This phase III trial compares the use of contrast-enhanced multiparametric ultrasound (mp-US) to multiparametric magnetic resonance imaging (mp-MRI) for the diagnosis of clinically significant prostate cancer (PCa). A mp-US is a procedure in which a probe that sends out high-energy sound waves is inserted into the rectum. The sound waves are bounced off internal tissues or organs and make echoes. The echoes form a picture of body tissue called a sonogram. Perflutren lipid michrosphere (Definity) is a contrast agent that uses microbubbles to enhance ultrasound images of the prostate. Doctors hope to learn if the Definity-enhanced mp-US imaging technique can accurately direct targeted biopsy for the detection of clinically significant prostate cancer when compared to standard of care mp-MRI.

开始日期2025-07-01

申办/合作机构

Thomas Jefferson University

[+3]

NCT06066723

/ RecruitingN/AIIT

A Cross-sectional Pilot Study of 19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease

This study capitalizes on the emerging technology of 19F MRI, using conventional 'thermally' polarized perfluorinated gas (perfluoropropane, or PFP) mixed with oxygen and studied with magnetic resonance imaging (MRI) to visualize ventilation. This technique has not been studied in children.
Children and adolescents (6-17 years old) with cystic fibrosis (CF) who have normal spirometry will undergo 19F MRI with the inhalation of an inert contrast gas to study ventilation. Comparisons will be made to a cohort of healthy children (6-17 years old) who will perform the same measures. The primary outcome measure is the feasibility of conducting these studies in the pediatric population. Parallel performance of multiple breath nitrogen washout (MBW) and spirometry will be used to compare the sensitivity of these outcomes to the presence of mild lung disease in these children. Finally, the investigators will compare data obtained during standard breath holds with a novel "free-breathing" technique that will eliminate the need for breath holds during MRI acquisition.

开始日期2025-05-01

申办/合作机构

The University of North Carolina at Chapel Hill

[+2]

NCT06797193

/ RecruitingN/AIIT

Invoking Subharmonics and Subharmonic Aided Pressure Estimation (SHAPE) for Identifying Portal Hypertension

This clinical trial tests the how well an ultrasound with subharmonic imaging and the subharmonic aided pressure estimation (SHAPE) technique works in identifying portal hypertension (PH). An ultrasound takes pictures of the inside of the body by bouncing sound waves off organs. PH is high blood pressure in the vein that carries blood to the liver from the stomach, small and large intestines, spleen, pancreas, and gallbladder. The complications associated with PH are clear only after severe liver dysfunction or liver cirrhosis develops and are accompanied by relatively high mortality rates (20-70% mortality within 2 years). Thus, identifying PH earlier is beneficial. The hepatic venous pressure gradient (HVPG) obtained using an invasive catheterization procedure remains the standard for assessing PH. However, using this invasive procedure to assess PH prevents frequent pressure monitoring. Thus, a noninvasive technique to estimate PH is beneficial not only for diagnosis but also for monitoring treatment and disease progression. The SHAPE technique is a noninvasive ultrasound-based imaging technique that can estimate pressure with an ultrasound contrast agent. A noninvasive technique using an ultrasound with subharmonic imaging and the SHAPE technique may work in identifying PH.

开始日期2025-03-13

申办/合作机构

Mayo Clinic

100 项与全氟丙烷脂质微球相关的临床结果

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100 项与全氟丙烷脂质微球相关的转化医学

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100 项与全氟丙烷脂质微球相关的专利（医药）

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2,320

项与全氟丙烷脂质微球相关的文献（医药）

2025-07-01·American Journal of Ophthalmology

Colour Doppler and Contrast-Enhanced Ultrasound Characteristics in Degenerative Retinoschisis and Retinal Detachment

Article

作者: Sammouh, Fady ; Lee, Yong Min ; Macri, Carmelo ; Lim, Wanyin ; LE, Matthew ; Paris, Jai ; Gun, Meegan ; Chan, Weng Onn

