To Evaluate the Tolerance, pd, and pk of Lanthanum Polystyrene-sulfonate Powder in a Phase Ib/ IIa Clinical Trial in Patients With ESRD-HD Hyperphosphatemia With Multi-center, Multi-dose, Give the Drug Multiple Time

The aim of the study is:
To evaluate the tolerance of lanthanum polystyrene sulfonate powder in patients with end-stage renal disease (ESRD-HD) hyperphosphatemia with multiple doses and multiple doses； To evaluate the pharmacodynamics of lanthanum polystyrene sulfonate powder in hyperphosphatemia patients with end-stage renal disease on hemodialysis (ESRD-HD); To evaluate the pharmacokinetics of lanthanum polystyrene sulfonate powder in patients with end-stage renal disease (ESRD-HD) hyperphosphatemia after multi-dose and multiple administration.

开始日期2020-10-21

申办/合作机构

远大生命科学（辽宁）有限公司

[+1]

NCT03451019 / Completed临床4期IIT

Effect of Lanthanum Carbonate and Sevelamer Hydrochloride on Gastrointestinal Calcium Absorption in Patients With Moderate to Advanced Chronic Kidney Disease

Sevelamer hydrochloride (SE) can increase intestinal calcium absorption in contrast to lanthanum carbonate (LA). Study compared effect of LA and SE on serum and urine phosphate and calcium, and hormones regulating mineral-bone metabolism.

开始日期2018-03-01

申办/合作机构

Medical University of Lodz

[+1]

JPRN-UMIN000030503 / SuspendedN/AIIT

The study about the effect of combination therapy of active form of vitamin D and lanthanum carbonate for serum concentration of FGF23 - CVD-LAF study

开始日期2018-01-20

申办/合作机构

Fujita Health University

100 项与碳酸镧相关的临床结果

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100 项与碳酸镧相关的转化医学

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100 项与碳酸镧相关的专利（医药）

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项与碳酸镧相关的文献（医药）

2024-04-01·Journal of applied toxicology : JAT

Effect of lanthanum nitrate on adipogenesis in mice

Article

作者: Hao, Weidong ; Liu, Qianyi ; Wei, Xuetao ; Wang, Xiaoxia ; Ma, Yuhong ; Zhao, Zhe ; Guo, Wanqian ; Yuan, Lilan ; Kang, Chenping ; Xiao, Qianqian

Abstract:

Lanthanum (La) is widely used in modern industry and agriculture because of its unique physicochemical properties and is broadly exposed in the population. Some studies have shown that La may have some effects on adipogenesis, but there is a lack of related in vivo evidence. In this study, the effects of La(NO3)3 on adipogenesis and its associated mechanism were studied using C57BL/6J mouse model. The results showed that La(NO3)3 exposure caused a decrease in body weight and the percentage of fat content in mice. In addition, the adipose marker molecules and specific adipogenic transcription factors decreased in both white adipose tissue (WAT) and brown adipose tissue (BAT). Detection of signaling pathway‐related molecules revealed that canonical wnt/β‐catenin pathway‐related molecules were upregulated in both adipose tissues. In summary, in vivo exposure to La(NO3)3 might inhibited adipogenesis in mice, possibly through upregulation of the canonical Wnt/β‐catenin signaling pathway.

2024-03-01·Biological trace element research

The Effect of Lanthanum (III) Nitrate on the Osteogenic Differentiation of Mice Bone Marrow Stromal Cells

Article

作者: Wang, Qian ; Zhang, Hai-Song ; Li, Xue-Zhong ; Gao, Yan ; Li, Yi-Fan ; Fan, Xing

Abstract:

To study the species of lanthanum (III) nitrate (La[NO3]3) dispersed in cell media and the effect on the osteoblast differentiation of bone marrow stroma cells (BMSCs). Different La-containing precipitations were obtained by adding various concentrations of La(NO3)3 solutions to Dulbecco’s modified Eagle medium (DMEM) or DMEM with fetal bovine serum (FBS). A series of characterisation methods, including dynamic light scattering, scanning electron microscopy, transmission electron microscopy, energy-dispersive X-ray spectroscopy, and protein quantification were employed to clarify the species of the different La-containing precipitations. The primary BMSCs were isolated, and the cell viability, alkaline phosphatase activity, and the formation of a mineralised nodule of BMSCs were tested when treated with different La-containing precipitations. The La(NO3)3 solutions in DMEM could form LaPO4, which exits in the particle formation, while the La(NO3)3 solutions in DMEM with FBS could form a La-PO4-protein compound. When treated with La(NO3)3 solutions in DMEM, the cell viability of the BMSCs was inhibited at the concentrations of 1, 10, and 100 μM at 1 day and 3 days. Meanwhile, the supernatant derived from the La(NO3)3 solutions in DMEM did not affect the cell viability of the BMSCs. In addition, the precipitate derived from the La(NO3)3 solutions in DMEM added to the complete medium inhibited the cell viability of the BMSCs at concentrations of 10 μM and 100 μM. When treated with La(NO3)3 solutions in DMEM with FBS, the derived precipitate and supernatant did not affect the cell viability of the BMSCs, except for the concentration of 100 μM La(NO3)3. The La-PO4-protein formed from the La(NO3)3 solutions in DMEM with FBS inhibited the osteoblast differentiation of BMSCs at the concentration of 1 μM La(NO3)3 (P < 0.05) but had no effect on either the osteoblast differentiation at the concentrations of 0.001 and 0.1 μM or on the formation of a mineralised nodule at all tested concentrations of La(NO3)3. Overall, La(NO3)3 solutions in different cell culture media could form different La-containing compounds: La-PO4 particles (in DMEM) and a La-PO4-protein compound (in DMEM with FBS). The different La-containing compounds caused different effects on the cell viability, osteoblast differentiation, and the formation of a mineralised nodule of the BMSCs. The La-containing precipitation inhibited the osteoblast differentiation by inhibiting the expression of osteoblast-related genes and proteins, providing a theoretical basis for clinical doctors to apply phosphorus-lowering drugs such as lanthanum carbon.

