The goal of this clinical trial is to learn the plasma concentration of isavuconazole in pediatric patients. It will also learn about the relationship of isavuconazole plasma concentrations to efficacy and safety in pediatric patients. The main questions it aims to answer are:
What is the plasma concentration after using isavuconazole in pediatric patients? What is the effective range of plasma concentration of isavuconazole in pediatric patients? What is the safe range of plasma concentration of isavuconazole in pediatric patients? Researchers will measure the plasma concentration of isavuconazole to see whether it is appropriate.
Participants will:
Take drug isavuconazole as prescribed by the doctor;
1mL of blood is drawn 30min before the next dose.

开始日期2024-07-01

申办/合作机构

上海儿童医学中心

CTR20240351 / CompletedN/A

评估受试制剂硫酸艾沙康唑胶囊（规格：以艾沙康唑计100 mg）与参比制剂硫酸艾沙康唑胶囊（CRESEMBA®）（规格：以艾沙康唑计100 mg）在健康成年参与者餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验

主要试验目的：研究餐后状态下单次口服受试制剂硫酸艾沙康唑胶囊（规格：以艾沙康唑计100 mg，江苏宣泰药业有限公司生产）与参比制剂硫酸艾沙康唑胶囊（CRESEMBA®，规格：以艾沙康唑计100 mg；Swiss Co Services AG生产）在健康参与者体内的药代动力学特征，评价餐后状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂硫酸艾沙康唑胶囊（规格：以艾沙康唑计100 mg）和参比制剂硫酸艾沙康唑胶囊（CRESEMBA®）（规格：以艾沙康唑计100 mg）在健康参与者中的安全性。

开始日期2024-02-20

申办/合作机构

江苏宣泰药业有限公司

CTR20234168 / Active, not recruitingN/A

硫酸艾沙康唑胶囊在健康成年受试者中的单中心、随机、开放、两周期、两制剂、双交叉、空腹及餐后单次给药生物等效性试验

主要目的：考察空腹及餐后条件下单次口服受试制剂硫酸艾沙康唑胶囊（规格：100 mg（按C22H17F2N5OS计））与参比制剂硫酸艾沙康唑胶囊（商品名：CRESEMBA®，规格：100 mg（按C22H17F2N5OS计））在健康受试者体内的药代动力学特征，评价空腹及餐后条件下口服两种制剂的生物等效性。次要目的：考察受试制剂硫酸艾沙康唑胶囊和参比制剂硫酸艾沙康唑胶囊（CRESEMBA®）在健康受试者中的安全性。

开始日期2024-01-09

申办/合作机构

江西国药有限责任公司

100 项与硫酸艾沙康唑鎓相关的临床结果

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100 项与硫酸艾沙康唑鎓相关的转化医学

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100 项与硫酸艾沙康唑鎓相关的专利（医药）

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项与硫酸艾沙康唑鎓相关的文献（医药）

2024-06-01·Artificial intelligence chemistry

Machine learning models to predict ligand binding affinity for the orexin 1 receptor

Article

作者: O'Connor, Shayna L ; James, Morgan H ; Welsh, William J ; Zhang, Vanessa Y

The orexin 1 receptor (OX1R) is a G-protein coupled receptor that regulates a variety of physiological processes through interactions with the neuropeptides orexin A and B. Selective OX1R antagonists exhibit therapeutic effects in preclinical models of several behavioral disorders, including drug seeking and overeating. However, currently there are no selective OX1R antagonists approved for clinical use, fueling demand for novel compounds that act at this target. In this study, we meticulously curated a dataset comprising over 1300 OX1R ligands using a stringent filter and criteria cascade. Subsequently, we developed highly predictive quantitative structure-activity relationship (QSAR) models employing the optimized hyper-parameters for the random forest machine learning algorithm and twelve 2D molecular descriptors selected by recursive feature elimination with a 5-fold cross-validation process. The predictive capacity of the QSAR model was further assessed using an external test set and enrichment study, confirming its high predictivity. The practical applicability of our final QSAR model was demonstrated through virtual screening of the DrugBank database. This revealed two FDA-approved drugs (isavuconazole and cabozantinib) as potential OX1R ligands, confirmed by radiolabeled OX1R binding assays. To our best knowledge, this study represents the first report of highly predictive QSAR models on a large comprehensive dataset of diverse OX1R ligands, which should prove useful for the discovery and design of new compounds targeting this receptor.

2024-05-01·Annales pharmaceutiques francaises

ANTIFON-CLIC®, a new clinical decision support system for the treatment of invasive aspergillosis: is it clinically relevant?

Article

作者: Chapuis, C ; Kahale, E ; Maucort-Boulch, D ; Bourget, S ; Duréault, A ; Pavese, P ; Dode, X ; Leray, V ; Roux, S ; Ghesquières, H ; Leboucher, G ; Bienvenu, A-L ; Guichon, C ; Subtil, F ; Talbot, F ; Chaabane, W

BACKGROUND:

Invasive aspergillosis (IA) is increasing especially in new groups of patients. Despite advances in management, morbidity and mortality related to IA remain high. Thus, Clinical Decision Support System (CDSS) dedicated to IA are needed to promote the optimal antifungal for each group of patients.

PATIENTS AND METHODS:

This was a retrospective multicenter cohort study involving intensive care units and medical units. Adult patients who received caspofungin, isavuconazole, itraconazole, liposomal amphotericin B, posaconazole, or voriconazole, for the treatment of IA were eligible for enrollment. The primary objective was the concordance between the clinician's prescription and the prescription recommended by the CDSS. The secondary objective was the concordance according to different hospitals, departments, and indications.

