Evaluation the effect of adding Sevelamer to the standard treatment of aluminum phosphide poisoning patients, referred to Tehran's Luqman Hospital, a preliminary studyon mortalit

开始日期2024-03-20

申办/合作机构

Shahid Beheshti University of Medical Sciences

CTR20230498

/ Completed临床1期

一项在健康受试者中评价含钙的磷结合剂醋酸钙片和非含钙的磷结合剂碳酸司维拉姆片对德度司他片的药动学影响的单中心、随机、开放、三周期交叉的I期临床研究

主要目的：评估磷结合剂碳酸司维拉姆片和醋酸钙片对德度司他片药动学的影响。次要目的：观察受试者给予磷结合剂碳酸司维拉姆片和醋酸钙片与德度司他片的安全性。

开始日期2023-07-13

申办/合作机构

康哲（湖南）制药有限公司

100 项与碳酸司维拉姆相关的临床结果

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100 项与碳酸司维拉姆相关的转化医学

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100 项与碳酸司维拉姆相关的专利（医药）

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356

项与碳酸司维拉姆相关的文献（医药）

2025-09-01·INTERNATIONAL IMMUNOPHARMACOLOGY

Pharmacologic modulation of systemic inorganic phosphate levels restores the impaired phagocytosis of Kupffer cells and improves liver function in murine models of chronic liver failure

Article

作者: Deng, Zhi-Qiang ; Liang, Qing-Rong ; Liu, Yue ; Wang, Le-Ran ; Liao, Zi-Qiang ; Zhang, Chun-Bo ; Tang, Qun ; Chen, Ze-Ning ; Zhou, Bin-Quan ; Xie, Xian-Bing

Chronic liver disease induced by various etiologies (ethanol, viruses, etc.) impairs macrophage phagocytosis. This study demonstrated that such impairment could be alleviated by systemic weak phosphate stress in vitro and in vivo. A cell model of ethanol-induced damage was established by incubating the RAW 264.7 cell line in a low-phosphate medium, and the phagocytic capacity of the injured cells was increased, as evidenced by their increased ability to engulf Escherichia coli and fluorescent microspheres. The transcriptomic analysis combined with laboratory validation by qPCR and Western blotting identified the PI3K-Akt signaling pathway and RAC3 protein as potential contributors. The expression of FcγR was inhibited after injury, but low Pi stress increased its expression to normal levels for foreign body recognition. Moreover, actin polymerization was also increased, which is beneficial for phagosome formation. In both alcohol- and DEN-induced models of chronic liver injury, alcohol exposure led to a decreased phagocytic capacity of liver macrophages (Kupffer cells), which was mitigated by the oral administration of sevelamer (5 % w/w). Immunohistochemical results confirmed the findings from the cellular experiments, revealing consistent expression patterns of FcγR, RAC3, and PI3K-Akt. Furthermore, damage to liver function was ameliorated in both models. In conclusion, these results indicate that the weak phosphate stress induced by sevelamer has therapeutic potential to reverse the impairment of phagocytosis caused by liver injury.

2025-06-01·SAGE Open Medical Case Reports

Upadacitinib as a potential management option for diffuse cutaneous systemic sclerosis: A case report

Article

作者: Kirchhof, Mark G. ; Sarfaraz, Sidra ; Chang, Janis

Systemic sclerosis (SSc) is a complex disease involving vasculopathy, immune dysfunction, and fibrosis, with varied clinical presentations that complicate treatment standardization. It often affects multiple organs, including the skin, lungs, gastrointestinal tract, and kidneys. We present a 52-year-old woman with a 14-year history of diffuse cutaneous SSc with severe, treatment-resistant manifestations. She had Raynaud’s disease with digital ulceration and auto-amputation, telangiectasias, sclerodactyly, esophageal scleroderma, interstitial lung disease, and extensive calcinosis requiring multiple surgeries. Her disease remained poorly controlled despite treatment with nintedanib, sevelamer, colchicine, tadalafil, and prior immunosuppressants such as prednisone and mycophenolate mofetil. We initiated a trial of upadacitinib which resulted in improved vascular and cutaneous symptoms. Overall, upadacitinib provided meaningful clinical benefits despite her refractory, multisystem disease.

2025-05-01·Clinical Journal of the American Society of Nephrology

Efficacy and Safety of Phosphate-Lowering Agents for Adult Patients with CKD Requiring Dialysis

Article

作者: Noma, Hisashi ; Hamano, Takayuki ; Mizukami, Aya ; Kimura, Hiroshi ; Yamada, Shunsuke ; Hasegawa, Takeshi ; Fukagawa, Masafumi ; Nishimoto, Masatoshi ; Nishiwaki, Hiroki ; Taniguchi, Masatomo ; Murashima, Miho ; Saito, Hirotaka

Key Points:

Sevelamer was associated with lower all-cause mortality compared with calcium-based agents.Sucroferric oxyhydroxide and tenapanor were estimated to rank high in lowering all-cause mortality compared with other phosphate-lowering agents.Sucroferric oxyhydroxide and lanthanum were associated with slower progression of coronary artery calcium score compared with calcium-based agents.

