Budesonide

This official launch marks a significant advancement in patient care in mainland China, introducing a new era in the treatment of IgA nephropathy ​ (IgAN). IgA nephropathy (IgAN) is a common chronic kidney disease which mainly affects young adults. In IgAN a protein called immunoglobulin A (IgA) becomes trapped in the very fine filters of the kidney (glomeruli), causing damage and scarring to the whole kidney. China has the highest prevalence of primary glomerular diseases globally, with IgAN accounting for about 35% to 50% of cases. Most IgAN patients risk progressing to end-stage renal disease during their lifetime, often requiring dialysis or kidney transplantation. Current treatments, like renin-angiotensin system (RAS) inhibitors, fail to address the underlying disease progression, highlighting a significant unmet medical need. Rogers Yongqing Luo, chief executive officer of Everest Medicines, said the commercialization of Nefecon in the Chinese market represents a significant milestone for Everest and a breakthrough for IgAN patients in China. Nefecon has undergone a 20-year research and development process, becoming the first non-oncology therapeutic to receive Breakthrough Therapy Designation in China by the China National Medical Products Administration (NMPA), and the first treatment for IgAN to receive full approval from the US Food and Drug Administration (FDA). Five million IgAN patients in China He said: “It is also the first approved medicine with an IgAN indication by the NMPA in China. On behalf of the company, I would like to extend my gratitude to all parties who have assisted in obtaining the approval for Nefecon’s market entry and clinical use in mainland China, especially the clinical investigators and the 62 Chinese patients who participated in the global phase 3 clinical trials. With approximately 5 million IgAN patients in China and over 100,000 newly diagnosed patients annually, there is a significant unmet clinical demand. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Professor Zhang Hong is from Peking University First Hospital, a member of the global steering committee for the phase 3 clinical study NefIgArd. He said: “We will actively engage with all stakeholders to improve the accessibility and affordability of this innovative therapy for IgAN. Moreover, we will contribute to improving nephropathy diagnosis, treatment, and disease management, ultimately benefiting more patients. As we advance the commercialization of Nefecon in China and Asia, we will also actively promote the development of other innovative drugs in the nephropathy field, extending benefits to more patients.” “IgAN is the most common primary glomerular disease, occurring at a young age with a high possibility of progressing to end-stage renal disease. Compared to European and American populations, Chinese IgAN patients experience faster disease progression and poorer prognosis, imposing a heavy burden on patients and society. The full results of the NefIgArd study demonstrate that Nefecon can protect renal function, delay progression to dialysis or kidney transplantation, and significantly reduce urinary protein and hematuria. It is also safe and well-tolerated.” “Data analysis of the Chinese population shows that Nefecon reduces kidney function decline by 66%, and delays disease progression to dialysis or kidney transplantation by 12.8 years. The approval of Nefecon fills the gap in targeted therapy for IgAN in China, benefiting Chinese patients, improving disease prognosis, and providing clinicians with new treatment options.” Nefecon - even greater benefit in delaying kidney function decline The company says the latest analysis, presented at the World Congress of Nephrology 2024, provides further evidence that Nefecon may offer even greater benefit in delaying kidney function decline in Chinese patients with more rapidly progressing disease, without compromising patients' quality of life. Positive results from the global Open Label Extension (OLE) study based on the NefIgArd phase 3 study validated the efficacy and safety of re-treatment with Nefecon independent of prior treatment cycles, providing a solid scientific basis for future long-term maintenance regimens of Nefecon. "IgAN is highly prevalent in Asia and is one of the main causes of kidney failure in young adults in China. Among IgAN patients, the risk of progressing to end-stage renal disease in Asian populations is 56% higher compared to other populations, and the disease progresses more rapidly, imposing a significant medical burden on patients, families, and society. Therefore, more proactive treatment is needed to intervene and control the risk of disease progression, delaying the need for dialysis or kidney transplantation. “For a long time, this disease has lacked targeted treatment options, resulting in significant unmet clinical needs," said Professor Xie Jingyuan, chief physician of the Department of Nephrology, Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine. “Nefecon, as the world's first-in-disease therapy for IgAN, has treated over one hundred patients in total through its early-access program in Boao last April. During the follow-up period, Nefecon was found to be effective in stabilizing renal function, reducing proteinuria and hematuria, and was well tolerated by the patients. It is of great significance for Nefecon to be officially commercialized in mainland China, helping patients with IgAN to initiate treatment as early as possible.” Nefecon received approval from the China NMPA in November 2023 for the treatment of primary IgAN in adults at risk of disease progression. Additionally, Nefecon has been approved in multiple countries and territories across Europe, the US, and Asia.

