Liver resection have been a primary treatment option for lesions found in the liver. With improvements in surgical technique and perioperative patient management, morbidity and mortality related to liver resection have been greatly reduced. However, many patients with hepatocellular carcinoma have underlying liver disease. Severity of underlying liver disease plays an important role in decision making of resection extent. Therefore, liver failure and decreased liver function following liver resection still remains to be an critical issue.
Postresection liver failure is generally defined by serum total bilirubin greater than 3mg/dL and prothrombin time of less than 50% of normal (INR >1.7). Pathophysiology of postresection liver failure is not yet well known. However, sepsis after liver resection, small-for-size syndrome (SFSS), and ischemia/reperfusion injury are known to have important roles in persistant liver injury after resection.
After a liver resection, kupffer cells are drastically decreased and innate immunity of the patient is also damaged. This process causes the patient to be vulnerable to infection. In addition, with continuous endotoxin secretion, dysfunction in kupffer cells are triggered and liver regeneration is affected.
Complex mechanisms leading to dysfunctional kupffer cells and apoptosis and necrosis of hepatocytes are mediated by neutrophils, complement, reactive oxygen species, and acute inflammatory cytokines.
Recent studies have reported on many promising effects of the synthetic protease inhibitor, such as Gabexate mesilate. These include antioxidant effect, inhibition of acute inflammatory cytokine reaction, and anticoagulatory property. Based on these effects, synthetic protease inhibitor have gained attention in the role of hepatocyte protection after liver resection.
Currently, there is a report on the hepatocyte protective effects of Gabexate Mesilate on ischemia/reperfusion injury caused by the Pringle maneuver. However, with the advances in surgical technique and equipment, many surgeons now perform liver resection without Pringle maneuver. Therefore, this study was designed to determine effects of Gabexate Mesilate in the liver resection performed without Pringle maneuver.

开始日期2012-02-24

申办/合作机构

Yonsei University

100 项与甲磺酸加贝酯相关的临床结果

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100 项与甲磺酸加贝酯相关的转化医学

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100 项与甲磺酸加贝酯相关的专利（医药）

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542

项与甲磺酸加贝酯相关的文献（医药）

2024-05-07·ACS Nano

Inflammation and Acinar Cell Dual-Targeting Nanomedicines for Synergistic Treatment of Acute Pancreatitis via Ca²⁺ Homeostasis Regulation and Pancreas Autodigestion Inhibition

Article

作者: Wang, Xinyuan ; Yu, Liangmin ; Yan, Xuefeng ; Wang, Yanan ; Qian, Deyao ; Meng, Xinlei ; He, Zhiyu ; Xu, Yatao ; Zhang, Xue ; Zhang, Baomei

Severe acute pancreatitis (AP) is a life-threatening pancreatic inflammatory disease with a high mortality rate (∼40%). Existing pharmaceutical therapies in development or in clinical trials showed insufficient treatment efficacy due to their single molecular therapeutic target, poor water solubility, short half-life, limited pancreas-targeting specificity, etc. Herein, acid-responsive hollow mesoporous Prussian blue nanoparticles wrapped with neutrophil membranes and surface modified with the N,N-dimethyl-1,3-propanediamine moiety were developed for codelivering membrane-permeable calcium chelator BAPTA-AM (BA) and trypsin activity inhibitor gabexate mesylate (Ga). In the AP mouse model, the formulation exhibited efficient recruitment at the inflammatory endothelium, trans-endothelial migration, and precise acinar cell targeting, resulting in rapid pancreatic localization and higher accumulation. A single low dose of the formulation (BA: 200 μg kg^-1, Ga: 0.75 mg kg^-1) significantly reduced pancreas function indicators to close to normal levels at 24 h, effectively restored the cell redox status, reduced apoptotic cell proportion, and blocked the systemic inflammatory amplified cascade, resulting in a dramatic increase in the survival rate from 58.3 to even 100%. Mechanistically, the formulation inhibited endoplasmic reticulum stress (IRE1/XBP1 and ATF4/CHOP axis) and restored impaired autophagy (Beclin-1/p62/LC3 axis), thereby preserving dying acinar cells and restoring the cellular "health status". This formulation provides an upstream therapeutic strategy with clinical translation prospects for AP management through synergistic ion homeostasis regulation and pancreatic autodigestion inhibition.