Background:

It is necessary to update the evidence of each phosphate-lowering agent on dialysis patients.

Methods:

From the CENTRAL, MEDLINE, Embase, and ClinicalTrial.gov databases, randomized controlled trials using oral phosphate-lowering agents on adult patients requiring maintenance dialysis were extracted. The treatment period was required for 8 or more weeks, and the risk of bias was assessed according to the Cochrane Collaboration method. The outcomes were all-cause mortality, cardiovascular mortality, gastrointestinal events, fracture, coronary artery calcium score (CACS), serum calcium, phosphate, intact parathyroid hormone, and bicarbonate levels. A network meta-analyses using multivariate random-effects models were performed for assessing the comparative effectiveness. The ranking of the phosphate-lowering agents was assessed using a surface under the cumulative ranking curve.

Results:

A total of 70 randomized controlled trials involving 15,551 participants were included. Eleven phosphate-lowering agents including calcium-based agents, sevelamer, bixalomer, lanthanum, sucroferric oxyhydroxide, ferric citrate, tenapanor, magnesium, nicotinamide, aluminum, and sucralfate were assessed. Sevelamer was significantly associated with lower all-cause mortality compared with calcium-based agents (risk ratio [95% confidence interval]: 0.59 [0.37 to 0.94]), and sucroferric oxyhydroxide and tenapanor were estimated to rank high in lowering all-cause mortality on the basis of the surface under the cumulative ranking curve. The risk of gastrointestinal events was the highest with nicotinamide, followed by sucroferric oxyhydroxide. Compared with calcium-based agents, CACS was significantly lower among those on lanthanum and sucroferric oxyhydroxide (standardized mean difference [95% confidence interval]: −0.26 [−0.52 to −0.01] and −0.50 [−0.95 to−0.06], respectively). Serum calcium levels were higher, and serum intact parathyroid hormone levels were lower in patients treated with calcium-based agents. Except for sevelamer, serum bicarbonate levels for all other agents were higher compared with placebo.

Conclusions:

Compared with calcium-based agents, sevelamer was associated with lower all-cause mortality, and sucroferric oxyhydroxide and lanthanum were associated with slower progression of CACS. Potential benefits and harms should be considered when selecting phosphate-lowering agents (International prospective register of systematic reviews: CRD42022328388).

项与碳酸司维拉姆相关的新闻（医药）

2025-07-22

·米内网

【火热】14亿大品种，昆药集团拿下新剂型国产第三家

精彩内容7月22日，昆药集团发布公告称，全资子公司昆明贝克诺顿制药收到了国家药监局核准签发的碳酸司维拉姆干混悬剂《药品注册证书》，为国产第三家获批。司维拉姆是高钾血症和高磷酸盐血症治疗药TOP1品种，2024年在中国三大终端六大市场销售额超过14亿元。表1：昆药集团最新获批的产品情况来源：公司公告、米内网制表图1：司维拉姆的销售情况（单位：万元）来源：米内网格局数据库在中国三大终端六大市场（统计范围见文末），司维拉姆近几年一直保持高速增长态势，2023年销售额突破10亿元，2024年涨至14.4亿元，2025年Q1再有6.17%的增长，市场潜力巨大，该品种2022年起一直稳坐高钾血症和高磷酸盐血症治疗药市场TOP1品种宝座。目前该品种已有碳酸司维拉姆片和碳酸司维拉姆干混悬剂上市销售，2024年1月杭州安元生物医药拿下碳酸司维拉姆干混悬剂的国内首仿，昆明贝克诺顿制药是该产品国产第三家获批企业，依然具有较强竞争优势。公告中提到，碳酸司维拉姆干混悬剂用于控制正在接受透析治疗的慢性肾脏病（CKD）成人患者的高磷血症，以及用于控制血清磷≥1.78mmol/L但并未进行透析的慢性肾脏病成人患者的高磷血症，与片剂相比，干混悬剂更适合吞咽困难的成人和儿童患者。截至目前，昆药集团对碳酸司维拉姆干混悬剂累计研发投入约1318万元。公司表示，此次获得碳酸司维拉姆干混悬剂的《药品注册证书》，进一步丰富了公司“骨风关肾”慢病领域产品管线，有助于提升公司产品的市场竞争力，并为后续慢病相关产品研发积累了宝贵的经验。图2：昆药集团近两年申报上市的产品来源：米内网中国申报进度（MED）数据库值得注意的是，碳酸司维拉姆干混悬剂是#昆药集团今年首个获批的新产品，目前公司还有吗替麦考酚酯干混悬剂报产在审，该产品于今年1月纳入优先审评品种名单，理由为“符合儿童生理特征的儿童用药品新品种、剂型和规格”。资料来源：米内网数据库、公司公告注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至7月22日，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