RESULTS:

Eighty-eight patients (n=88) from three medical hospitals were included. The overall concordance was 97% (85/88) including 100% (41/41) for center A, 92% (23/25) for center B, and 95% (21/22) for center C. There was no significant difference in concordance among the hospitals (P=0.973), the departments (P=1.000), and the indications (P=0.799). The concordance was 70% (7/10) for isavuconazole due to its use as an empirical treatment and 100% (78/78) for the other antifungals.

DISCUSSION:

The concordance rate was high whatever the hospital, the department, and the indication. The only discrepancy was attributed to the use of isavuconazole as an empirical treatment which is a therapeutic option not included in the CDSS.

CONCLUSIONS:

This new CDSS dedicated to IA is meeting the clinical practice. Its implementation in routine will help to support antifungal stewardship.

2024-02-01·Journal of chromatography. A

Facile room-temperature synthesis of a spherical mesoporous covalent organic framework for capillary electrochromatography

Article

作者: Li, Zhentao ; Liao, Zhengzheng ; Chen, Zilin ; Hu, Jinfang ; Ding, Xiaoru

Herein, a spherical covalent organic framework COF TAPB-DMTP was facilely synthesized from 2,5-dimethoxyterephthalaldehyde (DMTP) and 1,3,5-tri-(4-aminophenyl)benzene (TAPB) as monomers. COF TAPB-DMTP with regular mesoporous and excellent mass transfer ability was first introduced into the capillary and immobilized on the inner wall of the capillary through a simple in situ growth method. Through various characterization results, COF TAPB-DMTP was successfully prepared and modified onto the capillary inner wall. The separation performance and potential of COF TAPB-DMTP modified capillary column was explored. The new developed COF modified column achieved a highly efficiency and selective separation between analytes with different properties, including halogeno benzenes, alkylbenzenes, phenols and sulfonamides. Satisfactory stability and reproducibility were observed on COF TAPB-DMTP modified columns. The intraday, interday and three batch columns relative standard deviations were all less than 1.85 % for the retention time. The separation performance of prepared column has no significant change after 90 continuous runs. Additionally, the COF TAPB-DMTP modified capillary column was successfully used for separation and detection of triazole antifungal drugs in human plasma, and the recoveries of three antifungal drugs (fluconazole, isavuconazole and posaconazole) in spiked samples were in the range of 98.6-100.8 %, 92.4-102.1 % and 99.9-107.5 %, respectively. This self-made column showed excellent application potential in chromatography separation science.