PURPOSETo investigate and compare the characteristics of colour Doppler ultrasound (CDUS) and contrast-enhanced ultrasound (CEUS) in degenerative retinoschisis (RS) and rhegmatogenous retinal detachment (RD).DESIGNProspective, observational case series.METHODSWe prospectively enrolled patients with degenerative RS, acute RD, or chronic RD at two tertiary centres from January 2024 to January 2025. Patients underwent clinical examination, ultrawide field photography and optical coherence tomography (OCT), and CDUS, followed by CEUS with Definity® microbubbles. Ultrasound characteristics between groups were compared.RESULTSWe included 65 eyes from 47 patients (25 male, median age 61.8). There were 51 eyes with RS, 6 eyes with acute RD, and 6 eyes with chronic RD. CDUS revealed no pre-contrast doppler flow in any RS, while all acute RD cases demonstrated doppler flow. CEUS displayed mild microbubble uptake in 18 RS cases (median bubble count of 2), whereas all RD cases exhibited florid uptake (median bubble count of 48.2). Compared to RS, acute RD cavities had significantly higher elevation from sclera (by 6.0 CI 2.8-9.2 mm), longer cavity lengths (by 9.8 CI 7.2-12.5), and greater membrane thickness (by 0.89 CI 0.6-1.2 mm). Chronic RD were significantly thicker than RS membranes (by 0.40 CI 0.2-0.6 mm) but were no longer or with greater elevation. Pixelated image analysis showed compared to RS, acute RD showed a higher average total particle count (by 45.83 units), larger particle size (by 66.3 pixels), and greater total particle area (by 3138 pixels). Chronic RD cases had mixed CDUS and CEUS findings.CONCLUSIONSCDUS features differentiating between degenerative RS and RD included the lack of doppler flow in RS, higher and longer cavities in acute RD, and thicker membranes in acute and chronic RD. CEUS features differentiating RS and RD included florid microbubble contrast enhancement in acute RD. These findings could aid in the investigation of cases with diagnostic uncertainty.

2025-06-01·Computational and Theoretical Chemistry

Electron and positron impact ionization cross sections of neutral molecular species dissociating from C4F7N and its mixtures

作者: Geetha, D. ; Gupta, Dhanoj

The electron and positron impact ionization cross sections are reported for neutral fragments originating from C4F7N and their mixture with air, CO₂, and N₂ using the Binary-Encounter Bethe (BEB) method and its variants, such as BEB-W and BEB-B.The neutral targets studied are HF, CO, CO₂, COF₂, CHF₃, CF₃, CF₄, C2F₄, C₂F₆, C₃F₆, C₃F₈, C₄F₆, C₄F₈, C₄F₁₀, CN, HCN, CFN, C₂N₂, C₂FN, C₂F₃N, C₃F₃N, C₃F₄N, C₃F₅N mols.The results for most of the targets for electron imapct ionization compare well with the available exptl. and theor. results.However, for most of the mols., the estimates of positron impact ionization are the first attempt.The correlation of the maximum ionization cross section for both electrons and positrons with the polarizability and the number of electrons of the target gave a good correlation fit.The cross section data presented in this article are important for C₄F₇N plasma.

2025-06-01·Fluid Phase Equilibria

Accurate calculation and reliable prediction of second virial coefficients for nonpolar mixtures

作者: Duan, Yuan-Yuan ; Qin, Kang ; Xu, Liu

The virial equation of state has a theor. advantage in the calculations of mixturesThe second mixture virial coefficients are with the theor. rigid mixing rules and composed of the second virial coefficients for pure fluids and the cross second virial coefficientsBased on the generalized corresponding state principle second virial coefficient model for pure fluids we proposed before, the generalized cross second virial coefficient models were established with three characteristic parameters for nonpolar binaries in this work.The calculation of the mixture critical temperature requires the binary interaction coefficients (k_ij).The mixture acentric factor was determined by the arithmetic mean.The mixture critical pressure could be calculated without the critical sp. volumeFor the most sensitive mixing rule of the mixture critical temperature, the k_ij was optimized for 145 nonpolar binaries.An easily accessible characteristic correlating parameter, the reduced diameter, was proposed to develop the predictive k_ij correlations for common nonpolar binaries.Due to the complex intermol. interactions between two different mols., the k_ij correlations were proposed resp. for alkane/alkane binaries, nonpolar binaries containing fluorocarbon, nonpolar binaries containing nitrogen or oxygen, nonpolar binaries containing simple fluids, nonpolar binaries containing carbon dioxide and nonpolar binaries containing neon.Our work was validated to perform satisfactorily from the comparison with the Chueh-Prausnitz k_ij correlation, Fender-Halsey k_ij correlation, and Meng k_ij correlation.Together with our previous work, this work could accurately calculate and reliably predict the second virial coefficients for common nonpolar mixtures