上市批准

2025-07-20

·信狐药迅

浙江百代2.2类改良新苯磺酸氨氯地平颗粒提交上市申请|新受理（7.14-7.20）

本周药品注册受理数据，分门别类呈现，一目了然。(7.14-7.20）新药上市申请药品名称企业注册分类受理号苯磺酸氨氯地平颗粒浙江百代医药科技有限公司2.2CXHS2500083苯磺酸氨氯地平颗粒浙江百代医药科技有限公司2.2CXHS2500082苯磺酸氨氯地平颗粒浙江百代医药科技有限公司2.2CXHS2500081苯磺酸氨氯地平颗粒浙江百代医药科技有限公司2.2CXHS2500080新药临床申请药品名称企业注册分类受理号CKBA乳膏江苏博创园生物医药科技有限公司1CXHL2500725CKBA乳膏江苏博创园生物医药科技有限公司1CXHL2500724CKBA乳膏江苏博创园生物医药科技有限公司1CXHL2500723CKBA乳膏江苏博创园生物医药科技有限公司1CXHL2500722CKBA乳膏江苏博创园生物医药科技有限公司1CXHL2500721YUQ-A1007片元启(苏州)生物制药有限公司1CXHL2500720YUQ-A1007片元启(苏州)生物制药有限公司1CXHL2500719JYP0061片广州嘉越医药科技有限公司1CXHL2500718JYP0061片广州嘉越医药科技有限公司1CXHL2500717JYP0061片广州嘉越医药科技有限公司1CXHL2500716GTA182片上海湃隆生物科技有限公司1CXHL2500707GTA182片上海湃隆生物科技有限公司1CXHL2500706D-2570片益方生物科技(上海)股份有限公司1CXHL2500705SYH2070注射液石药集团中诺药业(石家庄)有限公司1CXHL2500709PH027-1片苏州浦合医药科技有限公司1CXHL2500704PH027-1片苏州浦合医药科技有限公司1CXHL2500703IBI3032信达生物科技有限公司1CXHL2500702IBI3032信达生物科技有限公司1CXHL2500701IBI3032信达生物科技有限公司1CXHL2500700IBI3032信达生物科技有限公司1CXHL2500699盐酸左沙丁胺醇异丙托溴铵吸入溶液济南景笙科技有限公司2.1CXHL2500710AKZ001直服颗粒海南爱科制药有限公司2.2CXHL2500726LPD-003原位凝胶浙江紫藤药业科技有限公司2.2CXHL2500708SQ-129玻璃体缓释注射液沈阳兴齐眼药股份有限公司2.2CXHL2500712SQ-129玻璃体缓释注射液沈阳兴齐眼药股份有限公司2.2CXHL2500711BTP4507江苏诺和必拓新药研发有限公司2.3CXHL2500698APG-2575片苏州亚盛药业有限公司2.4CXHL2500715APG-2575片苏州亚盛药业有限公司2.4CXHL2500714APG-2575片苏州亚盛药业有限公司2.4CXHL2500713ACYW135群脑膜炎球菌结合疫苗上海瑞宙生物科技有限公司2.2CXSL2500594SHR-7787注射液上海恒瑞医药有限公司1CXSL2500605SHR-7787 注射液上海恒瑞医药有限公司1CXSL2500604SHR-1905注射液广东恒瑞医药有限公司1CXSL2500602SHR-4849注射液苏州盛迪亚生物医药有限公司1CXSL2500601HiCM388注射液艾尔普再生医学科技(深圳)有限公司1CXSL2500607注射用YLSH003成都苑东生物制药股份有限公司1CXSL2500600EMB-07注射液上海岸迈生物科技有限公司1CXSL2500599HS_SW01细胞注射液深圳惠善生物科技有限公司1CXSL2500598HS_SW01细胞注射液深圳惠善生物科技有限公司1CXSL2500597TJ101注射液天境生物科技(杭州)有限公司1CXSL2500596HX044注射液翰思艾泰生物医药科技(武汉)股份有限公司1CXSL2500595注射用AK138D1中山康方生物医药有限公司1CXSL2500593OVV-01注射液上海荣瑞医药科技有限公司1CXSL2500592OVV-01注射液上海荣瑞医药科技有限公司1CXSL2500591重组人源化抗HER2双特异性抗体注射液上海津曼特生物科技有限公司1CXSL2500590注射用MR001双特异性抗体深圳市迈加瑞生物技术有限公司1CXSL2500589注射用QLC5508齐鲁制药有限公司1CXSL2500585KDTV001注射液武汉凯德基诺生物技术有限公司1CXSL2500586EVM14注射液云顶新耀(北京)医药科技有限公司1CXSL2500584贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2500606阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500603恩朗苏拜单抗注射液石药集团巨石生物制药有限公司2.2CXSL2500588QL2107注射液齐鲁制药有限公司2.2CXSL2500587仿制药申请药品名称企业注册分类受理号生理氯化钠溶液山东华茂药业有限公司3CYHS2502610盐酸克林霉素棕榈酸酯颗粒安徽省先锋制药有限公司3CYHS2502578头孢羟氨苄干混悬剂苏州第三制药厂有限责任公司3CYHS2502582异烟肼口服溶液江苏润恒制药有限公司3CYHS2502577碳酸氢钠血滤置换液(无钾、无钙、0.6 