项与硫酸艾沙康唑鎓相关的新闻（医药）

2024-06-24

·信狐药迅

长春澜江苯海拉明布洛芬和住友制药来法莫林注射用浓溶液等潜在首仿提交上市申请|新受理（6.17-6.23）

本周药品注册受理数据，分门别类呈现，一目了然。(6.17-6.23）新药上市申请无新药临床申请药品名称企业注册分类受理号CVL237片甫康(上海)健康科技有限责任公司1CXHL2400623TQC3721吸入粉雾剂正大天晴药业集团股份有限公司1CXHL2400625TQC3721吸入粉雾剂正大天晴药业集团股份有限公司1CXHL2400624HS-10502片江苏豪森药业集团有限公司1CXHL2400620HS-10502片江苏豪森药业集团有限公司1CXHL2400619RG002C0106注射液北京炫景瑞医药科技有限公司1CXHL2400617177Lu-TR0471注射液通瑞生物制药(成都)有限公司1CXHL2400616吸入用LH-1901江苏联环药业股份有限公司1CXHL2400615吸入用LH-1901江苏联环药业股份有限公司1CXHL2400614HRS9950片成都盛迪医药有限公司1CXHL2400611HRS9950片成都盛迪医药有限公司1CXHL2400610HRS-5635注射液福建盛迪医药有限公司1CXHL2400609PG-033片北京普祺医药科技股份有限公司1CXHL2400607PG-033片北京普祺医药科技股份有限公司1CXHL2400606TY751注射液天津药物研究院有限公司1CXHL2400605注射用醋酸曲普瑞林缓释微球南京恒生制药有限公司2.2CXHL2400621ZP036华润紫竹药业有限公司2.2CXHL2400618JW202313吸入粉雾剂山东京卫制药有限公司2.2CXHL2400613HCD干混悬剂浙江圣博康药业有限公司2.2CXHL2400612HY22005I片长春海悦药业股份有限公司2.2CXHL2400608BCM476胶囊上海云晟研新生物科技有限公司2.3CXHL2400622盐酸卡利拉嗪胶囊成都奥邦药业有限公司3CYHL2400125盐酸卡利拉嗪胶囊成都奥邦药业有限公司3CYHL2400124盐酸米诺环素泡沫剂山西振东安欣生物制药有限公司3CYHL2400123盐酸米诺环素泡沫剂山西振东安欣生物制药有限公司3CYHL2400122去氧胆酸注射液北京藏卫信康医药研发有限公司3CYHL2400121立他司特滴眼液浙江莎普爱思药业股份有限公司3CYHL2400120氟[18F]妥司特注射液北京先通国际医药科技股份有限公司3CYHL2400119布立西坦片辰欣药业股份有限公司3CYHL2400118布立西坦片辰欣药业股份有限公司3CYHL2400117布立西坦片辰欣药业股份有限公司3CYHL2400116盐酸卡利拉嗪胶囊武汉人福药业有限责任公司3CYHL2400115盐酸卡利拉嗪胶囊武汉人福药业有限责任公司3CYHL2400114去氧胆酸注射液北京诺博特生物科技有限公司3CYHL2400113SCTV04C注射液神州细胞工程有限公司1.2CXSL2400397SCTV04C注射液神州细胞工程有限公司1.2CXSL2400396注射用SSGJ-709沈阳三生制药有限责任公司1CXSL2400408注射用HS-20093上海翰森生物医药科技有限公司1CXSL2400406注射用HS-20089上海翰森生物医药科技有限公司1CXSL2400407AK135注射液中山康方生物医药有限公司1CXSL2400405CS01单抗注射液中山恒动生物制药有限公司1CXSL2400402TQB2825注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400404TQB2825注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400403VUM02注射液武汉光谷中源药业有限公司1CXSL2400401RJMty19注射液浙江瑞加美生物科技有限公司1CXSL2400400MG-K10人源化单抗注射液上海麦济生物技术有限公司1CXSL2400399SYSA1801注射液石药集团巨石生物制药有限公司1CXSL2400395注射用重组A型肉毒毒素苏州迪新宸科生物科技有限公司2.4CXSL2400398 仿制药申请药品名称企业注册分类受理号阿达帕林过氧苯甲酰凝胶苏州高迈药业有限公司3CYHS2401869间苯三酚口腔崩解片河北汇德旭盛医药科技有限公司3CYHS2401867恩格列净二甲双胍缓释片浙江昂利康制药股份有限公司3CYHS2401866吡格列酮二甲双胍片浙江江北药业有限公司3CYHS2401853注射用青霉素钠辽宁省连科药业有限公司3CYHS2401852注射用青霉素钠辽宁省连科药业有限公司3CYHS2401851注射用青霉素钠辽宁省连科药业有限公司3CYHS2401850注射用磷霉素钠广州艾奇西新药研究有限公司3CYHS2401849注射用磷霉素钠广州艾奇西新药研究有限公司3CYHS2401848重酒石酸卡巴拉汀口服液上海美优制药有限公司3CYHS2401833注射用拉氧头孢钠山东宜和生物医药科技有限公司3CYHS2401826富马酸酮替芬滴眼液成都普什制药有限公司3CYHS2401825西格列汀二甲双胍缓释片广东东阳光药业股份有限公司3CYHS2401819盐酸甲氧氯普胺注射液江苏瑜兴医药科技有限公司3CYHS2401815枸橼酸苯海拉明布洛芬片长春澜江医药科技有限公司3CYHS2401813西格列汀二甲双胍缓释片常州制药厂有限公司3CYHS2401812阿仑膦酸钠口服溶液广州一品红制药有限公司3CYHS2401811马来酸曲美布汀片浙江华海药业股份有限公司3CYHS2401822他达拉非片迪沙药业集团有限公司4CYHS2401871他达拉非片迪沙药业集团有限公司4CYHS2401870非诺贝特胶囊江苏德源药业股份有限公司4CYHS2401868伊班膦酸钠注射液上海旭东海普药业有限公司4CYHS2401865伊班膦酸钠注射液上海旭东海普药业有限公司4CYHS2401864伊班膦酸钠注射液上海旭东海普药业有限公司4CYHS2401863硫酸氨基葡萄糖胶囊安徽九洲方圆制药有限公司4CYHS2401862聚多卡醇注射液成都市海通药业有限公司4CYHS2401861聚多卡醇注射液成都市海通药业有限公司4CYHS2401860聚多卡醇注射液成都市海通药业有限公司4CYHS2401859波生坦分散片华润双鹤利民药业(济南)有限公司4CYHS2401858地屈孕酮片浙江爱生药业有限公司4CYHS2401857氧(液态)河北舜广联合气体有限公司4CYHS2401856蛋白琥珀酸铁口服溶液四川海梦智森生物制药有限公司4CYHS2401855左卡尼汀注射液成都市海通药业有限公司4CYHS2401854比索洛尔氨氯地平片华益药业科技(安徽)有限公司4CYHS2401847注射用头孢唑肟钠南京恩泰医药科技有限公司4CYHS2401846乳果糖口服溶液南京海纳制药有限公司4CYHS2401845硫酸氨基葡萄糖胶囊合肥康惠医药技术有限公司4CYHS2401844乳果糖口服溶液南京海纳制药有限公司4CYHS2401843他氟前列素滴眼液海南斯达制药有限公司4CYHS2401842比索洛尔氨氯地平片华润赛科药业有限责任公司4CYHS2401841盐酸奥洛他定滴眼液江西马应龙美康药业有限公司4CYHS2401840注射用亚胺培南西司他丁钠深圳华药南方制药有限公司4CYHS2401839泊沙康唑注射液山东新时代药业有限公司4CYHS2401838依折麦布辛伐他汀片北京百奥药业有限责任公司4CYHS2401837马来酸氟伏沙明片重庆赛维药业有限公司4CYHS2401836马来酸氟伏沙明片重庆赛维药业有限公司4CYHS2401835硫酸镁钠钾口服用浓溶液浙江百代医药科技有限公司4CYHS2401834沙格列汀二甲双胍缓释片(III)平光制药股份有限公司4CYHS2401832沙格列汀二甲双胍缓释片(I)平光制药股份有限公司4CYHS2401831左卡尼汀口服溶液岳阳新华达制药有限公司4CYHS2401830亚叶酸钙注射液西藏海金药业有限公司4CYHS2401829左卡尼汀口服溶液海南卓科制药有限公司4CYHS2401828左卡尼汀口服溶液江苏盈科生物制药有限公司4CYHS2401827注射用硫酸艾沙康唑成都天台山制药股份有限公司4CYHS2401824吸入用布地奈德混悬液艾特美(苏州)医药科技有限公司4CYHS2401818醋酸来法莫林注射用浓溶液住友制药(苏州)有限公司4CYHS2401817盐酸尼卡地平注射液浙江沣华医药科技有限公司4CYHS2401816二甲双胍恩格列净片(I)北京圣永制药有限公司4CYHS2401814碘美普尔注射液北京北陆药业股份有限公司4CYHS240181010%脂肪乳(OO)/5.5%氨基酸(15)/葡萄糖(20%)注射液四川科伦药业股份有限公司4CYHS2401823阿法骨化醇软胶囊东海制药(河北)有限公司4CYHS2401821注射用尼可地尔山东新华鲁抗医药有限公司4CYHS2401820精氨酸布洛芬片海南先声药业有限公司4CYHS2401809注射用重组人促甲状腺激素苏州泽璟生物制药股份有限公司3.2CXSS2400060 进口申请药品名称企业注册分类受理号甲磺酸奥希替尼片AstraZeneca AB2.4JXHS2400042甲磺酸奥希替尼片AstraZeneca AB2.4JXHS2400041司库奇尤单抗注射液Novartis Pharma Schweiz AG3.1JXSS2400048注射用坦昔妥单抗Incyte Biosciences Distribution B.V.3.1JXSS2400050司库奇尤单抗注射液Novartis Pharma Schweiz AG3.1JXSS2400049BRII-835 (VIR-2218) 注射液Brii Biosciences Limited1JXHL2400142奥贝胆酸(OCA)Intercept Pharmaceuticals, Inc.2.4JXHL2400144奥贝胆酸(OCA)Intercept Pharmaceuticals, Inc.2.4JXHL2400143BRII-179注射液Brii Biosciences Limited1JXSL2400115贝利尤单抗注射液GlaxoSmithKline (Ireland) Limited2.2JXSL2400116注射用戈沙妥珠单抗Gilead Sciences, Inc.2.2JXSL2400114 中药相关申请药品名称企业注册分类受理号白脉软膏西藏奇正藏药股份有限公司2.3CXZL2400034 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