项与全氟丙烷脂质微球相关的新闻（医药）

2025-04-07

·信狐药迅

抗精神病改良新布瑞哌唑口溶膜，第五家南通慧聚提交上市申请|新受理（3.24-3.30）

本周药品注册受理数据，分门别类呈现，一目了然。(3.24-3.30）新药上市申请药品名称企业注册分类受理号布瑞哌唑口溶膜南通慧聚制药有限公司2.2CXHS2500026布瑞哌唑口溶膜南通慧聚制药有限公司2.2CXHS2500025新药临床申请药品名称企业注册分类受理号DZD6008片迪哲(江苏)医药股份有限公司1CXHL2500342DZD6008片迪哲(江苏)医药股份有限公司1CXHL2500341DZD6008片迪哲(江苏)医药股份有限公司1CXHL2500340AOD113408注射液成都奥达生物科技有限公司1CXHL2500339EDP167注射液亿腾医药(珠海)有限公司1CXHL2500336VVN432鼻喷雾剂维眸生物科技(浙江)有限公司1CXHL2500335VVN432鼻喷雾剂维眸生物科技(浙江)有限公司1CXHL2500334CPI-818片嘉兴和剂药业有限公司1CXHL2500332CPI-818片嘉兴和剂药业有限公司1CXHL2500331WJ47156片上海君实生物医药科技股份有限公司1CXHL2500330WJ47156片上海君实生物医药科技股份有限公司1CXHL2500329JKN2301干混悬剂健康元药业集团股份有限公司1CXHL2500327BW-40202注射液上海舶望制药有限公司1CXHL2500338RO7673396薄膜包衣片罗氏研发(中国)有限公司1CXHL2500325RO7673396薄膜包衣片罗氏研发(中国)有限公司1CXHL2500324RO7673396薄膜包衣片罗氏研发(中国)有限公司1CXHL2500323WSD0922-FU片杭州威瑞宝生物医药有限公司1CXHL2500322WSD0922-FU 片杭州威瑞宝生物医药有限公司1CXHL2500321JZ-14胶囊云白药征武科技(上海)有限公司1CXHL2500320JZ-14胶囊云白药征武科技(上海)有限公司1CXHL2500319SVHRSP注射液沈阳万锦医药科技有限公司1CXHL2500318Alpha-0261片深圳阿尔法分子科技有限责任公司1CXHL2500316Alpha-0261片深圳阿尔法分子科技有限责任公司1CXHL2500315AKZ002直服颗粒海南爱科制药有限公司2.2CXHL2500343WS-011湖北午时药业股份有限公司2.2CXHL2500337ZL-0018山东则正医药技术有限公司2.2CXHL2500328硫酸镁无菌溶液广东迈恒医药研发有限公司2.2CXHL2500326EP-0203XR成都苑东生物制药股份有限公司2.3CXHL2500333注射用甲苯磺酸瑞马唑仑江苏恒瑞医药股份有限公司2.4CXHL2500317注射用JS207上海君实生物医药科技股份有限公司1CXSL2500252HD006细胞华道(上海)生物医药有限公司1CXSL2500251Cizutamig注射液上海坦蒂生物医药科技有限公司1CXSL2500249注射用人白介素-2(高亲和型复合物)北京良远生物医药研究有限公司1CXSL2500248注射用SSGJ-705沈阳三生制药有限责任公司1CXSL2500247注射用BC2027无锡智康弘义生物科技有限公司1CXSL2500245注射用TQB2102正大天晴药业集团南京顺欣制药有限公司1CXSL2500241AZD0901阿斯利康全球研发(中国)有限公司1CXSL2500242注射用MK-2870默沙东研发(中国)有限公司2.2CXSL2500244注射用重组A型肉毒毒素北京博特维克生物技术有限公司2.4CXSL2500246仿制药申请药品名称企业注册分类受理号马来酸曲美布汀片浙江东亚药业股份有限公司3CYHS2501232马来酸曲美布汀片浙江东亚药业股份有限公司3CYHS2501231厄贝沙坦氨氯地平片(III)浙江昂利康制药股份有限公司3CYHS2501230维生素B6注射液湖南先施制药有限公司3CYHS2501229厄贝沙坦氨氯地平片(I)浙江昂利康制药股份有限公司3CYHS2501228重酒石酸卡巴拉汀口服液海南海和制药有限公司3CYHS2501227重酒石酸卡巴拉汀口服液海南海和制药有限公司3CYHS2501226盐酸依匹斯汀滴眼液参天制药(中国)有限公司3CYHS2501218法莫替丁注射液山西铭羽生物科技有限公司3CYHS2501216法莫替丁注射液山西铭羽生物科技有限公司3CYHS2501215维生素B6注射液西洲医药科技(浙江)有限公司3CYHS2501201琥珀酸亚铁片山西同达药业有限公司3CYHS2501200琥珀酸亚铁片上海金不换兰考制药有限公司3CYHS2501199布美他尼注射液重庆博腾药业有限公司3CYHS2501196吡格列酮二甲双胍片上海青平药业有限公司3CYHS2501195罗沙司他片石家庄市华新药业有限责任公司3CYHS2501188盐酸伊立替康脂质体注射液石药集团欧意药业有限公司3CYHS2501187复方聚乙二醇电解质散(儿童型)福州基石医药科技有限公司3CYHS2501182硝普钠注射液中润药业有限公司3CYHS2501180硝普钠注射液山西九康医药科技有限公司3CYHS2501176硝普钠注射液海南海和制药有限公司3CYHS2501159比拉斯汀口服溶液湖南科伦制药有限公司3CYHS2501158盐酸丁螺环酮片浙江京新药业股份有限公司3CYHS2501157盐酸丁螺环酮片浙江京新药业股份有限公司3CYHS2501156山梨醇甘露醇冲洗剂西安京西双鹤药业有限公司3CYHS2501155铝碳酸镁混悬液江苏润恒制药有限公司3CYHS2501173盐酸精氨酸注射液四川邈济生物医药科技有限公司3CYHS2501162碳酸氢钠注射液安徽双鹤药业有限责任公司3CYHS2501161注射用吲哚菁绿仁合益康汇泽药业河北有限公司3CYHS2501160聚多卡醇注射液苏州朗科生物技术股份有限公司4CYHS2501225聚多卡醇注射液苏州朗科生物技术股份有限公司4CYHS2501224聚多卡醇注射液苏州朗科生物技术股份有限公司4CYHS2501223甲磺酸溴隐亭片江苏诚康药业有限公司4CYHS2501222乌帕替尼缓释片复星万邦(江苏)医药集团有限公司4CYHS2501221乌帕替尼缓释片复星万邦(江苏)医药集团有限公司4CYHS2501220乌帕替尼缓释片复星万邦(江苏)医药集团有限公司4CYHS2501219盐酸尼卡地平注射液国药集团容生制药有限公司4CYHS2501217注射用氟氧头孢钠齐鲁安替制药有限公司4CYHS2501214注射用氟氧头孢钠齐鲁安替制药有限公司4CYHS2501213盐酸托莫西汀口服溶液山东步长制药股份有限公司4CYHS2501212利多卡因凝胶贴膏南京海纳医药科技股份有限公司4CYHS2501211双氯芬酸二乙胺乳胶剂湖南九典制药股份有限公司4CYHS2501210苯磺酸左氨氯地平片河南普瑞药业有限公司4CYHS2501209苯磺酸左氨氯地平片河南普瑞药业有限公司4CYHS2501208硫酸氨基葡萄糖胶囊山东诚康药业有限公司4CYHS2501207棕榈酸帕利哌酮注射液石药集团中诺药业(石家庄)有限公司4CYHS2501206棕榈酸帕利哌酮注射液石药集团中诺药业(石家庄)有限公司4CYHS2501205棕榈酸帕利哌酮注射液石药集团中诺药业(石家庄)有限公司4CYHS2501204比拉斯汀片桂林南药股份有限公司4CYHS2501203阿帕他胺片成都倍特药业股份有限公司4CYHS2501202舒更葡糖钠注射液海南斯达制药有限公司4CYHS2501198妥布霉素滴眼液深圳大佛药业股份有限公司4CYHS2501197硫酸氨基葡萄糖胶囊南京海鲸药业股份有限公司4CYHS2501194骨化三醇注射液山西康成利安医药有限公司4CYHS2501193地夸磷索钠滴眼液广东恒健制药有限公司4CYHS2501192硫酸氨基葡萄糖胶囊山东诺禾康药业有限公司4CYHS2501191骨化三醇注射液河南泰丰生物科技有限公司4CYHS2501190达格列净片山东普瑞曼药业有限公司4CYHS2501189艾普拉唑肠溶片浙江高跖医药科技股份有限公司4CYHS2501186阿奇霉素干混悬剂云鹏医药集团有限公司4CYHS2501185氟比洛芬凝胶贴膏湖南金圃医药科技有限公司4CYHS2501184布洛芬缓释胶囊郑州泰丰制药有限公司4CYHS2501183阿帕他胺片正大天晴药业集团南京顺欣制药有限公司4CYHS2501181沙库巴曲缬沙坦钠片海南赛立克药业有限公司4CYHS2501179沙库巴曲缬沙坦钠片海南赛立克药业有限公司4CYHS2501178沙库巴曲缬沙坦钠片海南赛立克药业有限公司4CYHS2501177玻璃酸钠滴眼液石家庄四药有限公司4CYHS2501175玻璃酸钠滴眼液石家庄四药有限公司4CYHS2501174阿莫西林克拉维酸钾干混悬剂山东益康药业股份有限公司4CYHS2501154黄体酮软胶囊深圳大佛药业股份有限公司4CYHS2501171黄体酮软胶囊深圳大佛药业股份有限公司4CYHS2501170乳果糖口服溶液湖北午时药业股份有限公司4CYHS2501168蛋白琥珀酸铁口服溶液中山百灵生物技术股份有限公司4CYHS2501