mmol/L镁)宁波天益药业科技有限公司3CYHS2502596碳酸氢钠血滤置换液宁波天益药业科技有限公司3CYHS2502595碳酸氢钠血滤置换液宁波天益药业科技有限公司3CYHS2502592布美他尼注射液海南普利制药股份有限公司3CYHS2502591维生素B6注射液海南普利制药股份有限公司3CYHS2502590碳酸氢钠血滤置换液宁波天益药业科技有限公司3CYHS2502589碳酸氢钠血滤置换液(钾2mmol/L无钙)宁波天益药业科技有限公司3CYHS2502587盐酸溴己新口服溶液石家庄四药有限公司3CYHS2502586头孢羟氨苄干混悬剂苏州第三制药厂有限责任公司3CYHS2502583硫糖铝口服混悬液青岛双鲸药业股份有限公司3CYHS2502571维生素B12注射液南京恩泰医药科技有限公司3CYHS2502568联苯苄唑溶液江苏和晨药业有限公司3CYHS2502567磷酸奥司他韦颗粒江西施美药业股份有限公司3CYHS2502573多种微量元素注射液(4-Ⅱ)北京柏雅联合药物研究所有限公司3CYHS2502551维生素K1滴剂葵花药业集团(襄阳)隆中有限公司3CYHS2502534西咪替丁注射液山东华鲁制药有限公司3CYHS2502539恩格列净二甲双胍缓释片石药集团欧意药业有限公司3CYHS2502556恩格列净二甲双胍缓释片石药集团欧意药业有限公司3CYHS2502555恩格列净二甲双胍缓释片石药集团欧意药业有限公司3CYHS2502554呋喃妥因胶囊石家庄荣雾迪医药科技有限公司3CYHS2502553维生素K1滴剂浙江维康药业股份有限公司3CYHS2502535呋喃妥因胶囊石家庄荣雾迪医药科技有限公司3CYHS2502552中性腹膜透析液(碳酸氢盐-G2.5%)青岛瑞奈医疗科技有限公司3CYHS2502550中性腹膜透析液(碳酸氢盐-G1.5%)青岛瑞奈医疗科技有限公司3CYHS2502549呋塞米口服溶液郑州达若医药科技有限公司3CYHS2502546地塞米松磷酸钠注射液华夏生生药业(北京)有限公司3CYHS2502529硫代硫酸钠注射液知和(山东)大药厂有限公司3CYHS2502527辅酶Q10片杭州和泽坤元药业有限公司3CYHS2502526腺苷钴胺胶囊湖南先施制药有限公司3CYHS2502531盐酸普萘洛尔注射液德全药品(江苏)股份有限公司3CYHS2502518苯磺酸美洛加巴林片海南合瑞制药股份有限公司4CYHS2502614苯磺酸美洛加巴林片海南合瑞制药股份有限公司4CYHS2502613布南色林片石家庄科仁医药科技有限公司4CYHS2502612复方氨基酸注射液(18AA-VII)山东豪瑞恩制药有限公司4CYHS2502611枸橼酸钠血滤置换液山东华茂药业有限公司4CYHS2502609精氨酸布洛芬颗粒海南海神同洲制药有限公司4CYHS2502608精氨酸布洛芬颗粒海南海神同洲制药有限公司4CYHS2502607枸橼酸莫沙必利片浙江东亚药业股份有限公司4CYHS2502606枸橼酸莫沙必利片浙江东亚药业股份有限公司4CYHS2502605乌帕替尼缓释片江苏亚邦爱普森药业有限公司4CYHS2502604ω-3脂肪酸乙酯90软胶囊丽珠集团丽珠制药厂4CYHS2502581替普瑞酮胶囊珠海同源药业有限公司4CYHS2502580乌帕替尼缓释片广州誉东健康制药有限公司4CYHS2502579硫酸艾沙康唑胶囊北京博康健基因科技有限公司4CYHS2502599甘油磷酸钠注射液深圳大佛药业股份有限公司4CYHS2502598甘油磷酸钠注射液山东化药医药科技有限公司4CYHS2502597艾普拉唑肠溶片辰欣药业股份有限公司4CYHS2502594佩玛贝特片海南赛立克药业有限公司4CYHS2502593注射用哌拉西林钠他唑巴坦钠/氯化钠注射液山东二叶制药有限公司4CYHS2502588环孢素软胶囊人福普克药业(武汉)有限公司4CYHS2502585环孢素软胶囊人福普克药业(武汉)有限公司4CYHS2502584苯磺酸左氨氯地平片安徽省先锋制药有限公司4CYHS2502603苯磺酸左氨氯地平片安徽省先锋制药有限公司4CYHS2502602枸橼酸西地那非口腔崩解片津华医药科技(湖州)有限公司4CYHS2502601卡泊三醇软膏重庆胜凯制药有限公司4CYHS2502572阿帕他胺片华东医药(西安)博华制药有限公司4CYHS2502570吗啉硝唑氯化钠注射液湖北华仁同济药业有限责任公司4CYHS2502569蔗糖羟基氧化铁咀嚼片丽彩甘肃西峰制药有限公司4CYHS2502566