2024-06-20

·BioSpace

Basilea partners oncology drug candidate lisavanbulin with Glioblastoma Foundation

Allschwil, Switzerland, June 20, 2024 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has entered into an asset purchase agreement with the Glioblastoma Foundation Inc., for Basilea’s oncology drug candidate lisavanbulin (BAL101553), which has been developed as a potential therapy for glioblastoma, the most common type of primary brain cancer.1 Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “Glioblastoma is one of the most lethal types of brain cancer and available therapeutic options are very limited. Partnering lisavanbulin with the Glioblastoma Foundation is important to us, as it enables patients to continue having access to this promising anticancer drug candidate, now that Basilea has changed its strategic focus to anti-infectives.” Dr. Gita Kwatra, Chief Executive Officer of the Glioblastoma Foundation, said: “We are delighted to partner with Basilea and take over the development of lisavanbulin for glioblastoma patients. Lisavanbulin has shown excellent activity against glioblastoma in PDX preclinical models as well as efficacy in phase 1 and 2 studies. We strongly believe that lisavanbulin will be effective in a subset of glioblastoma patients and we are looking forward to initiating clinical trials of lisavanbulin in the US.” Under the terms of the agreement, Basilea sells and transfers all rights to lisavanbulin to the Glioblastoma Foundation for an undisclosed initial purchase price. In addition, Basilea will participate in future proceeds from any potential commercial partnerships at a fixed double-digit percentage. The Glioblastoma Foundation will continue the post-trial access program for patients from previous clinical studies to continue to receive lisavanbulin. Also, the Glioblastoma Foundation will further explore the therapeutic value of lisavanbulin for the treatment of glioblastoma. About lisavanbulin (BAL101553) Lisavanbulin (BAL101553, the prodrug of BAL27862)2, has been investigated as a potential therapy for glioblastoma in clinical phase 1 and 2 studies.3, 4, 5 In preclinical studies, lisavanbulin demonstrated in-vitro and in-vivo activity against diverse treatment-resistant cancer models, including tumors refractory to conventional approved therapeutics and radiotherapy.6, 7, 8 Lisavanbulin efficiently distributes to the brain, with anticancer activity in glioblastoma models.9, 10 The active moiety, BAL27862, binds to the colchicine site of tubulin, with distinct effects on microtubule organization,11 resulting in the activation of the "spindle assembly checkpoint" which promotes tumor cell death.12 Lisavanbulin has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of malignant glioma (brain cancer), including glioblastoma. About Glioblastoma Foundation The mission of the Glioblastoma Foundation is to transform the standard of care for glioblastoma. It is based in Durham, North Carolina (USA) and supports the development of new drugs and other effective therapies for glioblastoma. Because each glioblastoma is different, it is likely that no one drug will work for everyone, and any therapies for glioblastoma will need to be targeted. The Glioblastoma Foundation supports the development of targeted therapies for glioblastoma. The organization also provides support for patients, and raises awareness of glioblastoma. For more information, please visit glioblastomafoundation.org. About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor Relations Basilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b 4123 Allschwil Switzerland Phone +41 61 606 1102 E-mail media_relations@basilea.com investor_relations@basilea.com This press release can be downloaded from . References B. M. Alexander, T. F. Cloughesy. Adult Glioblastoma. Journal of Clinical Oncology 2017 (35), 2402-2409 J. Pohlmann, F. Bachmann, A. Schmitt-Hoffmann et al. BAL101553: An optimized prodrug of the microtubule destabilizer BAL27862 with superior antitumor activity. Cancer Research 2011, 71 (8 supplement), abstract 1347 ClinicalTrials.gov identifier: NCT03250299 ClinicalTrials.gov identifier: NCT02895360; M. Joerger, T. Hundsberger, S. Haefliger et al. Safety and anti-tumor activity of lisavanbulin administered as 48-hour infusion in patients with ovarian cancer or recurrent glioblastoma: a phase 2a study. Investigational New Drugs 2023 (41), 267-275 ClinicalTrials.gov identifier: NCT02490800; J. S. Lopez, S. Häfliger, R. Plummer et al. Evaluation of response-predictive biomarkers for lisavanbulin: A phase II study in patients with recurrent glioblastoma. ESMO Open 2023, Vol 8, 1, Suppl 2, 100941. A. Sharma, A. Broggini-Tenzer, V. Vuong et al. The novel microtubule targeting agent BAL101553 in combination with radiotherapy in treatment-refractory tumor models. Radiotherapy Oncology 2017 (124), 433-438 G. E. Duran, H. Lane, F. Bachmann et al. In vitro activity of the novel tubulin active agent BAL27862 in MDR1(+) and MDR1(-) human breast and ovarian cancer variants selected for resistance to taxanes. Cancer Research 2010, 70 (8 supplement), abstract 4412 F. Bachmann, K. Burger, G. E. Duran et al. BAL101553 (prodrug of BAL27862): A unique microtubule destabilizer active against drug refractory breast cancers alone and in combination with trastuzumab. Cancer Research 2014, 74 (19 supplement), abstract 831 A. Schmitt-Hoffmann, D. Klauer, K. Gebhardt et al. BAL27862: a unique microtubule-targeted agent with a potential for the treatment of human brain tumors. Molecular Cancer Therapeutics 2009, 8 (12 supplement), C233 A. C. Mladek, J. L. Pokorny, H. Lane et al. The novel tubulin-binding 'tumor checkpoint controller' BAL101553 has anti-cancer activity alone and in combination treatments across a panel of GBM patient-derived xenografts. Cancer Research 2016, 76 (14 supplement), abstract 4781 A. E. Prota, F. Danel, F. Bachmann et al. The novel microtubule-destabilizing drug BAL27862 binds to the colchicine site of tubulin with distinct effects on microtubule organization. Journal of Molecular Biology 2014 (426), 1848-1860 F. Bachmann, K. Burger, H. Lane. BAL101553 (prodrug of BAL27862): the spindle assembly checkpoint is required for anticancer activity. Cancer Research 2015, 75 (15 supplement), abstract 3789 Press release (PDF)