2024-03-01·European Journal of Pharmacology

Involvement of peripheral mast cells in a fibromyalgia model in mice

Article

作者: Fialho, Maria Fernanda Pessano ; Becker, Gabriela ; Oliveira, Sara Marchesan ; Brum, Evelyne da Silva ; Nogueira, Cristina Wayne

Fibromyalgia is a painful disorder of unknown aetiology that presents activation and recruitment of innate immune cells, including mast cells. Efforts have been made to understand its pathogenesis to manage it better. Thus, we explored the involvement of peripheral mast cells in an experimental model of fibromyalgia induced by reserpine. Reserpine (1 mg/kg) was subcutaneously (s.c.) injected once daily in the back of male Swiss mice for three consecutive days. We analysed mechanical and cold allodynia, muscle fatigue and number of mast cell in plantar tissue. The fibromyalgia induction produced mast cell infiltration (i.e., mastocytosis) in the mice's plantar tissue. The depletion of mast cell mediators with the compound 48/80 (0.5-4 mg/kg, intraperitoneal (i.p.)) or the mast cell membrane stabilizer ketotifen fumarate (10 mg/kg, oral route (p.o.) widely (80-90 %) and extensively (from 1 up to 10 days) prevented reserpine-induced mechanical and cold allodynia and muscle fatigue. Compound 48/80 also prevented the reserpine-induced mastocytosis. Finally, we demonstrated that PAR-2, 5-HT_2A, 5-HT₃, H₁, NK1 and MrgprB2 receptors, expressed in neuronal or mast cells, seem crucial to mediate fibromyalgia-related cardinal symptoms since antagonists or inhibitors of these receptors (gabexate (10 mg/kg, s.c.), ENMD-1068 (10 mg/kg, i.p.), ketanserin (1 mg/kg, i.p.), ondansetron (1 mg/kg, p.o.), promethazine (1 mg/kg, i.p.), and L733,060 (5 mg/kg, s.c.), respectively) transiently reversed the reserpine-induced allodynia and fatigue. The results indicate that mast cells mediate painful and fatigue behaviours in this fibromyalgia model, representing potential therapy targets to treat fibromyalgia syndrome.

2023-12-01·Pancreatology

No role for protease inhibitors as a mitigation strategy for postpancreatectomy acute pancreatitis (PPAP): Propensity score matching analysis

Article

作者: Cattelani, Alice ; Salvia, Roberto ; Bannone, Elisa ; Marchetti, Alessio ; Vacca, Pier Giuseppe ; Bassi, Claudio ; Pulvirenti, Alessandra ; Marchegiani, Giovanni

BACKGROUNDWhile the use of protease inhibitor gabexate mesylate (GM) is still controversial in acute pancreatitis, it has never been tested for postpancreatectomy acute pancreatitis (PPAP). This study aims to assess the impact of GM on postoperative serum hyperamylasaemia (POH) or PPAP after pancreatoduodenectomy (PD).METHODSConsecutive patients developing POH after PD between 2016 and 2021 were included. According to GM administration, patients were divided into GM-treated and control (CTR) groups. GM was administered from postoperative day 1-3 in POH patients who underwent surgery before 2017. A 2:1 propensity matching was used to minimize the risk of bias.RESULTSOverall, 264 patients with POH were stratified in the GM (59 patients) and CTR (104 patients) cohorts, which showed balanced baseline characteristics after matching. No difference in postoperative complications was observed between the groups (all p > 0.05), except for PPAP occurrence, which was significantly higher in the GM group (37% vs. 22%, p = 0.037). A total of 45 patients (28%) evolved to PPAP. Comparing PPAP patients in the GM and CTR groups, no significant differences in POPF, relaparotomy, and mortality (all p > 0.09) were found. No difference in intravenous crystalloid administration was found in patients with PPAP, whether or not they developed major complications or pancreatic fistula (p > 0.05) CONCLUSION: Protease inhibitor seems ineffective in preventing a PPAP after PD once a POH has occurred. Further studies are needed to achieve benchmarks for treating PPAP and identify mitigation strategies to prevent the evolution of POH into additional morbidity.