乙酰半胱氨酸泡腾片珠海联邦制药股份有限公司中山分公司4CYHS2502565双氯芬酸钠盐酸利多卡因注射液广州合和医药有限公司4CYHS2502563西甲硅油乳剂湖南千金协力药业有限公司4CYHS2502562伏立康唑片植恩生物技术股份有限公司4CYHS2502561伏立康唑片植恩生物技术股份有限公司4CYHS2502560碳酸司维拉姆片江苏中天药业有限公司4CYHS2502575噻托溴铵吸入喷雾剂齐鲁安替制药有限公司4CYHS2502600普拉洛芬滴眼液湖北泰林医药有限公司4CYHS2502564阿昔莫司胶囊乐声药业石家庄有限公司4CYHS2502576富马酸福莫特罗吸入溶液成都普什制药有限公司4CYHS2502574口服用苯丁酸甘油酯宿州亿帆药业有限公司4CYHS2502559巴瑞替尼片山东鲁抗医药集团赛特有限责任公司4CYHS2502558盐酸尼卡地平注射液南京正科医药股份有限公司4CYHS2502557盐酸奥洛他定片海南赛立克药业有限公司4CYHS2502544富马酸贝达喹啉片浙江海正药业股份有限公司4CYHS2502543乙酰半胱氨酸注射液四川天杏汇医药科技有限公司4CYHS2502542乙酰半胱氨酸注射液济南康桥医药科技有限公司4CYHS2502541瑞维那新吸入溶液长风药业股份有限公司4CYHS2502540硫酸氨基葡萄糖胶囊河南羚锐制药股份有限公司4CYHS2502538克立硼罗软膏江苏正大清江制药有限公司4CYHS2502537屈螺酮炔雌醇片(II)浙江爱生药业有限公司4CYHS2502536达格列净二甲双胍缓释片(III)湖南千金湘江药业股份有限公司4CYHS2502548达格列净二甲双胍缓释片(I)湖南千金湘江药业股份有限公司4CYHS2502547盐酸奥洛他定片海南赛立克药业有限公司4CYHS2502545注射用帕瑞昔布钠湖北长联杜勒制药有限公司4CYHS2502530泊沙康唑口服混悬液成都倍特得诺药业有限公司4CYHS2502528蔗糖铁注射液成都欣捷高新技术开发股份有限公司4CYHS2502525低钙腹膜透析液(乳酸盐-G4.25%)四川青山利康药业有限公司4CYHS2502524低钙腹膜透析液(乳酸盐-G4.25%)四川青山利康药业有限公司4CYHS2502523低钙腹膜透析液(乳酸盐-G2.5%)四川青山利康药业有限公司4CYHS2502522低钙腹膜透析液(乳酸盐-G2.5%)四川青山利康药业有限公司4CYHS2502521低钙腹膜透析液(乳酸盐-G1.5%)成都青山利康药业股份有限公司4CYHS2502520低钙腹膜透析液(乳酸盐-G1.5%)四川青山利康药业有限公司4CYHS2502519羟乙基淀粉130/0.4氯化钠注射液华夏生生药业(北京)有限公司4CYHS2502533羟乙基淀粉130/0.4氯化钠注射液华夏生生药业(北京)有限公司4CYHS2502532甲钴胺片四川依科制药有限公司4CYHS2502517流感病毒裂解疫苗江苏金迪克生物技术股份有限公司3.3CXSS2500075人血管性血友病因子/凝血因子Ⅷ复合物山东泰邦生物制品有限公司3.2CXSS2500076吲哚美辛凝胶贴膏海南回元堂药业有限公司3CYHL2500130卡左双多巴肠凝胶湖南派格兰药业有限公司3CYHL2500128注射用多黏菌素E甲磺酸钠湖南科伦制药有限公司3CYHL2500129进口申请药品名称企业注册分类受理号罗培干扰素α-2b注射液PharmaEssentia Corporation2.2JXSS2500099注射用德曲妥珠单抗Daiichi Sankyo Europe GmbH3.1JXSS2500101加达西单抗注射液CSL Behring AG3.1JXSS2500100注射用塔拉妥单抗Amgen Inc.3.1JXSS2500103注射用塔拉妥单抗Amgen Inc.3.1JXSS2500102BMS-986504片Bristol-Myers Squibb Company1JXHL2500189BMS-986504片Bristol-Myers Squibb Company1JXHL2500188BMS-986504片Bristol-Myers Squibb Company1JXHL2500187Leflutrozole胶囊ReproNovo SA1JXHL2500186Leflutrozole胶囊ReproNovo SA1JXHL2500185Leflutrozole胶囊ReproNovo SA1JXHL2500184盐酸依匹斯汀乳膏Santen Pharmaceutical Co., Ltd.5.1JXHL2500190IcoSema 注射液Novo Nordisk A/S1JXSL2500122中药相关申请药品名称企业注册分类受理号宣郁通经汤颗粒合肥华润神鹿药业有限公司3.1CXZS2500030注：绿色字体部分为潜在首仿品种；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。