2024-03-01·Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis

Biochemical markers of iron status and iron accumulation in peritoneal dialysis patients treated with ferric citrate

Article

作者: Lea, Janice I ; Ajiboye, Oyintayo ; Navarrete, José E

Background::

Hyperphosphataemia is a common complication of kidney disease. Current dialysis techniques do not provide enough phosphorus clearance, hence the need to use phosphorus binders. Treatment options include calcium carbonate, calcium acetate, lanthanum carbonate, sevelamer hydrochloride and iron-based binders. Patients receiving peritoneal dialysis (PD) with sustained elevated ferritin levels exceeding 800 ng/mL are at a higher risk of death. We identify PD patients treated with iron-based binders and compare ferritin and risk of iron accumulation to patients treated with non-iron-based binders.

Methods::

All records of patients receiving PD at Emory dialysis centres until 30 October 2021 were reviewed for phosphorus binders. Basic demographics and laboratory data were time-referenced to the days on treatment with a particular binder. Patients were followed until discontinuation of the phosphorus binder, death, transplant, transfer to another dialysis provider or censoring at 36 months after medication was started.

Results::

Compared to calcium acetate and sevelamer, ferric citrate utilisation in PD patients resulted in a sustained increase in ferritin. The proportion of patients with a ferritin equal to or greater than 800 ng/dL and transferrin saturation greater than 40% increased over time in patients treated with ferric citrate and was higher during the second and third year of follow-up compared to baseline values and to patients treated with calcium acetate or sevelamer. Two patients (7%) treated with ferric citrate developed clinically significant haemosiderosis.

Conclusions::

Use of ferric citrated in PD resulted in significant iron accumulation as judged by ferritin levels.