本周药品注册受理数据，分门别类呈现，一目了然。(5.6-5.12）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迈华替尼片杭州中美华东制药有限公司1CXHS2400041迈华替尼片杭州中美华东制药有限公司1CXHS2400040塔戈利单抗注射液四川科伦博泰生物医药股份有限公司1CXSS2400049新药临床申请药品名称企业注册分类受理号HRS-4508片江苏恒瑞医药股份有限公司1CXHL2400465HRS-4508片江苏恒瑞医药股份有限公司1CXHL2400464TJ0113胶囊杭州天玑济世生物科技有限公司1CXHL2400459TJ0113胶囊杭州天玑济世生物科技有限公司1CXHL2400458注射用DN022150江西科睿药业有限公司1CXHL2400461注射用PLAT001海南普利制药股份有限公司1CXHL2400457AL2846胶囊正大天晴药业集团股份有限公司1CXHL2400463HRS-6209胶囊江苏恒瑞医药股份有限公司1CXHL2400447HRS-8080片山东盛迪医药有限公司1CXHL2400446HRS-8080片山东盛迪医药有限公司1CXHL2400445HRS-8080片山东盛迪医药有限公司1CXHL2400444HRS-8080片山东盛迪医药有限公司1CXHL2400443注射用盐酸ORIC-1940成都奥睿药业有限公司1CXHL2400442HS-10380片江苏豪森药业集团有限公司1CXHL2400441HS-10380片江苏豪森药业集团有限公司1CXHL2400440HRS-1358片山东盛迪医药有限公司1CXHL2400452HRS-1358片山东盛迪医药有限公司1CXHL2400451HRS-6209胶囊江苏恒瑞医药股份有限公司1CXHL2400450HRS-6209胶囊江苏恒瑞医药股份有限公司1CXHL2400449HRS-6209胶囊江苏恒瑞医药股份有限公司1CXHL2400448LPM787000048马来酸盐缓释片山东绿叶制药有限公司1CXHL2400456LPM787000048马来酸盐缓释片山东绿叶制药有限公司1CXHL2400455LPM787000048马来酸盐缓释片山东绿叶制药有限公司1CXHL2400454LPM787000048马来酸盐缓释片山东绿叶制药有限公司1CXHL2400453HP-001胶囊上海超阳药业有限公司1CXHL2400439HP-001胶囊上海超阳药业有限公司1CXHL2400438HP-001胶囊上海超阳药业有限公司1CXHL2400437HRN01胶囊北京华睿鼎信科技有限公司1CXHL2400436HRN01胶囊北京华睿鼎信科技有限公司1CXHL2400435LW347片上海长森药业有限公司1CXHL2400434LW347片上海长森药业有限公司1CXHL2400433NTQ3617片南京正大天晴制药有限公司1CXHL2400432NTQ3617片南京正大天晴制药有限公司1CXHL2400431NTQ3617片南京正大天晴制药有限公司1CXHL2400430SJP-0132滴眼液千寿制药科技(北京)有限公司1CXHL2400429HP560片海创药业股份有限公司1CXHL2400428HP560片海创药业股份有限公司1CXHL2400427B0123广州帝奇医药技术有限公司2.2CXHL2400460枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400470枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400469枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400468枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400467枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400466西达本胺片深圳微芯生物科技股份有限公司2.4CXHL2400462利多卡因丙胺卡因气雾剂山东华铂凯盛生物科技有限公司3CYHL2400089琥珀酸多西拉敏片江西新赣江药业股份有限公司3CYHL2400088盐酸毛果芸香碱滴眼液湖北远大天天明制药有限公司3CYHL2400087盐酸多塞平片南京泽恒医药技术开发有限公司3CYHL2400086盐酸多塞平片南京泽恒医药技术开发有限公司3CYHL2400085复方硫酸钠片北京韩美药品有限公司3CYHL2400084注射用多黏菌素E甲磺酸钠齐鲁制药(海南)有限公司3CYHL2400083铜[64Cu]氧奥曲肽注射液北京先通国际医药科技股份有限公司3CYHL2400082匹可硫酸钠口服溶液北京柏雅联合药物研究所有限公司3CYHL2400081洛索洛芬钠贴剂四川科伦药业股份有限公司4CYHL2400091洛索洛芬钠贴剂四川科伦药业股份有限公司4CYHL2400090带状疱疹IN001 