项与甲磺酸加贝酯相关的新闻（医药）

2024-08-08

·华森制药

华森制药携痛泻宁颗粒参加西南五省消化年会暨云南省消化病学术年会

为紧跟国际消化、消化内镜及肝病领域最新进展，探讨本领域热点难点问题，近日，由云南省医学会主办，云南省医学会消化病学分会，云南省医学会消化内镜学学分会共同承办，昆明医科大学第一附属医院消化内科协办的"2024年西南五省市区消化年会暨云南省医学会2024年消化病学术年会在云南省昆明市召开。据悉，本次大会云集国内消化、消化内镜及肝病领域知名专家，就当今本领域热点难点问题进行了共识解读、专题报告，以及就消化、消化内镜、肝病领域进行了精彩的分享。昆明医科大学第一附属医院南琼教授主持会议云南省卫生健康委员会副主任周洪梅开幕致辞昆明医科大学第一附属医院党委副书记、院长曾仲教授开幕致辞第二军医大学长海医院李兆申院士作《消化道癌早筛、早诊、早治高质量发展思考》主题报告空军军医大学西京消化病医院吴开春教授作《慢性胃炎正确观》主题报告昆明医科大学第一附属医院消化内科牛俊坤教授作《云南省炎症性肠病患者概况》主题报告消化系统疾病作为临床上的常见、多发且易复发的疾病类别，长期以来一直是医学界关注的焦点。华森制药在消化疾病治疗领域内深耕多年，形成了中西药融合、优势互补的发展布局，并打造出了一系列独具特色、品质卓越的产品。此次，华森制药携产品痛泻宁颗粒、注射用甲磺酸加贝酯、威快舒铝碳酸镁咀嚼片、奥美拉唑碳酸氢钠胶囊等消化线重点产品参加了会议，并向与会者进行了介绍和交流，得到大家的肯定和好评。