项与碳酸镧相关的新闻（医药）

2024-06-17

·信狐药迅

仿制药申请5个品规发通知件；临床申请品种均默示许可| 新获批（6.11-6.16）

每周药品注册获批数据，分门别类呈现，一目了然。(6.11-6.16）新药上市申请药品名称企业注册分类受理号泽美洛韦玛佐瑞韦单抗注射液兴盟生物医药(苏州)有限公司1CXSS2200053国;CXSS2200053泽美洛韦玛佐瑞韦单抗注射液兴盟生物医药(苏州)有限公司1CXSS2200052国;CXSS2200052特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2300053特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2300052 新药临床申请药品名称企业注册分类受理号SK-08片康臣药业(内蒙古)有限责任公司1CXHL2400317SK-08片康臣药业(内蒙古)有限责任公司1CXHL2400316SK-08片康臣药业(内蒙古)有限责任公司1CXHL2400315YK-051南京优科制药有限公司1CXHL2400296HSK42360片西藏海思科制药有限公司1CXHL2400306HSK42360片西藏海思科制药有限公司1CXHL2400305ASP3082注射液安斯泰来(中国)投资有限公司1CXHL2400308HY-021068片合肥医工医药股份有限公司1CXHL2400330KY386注射用浓溶液深圳开悦生命科技有限公司1CXHL2400338ASKC200搽剂江苏奥赛康药业有限公司2.2CXHL2400321ASKC200搽剂江苏奥赛康药业有限公司2.2CXHL2400320布洛芬注射液山东新华制药股份有限公司3CYHL2400067布洛芬注射液山东新华制药股份有限公司3CYHL2400066注射用IAP0971盛禾(中国)生物制药有限公司1CXSL2400100注射用BGB-R046广州百济神州生物制药有限公司1CXSL2400208HY1272注射液恒翼生物医药(上海)股份有限公司1CXSL2400211 仿制药申请药品名称企业注册分类受理号帕拉米韦氯化钠注射液江苏吴中医药集团有限公司苏州制药厂3CYHS2202034国;CYHS2202034缩宫素注射液上海葆隆生物科技有限公司3CYHS2000879国;CYHS2000879尼莫地平口服溶液广东金城金素制药有限公司3CYHS2100073国;CYHS2100073艾司奥美拉唑镁肠溶胶囊浙江永太药业有限公司3CYHS2200943国;CYHS2200943艾司奥美拉唑镁肠溶胶囊浙江永太药业有限公司3CYHS2200941国;CYHS2200941氨甲环酸注射液烟台鲁银药业有限公司3CYHS2201532国;CYHS2201532氨甲环酸注射液烟台鲁银药业有限公司3CYHS2201531国;CYHS2201531己酮可可碱注射液湖南科伦制药有限公司3CYHS2201638国;CYHS2201638西洛他唑片成都倍特药业股份有限公司3CYHS2201667国;CYHS2201667己酮可可碱注射液苏州朗科生物技术股份有限公司3CYHS2201692国;CYHS2201692倍他米松磷酸钠注射液重庆华邦制药有限公司3CYHS2201703国;CYHS2201703帕拉米韦注射液福安药业集团烟台只楚药业有限公司3CYHS2201738国;CYHS2201738盐酸多巴胺注射液通合生物医药(山东)有限公司3CYHS2201817国;CYHS2201817重酒石酸间羟胺注射液海南天盛保和生物科技有限公司3CYHS2202126国;CYHS2202126盐酸多巴酚丁胺注射液北京布霖生物科技有限公司3CYHS2300097盐酸多巴酚丁胺注射液华夏生生药业(北京)有限公司3CYHS2300094盐酸肾上腺素注射液海南倍特药业有限公司3CYHS2300192法莫替丁注射液重庆药谷制药有限公司3CYHS2300234盐酸倍他司汀片森淼(山东)药业有限公司3CYHS2300349盐酸右美托咪定注射液山西远扬医药科技有限公司3CYHS2300625复方磷酸盐颗粒嘉实(湖南)医药科技有限公司3CYHS2301310中性腹膜透析液(碳酸氢盐-G4.25)芜湖道润药业有限责任公司3CYHS2201647国;CYHS2201647中性腹膜透析液(碳酸氢盐-G2.5)芜湖道润药业有限责任公司3CYHS2201646国;CYHS2201646中性腹膜透析液(碳酸氢盐-G1.5)芜湖道润药业有限责任公司3CYHS2201644国;CYHS2201644中性低钙腹膜透析液(碳酸氢盐-G2.5)芜湖道润药业有限责任公司3CYHS2201642国;CYHS2201642盐酸利多卡因局部溶液成都慧德医药科技有限公司3CYHS2301936恩曲他滨丙酚替诺福韦片石家庄龙泽制药股份有限公司4CYHS2202116国;CYHS2202116氨氯地平阿托伐他汀钙片昆山龙灯瑞迪制药有限公司4CYHS2300338低钙腹膜透析液(乳酸盐-G4.25)上海长征富民金山制药有限公司4CYHS2300883低钙腹膜透析液(乳酸盐-G2.5)上海长征富民金山制药有限公司4CYHS2300882低钙腹膜透析液(乳酸盐-G1.5)上海长征富民金山制药有限公司4CYHS2300881沙库巴曲缬沙坦钠片南京正大天晴制药有限公司4CYHS2101755国;CYHS2101755沙库巴曲缬沙坦钠片南京正大天晴制药有限公司4CYHS2101754国;CYHS2101754沙库巴曲缬沙坦钠片南京正大天晴制药有限公司4CYHS2101753国;CYHS2101753塞来昔布胶囊北京世桥生物制药有限公司4CYHS2200718国;CYHS2200718钆特醇注射液正大天晴药业集团股份有限公司4CYHS2200913国;CYHS2200913富马酸伏诺拉生片重庆华森制药股份有限公司4CYHS2200908国;CYHS2200908富马酸伏诺拉生片重庆华森制药股份有限公司4CYHS2200907国;CYHS2200907富马酸丙酚替诺福韦片南京海辰药业股份有限公司4CYHS2201237国;CYHS2201237地诺孕素片西安太极药业有限公司4CYHS2201323国;CYHS2201323溴芬酸钠滴眼液中山万汉制药有限公司4CYHS2201340国;CYHS2201340盐酸雷洛昔芬片重庆圣华曦药业股份有限公司4CYHS2201439国;CYHS2201439溴芬酸钠滴眼液中山万汉制药有限公司4CYHS2201616国;CYHS2201616左卡尼汀注射液华中药业股份有限公司4CYHS2201640国;CYHS2201640左卡尼汀注射液华中药业股份有限公司4CYHS2201639国;CYHS2201639缬沙坦氨氯地平片(I)长春海悦药业股份有限公司4CYHS2201717国;CYHS2201717注射用哌拉西林钠他唑巴坦钠江苏睿实生物科技有限公司4CYHS2201726国;CYHS2201726注射用哌拉西林钠他唑巴坦钠江苏睿实生物科技有限公司4CYHS2201725国;CYHS2201