孤儿药临床1期引进/卖出临床2期临床结果

2024-06-11

·信狐药迅

百济神州优先品种 HER2双抗泽尼达妥单抗提交上市申请|新受理（6.3-6.10）

本周药品注册受理数据，分门别类呈现，一目了然。(6.3-6.10）新药上市申请药品名称企业注册分类受理号复迈替尼片上海复星医药产业发展有限公司1CXHS2400049复迈替尼片上海复星医药产业发展有限公司1CXHS2400048注射用泽尼达妥单抗百济神州(苏州)生物科技有限公司1CXSS2400056司普奇拜单抗注射液成都康诺行生物医药科技有限公司1CXSS2400055 新药临床申请药品名称企业注册分类受理号HZ-L105片杭州和正医药有限公司1CXHL2400582HZ-L105片杭州和正医药有限公司1CXHL2400581HZ-L105片杭州和正医药有限公司1CXHL2400580K-13片上海懿峰生物科技有限公司1CXHL2400579K-13片上海懿峰生物科技有限公司1CXHL2400578K-13片上海懿峰生物科技有限公司1CXHL2400577FP-208片北京富龙康泰生物技术有限公司1CXHL2400573FP-208片北京富龙康泰生物技术有限公司1CXHL2400572K-13片上海懿峰生物科技有限公司1CXHL2400571K-13片上海懿峰生物科技有限公司1CXHL2400570K-13片上海懿峰生物科技有限公司1CXHL2400569ZG-002片上海致根医药科技有限公司1CXHL2400568ZG-002片上海致根医药科技有限公司1CXHL2400567RP903片君实润佳(上海)医药科技有限公司1CXHL2400566RP903片君实润佳(上海)医药科技有限公司1CXHL2400565SIM0508片上海先祥医药科技有限公司1CXHL2400564SIM0508片上海先祥医药科技有限公司1CXHL2400563BGC515胶囊苏州桥济生物科技有限公司1CXHL2400562BGC515胶囊苏州桥济生物科技有限公司1CXHL2400561BGC515胶囊苏州桥济生物科技有限公司1CXHL2400560TLL-041片杭州高光制药有限公司1CXHL2400559TLL-041片杭州高光制药有限公司1CXHL2400558TLL-041片杭州高光制药有限公司1CXHL2400557注射用SC-102天津星联肽生物科技有限公司1CXHL2400556DAT-2645片北京丹擎医药科技有限公司1CXHL2400555DAT-2645片北京丹擎医药科技有限公司1CXHL2400554甘露醇山梨醇注射液石家庄四药有限公司3CYHL2400104注射用多黏菌素E甲磺酸钠健康元海滨药业有限公司3CYHL2400103PG-F01凝胶北京普祺医药科技股份有限公司2.2;2.4CXHL2400576PG-F01凝胶北京普祺医药科技股份有限公司2.2;2.4CXHL2400575PG-F01凝胶北京普祺医药科技股份有限公司2.2;2.4CXHL2400574四价重组诺如病毒疫苗(汉逊酵母)华北制药金坦生物技术股份有限公司1.1CXSL2400368四价重组诺如病毒疫苗(汉逊酵母)华北制药金坦生物技术股份有限公司1.1CXSL2400367流感病毒亚单位疫苗江苏中慧元通生物科技股份有限公司3.3CXSL2400370PreS1胶束注射液(冻干)普瑞斯万(武汉)生物科技有限公司1CXSL2400372CC312冻干粉针剂惠和生物技术(上海)有限公司1CXSL2400366GKL-006注射液北京基因启明生物科技有限公司1CXSL2400364外用红色诺卡氏菌细胞壁骨架辽宁天安生物制药股份有限公司2.2CXSL2400369门冬胰岛素30注射液宁波鲲鹏生物科技有限公司3.3CXSL2400365人凝血酶原复合物四川远大蜀阳药业有限责任公司3.4CXSL2400371注射用重组A型肉毒毒素君合盟生物制药(通化)有限公司2.2;2.4CXSL2400373 仿制药申请药品名称企业注册分类受理号ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液福建盛迪医药有限公司3CYHS2401726地奈德乳膏杭州民生药业股份有限公司3CYHS2401736草酸艾司西酞普兰口服溶液江苏长泰药业股份有限公司3CYHS2401733舒必利注射液海南卓科制药有限公司3CYHS2401731舒必利注射液海南卓科制药有限公司3CYHS2401730甲硫酸新斯的明注射液河北一品制药股份有限公司3CYHS2401728重酒石酸卡巴拉汀口服液广州一品红制药有限公司3CYHS2401727苯磺酸氨氯地平口腔崩解片广东万泰科创药业有限公司3CYHS2401715吸入用盐酸丙卡特罗溶液石家庄四药有限公司3CYHS2401717氨磺必利口服溶液宏越科技(湖州)有限公司3CYHS2401713盐酸丙卡特罗口服溶液黑龙江澳利达奈德制药有限公司3CYHS2401710盐酸丙卡特罗口服溶液黑龙江澳利达奈德制药有限公司3CYHS2401709盐酸甲氧氯普胺注射液嘉实(湖南)医药科技有限公司3CYHS2401705吸入用盐酸丙卡特罗溶液浙江福瑞喜药业有限公司3CYHS2401723吸入用盐酸丙卡特罗溶液浙江福瑞喜药业有限公司3CYHS2401722烟酸缓释片北京世桥生物制药有限公司3CYHS2401697盐酸异丙肾上腺素注射液华夏生生药业(北京)有限公司3CYHS2401694马来酸氯苯那敏注射液江苏瑜兴医药科技有限公司3CYHS2401692丙戊酸钠注射用浓溶液广州市联瑞制药有限公司3CYHS2401704注射用硫酸多黏菌素B健康元药业集团股份有限公司3CYHS2401700乙酰半胱氨酸注射液江苏迪赛诺制药有限公司3CYHS2401681左氧氟沙星注射液辰欣药业股份有限公司3CYHS2401672氨溴特罗口服溶液国药控股星鲨制药(厦门)有限公司3CYHS2401667腺苷钴胺胶囊浙江昂利康制药股份有限公司3CYHS2401689盐酸拉贝洛尔注射液遂成药业股份有限公司3CYHS2401686盐酸拉贝洛尔注射液遂成药业股份有限公司3CYHS2401684复方磺胺甲噁唑注射液华夏生生药业(北京)有限公司3CYHS2401671维生素B6注射液宝利化(南京)制药有限公司3CYHS2401674硫酸沙丁胺醇注射液湖北民康药业集团有限公司3CYHS2401659药用炭胶囊海南烨徽源医药科技有限公司3CYHS2401658硫酸沙丁胺醇口服溶液浙江凯润药业股份有限公司3CYHS2401657氯