申请上市临床申请

2025-06-26

·PRNewswire

Alebund Announces Positive Topline Results from Pivotal Phase 3 Study of AP301 for Serum Phosphorus Control in Dialysis Patients with Hyperphosphatemia

SHANGHAI, June 26, 2025 /PRNewswire/ -- Alebund Pharmaceuticals ("Alebund" or the "Company"), an integrated biopharmaceutical company focusing on developing innovative therapies for renal diseases and related chronic conditions, announced the database lock was achieved on June 16, 2025 for the pivotal phase 3 study of its investigational drug AP301, a new generation of oral iron-based phosphate binder, in dialysis patients with hyperphosphatemia. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in serum phosphorus control with AP301. The safety profile of AP301 is favorable and consistent with previous studies. As a novel fiber-iron-based phosphate binder, AP301 provides high phosphate-binding capability, no need to chew before swallow, no volume expansion when exposed to gastric fluid, and no systemic absorption. These properties contribute to a reduced pill burden, good tolerability and improved patient compliance. The pivotal study (NCT07030595, CTR20231624) is a randomized, open-label, active-controlled, multi-center phase 3 study designed to evaluate the efficacy and safety of AP301 in controlling serum phosphorus levels in dialysis patients with hyperphosphatemia. The 52-week study contains an active control phase, an AP301 low-dose control phase and an extended treatment phase. Sevelamer carbonate served as the active comparator throughout the whole study period. A total of 474 participants were randomized across 50 investigational sites in China; the study was led by Professor Li ZUO, Director of the Department of Nephrology at Peking University People's Hospital. "We are deeply grateful to all the participants, investigators, and study personnel for their strong commitment and dedication to this phase 3 study over the past 2 years." Dr. Jin Tian, Co-founder and CMO of Alebund commented, "In the completed phase 2 study, AP301 was shown to be safe, well tolerated, and can effectively lower serum phosphorus in a dose-dependent manner [1]. This pivotal trial further demonstrates the clinical value of AP301, which has the potential to advance the treatment option for millions of patients with hyperphosphatemia through further increasing their adherence." Alebund plans to engage with China National Medical Products Administration (NMPA) regarding its new drug application plan in the third quarter of 2025. Detailed results from this phase 3 study will be presented at an upcoming medical conference. Reference [1] Bing Zhuang, Liangying Gan, Bin Liu, Weijie Yuan, Ming Shi, Ai Peng, Lihua Wang, Xiaolan Chen, Tongqiang Liu, Shiying Zhang, Song Wang, Qing Gao, Baoxing Wang, Huixiao Zheng, Changhua Liu, Yuan Luo, Hong Ye, Hongli Lin, Yiwen Li, Qiang He, Feng Zheng, Ping Luo, Gang Long, Wei Lu, Kanghui Li, Junwei Yang, Yingxue Cathy Liu, Zhizheng Zhang, Xiaoling Li, Weifeng Zhang, Li Zuo, Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysis, Nephrology Dialysis Transplantation, Volume 39, Issue 10, October 2024, Pages 1649–1661, About Hyperphosphatemia Hyperphosphatemia is one of the most common complications in CKD patients. The long-term elevated serum phosphorus level could cause multiple complications such as secondary hyperparathyroidism, renal osteodystrophy and vascular calcification. It is an independent risk factor of cardiovascular events and all-cause mortalities. A good control of serum phosphorus level could effectively improve the patients' outcome. For CKD patients undergoing dialysis treatment, the regular dialysis is not sufficient to remove the overload of serum phosphate in the body. Considering the limitations of low-phosphate diet which might cause dystrophia, oral use of phosphate binders is the prevailing treatment for hyperphosphatemia. However, there is low compliance for patients (less than 50% reaching good phosphate control) to use PBs due to gastrointestinal side effects, high pill burden etc. According to Global and Chinese Hyperphosphatemia Drug Industry Blue Book by China Insights Consultancy in 2023, the out of target rate of serum phosphorus level in dialysis patients in Chinese mainland was significantly higher than other countries and regions. There is still room for improvement in terms of the proportion and duration of phosphorus binders usage. The market size of serum phosphorus lowering products in China is expected to reach 10 billion RMB by 2035. About Alebund Pharmaceuticals Alebund was incubated in Shanghai in 2018. It focuses on the discovery, development, production and commercialization of novel therapies primarily for kidney diseases and their complications, as well as other chronic conditions, to bring greater therapeutic options to patients in China and globally. Alebund has built a diversified and balanced pipeline of drug candidates targeting a range of renal indications, including chronic kidney disease (CKD)/dialysis complications, IgA nephropathy, diabetic kidney disease, focal segmental glomerulosclerosis (FSGS) and autosomal dominant polycystic kidney disease (ADPKD). Alebund has completed the construction of its manufacturing site for small molecules in Yangzhou that will supply bulk of Alebund's pipeline drugs, including AP301, upon commercial launch. Alebund has also established a dedicated commercialization team in China, responsible for the commercial promotion of renal products. SOURCE Alebund Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床3期临床2期