725盐酸乌拉地尔注射液吉林省辉南长龙生化药业股份有限公司4CYHS2201822国;CYHS2201822盐酸乌拉地尔注射液吉林省辉南长龙生化药业股份有限公司4CYHS2201821国;CYHS2201821奥拉帕利片杭州中美华东制药有限公司4CYHS2201855国;CYHS2201855奥拉帕利片杭州中美华东制药有限公司4CYHS2201854国;CYHS2201854溴莫尼定噻吗洛尔滴眼液艾尔健康眼药(辽宁)有限公司4CYHS2201864国;CYHS2201864丙酸氟替卡松雾化吸入用混悬液上海新黄河制药有限公司4CYHS2201885国;CYHS2201885枸橼酸西地那非口腔崩解片南京长澳制药有限公司4CYHS2201886国;CYHS2201886盐酸莫西沙星滴眼液海南斯达制药有限公司4CYHS2201904国;CYHS2201904伏立康唑片武汉启瑞药业有限公司4CYHS2201916国;CYHS2201916伏立康唑片武汉启瑞药业有限公司4CYHS2201915国;CYHS2201915富马酸丙酚替诺福韦片江苏科本药业有限公司4CYHS2201936国;CYHS2201936氢溴酸伏硫西汀片山东京卫制药有限公司4CYHS2202031国;CYHS2202031盐酸乌拉地尔注射液湖南科伦制药有限公司4CYHS2202064国;CYHS2202064盐酸乌拉地尔注射液湖南科伦制药有限公司4CYHS2202065国;CYHS2202065棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202111国;CYHS2202111棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202110国;CYHS2202110棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202109国;CYHS2202109棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202108国;CYHS2202108棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202107国;CYHS2202107舒更葡糖钠注射液南京正大天晴制药有限公司4CYHS2202129国;CYHS2202129舒更葡糖钠注射液南京正大天晴制药有限公司4CYHS2202128国;CYHS2202128卡培他滨片江苏诚康药业有限公司4CYHS2202139国;CYHS2202139钆特酸葡胺注射液山东威智百科药业有限公司4CYHS2202160国;CYHS2202160钆特酸葡胺注射液山东威智百科药业有限公司4CYHS2202159国;CYHS2202159钆特酸葡胺注射液山东威智百科药业有限公司4CYHS2202158国;CYHS2202158注射用盐酸表柔比星浙江华海药业股份有限公司4CYHS2202149国;CYHS2202149马昔腾坦片上海旭东海普药业有限公司4CYHS2202176国;CYHS2202176碳酸镧咀嚼片江西施美药业股份有限公司4CYHS2300102左氧氟沙星滴眼液苏州弘森药业股份有限公司4CYHS2300098磷酸特地唑胺片桂林南药股份有限公司4CYHS2300180盐酸奥洛他定滴眼液国药集团三益药业(芜湖)有限公司4CYHS2300255他达拉非片新乡市常乐制药有限责任公司4CYHS2300274间苯三酚注射液湖南科伦制药有限公司4CYHS2300283富马酸比索洛尔片浙江京新药业股份有限公司4CYHS2300376富马酸比索洛尔片浙江京新药业股份有限公司4CYHS2300375沙美特罗替卡松吸入粉雾剂健康元药业集团股份有限公司4CYHS2300405注射用哌拉西林钠他唑巴坦钠成都倍特药业股份有限公司4CYHS2300450注射用哌拉西林钠他唑巴坦钠成都倍特药业股份有限公司4CYHS2300449注射用哌拉西林钠他唑巴坦钠成都倍特药业股份有限公司4CYHS2300448吸入用硫酸沙丁胺醇溶液浙江百代医药科技有限公司4CYHS2300508恩格列净片宁波大红鹰药业股份有限公司4CYHS2300601注射用头孢他啶阿维巴坦钠山东百诺医药股份有限公司4CYHS2300703阿卡波糖片成都恒瑞制药有限公司4CYHS2300702多巴丝肼片北京福元医药股份有限公司4CYHS2300742格列齐特缓释片浙江京新药业股份有限公司4CYHS2301097阿伐替尼片基石药业(苏州)有限公司4CYHS2301700奥美沙坦酯氨氯地平片郑州韩都药业集团有限公司4CYHS2301875氧九龙气体河北有限公司4CYHS2302089氧辉县市广福贸易有限公司4CYHS2302128氧香格里拉藏龙纯净氧气体有限公司4CYHS2302226盐酸特比萘芬乳膏齐鲁制药(海南)有限公司4CYHS2301721头孢托仑匹酯颗粒海南葫芦娃药业集团股份有限公司4CYHS2401101头孢托仑匹酯颗粒海南葫芦娃药业集团股份有限公司4CYHS2401100西甲硅油乳剂成都诺和晟鸿生物制药有限公司4CYHS2401170富马酸喹硫平片Dr. Reddy's Laboratories Ltd.5.2JYHS2101007国;JYHS2101007富马酸喹硫平片Dr. Reddy's Laboratories Ltd.5.2JYHS2101006国;JYHS2101006富马酸喹硫平片Dr. Reddy's Laboratories Ltd.5.2JYHS2101005国;JYHS2101005 进口申请药品名称企业注册分类受理号高血糖素鼻用粉雾剂Eli Lilly and Company5.1JXHS2200063国;JXHS2200063依伏卡塞片Kyowa Kirin Co., Ltd.5.1JXHS2200069国;JXHS2200069依伏卡塞片Kyowa Kirin Co., Ltd.5.1JXHS2200068国;JXHS2200068地舒单抗注射液Amgen Europe B.V.3.1JXSS2300031Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400070Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400069Golcadomide胶囊Celgene Corporation1JXHL2400084Golcadomide胶囊Celgene Corporation1JXHL2400083Golcadomide胶囊Celgene Corporation1JXHL2400082PF-07264660注射液Pfizer Inc.1JXSL2400066PF-07275315注射液Pfizer Inc.1JXSL2400065CID-103注射液CASI Pharmaceuticals, Inc.1JXSL2400067 中药相关申请无注：橙色字体部分结论为不批准或收到通知件；