2024-01-02

·信狐药迅

广东众生甲流新药昂拉地韦片上市申请，厦门宝瑞注射用磷霉素钠一致性评价申请 | 新受理（12.25-12.31）

每周药品注册受理数据，分门别类呈现，一目了然。(12.25-12.31）新药上市申请药品名称企业名称分类受理号TAP-1503乳膏上海泽德曼医药科技有限公司2.4CXHS2300119四价流感病毒裂解疫苗浙江天元生物药业有限公司3.3CXSS2300101富马酸泰吉利定注射液江苏恒瑞医药股份有限公司1CXHS2300120富马酸泰吉利定注射液江苏恒瑞医药股份有限公司1CXHS2300121昂拉地韦片广东众生睿创生物科技有限公司1CXHS2300118格舒瑞昔片益方生物科技(上海)股份有限公司1CXHS2300122新药临床申请药品名称企业名称分类受理号113口服冻干粉北京海一药业有限公司2.2CXHL23014593HP-2827片思康睿奇(苏州)药业有限公司1CXHL23014843HP-2827片思康睿奇(苏州)药业有限公司1CXHL2301485ABP-745片江苏新元素医药科技有限公司1CXHL2301474ABP-745片江苏新元素医药科技有限公司1CXHL2301475ABP-745片江苏新元素医药科技有限公司1CXHL2301476BAT1308注射液百奥泰生物制药股份有限公司1CXSL2300906BD001细胞注射液深圳宾德生物技术有限公司1CXSL2300908BR005-036C片熙源安健医药(上海)有限公司1CXHL2301468BR005-036C片熙源安健医药(上海)有限公司1CXHL2301469CG-BM1异体人骨髓间充质干细胞注射液广州赛隽生物科技有限公司1CXSL2300909CUD005注射液四川康德赛医疗科技有限公司1CXSL2300903CYH001肠溶胶囊北京承颐医药科技有限公司1CXHL2301471CYH001肠溶胶囊北京承颐医药科技有限公司1CXHL2301472FHND6091胶囊江苏正大丰海制药有限公司1CXHL2301446FHND6091胶囊江苏正大丰海制药有限公司1CXHL2301447GP-2103滴眼液南京济群医药科技股份有限公司2.1CXHL2301456GP-2103滴眼液南京济群医药科技股份有限公司2.1CXHL2301457GP-2103滴眼液南京济群医药科技股份有限公司2.1CXHL2301458GT919胶囊标新生物医药科技(上海)有限公司1CXHL2301477GT919胶囊标新生物医药科技(上海)有限公司1CXHL2301478GT919胶囊标新生物医药科技(上海)有限公司1CXHL2301479GW201口崩片北京广为医药科技有限公司1CXHL2301466GW201口崩片北京广为医药科技有限公司1CXHL2301467GY-1068胶囊上海贵之言医药科技有限公司1CXHL2301445HLX6018上海复宏汉霖生物技术股份有限公司1CXSL2300889HX101胶囊华夏生生药业(北京)有限公司1CXHL2301473ICP-248片北京诺诚健华医药科技有限公司1CXHL2301460ICP-248片北京诺诚健华医药科技有限公司1CXHL2301461INV-1120胶囊佛山市原力生物科技有限公司1CXHL2301482INV-1120胶囊佛山市原力生物科技有限公司1CXHL2301483JL18008注射液杰库(上海)生物医药研究有限公司1CXSL2300897KH801注射液北京康弘生物医药有限公司1CXSL2300890KPG-818胶囊康朴生物医药技术(合肥)有限公司1CXHL2301480KPG-818胶囊康朴生物医药技术(合肥)有限公司1CXHL2301481LD09163片上海璃道医药科技有限公司1CXHL2301443LD09163片上海璃道医药科技有限公司1CXHL2301444LM-101注射液礼新医药科技(上海)有限公司1CXSL2300891LPC-025口溶膜海南中旺医疗科技开发有限公司2.2CXHL2301455NF2105胶囊深圳市泰力生物医药有限公司2.2CXHL2301462NF2105胶囊深圳市泰力生物医药有限公司2.2CXHL2301463NGGT002注射液苏州诺洁贝生物技术有限公司1CXSL2300905NS-041分散片纽欧申医药(上海)有限公司1CXHL2301453NS-041分散片纽欧申医药(上海)有限公司1CXHL2301454SCTB35注射液神州细胞工程有限公司1CXSL2300900SH081012口服用浓溶液山东百诺医药股份有限公司2.2CXHL2301441VIC-1911片捷思英达医药