mRNA疫苗深圳深信生物科技有限公司1.2CXSL240028723价肺炎球菌多糖疫苗复星安特金(成都)生物制药有限公司3.3CXSL2400290CM512注射液康诺亚生物医药科技(成都)有限公司1CXSL2400309重组I型单纯疱疹病毒R130注射液(Vero细胞)上海允英生物医药科技有限公司1CXSL2400308RC148注射液荣昌生物制药(烟台)股份有限公司1CXSL2400305TQB2868注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400307注射用MK-2870默沙东研发(中国)有限公司1CXSL2400304KAL-003成都厌氧君生物科技有限公司1CXSL2400303KAL-003成都厌氧君生物科技有限公司1CXSL2400302注射用BG-C9074广州百济神州生物制药有限公司1CXSL2400301RC1416注射液南京融捷康生物科技有限公司1CXSL2400300RC1416注射液南京融捷康生物科技有限公司1CXSL2400299IBI354信达生物制药(苏州)有限公司1CXSL2400298注射用CB-002上海麦科思生物医药有限公司1CXSL2400297LM-299注射液礼新医药科技(上海)有限公司1CXSL2400296KN069注射液苏州康宁杰瑞生物科技有限公司1CXSL24002949MW2821迈威(上海)生物科技股份有限公司1CXSL2400292注射用BL-M14D1成都百利多特生物药业有限责任公司1CXSL2400291HBM9027注射液和铂医药(上海)有限责任公司1CXSL2400289AFN0328注射液合肥阿法纳生物科技有限公司1CXSL2400288注射用QLS4131齐鲁制药有限公司1CXSL2400286TAL-T细胞注射液广州泛恩生物科技有限公司1CXSL2400285注射用维迪西妥单抗荣昌生物制药(烟台)股份有限公司2.2CXSL2400306德谷胰岛素注射液山东新时代药业有限公司3.3CXSL2400293泰它西普注射液荣昌生物制药(烟台)股份有限公司2.1;2.2CXSL2400295仿制药申请药品名称企业注册分类受理号盐酸多巴胺注射液海南普利制药股份有限公司3CYHS2401431盐酸溴己新口服溶液南京海纳制药有限公司3CYHS2401419盐酸溴己新口服溶液南京海纳制药有限公司3CYHS2401416注射用尼可地尔湖南赛隆药业(长沙)有限公司3CYHS2401411注射用尼可地尔湖南赛隆药业(长沙)有限公司3CYHS2401410注射用尼可地尔湖南赛隆药业(长沙)有限公司3CYHS2401409生理氯化钠溶液重庆药谷制药有限公司3CYHS2401405马来酸依那普利口服溶液成都倍特得诺药业有限公司3CYHS2401404盐酸多西环素片浙江赛默制药有限公司3CYHS2401422盐酸多西环素片浙江赛默制药有限公司3CYHS2401421盐酸曲唑酮片华益药业科技(安徽)有限公司3CYHS2401400吲哚布芬片湖南方盛制药股份有限公司3CYHS2401392依托泊苷注射液四川汇宇制药股份有限公司3CYHS2401384注射用吲哚菁绿海南紫程众投生物科技有限公司3CYHS2401375马来酸曲美布汀片湖南诺纳医药科技有限公司3CYHS2401370门冬氨酸钾镁注射液海南紫程众投生物科技有限公司3CYHS2401369葡萄糖酸钙氯化钠注射液江苏亚尧生物科技有限公司3CYHS2401383葡萄糖酸钙氯化钠注射液江苏亚尧生物科技有限公司3CYHS2401382盐酸纳美芬注射液福建新迪医药科技有限公司3CYHS2401361西咪替丁注射液云南药科院生物医药股份有限公司3CYHS2401360盐酸洛美沙星滴眼液江苏广承药业有限公司3CYHS2401352盐酸甲氧氯普胺注射液南京康发生物科技有限公司3CYHS2401351头孢地尼干混悬剂浙江巨泰药业有限公司3CYHS2401349头孢地尼干混悬剂浙江巨泰药业有限公司3CYHS2401348盐酸奥普力农注射液遂成药业股份有限公司3CYHS2401340利多卡因凝胶贴膏浙江赛默制药有限公司3CYHS2401368米诺地尔搽剂西安德立生物化工有限公司3CYHS2401338吸入用盐酸