申请上市临床申请

2024-06-03

·信狐药迅

仿制药申请6个品规发通知件；临床申请品种均默示许可| 新获批（5.27-6.2）

每周药品注册获批数据，分门别类呈现，一目了然。(5.27-6.2）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依沃西单抗注射液康方赛诺医药有限公司1CXSS2300061地舒单抗注射液山东博安生物技术股份有限公司3.3CXSS2300014精蛋白锌赖脯胰岛素混合注射液(50R)江苏万邦生化医药集团有限责任公司3.3CXSS2200071国;CXSS2200071人凝血酶原复合物深圳市卫光生物制品股份有限公司3.4CXSS2200091国;CXSS2200091新药临床申请药品名称企业注册分类受理号盐酸杰克替尼片苏州泽璟生物制药股份有限公司1CXHL2400298盐酸杰克替尼片苏州泽璟生物制药股份有限公司1CXHL2400297盐酸希美替尼片中国科学院上海药物研究所1CXHL2400288D-1553片益方生物科技(上海)股份有限公司1CXHL2400287ABP1618片上海爱博医药科技有限公司1CXHL2400285ABP1618片上海爱博医药科技有限公司1CXHL2400284FC084CSA片中山医诺维申新药研发有限公司1CXHL2400283FC084CSA片中山医诺维申新药研发有限公司1CXHL2400282替古索司他片信达生物制药(苏州)有限公司1CXHL2400278替古索司他片信达生物制药(苏州)有限公司1CXHL2400277替古索司他片信达生物制药(苏州)有限公司1CXHL2400276盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2400295盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2400294盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2400293吸入用盐酸溴己新溶液江苏正大清江制药有限公司3CYHL2400062吸入用盐酸溴己新溶液江苏正大清江制药有限公司3CYHL2400061酒石酸匹莫范色林胶囊江苏艾立康医药科技有限公司3CYHL2400060拉米地坦片江苏恩华药业股份有限公司3CYHL2400059拉米地坦片江苏恩华药业股份有限公司3CYHL2400058氟比洛芬凝胶贴膏浙江百代医药科技有限公司4CYHL2400057注射用重组酰化胰高血糖素样肽2类似物重庆派金生物科技有限公司1CXSL2400204注射用DB-1305映恩生物制药(苏州)有限公司1CXSL2400196DP303c注射液石药集团巨石生物制药有限公司1CXSL2400195DP303c注射液石药集团巨石生物制药有限公司1CXSL2400194贝伐珠单抗注射液百奥泰生物制药股份有限公司2.2CXSL2400202贝伐珠单抗注射液百奥泰生物制药股份有限公司2.2CXSL2400201仿制药申请药品名称企业注册分类受理号阿瑞匹坦注射液江苏康禾生物制药有限公司3CYHS2302273盐酸丙美卡因滴眼液合肥立方制药股份有限公司3CYHS2301650注射用拉氧头孢钠江苏江丰医药科技有限公司3CYHS2300871左氧氟沙星注射液河北天成药业股份有限公司3CYHS2300402左氧氟沙星注射液河北天成药业股份有限公司3CYHS2300401注射用青霉素钠成都天之翼尚品医药科技有限公司3CYHS2300019国;CYHS2300019注射用青霉素钠成都天之翼尚品医药科技有限公司3CYHS2300018国;CYHS2300018注射用青霉素钠成都天之翼尚品医药科技有限公司3CYHS2300017国;CYHS2300017左氧氟沙星注射液国仁健康制药(北京)有限公司3CYHS2202080国;CYHS2202080醋酸维持液南京恩泰医药科技有限公司3CYHS2201921国;CYHS2201921醋酸维持液南京恩泰医药科技有限公司3CYHS2201920国;CYHS2201920地氯雷他定口服溶液锦州奥鸿药业有限责任公司3CYHS2201876盐酸氨溴索滴剂北京民康百草医药科技有限公司3CYHS2201643国;CYHS2201643阿立哌唑口服溶液沈阳天邦药业有限公司3CYHS2201311国;CYHS2201311铝碳酸镁混悬液浙江寰领医药科技有限公司3CYHS2201322国;CYHS2201322奥硝唑片福安药业集团烟台只楚药业有限公司3CYHS2201100国;CYHS2201100多种微量元素注射液(I)洋浦京泰药业有限公司3CYHS2200906国;CYHS2200906阿立哌唑口腔崩解片瑞阳制药股份有限公司3CYHS2200439国;CYHS2200439吸入用布地奈德混悬液艾特美(苏州)医药科技有限公司4CYHS2302443氧武汉润桦辉氧气气瓶检验有限责任公司4CYHS2301933普拉洛芬滴眼液广东华南药业集团有限公司4CYHS2300908多索茶碱注射液山东鲁抗医药集团赛特有限责任公司4CYHS2300616硝酸异山梨酯注射液山东新时代药业有限公司4CYHS2300442马昔腾坦片上海上药睿尔药品有限公司4CYHS2300472乙酰半胱氨酸颗粒河北龙海药业有限公司4CYHS2300348骨化三醇软胶囊四川科伦药业股份有限公司4CYHS2300302乙酰半胱氨酸颗粒四川海梦智森生物制药有限公司4CYHS2300251乙酰半胱氨酸颗粒四川海梦智森生物制药有限公司4CYHS2300250拉考沙胺注射液舒美奇成都生物科技有限公司4CYHS2300206拉考沙胺注射液舒美奇成都生物科技有限公司4CYHS2300205盐酸多柔比星脂质体注射液齐鲁制药(海南)有限公司4CYHS2300202盐酸多柔比星脂质体注射液齐鲁制药(海南)有限公司4CYHS2300201他达拉非片江西施美药业股份有限公司4CYHS2300217他达拉非片江西施美药业股份有限公司4CYHS2300216他达拉非片江西施美药业股份有限公司4CYHS2300215他克莫司颗粒杭州中美华东制药有限公司4CYHS2300