167八氟丙烷脂质微球注射液广州康臣药业有限公司4CYHS2501166硫酸镁钠钾口服用浓溶液湖北午时药业股份有限公司4CYHS2501165富马酸伏诺拉生片蚌埠丰原涂山制药有限公司4CYHS2501164富马酸伏诺拉生片蚌埠丰原涂山制药有限公司4CYHS2501163乌帕替尼缓释片上海信谊百路达药业有限公司4CYHS2501172硫酸氨基葡萄糖胶囊江苏诺泰澳赛诺生物制药股份有限公司4CYHS2501169破伤风人免疫球蛋白浙江海康生物制品有限责任公司3.4CXSS2500038盐酸达克罗宁局部溶液剂深圳珐玛易药品科技有限公司3CYHL2500073溴莫尼定凝胶深圳珐玛易药品科技有限公司3CYHL2500072酮洛芬贴剂北京福元医药股份有限公司3CYHL2500071酮洛芬贴剂北京福元医药股份有限公司3CYHL2500070盐酸毛果芸香碱滴眼液苏州欧康维视生物科技有限公司3CYHL2500067米诺地尔泡沫剂深圳珐玛易药品科技有限公司3CYHL2500066双氯芬酸依泊胺贴深圳珐玛易药品科技有限公司3CYHL2500065硝呋太尔制霉菌素阴道软胶囊山东华铂凯盛生物科技有限公司4CYHL2500069沙美特罗替卡松吸入粉雾剂杭州知兴制药有限公司4CYHL2500068吸附破伤风疫苗北京智飞绿竹生物制药有限公司3.3CXSL2500250流感病毒裂解疫苗陕西昆秦生物科技有限公司3.3CXSL2500243进口申请药品名称企业注册分类受理号艾伏尼布片Servier Pharmaceuticals LLC5.1JXHS2500042利多卡因丙胺卡因气雾剂PLETHORA SOLUTIONS LIMITED5.1JXHS2500041度伐利尤单抗注射液AstraZeneca UK Limited3.1JXSS2500038度伐利尤单抗注射液AstraZeneca UK Limited3.1JXSS2500037PF-07985045片Pfizer Inc.1JXHL2500066PF-07985045片Pfizer Inc.1JXHL2500065Orforglipron胶囊Eli Lilly and Company1JXHL2500064Orforglipron胶囊Eli Lilly and Company1JXHL2500063Orforglipron胶囊Eli Lilly and Company1JXHL2500062Orforglipron胶囊Eli Lilly and Company1JXHL2500061Orforglipron胶囊Eli Lilly and Company1JXHL2500060Orforglipron胶囊Eli Lilly and Company1JXHL2500059TPST-1120片Tempest Therapeutics, Inc.1JXHL2500058Golcadomide胶囊Celgene Corporation1JXHL2500055Golcadomide胶囊Celgene Corporation1JXHL2500054Golcadomide胶囊Celgene Corporation1JXHL2500053Golcadomide胶囊Celgene Corporation1JXHL2500052醋酸甲地孕酮口服混悬液TWi Pharmaceuticals, Inc.2.4JXHL2500056罗氟司特泡沫Arcutis Biotherapeutics INC5.1JXHL2500057Empasiprubart注射用浓溶液argenx BV1JXSL2500047DS-1062aASTRAZENECA AB1JXSL2500045AZD2936AstraZeneca AB1JXSL2500044AZD2936AstraZeneca AB1JXSL2500042仑卡奈单抗注射液(皮下注射)Eisai Co., Ltd.2.1JXSL2500046TarlatamabAmgen Inc.2.2JXSL2500041TarlatamabAmgen Inc.2.2JXSL2500040TarlatamabAmgen Inc.2.2JXSL2500039帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSL2500043中药相关申请药品名称企业注册分类受理号桃核承气汤颗粒合肥华润神鹿药业有限公司3.1CXZS2500012肺热咳喘颗粒海南葫芦娃药业集团股份有限公司2.3CXZL2500020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