化钾口服溶液安徽茂康药业有限公司3CYHS2401656吸入用盐酸氨溴索溶液济南景笙科技有限公司3CYHS2401655氯化钾口服溶液遂成药业股份有限公司3CYHS2401653重酒石酸去甲肾上腺素注射液遂成药业股份有限公司3CYHS2401652硫酸氨基葡萄糖胶囊吉林道君药业股份有限公司4CYHS2401740艾地骨化醇软胶囊山东简道制药有限公司4CYHS2401739艾地骨化醇软胶囊山东简道制药有限公司4CYHS2401738甲硝唑凝胶合肥启旸生物医药科技有限公司4CYHS2401737克立硼罗软膏山东辰欣佛都药业股份有限公司4CYHS2401735注射用硫酸艾沙康唑合肥亿帆生物制药有限公司4CYHS2401734富马酸伏诺拉生片南京正科医药股份有限公司4CYHS2401732富马酸伏诺拉生片南京正科医药股份有限公司4CYHS2401729恩格列净片佑华医药科技有限公司4CYHS2401721恩格列净片佑华医药科技有限公司4CYHS2401720盐酸伊立替康注射液连云港众维生物医药有限公司4CYHS2401719盐酸伊立替康注射液连云港众维生物医药有限公司4CYHS2401718氟康唑氯化钠注射液哈尔滨三联药业股份有限公司4CYHS2401716尼可地尔片重庆莱美药业股份有限公司4CYHS2401714聚乙二醇钠钾散湖南华纳大药厂股份有限公司4CYHS2401712注射用头孢唑肟钠南京赛瑞谱顿制药有限公司4CYHS2401711盐酸尼卡地平注射液广东君康药业有限公司4CYHS2401707乳果糖口服溶液江苏广承药业有限公司4CYHS2401706注射用头孢他啶阿维巴坦钠海南葫芦娃药业集团股份有限公司4CYHS2401725盐酸纳呋拉啡口腔崩解片郑州泰丰制药有限公司4CYHS2401724注射用硫酸艾沙康唑海南广升誉制药有限公司4CYHS2401708甲氨蝶呤注射液海南卓泰制药有限公司4CYHS2401699甲氨蝶呤注射液海南卓泰制药有限公司4CYHS2401698精氨酸培哚普利片江西施美药业股份有限公司4CYHS2401696精氨酸培哚普利片江西施美药业股份有限公司4CYHS2401695熊去氧胆酸胶囊贵州瑞和制药有限公司4CYHS2401693盐酸达泊西汀片河北万岁药业有限公司4CYHS2401703盐酸达泊西汀片河北万岁药业有限公司4CYHS2401702多索茶碱注射液云南药科院生物医药股份有限公司4CYHS2401701硫酸氢氯吡格雷片重庆药友制药有限责任公司4CYHS2401683那屈肝素钙注射液华北制药华坤河北生物技术有限公司4CYHS2401677艾考糊精腹膜透析液青岛瑞奈医疗科技有限公司4CYHS2401682盐酸西替利嗪片上海强生制药有限公司4CYHS2401676硫酸镁钠钾口服用浓溶液广州合和医药有限公司4CYHS2401675丙酸氯倍他索搽剂江苏知原药业股份有限公司4CYHS2401668蒙脱石散海南斯达制药有限公司4CYHS2401688罗沙司他胶囊湖南埃威格林医药科技有限公司4CYHS2401680罗沙司他胶囊湖南埃威格林医药科技有限公司4CYHS2401679巴瑞替尼片杭州民生药业股份有限公司4CYHS2401678尼可地尔片本溪匠成医药科技有限公司4CYHS2401673依折麦布阿托伐他汀钙片(I)成都倍特药业股份有限公司4CYHS2401670依折麦布阿托伐他汀钙片(II)成都倍特药业股份有限公司4CYHS2401669盐酸尼卡地平注射液河南润弘制药股份有限公司4CYHS2401690氢溴酸伏硫西汀片宁波大红鹰药业股份有限公司4CYHS2401687氢溴酸伏硫西汀片宁波大红鹰药业股份有限公司4CYHS2401685注射用硫酸艾沙康唑广州一品红制药有限公司4CYHS2401691富马酸依美斯汀滴眼液广州仁恒医药科技股份有限公司4CYHS2401666碳酸司维拉姆片浙江昂利康制药股份有限公司4CYHS2401665沙库巴曲缬沙坦钠片江苏利泰尔药业有限公司4CYHS2401664沙库巴曲缬沙坦钠片江苏利泰尔药业有限公司4CYHS2401663间苯三酚注射液杭州和泽坤元药业有限公司4CYHS2401662巴瑞替尼片南京海纳制药有限公司4CYHS2401661莫匹罗星软膏浙江赛默制药有限公司4CYHS2401660注射用替加环素北京融英医药科技有限公司4CYHS2401654 进口申请药品名称企业注册分类受理号伊那利塞片Roche Pharma (Schweiz) AG1JXHS2400038伊那利塞片Roche Pharma (Schweiz) AG1JXHS2400037盐酸匹美西林片Karo Pharma AB5.1JXHS2400040盐酸匹美西林片Karo Pharma AB5.1JXHS2400039利生奇珠单抗注射液AbbVie Inc.2.2JXSS2400047利生奇珠单抗注射液(皮下注射)AbbVie Inc.2.2JXSS2400046利生奇珠单抗注射液(皮下注射)AbbVie Inc.2.2JXSS2400045Bexotegrast片Pliant Therapeutics, Inc.1JXHL2400126Upadacitinib口服溶液AbbVie Inc.2.2JXHL2400131Upadacitinib口服溶液AbbVie Inc.2.2JXHL2400130Upadacitinib片AbbVie Inc.2.4JXHL2400129Upadacitinib片AbbVie Inc.2.4JXHL2400128Upadacitinib片AbbVie Inc.2.4JXHL2400127RO7200220 注射液F. Hoffmann-La Roche Ltd.1JXSL2400112RO7200220 注射液F. Hoffmann-La Roche Ltd.1JXSL2400111Amlitelimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400108注射用AZD7798AstraZeneca AB1JXSL2400110Amlitelimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400109 中药相关申请药品名称企业注册分类受理号升陷颗粒吉林敖东洮南药业股份有限公司3.1CXZS2400020三七通舒胶囊成都神鹤药业有限责任公司4CYZS2400002 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