146他达拉非片浙江康恩贝制药股份有限公司4CYHS2300061依折麦布片山东丹红制药有限公司4CYHS2300031国;CYHS2300031吡仑帕奈片江苏康缘药业股份有限公司4CYHS2202172国;CYHS2202172吡仑帕奈片江苏康缘药业股份有限公司4CYHS2202171国;CYHS2202171硫酸羟氯喹片苏州长征-欣凯制药有限公司4CYHS2202067国;CYHS2202067恩他卡朋片福建省宝诺医药研发有限公司4CYHS2202051国;CYHS2202051磷酸特地唑胺片齐鲁制药(海南)有限公司4CYHS2202036国;CYHS2202036间苯三酚注射液亚宝药业集团股份有限公司4CYHS2202024国;CYHS2202024他达拉非片好医生药业集团有限公司4CYHS2202010国;CYHS2202010卡贝缩宫素注射液海南中和药业股份有限公司4CYHS2201993国;CYHS2201993非布司他片涿州东乐制药有限公司4CYHS2201938国;CYHS2201938孟鲁司特钠颗粒山东华铂凯盛生物科技有限公司4CYHS2201928国;CYHS2201928甲磺酸雷沙吉兰片浙江华海药业股份有限公司4CYHS2201914国;CYHS2201914马来酸茚达特罗吸入粉雾剂健康元药业集团股份有限公司4CYHS2201835国;CYHS2201835注射用唑来膦酸浓溶液山东新时代药业有限公司4CYHS2201794国;CYHS2201794盐酸昂丹司琼注射液石家庄四药有限公司4CYHS2201678国;CYHS2201678盐酸昂丹司琼注射液石家庄四药有限公司4CYHS2201677国;CYHS2201677盐酸奥洛他定滴眼液艾尔健康眼药(辽宁)有限公司4CYHS2201628国;CYHS2201628醋酸加尼瑞克注射液深圳翰宇药业股份有限公司4CYHS2201612国;CYHS2201612酒石酸溴莫尼定滴眼液艾尔健康眼药(辽宁)有限公司4CYHS2201598国;CYHS2201598甲钴胺片浙江京新药业股份有限公司4CYHS2201586国;CYHS2201586西格列汀二甲双胍片(II)惠升生物制药股份有限公司4CYHS2201496国;CYHS2201496西格列汀二甲双胍片(I)惠升生物制药股份有限公司4CYHS2201495国;CYHS2201495注射用氯诺昔康知和(山东)大药厂有限公司4CYHS2201438国;CYHS2201438枸橼酸坦度螺酮片江苏百奥信康医药科技有限公司4CYHS2201415国;CYHS2201415熊去氧胆酸胶囊绍兴来多科技有限公司4CYHS2201412国;CYHS2201412盐酸莫西沙星滴眼液广州仁恒医药科技股份有限公司4CYHS2201299国;CYHS2201299注射用哌拉西林钠他唑巴坦钠福安药业集团庆余堂制药有限公司4CYHS2201229国;CYHS2201229注射用哌拉西林钠他唑巴坦钠福安药业集团庆余堂制药有限公司4CYHS2201228国;CYHS2201228注射用哌拉西林钠他唑巴坦钠福安药业集团庆余堂制药有限公司4CYHS2201226国;CYHS2201226头孢地尼胶囊海南日中天制药有限公司4CYHS2201279国;CYHS2201279酒石酸美托洛尔片翎耀生物科技(上海)有限公司4CYHS2201191国;CYHS2201191酒石酸美托洛尔片翎耀生物科技(上海)有限公司4CYHS2201190国;CYHS2201190碳酸镧咀嚼片仁合益康集团有限公司4CYHS2201134国;CYHS2201134碳酸镧咀嚼片仁合益康集团有限公司4CYHS2201133国;CYHS2201133盐酸达泊西汀片瑞阳制药股份有限公司4CYHS2201132国;CYHS2201132盐酸达泊西汀片瑞阳制药股份有限公司4CYHS2201131国;CYHS2201131吡仑帕奈片西安远大科创医药科技有限公司4CYHS2201092吡仑帕奈片西安远大科创医药科技有限公司4CYHS2201091头孢克洛干混悬剂苏州第三制药厂有限责任公司4CYHS2200891国;CYHS2200891缬沙坦氨氯地平片(Ⅰ)宁波科尔康美诺华药业有限公司4CYHS2200835国;CYHS2200835钆贝葡胺注射液上海司太立制药有限公司4CYHS2200367国;CYHS2200367丙酸氟替卡松雾化吸入用混悬液上海方予健康医药科技有限公司4CYHS2200372国;CYHS2200372甲钴胺片北京春风药业有限公司4CYHS2102249国;CYHS2102249进口申请药品名称企业注册分类受理号盐酸替洛利生片Bioprojet Pharma5.1JXHS2300058盐酸替洛利生片Bioprojet Pharma5.1JXHS2300057醋酸氟氢可的松片ASPEN PHARMA TRADING LIMITED5.1JXHS2300033依西美坦片Cipla Ltd.5.2JYHS2200048国;JYHS2200048达格列净片M/s Cipla Ltd.5.2JYHS2101019国;JYHS2101019Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400064Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400063TAR-210Janssen Research & Development, LLC2.2;2.4JXHL2400065呼吸道合胞病毒减毒活疫苗Sanofi Pasteur Inc.1.1JXSL2400058MK-7240注射用浓溶液Merck Sharp & Dohme LLC1JXSL2400063MK-7240注射液Merck Sharp & Dohme LLC1JXSL2400062BudigalimabAbbVie Inc.1JXSL2400061中药相关申请药品名称企业注册分类受理号柴桂解感颗粒山东中医药大学1.1CXZL2400016温肺定喘颗粒山东康众宏医药科技开发有限公司1.1CXZL2400015注：橙色字体部分结论为不批准或收到通知件；