技术(上海)有限公司1CXHL2301448WS-0101溶液北京厚燊维康科技有限责任公司1CXHL2301464XP-102SC胶囊徐诺药业(南京)有限公司1CXHL2301470冻干人用狂犬病疫苗(Vero细胞)山东亦度生物技术有限公司2.5CXSL2300901司美格鲁肽注射液成都倍特生物制药有限公司3.3CXSL2300892司美格鲁肽注射液成都倍特生物制药有限公司3.3CXSL2300893司美格鲁肽注射液成都倍特生物制药有限公司3.3CXSL2300894司美格鲁肽注射液成都倍特生物制药有限公司3.3CXSL2300895司美格鲁肽注射液成都倍特生物制药有限公司3.3CXSL2300896小儿泼尼松肠溶干混悬剂文韬创新药物研究(北京)有限责任公司2.2CXHL2301452注射用AST2169脂质体上海艾力斯医药科技股份有限公司1CXHL2301442注射用BAT8008百奥泰生物制药股份有限公司1CXSL2300907注射用BL-M05D1成都百利多特生物药业有限责任公司1CXSL2300904注射用LB4330上海健信生物医药科技有限公司1CXSL2300898注射用MK-1200默沙东研发(中国)有限公司1CXSL2300888注射用NC527-X浙江海擘生物科技有限公司1CXHL2301465注射用重组抗PD1/TIM3人源化双特异抗体上海健信生物医药科技有限公司1CXSL2300899泼尼松肠溶胶囊文韬创新药物研究(北京)有限责任公司2.2CXHL2301451硫酸阿托品滴眼液乐普药业股份有限公司2.2;2.4CXHL2301449硫酸阿托品滴眼液乐普药业股份有限公司2.2;2.4CXHL2301450重组带状疱疹疫苗(CHO细胞)安徽智飞龙科马生物制药有限公司1.3CXSL2300902仿制药申请药品名称企业名称分类受理号丙戊酸钠缓释片(I)锦州奥鸿药业有限责任公司4CYHS2303666乙酰半胱氨酸口服液南京易腾药物研究院有限公司3CYHS2303640乙酰半胱氨酸注射液海南爱科制药有限公司3CYHS2303606依维莫司片山东新时代药业有限公司4CYHS2303678利丙双卡因乳膏滨海美康药业有限公司4CYHS2303647利丙双卡因乳膏福元药业有限公司4CYHS2303632利多卡因丙胺卡因气雾剂江苏柯菲平医药股份有限公司3CYHL2300167卡泊三醇倍他米松软膏重庆华邦制药有限公司4CYHS2303654卡泊三醇倍他米松软膏重庆华邦制药有限公司4CYHS2303655双氯芬酸二乙胺乳胶剂浙江赛默制药有限公司4CYHS2303687叶酸注射液北京布霖生物科技有限公司3CYHS2303592叶酸注射液北京布霖生物科技有限公司3CYHS2303593吲哚美辛凝胶贴膏湖南九典制药股份有限公司3CYHS2303665地塞米松眼内插入剂北京仁众药业有限公司3CYHL2300163地氯雷他定口服溶液江苏东科康德药业有限公司3CYHS2303649坎地沙坦酯氨氯地平片江西施美药业股份有限公司3CYHL2300165复方匹可硫酸钠口服溶液北京民康百草医药科技有限公司3CYHS2303677复方氨基酸(15)双肽(2)注射液华夏生生药业(北京)有限公司4CYHS2303669复方氨基酸注射液(18AA-VII)华夏生生药业(北京)有限公司4CYHS2303621复方电解质醋酸钠注射液山东科伦药业有限公司3CYHS2303623复方聚乙二醇电解质散(III)广州一品红制药有限公司4CYHS2303671小儿复方氨基酸注射液(19AA-I)广州绿十字制药股份有限公司3CYHS2303617左氧氟沙星氯化钠注射液海南爱科制药有限公司4CYHS2303642左氧氟沙星氯化钠注射液海南爱科制药有限公司4CYHS2303643左氧氟沙星片浙江东亚药业股份有限公司4CYHS2303685左羟丙哌嗪口服溶液安徽茂康药业有限公司3CYHS2303633左羟丙哌嗪口服溶液安徽茂康药业有限公司3CYHS2303634帕利哌酮缓释片合肥立方制药股份有限公司4CYHS2303618帕利哌酮缓释片合肥立方制药股份有限公司4CYHS2303619拉考沙胺口服溶液岳阳新华达制药有限公司4CYHS2303614普瑞巴林缓释片华润双鹤利民药业(济南)有限公司3CYHL2300160替格瑞洛分散片天津力生制药股份有限公司4CYHS2303673替米沙坦氨氯地平片吉林天衡药业有限公司4CYHS2303638替米沙坦氨氯地平片上海青平药业有限公司4CYHS2303620氨氯地平阿托伐他汀钙片安徽宏业药业有限公司4CYHS2303599氨氯地平阿托伐他汀钙片安徽宏业药业有限公司4CYHS2303600氯化钾注