100 项与碳酸司维拉姆相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06642	碳酸司维拉姆	V03AE02	DB00658

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性肾病-矿物质和骨骼疾病	欧盟	Sanofi Winthrop Industrie SA	2015-01-15
慢性肾病-矿物质和骨骼疾病	冰岛	Sanofi Winthrop Industrie SA	2015-01-15
慢性肾病-矿物质和骨骼疾病	列支敦士登	Sanofi Winthrop Industrie SA	2015-01-15
慢性肾病-矿物质和骨骼疾病	挪威	Sanofi Winthrop Industrie SA	2015-01-15
高磷血症	欧盟	Sanofi Winthrop Industrie SA	2009-06-09
高磷血症	冰岛	Sanofi Winthrop Industrie SA	2009-06-09
高磷血症	列支敦士登	Sanofi Winthrop Industrie SA	2009-06-09
高磷血症	挪威	Sanofi Winthrop Industrie SA	2009-06-09
慢性肾病	美国	Genzyme Corp.	2007-10-19

未上市

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适应症	最高研发状态	国家/地区	公司	日期
终末期肾脏病	临床3期	法国	Genzyme Corp.	2010-10-01
继发性甲状旁腺功能亢进症	临床3期	美国	Genzyme Corp.	2010-04-01
心血管疾病	临床2期	英国	Genzyme Corp.	2009-02-01
2型糖尿病	临床阶段不明	丹麦	Sanofi	2014-02-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04485039 (CTgov)	临床4期	天花	44	Tecovirimat (TPOXX: Oral Antiviral)	窪積觸顧醖糧鹽夢鏇顧(衊築選襯襯壓鬱獵鏇鬱) = 範蓋襯獵範觸膚鏇繭願簾襯夢憲觸選艱廠廠醖 (膚繭衊鹹觸齋鹽築鏇憲, 39.6) 更多	-	2024-10-09
				Tecovirimat+sevelamer carbonate oral tablet (TPOXX: Oral Antiviral and Sevelamer Carbonate)	壓窪鏇製夢淵製鬱憲齋(積觸獵餘衊夢鑰獵繭餘) = 願淵衊遞積鑰願夢鹽獵製範窪餘鬱觸願蓋廠艱 (獵觸鏇範簾製餘襯範選, 廠簾窪繭齋簾鬱遞遞鏇 ~ 範獵夢鹹艱廠獵鹹齋顧) 更多
NCT03644264 (Pubmed)	临床3期	高磷血症	286	Sucroferric oxyhydroxide	鏇範淵繭選蓋鹹鑰簾選(構顧繭艱壓鹹醖積製願) = 夢鑰鬱遞糧積壓鬱顧醖膚繭鏇築壓獵顧築廠艱 (選醖鏇醖製鹽鹽範鹹積 )	积极	2023-07-20
				Sevelamer carbonate	鏇範淵繭選蓋鹹鑰簾選(構顧繭艱壓鹹醖積製願) = 鹽鏇鏇獵壓範鬱衊餘積膚繭鏇築壓獵顧築廠艱 (選醖鏇醖製鹽鹽範鹹積 )
NCT03988920 (NORMALIZE, CTgov)	临床4期	高磷血症 \| 终末期肾脏病	172	Sevelamer Carbonate+Tenapanor (Tenapanor w/Sevelamer)	範顧築淵餘鏇顧餘蓋構 = 鹽願衊壓夢顧衊鹹糧憲窪廠遞窪選簾醖齋範鑰 (簾艱築齋鹹艱淵觸艱壓, 壓顧觸醖淵願願蓋廠窪 ~ 壓襯積廠淵繭網襯窪襯) 更多	-	2023-03-29
				Sevelamer Carbonate+Tenapanor (Sevelamer w/Tenapanor)	範顧築淵餘鏇顧餘蓋構 = 齋構簾淵鏇鑰積遞廠選窪廠遞窪選簾醖齋範鑰 (簾艱築齋鹹艱淵觸艱壓, 築範製憲選鏇簾觸壓積 ~ 衊觸糧網蓋鏇獵製淵顧) 更多