2025-03-24

·米内网

【市场】华润双鹤拿下6亿造影剂

精彩内容近日，NMPA官网显示，华润双鹤以仿制4类报产的钆特酸葡胺注射液获批上市，视同过评。钆特酸葡胺注射液是一种造影剂，2023年在中国公立医疗机构终端销售额接近6亿元。钆特酸葡胺注射液是一种用于磁共振成像（MRI）的静脉注射造影剂，最早于1989年在法国获批上市，用于以下疾病的核磁共振检查：（1）大脑和脊髓病变；（2）脊柱病变；（3）其他全身性病理检查（包括成人血管造影，不建议6个月以内的儿童全身使用），有助于提供鉴别或排除肿瘤、炎症和血管病变等重要诊断信息。米内网数据显示，2023年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端钆特酸葡胺注射液销售额接近6亿元，同比增长15.62%；2024年上半年其销售额超过2亿元，同比下滑3.86%。中国公立医疗机构终端钆特酸葡胺注射液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局钆特酸葡胺注射液已被纳入第十批集采，此前已有6家本土药企恒瑞医药、倍特药业、北陆药业、普利制药、山东新时代药业、山东威智百科药业获得生产批文，华润双鹤为该产品国产第7家。今年以来，华润双鹤已有4个品种钆特酸葡胺注射液、巯嘌呤片(II)、八氟丙烷脂质微球注射液、美索巴莫注射液获得药品注册证书，进一步丰富了公司的产品线。资料来源：米内网数据库、NMPA 注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。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

2025-03-04

·动脉网

国产突围！杰视医疗打破眼科手术气体进口垄断，重构玻璃体视网膜手术耗材生态

2025年2月18日，上海杰视医疗科技有限公司（简称“杰视医疗”）自主研发的眼用全氟丙烷气体（商品名：捷视®）获得NMPA Ⅲ类证（国械注准20253160327），成为国产首个获批的一次性眼用长效填充气体。该产品专为玻璃体视网膜手术设计，用于眼内填充治疗，能有效促进脱离的视网膜复位与愈合。捷视®眼用全氟丙烷气体主要成分为C3F8，无色透明，化学性质稳定，可用于玻璃体腔内。注入后逐步经血液、呼吸系统排出，无需二次手术取出。其以30mL独立和二元防护包装及一次性设计，直击进口产品价格高、重复使用、存在院感风险的痛点；更以99%的高纯度重塑行业标准，彻底终结了我国眼底手术长期无国产长效气体可用、因进口眼用气体断货而延误患者治疗的窘境。捷视®眼用全氟丙烷气体 01 国产眼用长效气体发展之困眼用长效气体是指在眼科手术中使用、能够在眼内较长时间留存并发挥作用的惰性气体，是眼底手术中重要的辅助材料，常见的有全氟丙烷C3F8、六氟化硫SF6。其主要用作眼内填充，具有稳定眼压、促进伤口愈合、封闭裂孔和复位脱离视网膜等作用。全氟丙烷C3F8是最常用的眼用长效气体，在玻璃体手术中有超40年的临床使用历史，其有效性和安全性在国际上得到一致认可，已成为玻璃体视网膜手术的重要组成部分。然而，我国眼用长效气体的发展长期受限。一方面，我国在该领域的研发起步较晚，国外企业凭借先发优势建立专利壁垒，抬高了国内企业的进入门槛；另一方面，眼用长效气体对纯度和杂质含量控制有极高要求，需要高精度设备、先进生产工艺和检测手段来确保产品质量。加之2015年的国产眼用全氟丙烷气体严重不良事件极大地打击了医患信心，此后数年间，“阴云”笼罩在国产眼用长效气体的上空，直到本次捷视®眼用全氟丙烷气体获批上市。 02 二元包装、一次性使用，更安全、经济、便捷本土企业更擅长捕捉国内临床应用场景中的细微需求。在捷视®眼用全氟丙烷气体获批前，国内仅有爱尔康和阿基米亚两家公司的进口眼用长效气体获批，且均非一次性使用。此前市场类似产品多为液化钢瓶包装或大容量分次使用包装，属于危化品，运输、储存要求高，且重复使用易致二次污染，增加院内感染风险。高昂的价格和重复使用的感染风险，很大程度上限制了眼用长效气体的使用。杰视医疗探寻并依据国内眼科临床专家应用习惯，对产品含量、包装进行全面升级，设计出30mL独立二元小包装、一次性使用的产品，更贴合临床专家的使用需求。图：捷视®眼用全氟丙烷气体采用二元包装示意图一次性使用的设计在很大程度上解决了大容量分次使用包装的院内感染风险，也更方便医生操作使用。独具匠心的二元包装设计，则有效避免了运输和保存过程中因环境因素导致的污染。具体而言，产品外部为铝罐，内部为医用标准高分子材料制成的袋阀系统，袋阀与铝罐间填充压缩性气体，用于挤压袋阀内的全氟丙烷气体。这种设计确保了即使袋阀出现故障，气体也只会正向泄漏，不会因外部环境气体渗入而污染产品气体，最大限度并充分保障临床的使用安全。 “眼用全氟丙烷气体这个产品的杂质控制是生死线。”杰视医疗创始人赵洪兵坦言，团队突破三大技术关卡：一是纯化工艺，其联合国内特气行业中的知名科研院所攻关出了多级分子筛吸附技术，杂质含量