丙卡特罗溶液海南金瑞宝医药科技有限公司3CYHS2401337吸入用盐酸丙卡特罗溶液海南金瑞宝医药科技有限公司3CYHS2401336阿仑膦酸钠口服溶液山东如至生物医药科技有限公司3CYHS2401335氯化钙注射液广西铭磊维生制药有限公司3CYHS2401334阿伐那非片昆明积大制药股份有限公司3CYHS2401333阿伐那非片昆明积大制药股份有限公司3CYHS2401332吸入用布地奈德混悬液浙江赛默制药有限公司4CYHS2401432盐酸特比萘芬喷雾剂浙江寰领医药科技有限公司4CYHS2401430布洛芬缓释胶囊山东丹红制药有限公司4CYHS2401429沙库巴曲缬沙坦钠片山东新华制药股份有限公司4CYHS2401428盐酸贝尼地平片深圳大佛药业股份有限公司4CYHS2401427盐酸贝尼地平片深圳大佛药业股份有限公司4CYHS2401426单硝酸异山梨酯片珠海润都制药股份有限公司4CYHS2401415枸橼酸西地那非片南京正科医药股份有限公司4CYHS2401420枸橼酸西地那非片南京正科医药股份有限公司4CYHS2401418枸橼酸西地那非片南京正科医药股份有限公司4CYHS2401417克唑替尼胶囊重庆华森制药股份有限公司4CYHS2401414非布司他片四川依科制药有限公司4CYHS2401413非布司他片四川依科制药有限公司4CYHS2401412盐酸贝尼地平片石家庄四药有限公司4CYHS2401408克立硼罗软膏广东华润顺峰药业有限公司4CYHS2401407结构脂肪乳注射液(C6-24)江苏盈科生物制药有限公司4CYHS2401406硫酸氨基葡萄糖胶囊恒昌(广州)新药研究有限公司4CYHS2401425氧海东市平安区永安气体有限公司4CYHS2401424瑞巴派特片浙江赛默制药有限公司4CYHS2401423盐酸奥布卡因滴眼液浙江视方极医药科技有限公司4CYHS2401399甲硝唑凝胶浙江寰领医药科技有限公司4CYHS2401398硫酸特布他林雾化吸入用溶液浙江莎普爱思药业股份有限公司4CYHS2401397蔗糖羟基氧化铁咀嚼片南京恒生制药有限公司4CYHS2401396马来酸氟伏沙明片重庆赛维药业有限公司4CYHS2401395马来酸氟伏沙明片重庆赛维药业有限公司4CYHS2401394西格列汀二甲双胍片(II)湖南威特制药股份有限公司4CYHS2401393富马酸伏诺拉生片海口市制药厂有限公司4CYHS2401391富马酸伏诺拉生片海口市制药厂有限公司4CYHS2401390非诺贝特酸胆碱缓释胶囊湖南九典制药股份有限公司4CYHS2401389聚乙二醇钠钾散重庆希尔安药业有限公司4CYHS2401388聚乙二醇钠钾散四川信拓医药技术有限公司4CYHS2401387马来酸氟伏沙明片辰欣药业股份有限公司4CYHS2401386依折麦布阿托伐他汀钙片(I)江苏万高药业股份有限公司4CYHS2401385氧(液态)侨源(金堂)气体有限公司4CYHS2401403腺苷注射液大道隆达(北京)医药科技发展有限公司4CYHS2401402双醋瑞因胶囊赛灵药业科技集团股份有限公司4CYHS2401401左卡尼汀口服溶液广州一品红制药有限公司4CYHS2401381瑞格列奈片成都恒瑞制药有限公司4CYHS2401380恩格列净片浙江宏元药业股份有限公司4CYHS2401379氘丁苯那嗪片南京正大天晴制药有限公司4CYHS2401378氘丁苯那嗪片南京正大天晴制药有限公司4CYHS2401377氘丁苯那嗪片南京正大天晴制药有限公司4CYHS2401376富马酸伏诺拉生片天方药业有限公司4CYHS2401374富马酸伏诺拉生片天方药业有限公司4CYHS2401373二甲硅油乳剂成都倍特得诺药业有限公司4CYHS2401372二甲硅油乳剂成都倍特得诺药业有限公司4CYHS2401371碳酸司维拉姆片江苏天士力帝益药业有限公司4CYHS2401359马来酸非尼拉敏盐酸萘甲唑啉滴眼液浙江视方极医药科技有限公司4CYHS2401358中长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液瑞阳制药股份有限公司4CYHS2401357阿司匹林肠溶片浙江易泽达医药科技有限公司4CYHS2401356乙磺酸尼达尼布软胶囊瑞阳制药股份有限公司4CYHS2401355骨化三醇软胶囊浙江浙北药业有限公司4CYHS2401354富马酸卢帕他定片浙江赛默制药有限公司4CYHS2401353盐酸阿莫罗芬搽剂浙江寰领医药科技有限公司4CYHS2401350吡仑帕奈片成都苑东生物制药股份有限公司4CYHS2401347吡仑帕奈片成都苑东生物制药股份有限公司4CYHS2401346