申请上市临床申请生物类似药

2024-06-01

·GlobeNewswire-Health Care

Y-mAbs Announces Publication of Preclinical GD2-SADA Data at 2024 ASCO Annual Meeting

NEW YORK, June 01, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced the publication of preclinical GD2-SADA data at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 31 through June 4, 2024, in Chicago, IL. The published abstract titled “Preclinical characterization of pretargeted radioimmunotherapy with GD2-SADA, a self-assembling and disassembling bispecific fusion protein” characterizes the binding properties of GD2-SADA across several GD2-expressing cell lines and lanthanide metal-DOTA complexes, while also demonstrating its anti-tumor efficacy when used with Lutetium 177 (Lu177)-DOTA in a two-step approach to pretargeted radioimmunotherapy (“PRIT”). In this analysis, GD2-SADA showed tight binding to cell lines expressing GD2, a glycolipid implicated in the malignant transformation of multiple solid tumors. GD2-SADA binding was significantly improved by a p53-derived domain that drives the self-assembly and disassembly (“SADA”) of GD2-SADA tetramers, which possess four distinct GD2-binding domains that cumulatively enhance binding. Previous studies have shown that the unbound GD2-SADA protein disassembles over time, facilitating clearance by the kidneys. “We believe that these data further validate GD2-SADA's promise as a novel targeted radioimmunotherapy and support the continued advancement of our SADA PRIT technology platform and clinical programs,” said Vignesh Rajah, MBBS, DCH, MRCP (UK), Chief Medical Officer. The analysis further demonstrated high-affinity binding of GD2-SADA to DOTA complexes chelated with lutetium and lanthanum, among other lanthanide metals. By contrast, GD2-SADA showed negligible binding to trace metal-DOTA complexes or empty DOTA, an important consideration for the targeted delivery of the radioactive payload in patients. “We are especially encouraged by the selective binding of GD2-SADA to lanthanide metal-DOTA complexes with current and emerging applications in the diagnosis and targeted treatment of solid tumors,” said Brian H. Santich, Ph.D., the lead author and co-inventor of the SADA PRIT technology platform. Taken together, the binding properties of the GD2-SADA protein provide a pharmacological basis for the robust and dose-responsive anti-tumor effects of GD2-SADA Lu177 PRIT in vivo, also presented in this seminal research. These findings have paved the way for the clinical development of GD2-SADA PRIT in adults and adolescents with GD2-positive tumors (NCT05130255). Y-mAbs will be available for comment at booth #35151 on the Exhibition Floor of McCormick Place. Researchers at MSK, including Dr. Nai-Kong Cheung, developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs. Dr. Cheung has intellectual property rights and interests in the technology, and as a result of this licensing arrangement, MSK has institutional financial interests in the technology. About Y-mAbs Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, radioimmunotherapy and antibody-based therapeutic cancer products. The Company’s technologies include its investigational Self-Assembly DisAssembly (“SADA”) Pretargeted Radioimmunotherapy Platform (“PRIT”) and bispecific antibodies generated using the Y-BiClone platform. The Company’s broad and advanced product pipeline includes the anti-GD2 therapy DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after a partial response, minor response, or stable disease to prior therapy. Forward-Looking StatementsStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, statements about our business model, including financial outlook for 2023 and beyond, including estimated operating expenses, cash burn and DANYELZA product revenue and sufficiency of cash resources and related assumptions; implied and express statements regarding the future of the Company’s business, including with respect to expansion and its goals; the Company’s plans and strategies, development, commercialization and product distribution plans, including potential partnerships; expectations with respect to the Company’s products and product candidates, including potential territory and label expansion of DANYELZA and the potential market opportunity related thereto and potential benefits thereof, and the potential of the SADA Technology and potential benefits and applications thereof; statements with respect to DANYELZA as a growing commercial product and SADA as a differentiated radioimmunotherapy platform positioning the Company on a path to potentially transform the treatment paradigm for a variety of cancers and improve patients’ lives; expectations relating to key anticipated development milestones, including potential expansion of international commercialization efforts with respect to DANYELZA development efforts and the SADA Technology, including potential indications and applications, and the timing thereof; expectations with respect to current and future clinical and pre-clinical studies and the Company’s research and development programs, including with respect to timing and results; expectations related to the timing of the initiation and completion of regulatory submissions; additional product candidates and technologies; expectations regarding collaborations or strategic partnerships and the potential benefits thereof; expectations related to the use of cash and cash equivalents, and the need for, timing and amount of any future financing transaction; expectations with respect to the Company’s future financial performance; and other statements that are not historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “will”, ‘‘would’’, “guidance,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company’s financial condition and need for additional capital; the risks that actual results of the Company’s restructuring plan and revised business plan will not be as expected; risks associated with the Company’s development work; cost and success of the Company’s product development activities and clinical trials; the risks of delay in the timing of the Company’s regulatory submissions or failure to receive approval of its drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of product candidates; development of sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for products; the risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture; the Company’s inability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of the Company’s intellectual property rights; risks related to employee matters and managing growth; risks related to the Company’s common stock, risks associated with macroeconomic conditions, including the conflict between Russia and Ukraine and sanctions related thereto, the state of war between Israel and Hamas and the related risk of a larger regional conflict, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 and future filings and reports by the Company. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. DANYELZA® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc. Investor Contact:Courtney DuganVP, Head of Investor Relationscdu@ymabs.com

免疫疗法引进/卖出ASCO会议上市批准临床研究

100 项与碳酸镧相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04667	碳酸镧	V03AE03	DB06792

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
高磷血症	日本	Bayer Yakuhin Ltd.	2008-10-16
终末期肾脏病	美国	Takeda Pharmaceuticals U.S.A., Inc.	2004-10-26

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性肾病	临床3期	日本	Bayer AG	2010-06-01
慢性肾病，V期	临床3期	美国	Shire Plc	2007-01-05
慢性肾病，V期	临床3期	德国	Shire Plc	2007-01-05
慢性肾病，V期	临床3期	波多黎各	Shire Plc	2007-01-05
慢性肾病，V期	临床3期	英国	Shire Plc	2007-01-05
钙化防御	临床1期	美国	Shire Plc	2011-02-01

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临床结果

适应症

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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