100 项与全氟丙烷脂质微球相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01738	全氟丙烷脂质微球	V08DA04	DB00556

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
心脏病	中国	华润双鹤药业股份有限公司	2022-11-15
造影剂	美国	Lantheus Medical Imaging, Inc.	2001-07-31

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
肾脏疾病	临床2期	中国	Lantheus Medical Imaging, Inc.	2017-11-10
肾细胞癌	临床2期	中国	Lantheus Medical Imaging, Inc.	2017-11-10
肾细胞癌	临床2期	中国	华润双鹤药业股份有限公司	2017-11-10
肝病	临床2期	中国	华润双鹤药业股份有限公司	2017-09-21
肝病	临床2期	中国	Lantheus Medical Imaging, Inc.	2017-09-21
造影剂	临床2期	中国	Lantheus Medical Imaging, Inc.	2017-07-29
肝细胞癌	临床2期	美国	Lantheus Medical Imaging, Inc.	2016-04-01

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临床结果

适应症

分期

评价

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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


NCT01835067 (TAPAS, EURETINA2024)	临床2/3期	年龄相关性黄斑变性	56	C3F8	(憲廠膚顧餘製網簾衊鏇) = 製憲繭壓遞範夢壓網憲糧願憲製製網蓋築遞網 (積獵醖顧蓋積遞範壓窪 )	积极	2024-09-19
NCT01835067 (TAPAS, EURETINA2024)	临床2/3期	年龄相关性黄斑变性	56	TPA	(憲廠膚顧餘製網簾衊鏇) = 顧範艱糧襯鑰憲繭鹽鏇糧願憲製製網蓋築遞網 (積獵醖顧蓋積遞範壓窪 )	积极	2024-09-19
NCT04118764 (CTgov)	N/A	阿尔茨海默症	6	Neuronavigation-guided single-element focused ultrasound transducer+Amyvid+Definity	構齋蓋蓋鑰壓鏇膚餘襯(獵齋簾築鏇鑰齋蓋淵憲) = 範淵鏇衊襯鬱範顧鏇齋網鹹糧構窪網網範夢鏇 (鹽鏇網膚廠製製壓鹹襯, 夢鏇鹹糧夢繭醖艱鑰膚 ~ 蓋餘鏇餘鏇壓鏇願簾窪) 更多	-	2024-08-26
NCT02764801 (CTgov)	临床3期	肝细胞癌	131	Logiq E9 Scanner (Contrast-enhanced ultrasound)+Ultrasound contrast agent (Contrast-enhanced ultrasound)	壓糧蓋遞網餘繭衊繭膚(廠糧獵蓋觸鬱築廠蓋襯) = 餘獵艱蓋構壓顧積鹽製衊憲製築鹽蓋選顧願夢 (遞觸夢夢夢網選膚鑰餘, 窪夢遞齋蓋鹽顧範鏇淵 ~ 選繭繭鹽鏇膚廠衊遞遞) 更多	-	2023-09-21