100 项与硫酸艾沙康唑鎓相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10643	硫酸艾沙康唑鎓	G01AG J02AC	DB06636

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
隐球菌病	日本	Asahi Kasei Pharma Corp.	2022-12-23
曲霉菌病	中国	Pfizer Inc.	2021-12-31
侵袭性曲霉菌病	美国	Astellas Pharma US, Inc.	2015-03-06
毛霉菌病	美国	Astellas Pharma US, Inc.	2015-03-06

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
侵袭性真菌感染	申请上市	日本	Asahi Kasei Corp.	2022-01-30
深部真菌病	临床3期	日本	Asahi Kasei Pharma Corp.	2018-04-16
念珠菌血症	临床3期	美国	Astellas Pharma, Inc.	2007-03-08
念珠菌血症	临床3期	中国	Astellas Pharma, Inc.	2007-03-08
念珠菌血症	临床3期	阿根廷	Astellas Pharma, Inc.	2007-03-08
念珠菌血症	临床3期	澳大利亚	Astellas Pharma, Inc.	2007-03-08
念珠菌血症	临床3期	比利时	Astellas Pharma, Inc.	2007-03-08
念珠菌血症	临床3期	巴西	Astellas Pharma, Inc.	2007-03-08
念珠菌血症	临床3期	加拿大	Astellas Pharma, Inc.	2007-03-08
念珠菌血症	临床3期	智利	Astellas Pharma, Inc.	2007-03-08