NCT03136705 (CTgov)	临床1期	-	39	Lanthanum Carbonate+Nicotinamide (Lanthanum + Nicotinamide)	蓋壓繭衊築獵醖襯齋衊(壓憲衊餘醖壓壓壓鬱構) = 簾憲衊顧夢憲鹹廠獵積衊獵憲選衊製窪製膚願 (衊鬱膚淵顧膚觸憲艱憲, 襯壓鹹簾蓋觸鑰鬱製壓 ~ 齋糧襯選築鑰鏇衊鹹夢) 更多	-	2024-02-23
				Lanthanum Carbonate+Nicotinamide Placebo (Lanthanum + Nicotinamide Placebo)	蓋壓繭衊築獵醖襯齋衊(壓憲衊餘醖壓壓壓鬱構) = 網鏇壓壓簾繭夢淵糧鹹衊獵憲選衊製窪製膚願 (衊鬱膚淵顧膚觸憲艱憲, 醖醖繭襯積醖構鏇淵壓 ~ 範築膚齋願鬱鏇觸廠鏇) 更多
NCT02209636 (ASN ‘21 PO-0543, ASN2022)	临床4期	慢性肾病	15	Lanthanum Carbonate	鏇觸齋憲壓鹹夢壓齋製(構艱鬱鑰網醖願蓋蓋鏇) = 壓淵醖憲選鹽蓋窪齋獵膚築觸選糧遞鹹製鬱窪 (壓衊鹹艱鹽製艱餘夢餘 )	不佳	2022-11-05
				Placebo	鏇觸齋憲壓鹹夢壓齋製(構艱鬱鑰網醖願蓋蓋鏇) = 醖廠襯製選糧淵願構製膚築觸選糧遞鹹製鬱窪 (壓衊鹹艱鹽製艱餘夢餘 )
NCT02209636 (ASN2021)	临床4期	慢性肾病	15	Lanthanum Carbonate	觸網鹽築構構鑰觸鑰鬱(鑰淵顧艱獵夢鬱憲積觸) = 製夢鹹顧簾鹹積繭築憲廠遞願遞獵獵糧餘製齋 (鏇艱鬱蓋廠積鬱餘壓簾 )	积极	2021-10-27
				Placebo	觸網鹽築構構鑰觸鑰鬱(鑰淵顧艱獵夢鬱憲積觸) = 廠鏇憲餘獵鬱廠獵觸衊廠遞願遞獵獵糧餘製齋 (鏇艱鬱蓋廠積鬱餘壓簾 )
NCT02258074 (COMBINE \| CKD Optimal Management with Binders and Nicotinamide (COMBINE), CTgov)	临床2期	慢性肾病	205	Lanthanum Carbonate+Nicotinamide (Lanthanum Carbonate + Nicotinamide)	餘範衊廠觸廠襯製顧窪(糧膚繭壓觸繭壓顧選範) = 膚蓋選壓憲積鹹蓋網糧蓋廠獵簾選淵鏇製餘範 (觸膚衊壓膚鑰鏇製夢鹽, 淵鹽積網餘廠鹽鏇襯艱 ~ 艱遞襯遞願積願齋網網) 更多	-	2021-07-30
				Lanthanum Carbonate+Placebo (for Nicotinamide) (Lanthanum Carbonate + Nicotinamide Placebo)	餘範衊廠觸廠襯製顧窪(糧膚繭壓觸繭壓顧選範) = 壓築鏇鹹築襯鹹壓顧鏇蓋廠獵簾選淵鏇製餘範 (觸膚衊壓膚鑰鏇製夢鹽, 鬱鏇遞蓋襯鑰遞壓膚鹽 ~ 壓窪鏇範艱艱遞遞夢廠) 更多
ASN2020	N/A	慢性肾病 serum phosphate concentrations	205	Lanthanum Carbonate	餘醖壓憲觸蓋廠願窪願(鬱顧鑰簾鑰膚艱鬱構襯) = 蓋構鑰壓鬱鑰夢夢夢夢獵蓋簾鹽膚鹹壓築壓遞 (範鹽醖夢顧網鹹繭糧鑰, 1 ~ 9)	不佳	2020-10-19
NCT01696279 (CTgov)	临床2期	高磷血症 \| 慢性肾病	63	lanthanum carbonate (Part 2 + Part 3: Lanthanum Carbonate)	顧壓齋獵鹹廠鏇齋壓簾(繭鹽夢積鹹鏇憲廠簾鬱) = 顧構顧網窪顧夢淵構夢窪夢簾齋製壓襯網觸鹹 (襯構廠遞獵齋繭糧餘構, 鑰鏇壓鏇憲餘顧蓋選鏇 ~ 醖餘鹹膚遞選糧窪築艱) 更多	-	2020-01-02
				calcium carbonate (Part 2: Calcium Carbonate)	觸艱廠襯艱憲鑰繭襯遞(構襯選窪觸窪窪齋襯遞) = 遞糧積淵製醖積衊夢夢艱壓鬱膚鏇鏇淵範廠憲 (糧壓繭築鑰顧夢觸選築, 網構構積鑰廠積衊構憲 ~ 顧製醖廠襯艱廠積餘醖) 更多
SP611 (ERA2019)	N/A	维持	71	Lanthanum Carbonate	鹹顧遞願遞蓋範鏇鑰膚(衊膚糧膚鑰鏇遞鏇糧夢) = 鹹觸壓繭醖選築顧範鑰艱構襯襯遞鏇襯鹽鹽鹹 (糧獵壓醖範衊簾醖構窪 )	积极	2019-06-13
				Ferric Citrate Hydrate	鹹顧遞願遞蓋範鏇鑰膚(衊膚糧膚鑰鏇遞鏇糧夢) = 醖廠顧製蓋餘醖選蓋鹹艱構襯襯遞鏇襯鹽鹽鹹 (糧獵壓醖範衊簾醖構窪 )
COMBINE Trial (ASN2018)	N/A	FGF23 \| PTH \| FEPI ... 更多	205	Lanthanum Carbonate	壓構遞壓糧夢簾窪餘壓(簾製鏇鹹齋顧鏇廠顧鏇) = 餘膚觸鑰糧淵齋選顧鑰衊網壓淵繭膚膚鹽願襯 (製網製築鹽鑰網願窪鏇, -24.2 ~ -3.7) 更多	积极	2018-10-23
NCT01845090 (Pubmed \| Pediatr Int)	临床4期	-	46	Lanthanum carbonate	壓廠蓋糧衊遞憲艱築選(憲膚夢夢窪構窪鹹鹹鏇) = 範製選蓋鏇襯積鹽範顧淵窪壓範獵衊齋糧夢製 (鹹顧範鑰壓膚築齋廠壓 )	-	2017-10-01
NCT00567723 (SP347, ERA2017)	N/A	终末期肾脏病	2,136	Lanthanum carbonate (LaC)	壓鏇壓鬱遞築鬱鹹網鬱(遞構醖鏇遞製夢構醖繭) = 淵築鬱鏇構窪願夢積觸糧製襯蓋餘鏇餘網壓衊 (鹹選鹹願鹹遞窪選積廠 ) 更多	积极	2017-05-26
				Comparator group (other phosphate binder)	壓鏇壓鬱遞築鬱鹹網鬱(遞構醖鏇遞製夢構醖繭) = 襯製獵網網齋襯淵選鏇糧製襯蓋餘鏇餘網壓衊 (鹹選鹹願鹹遞窪選積廠 ) 更多