有限公司3CYHS2401472氨磺必利注射液南京正科医药股份有限公司3CYHS2401488氨磺必利注射液南京正科医药股份有限公司3CYHS2401487法莫替丁注射液海南未见药业有限公司3CYHS2401455地奈德乳膏海南全盈药业有限公司3CYHS2401451环丝氨酸胶囊河北龙海药业有限公司3CYHS2401450盐酸甲氧氯普胺注射液江苏宝东医药科技有限公司3CYHS2401459盐酸去氧肾上腺素注射液云南龙海天然植物药业有限公司3CYHS2401452盐酸去氧肾上腺素注射液浙江博崤生物制药有限公司3CYHS2401460山梨醇甘露醇冲洗剂海南爱科制药有限公司3CYHS2401447复方聚乙二醇(3350)电解质散重庆希尔安药业有限公司3CYHS2401444法莫替丁注射液成都倍特药业股份有限公司3CYHS2401441坎地氢噻片北京福元医药股份有限公司3CYHS2401435洛索洛芬钠凝胶贴膏上海延安药业(湖北)有限公司4CYHS2401506盐酸氨溴索注射液江苏苏中药业集团生物制药有限公司4CYHS2401504他达拉非片烟台鲁银药业有限公司4CYHS2401503他达拉非片烟台鲁银药业有限公司4CYHS2401501他达拉非片烟台鲁银药业有限公司4CYHS2401500注射用头孢唑肟钠南京恩泰医药科技有限公司4CYHS2401499依折麦布阿托伐他汀钙片(I)晖致(海南)投资有限公司4CYHS2401495依折麦布阿托伐他汀钙片(II)晖致(海南)投资有限公司4CYHS2401494平衡盐溶液(供灌注用)海南爱科制药有限公司4CYHS2401492恩格列净片郑州韩都药业集团有限公司4CYHS2401491恩格列净片郑州韩都药业集团有限公司4CYHS2401490碳酸氢钠血滤置换液上海峰林生物科技有限公司4CYHS2401478利伐沙班干混悬剂南京海纳制药有限公司4CYHS2401486利伐沙班干混悬剂南京海纳制药有限公司4CYHS2401485地屈孕酮片浙江高跖医药科技股份有限公司4CYHS2401484富马酸伏诺拉生片合肥英太制药有限公司4CYHS2401483富马酸伏诺拉生片合肥英太制药有限公司4CYHS2401482左氧氟沙星滴眼液石家庄凯达生物工程有限公司4CYHS2401481盐酸艾司洛尔注射液中国大冢制药有限公司4CYHS2401471帕利哌酮缓释片合肥华方医药科技有限公司4CYHS2401470帕利哌酮缓释片合肥华方医药科技有限公司4CYHS2401469他克莫司缓释胶囊石药集团中诺药业(石家庄)有限公司4CYHS2401468他克莫司缓释胶囊石药集团中诺药业(石家庄)有限公司4CYHS2401467富马酸伏诺拉生片福建省宝诺医药研发有限公司4CYHS2401466洛索洛芬钠凝胶贴膏北京百奥药业有限责任公司4CYHS2401465间苯三酚注射液吉林振澳制药有限公司4CYHS2401454盐酸美金刚片四川尚锐生物医药有限公司4CYHS2401453复方氨基酸注射液(18AA-VII)四川太平洋药业有限责任公司4CYHS2401464盐酸莫西沙星滴眼液江苏福邦药业有限公司4CYHS2401463酒石酸溴莫尼定滴眼液浙江赛默制药有限公司4CYHS2401462聚乙烯醇滴眼液苏州欧康维视生物科技有限公司4CYHS2401461注射用磷酸特地唑胺江苏明圣康源药业有限公司4CYHS2401456瑞舒伐他汀钙片重庆药友制药有限责任公司4CYHS2401458瑞舒伐他汀钙片重庆药友制药有限责任公司4CYHS2401457盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2401449盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2401448苯磺顺阿曲库铵注射液本溪恒康制药有限公司4CYHS2401446苯磺顺阿曲库铵注射液本溪恒康制药有限公司4CYHS2401445二甲双胍恩格列净片(I)北京双鹭药业股份有限公司4CYHS2401443二甲双胍恩格列净片(V)北京双鹭药业股份有限公司4CYHS2401442氨氯地平阿托伐他汀钙片宁波大红鹰药业股份有限公司4CYHS2401440胞磷胆碱注射液山东化药医药科技有限公司4CYHS2401439胞磷胆碱注射液山东化药医药科技有限公司4CYHS2401438钆布醇注射液海南葫芦娃药业集团股份有限公司4CYHS2401437钆布醇注射液海南葫芦娃药业集团股份有限公司4CYHS2401436沙库巴曲缬沙坦钠片海南葫芦娃药业集团股份有限公司4CYHS2401434沙库巴曲缬沙坦钠片海南葫芦娃药业集团股份有限公司4CYHS2401433右酮洛芬氨丁三醇注射液北京百奥药业有限责任公司3CYHL2400098孟鲁司特钠口腔崩解片北京百奥药业有限责任公司3CYHL2400097孟鲁司特钠口腔崩解片北京百奥药业有限责任公司3CYHL2400096酒石酸阿福特罗雾化吸入用溶液海南葫芦娃药业集团股份有限公司3CYHL2400094右美沙芬安非他酮缓释片石药集团欧意药业有限公司3CYHL2400093甘露醇山梨醇注射液湖北欣泽霏药业有限公司3CYHL2400092沙美特罗替卡松吸入粉雾剂艾特美(苏州)医药科技有限公司4CYHL2400095四价流感病毒裂解疫苗深圳康泰生物制品股份有限公司3.3CXSL2400331进口申请药品名称企业注册分类受理号艾加莫德α注射液argenx BV2.2JXSS2400042本瑞利珠单抗注射液AstraZeneca AB3.1JXSS2400041地拉罗司颗粒Annora Pharma Private Limited5.2JYHS2400029地拉罗司颗粒Annora Pharma Private Limited5.2JYHS2400028熊去氧胆酸片Zydus Lifesciences Limited5.2JYHS2400027熊去氧胆酸片Zydus Lifesciences Limited5.2JYHS2400026甲磺酸贝舒地尔片Kadmon Pharmaceuticals, LLC2.4JXHL2400115Fezolinetant片Astellas Pharma Global Development, Inc.2.4JXHL2400114Upadacitinib片AbbVie Inc.2.4JXHL2400112Upadacitinib片AbbVie Inc.2.4JXHL2400111Upadacitinib片AbbVie Inc.2.4JXHL2400110镥(177Lu)vipivotide tetraxetan注射液Novartis Pharma AG2.4JXHL2400109镥(177Lu)vipivotide tetraxetan注射液Novartis Pharma AG2.4JXHL2400108用于制备放射性药物镓(68Ga)gozetotide注射液的药盒Novartis Europharm Limited5.1JXHL2400113Amlitelimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400093注射用M9140Merck Healthcare KGaA1JXSL2400096PF-06823859注射液Pfizer Inc.1JXSL2400092Dostarlimab注射液GlaxoSmithKline Research & Development Limited2.2JXSL2400095Dostarlimab注射液GlaxoSmithKline Research & Development Limited2.2JXSL2400094中药相关申请药品名称企业注册分类受理号二冬颗粒贵州威门药业股份有限公司3.1CXZS2400016JKN2303江西中医药大学1.2CXZL2400029JKN2303吸入溶液广西馨海药业科技有限公司1.2CXZL2400028JKN2303吸入溶液广西馨海药业科技有限公司1.2CXZL2400027JKN2303吸入溶液广西馨海药业科技有限公司1.2CXZL2400026JKN2303吸入溶液广西馨海药业科技有限公司1.2CXZL2400025不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。