贝前列素钠片山东百诺医药股份有限公司4CYHS2401345曲伏前列素滴眼液广州大光制药有限公司4CYHS2401344硫酸镁钠钾口服用浓溶液广西维威制药有限公司4CYHS2401343磷酸奥司他韦胶囊陕西步长高新制药有限公司4CYHS2401342盐酸氟西汀分散片山东达因海洋生物制药股份有限公司4CYHS2401339盐酸达泊西汀片浙江施强制药有限公司4CYHS2401367替米沙坦片河北山姆士药业有限公司4CYHS2401366注射用阿糖胞苷仁合熙德隆药业有限公司4CYHS2401365替米沙坦片河北山姆士药业有限公司4CYHS2401364注射用阿糖胞苷仁合熙德隆药业有限公司4CYHS2401363替米沙坦片河北山姆士药业有限公司4CYHS2401362盐酸多柔比星脂质体注射液河北天成药业股份有限公司4CYHS2401341达比加群酯胶囊天方药业有限公司4CYHS2401331达比加群酯胶囊天方药业有限公司4CYHS2401330乳果糖口服溶液湖南及正医药科技有限公司4CYHS2401329乳果糖口服溶液湖南及正医药科技有限公司4CYHS2401328乌司奴单抗注射液百奥泰生物制药股份有限公司3.3CXSS2400048乌司奴单抗注射液(静脉输注)百奥泰生物制药股份有限公司3.3CXSS2400047乌司奴单抗注射液百奥泰生物制药股份有限公司3.3CXSS2400046进口申请药品名称企业注册分类受理号Fitusiran注射液Genzyme Corporation1JXHS2400034Fitusiran注射液Genzyme Corporation1JXHS2400033盐酸氨酮戊酸己酯软膏光动力治疗系统ASIERIS MEDITEC (Hong Kong) CO., LIMITED2.2JXHS2400035地拉罗司片Annora Pharma Private Limited5.2JYHS2400025地拉罗司片Annora Pharma Private Limited5.2JYHS2400024地拉罗司片Annora Pharma Private Limited5.2JYHS2400023BI 690517片Boehringer Ingelheim International GmbH1JXHL2400106BI 690517片Boehringer Ingelheim International GmbH1JXHL2400105LOXO-435片Eli Lilly and Company1JXHL2400104LOXO-435片Eli Lilly and Company1JXHL2400103LOXO-435片Eli Lilly and Company1JXHL2400102BI 1810631 片Boehringer Ingelheim International GmbH1JXHL2400099RO7434656注射液F. Hoffmann-La Roche Ltd.1JXHL2400098马昔腾坦分散片Actelion Pharmaceuticals Ltd.2.2JXHL2400107Upadacitinib口服溶液AbbVie Inc.2.2JXHL2400097Upadacitinib口服溶液AbbVie Inc.2.2JXHL2400096Capivasertib片AstraZeneca AB2.4JXHL2400101Capivasertib片AstraZeneca AB2.4JXHL2400100BAY 3375968Bayer AG1JXSL2400088Relatlimab注射液Bristol-Myers Squibb Company1JXSL2400085DS-7300aDaiichi Sankyo, Inc.1JXSL2400087古塞奇尤单抗注射液Janssen Research & Development, LLC2.2JXSL2400091古塞奇尤单抗注射液Janssen Research & Development, LLC2.2JXSL2400090古塞奇尤单抗注射液Janssen Research & Development, LLC2.2JXSL2400089Ropeginterferon alfa-2b注射液PharmaEssentia Corporation2.2JXSL2400086中药相关申请药品名称企业注册分类受理号蒿平颗粒新奇康药业股份有限公司1.1CXZL2400024清血败毒丸江苏中雍红瑞制药有限公司1.1CXZL2400023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。