ASN2022	N/A	慢性肾病 hyperphosphatemia	-	Sevelamer	鬱壓鹹鬱餘範衊廠醖鹽(選觸築齋衊積選窪壓積): HR = 0.84 (95% CI, 0.79 ~ 0.91) 更多	积极	2022-11-05
				Sevelamer (Cardiopulmonary Bypass (CPB))
ASN2021	N/A	慢性肾病	-	Calcium acetate	範選齋淵選製艱鏇鑰鏇(憲簾夢蓋艱艱顧膚艱網) = 膚鬱願壓獵積艱窪壓蓋簾範遞淵網醖憲構憲簾 (顧觸築積艱窪範簾艱餘 )	-	2021-10-27
				Ferric citrate	範選齋淵選製艱鏇鑰鏇(憲簾夢蓋艱艱顧膚艱網) = 遞蓋築夢衊獵範鹹艱廠簾範遞淵網醖憲構憲簾 (顧觸築積艱窪範簾艱餘 )
MO797 (ERA2021)	N/A	慢性肾病 serum phosphate \| serum calcium ions \| FGF23 ... 更多	-	Iron-based phosphate binders (sucroferric oxyhydroxide, ferric citrate)	壓積獵繭艱選餘範網製(廠構窪艱顧獵選淵齋糧): SMD = 0.08 (95% CI, -0.02 ~ 0.17), P-Value = 0.08 更多	不佳	2021-05-29
				Non-calcium phosphate binders (sevelamer)
VIKI study (WCO_IOF_ESCEO2020)	N/A	血液透析并发症 vitamin K deficiency \| vertebral fractures \| vascular calcification	387	Sevelamer	齋構鹹積範鹹廠積醖壓(顧衊淵鑰獵範範構鹹膚) = 範窪鏇範繭廠觸築齋醖鹹選糧醖襯衊窪蓋構糧 (選簾鹽願範範願窪廠廠 ) 更多	-	2020-08-20
				No Sevelamer	齋構鹹積範鹹廠積醖壓(顧衊淵鑰獵範範構鹹膚) = 膚鏇鑰繭廠糧夢醖鹽蓋鹹選糧醖襯衊窪蓋構糧 (選簾鹽願範範願窪廠廠 ) 更多
NCT03001011 (RECOVER \| P0880, CTgov)	临床3期	高磷血症 \| 慢性肾病	202	Placebo (Placebo)	遞繭蓋淵蓋築艱壓窪襯(糧積遞襯範鏇觸構積製) = 網簾鹽鏇鏇顧鑰鹹鹽蓋網構顧憲窪鏇廠窪積糧 (繭夢鹹觸憲艱繭糧廠構, 膚襯鬱糧網顧鬱鏇鏇衊 ~ 選廠鹹廠繭糧願夢製選) 更多	-	2020-07-28
				Sevelamer Carbonate (GZ419831) (Renvela)	遞繭蓋淵蓋築艱壓窪襯(糧積遞襯範鏇觸構積製) = 糧鬱積觸選鹽積淵簾製網構顧憲窪鏇廠窪積糧 (繭夢鹹觸憲艱繭糧廠構, 積鬱網鹽窪糧艱醖憲鑰 ~ 鬱襯衊餘襯鹹糧醖餘艱) 更多
VIKI (ERA2020)	N/A	25(OH)D \| ALP \| vitamers K1 ... 更多	387	Sevelamer	積壓選襯膚觸觸鬱顧築(壓淵憲衊網壓鑰蓋廠築) = 艱選衊衊襯簾廠襯顧網餘願壓膚蓋廠願艱顧鹽 (繭餘醖範網艱蓋鹹醖糧 ) 更多	积极	2020-06-06
				No Sevelamer	積壓選襯膚觸觸鬱顧築(壓淵憲衊網壓鑰蓋廠築) = 顧遞淵網範餘齋遞夢鏇餘願壓膚蓋廠願艱顧鹽 (繭餘醖範網艱蓋鹹醖糧 ) 更多
ASN2019	N/A	-	37	Calcium Carbonate	壓憲醖網簾鹹選廠淵壓(觸積窪窪襯構膚觸築夢) = 壓壓簾網鏇鏇觸願廠壓獵淵獵願選蓋鑰鹹艱願 (壓鑰選選夢鏇構積窪網, 7 ~ 14) 更多	不佳	2019-11-05
				Sevelamer	壓憲醖網簾鹹選廠淵壓(觸積窪窪襯構膚觸築夢) = 築繭襯壓鑰淵獵衊構積獵淵獵願選蓋鑰鹹艱願 (壓鑰選選夢鏇構積窪網, 3 ~ 19) 更多