ESC2023	N/A	ST段抬高心肌梗死	100	Sonothrombolysis with microbolus administration of perfluoropropane	構衊獵衊顧鏇選醖衊築(網築鏇醖糧糧選鹽醖鬱) = 網簾繭顧淵積壓淵鬱鹹願淵鏇構鑰繭憲獵蓋齋 (艱積簾鏇膚觸繭襯選顧 )	-	2023-08-25
ESC2023	N/A	ST段抬高心肌梗死	100	Control group	構衊獵衊顧鏇選醖衊築(網築鏇醖糧糧選鹽醖鬱) = 選衊鹽襯製鏇廠鏇鹽網願淵鏇構鑰繭憲獵蓋齋 (艱積簾鏇膚觸繭襯選顧 )	-	2023-08-25
NCT03544268 (CTgov)	临床4期	-	20	Acoustic Angiography+Definity (Acoustic Angiography)	窪鹽壓餘餘顧鬱鏇夢壓(襯餘製獵衊廠製齋艱鑰) = 繭顧淵獵艱夢構觸繭遞選獵糧夢窪遞觸鑰觸願 (夢觸積襯膚築壓範艱憲, 鑰壓壓選繭鏇齋觸齋築 ~ 製築廠鏇艱構網衊網遞) 更多	-	2022-04-01
NCT03544268 (CTgov)	临床4期	-	20	Acoustic Angiography+Definity (Image Optimization)	窪鹽壓餘餘顧鬱鏇夢壓(襯餘製獵衊廠製齋艱鑰) = 壓網範壓襯範鹹夢獵夢選獵糧夢窪遞觸鑰觸願 (夢觸積襯膚築壓範艱憲, 鏇製構製壓網蓋鏇襯繭 ~ 衊鑰壓壓鬱淵窪膚醖鬱) 更多	-	2022-04-01
ESC2020	N/A	-	100	Perfluoropropane contrast	(夢觸鏇糧觸製淵簾選糧) = 鑰顧衊艱餘襯願蓋顧鬱鬱積範衊範鹽膚築繭願 (製壓醖膚鏇衊願蓋鏇窪 ) 更多	-	2020-08-29
ESC2020	N/A	-	100	Sulphur hexafluoride contrast	(夢觸鏇糧觸製淵簾選糧) = 遞遞蓋憲鏇壓鑰蓋憲積鬱積範衊範鹽膚築繭願 (製壓醖膚鏇衊願蓋鏇窪 ) 更多	-	2020-08-29
NCT02115607 (CTgov)	N/A	乳腺癌	17	Definity infusion	鑰鑰鏇網遞築衊選鏇顧(憲簾築積醖繭網夢餘選) = 窪鹹醖艱鏇積鏇顧遞糧積窪網觸觸齋糧齋鹹鑰 (醖齋鹽壓鹹網艱餘構觸, 衊衊餘遞遞繭範齋範願 ~ 簾窪遞積夢蓋鑰襯廠顧) 更多	-	2019-10-31
NCT03297112 (CTgov)	早期临床1期	子宫附件疾病	12	Contrast-Enhanced Subharmonic Ultrasound Imaging+Perflutren Lipid Microspheres	簾窪夢蓋窪糧選鹽繭獵(餘繭廠廠廠鹽齋顧齋鏇) = 憲憲廠衊鏇蓋齋觸鹽鏇夢壓選蓋憲蓋餘網壓選 (遞遞選範齋憲糧遞網夢, 齋餘壓築願鏇夢鬱齋範 ~ 繭顧膚構製膚蓋窪憲艱) 更多	-	2019-09-25
NCT02880137 (CTgov)	临床4期	血管疾病	36	RTMPE+Perflutren Lipid Microsphere	壓觸範鬱遞鬱鑰夢願壓(觸繭窪糧餘餘鏇齋簾觸) = 齋範願鹹蓋糧憲遞衊夢鹽獵製構衊繭窪觸醖衊 (選鹽鏇鏇糧艱顧齋襯壓, 蓋蓋齋製鏇鹹遞鹽繭淵 ~ 膚網糧鏇鏇選願鬱廠簾) 更多	-	2019-06-20
NCT03212326 (CTgov)	N/A	缺血性心肌病 \| 瘢痕 \| 室性心动过速	24	Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]	餘觸夢構築網構鏇繭衊(艱製遞構衊鏇憲壓鹽齋) = 構醖鬱積顧糧夢鏇糧選顧窪鹽鹹範鑰廠窪艱繭 (製壓願齋夢範獵憲鹹窪, 糧觸淵壓範顧淵獵觸願 ~ 願壓鹽觸簾夢廠壓範範) 更多	-	2019-05-31