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03816176 (CTgov)	临床2期	侵袭性曲霉菌病 \| 毛霉菌病	31	Isavuconazonium sulfate	淵襯襯襯網築壓醖獵醖(遞窪鏇窪製窪顧憲襯壓) = 選憲醖顧願獵憲餘鬱窪夢醖夢鑰鏇膚觸鬱鹽獵 (廠齋選鹹選鏇鏇鹽齋窪, 餘壓觸淵構艱艱鹽衊淵 ~ 鬱廠蓋蓋遞衊膚構鹽蓋) 更多	-	2023-09-21
EBMT2023	N/A	造血干细胞移植	50	Isavuconazole	鬱憲夢鏇願衊鏇夢醖簾(醖鑰衊憲簾淵願積簾衊) = No adverse events related to ISA were reported 廠糧網獵製遞憲鹹選鬱 (醖夢糧鏇網顧鹹窪獵襯 )	-	2023-04-23
ASN2022	N/A	低钠血症	-	Isavuconazonium sulfate	鏇鏇製艱顧餘構夢範鹽(積蓋膚衊餘鑰壓網顧範) = Isavuconazonium sulfate was discontinued for severe hyponatremia and patient was initiated on intravenous voriconazole. SNa progressively improved to 134 mmol/L, 10 days after discontinuation of isavuconazonium sulfate. 網築壓餘襯憲衊獵構齋 (艱築淵鏇廠齋網網簾繭 )	-	2022-11-05
				Voriconazole
NCT03471988 (Pubmed)	临床3期	真菌病	103	Isavuconazole	鏇顧築積鬱憲願鹹糧蓋(衊鬱獵壓糧鏇鑰鏇壓構) = Adverse drug reactions were reported in 32 (61.5%) patients receiving isavuconazole and 23 (85.2%) patients receiving voriconazole 襯積襯積觸製獵衊襯糧 (糧蓋醖遞壓範壓獵壓鏇 ) 更多	积极	2022-10-25
				Voriconazole
EBMT2022	N/A	造血干细胞移植	166	Isavuconazole for treatment of IFI	蓋齋顧憲製製鏇築範鹽(網顧繭鹹憲製壓顧餘顧) = 淵鹹網網積蓋窪積淵鑰壓觸鹹網鏇積範糧獵衊 (艱簾鏇醖齋鏇餘壓齋鏇 ) 更多	-	2022-03-19
				Isavuconazole for off-label prophylaxis	蓋齋顧憲製製鏇築範鹽(網顧繭鹹憲製壓顧餘顧) = 製選鬱襯獵網顧淵襯窪壓觸鹹網鏇積範糧獵衊 (艱簾鏇醖齋鏇餘壓齋鏇 ) 更多
NCT03019939 (CTgov)	临床2期	急性髓性白血病 \| 中性粒细胞减少 \| 侵袭性真菌感染 ... 更多	65	Isavuconazole	夢壓構窪憲醖醖簾糧襯(簾鏇鑰蓋鹹齋繭艱選範) = 鏇餘範壓繭選鏇鬱範夢窪鹽醖衊鬱鹽繭繭艱蓋 (獵糧繭齋壓選遞獵鹹顧, 壓範膚醖簾獵襯壓積鏇 ~ 齋範鹹醖網鏇壓醖顧糧) 更多	-	2021-09-24
NCT03019939 (Pubmed \| Clin Infect Dis) 人工标引	临床2期	急性髓性白血病 \| 骨髓增生异常综合征	75	Isavuconazole	襯鏇齋鹽獵製築構窪簾(網醖糧醖醖廠獵積夢醖) = 積觸淵艱簾壓顧齋觸顧鹹醖艱簾鑰製餘醖選衊 (憲窪製築積鏇築憲蓋觸 )	积极	2021-05-18
				venetoclax+Isavuconazole	襯鏇齋鹽獵製築構窪簾(網醖糧醖醖廠獵積夢醖) = 繭艱鬱膚選簾艱觸艱繭鹹醖艱簾鑰製餘醖選衊 (憲窪製築積鏇築憲蓋觸 )
NCT03149055 (CTgov)	临床2期	血液肿瘤 \| 侵袭性真菌感染 \| 骨髓增生性疾病	99	Isavuconazole	夢鑰鑰鬱蓋遞襯鏇顧襯(範餘製鏇顧選構積選願) = 憲鹹願衊積窪淵淵夢築淵製觸齋構觸廠網獵艱 (廠齋窪餘構願糧糧夢淵, 餘積衊選獵繭簾艱窪選 ~ 壓鹽餘廠壓襯獵繭願窪) 更多	-	2020-08-20
EHA2020	N/A	造血干细胞移植	30	Isavuconazole	網齋膚網壓醖鬱膚糧網(齋醖夢襯醖齋醖網網淵) = 4 hepatic toxicity (1 grade 1, 2 grade 3, 1 grade 4), 1 VOD with hepatic failure and 1 case of pancytopenia 簾膚鏇齋製襯鬱糧淵膚 (壓衊積醖積觸淵範齋鏇 ) 更多	-	2020-05-14
NCT00413218 (ACTIVE, Pubmed \| Clin Infect Dis) 人工标引	临床3期	念珠菌病 \| 念珠菌血症	450	Isavuconazole	廠蓋餘選襯構積廠鹹鏇(齋鹹範製積選餘襯艱願) = 衊獵壓鏇鑰淵觸淵衊艱範衊遞窪壓鑰鏇廠鹹廠 (膚築選觸鹽夢衊鬱繭醖 )	不佳	2019-05-30
				voriconazole+caspofungin	廠蓋餘選襯構積廠鹹鏇(齋鹹範製積選餘襯艱願) = 構築憲觸鏇襯襯壓繭衊範衊遞窪壓鑰鏇廠鹹廠 (膚築選觸鹽夢衊鬱繭醖 )