射液福建新迪医药科技有限公司3CYHS2303635沙格列汀二甲双胍缓释片(I)山东齐都药业有限公司4CYHS2303680泊沙康唑肠溶片上海智赋医药有限公司4CYHS2303639注射用头孢唑肟钠安徽省先锋制药有限公司4CYHS2303663注射用头孢唑肟钠安徽省先锋制药有限公司4CYHS2303664注射用头孢唑肟钠安徽威尔曼制药有限公司4CYHS2303596注射用头孢唑肟钠安徽威尔曼制药有限公司4CYHS2303597注射用头孢唑肟钠/氯化钠注射液苏州大冢制药有限公司4CYHS2303615注射用尼可地尔河北龙海药业有限公司3CYHS2303672注射用尼可地尔国药集团容生制药有限公司3CYHS2303641注射用替考拉宁浙江普利药业有限公司4CYHS2303679注射用甲磺酸加贝酯石家庄四药有限公司3CYHS2303631注射用盐酸瑞芬太尼江苏恩华药业股份有限公司3CYHS2303612注射用盐酸瑞芬太尼江苏恩华药业股份有限公司3CYHS2303613注射用盐酸罗沙替丁醋酸酯海南卫康制药(潜山)有限公司3CYHS2303622注射用阿糖胞苷上海上药睿尔药品有限公司4CYHS2303607注射用青霉素钠昆明南疆制药有限公司3CYHS2303650注射用青霉素钠昆明南疆制药有限公司3CYHS2303651注射用青霉素钠昆明南疆制药有限公司3CYHS2303652注射用青霉素钠昆明南疆制药有限公司3CYHS2303653洛索洛芬钠凝胶膏浙江赛默制药有限公司4CYHL2300159洛索洛芬钠口服溶液重庆华邦制药有限公司3CYHS2303660琥珀酰明胶注射液北京布霖生物科技有限公司4CYHL2300158琥珀酰明胶电解质醋酸钠注射液北京布霖生物科技有限公司4CYHL2300166甘露醇山梨醇注射液华夏生生药业(北京)有限公司3CYHL2300162盐酸丙卡特罗口服溶液合肥国药诺和药业有限公司3CYHS2303630盐酸右哌甲酯缓释胶囊河南中帅药业有限公司3CYHS2303628盐酸多巴胺注射液成都百裕制药股份有限公司3CYHS2303683盐酸多巴胺注射液成都百裕制药股份有限公司3CYHS2303684盐酸奈福泮注射液山东豪瑞恩制药有限公司3CYHS2303644盐酸奈福泮注射液安徽恒星制药有限公司3CYHS2303608盐酸左西替利嗪口服溶液国药集团汕头金石制药有限公司3CYHS2303686盐酸普罗帕酮注射液华夏生生药业(北京)有限公司3CYHS2303627盐酸普萘洛尔注射液福州基石医药科技有限公司3CYHS2303682盐酸毛果芸香碱滴眼液石药集团欧意药业有限公司3CYHL2300164盐酸氨酮戊酸口服溶液用粉末泰州复旦张江药业有限公司3CYHL2300157盐酸溴己新口服溶液浙江赛默制药有限公司3CYHS2303594盐酸达泊西汀片湖南九典制药股份有限公司4CYHS2303598硝呋太尔制霉菌素阴道软胶囊江苏万高药业股份有限公司4CYHL2300169硝普钠氯化钠注射液沈阳双鼎制药有限公司3CYHS2303648硫糖铝混悬凝胶北京诚济制药股份有限公司4CYHS2303611碘佛醇注射液重庆圣华曦药业股份有限公司4CYHS2303625碳酸氢钠注射液北京民康百草医药科技有限公司3CYHS2303675碳酸氢钠注射液广东鼎信医药科技有限公司3CYHS2303605维生素B6注射液广州绿十字制药股份有限公司3CYHS2303681缬沙坦氨氯地平片(I)翎耀生物科技(上海)有限公司4CYHS2303604罗沙司他胶囊重庆煜洋药业有限公司4CYHS2303610美沙拉秦肠溶片杭州煌森生物科技有限公司4CYHS2303657美索巴莫注射液北京沃邦医药科技有限公司3CYHS2303661美阿沙坦钾片山东朗诺制药有限公司4CYHS2303656美阿沙坦钾片山东朗诺制药有限公司4CYHS2303658美阿沙坦钾片江苏联环药业股份有限公司4CYHS2303602美阿沙坦钾片江苏联环药业股份有限公司4CYHS2303603肾上腺素注射液华夏生生药业(北京)有限公司3CYHS2303624腺苷钴胺胶囊海南元盈医药科技有限公司3CYHS2303626腺苷钴胺胶囊石药集团欧意药业有限公司3CYHS2303595膀胱灌注用盐酸氨酮戊酸己酯及专用溶剂广东精观生物医药科技有限公司3CYHL2300161莫匹罗星软膏浙江百代医药科技有限公司4CYHS2303609西格列汀二甲双胍缓释片浙江高跖医药科技股份有限公司3CYHS2303645西格列汀二甲双胍缓释片浙江高跖医药科技股份有限公司3CYHS2303646西格列汀二甲双胍缓释片江苏德源药业股份有限公司3CYHS2303601达格列净片福元药业有限公司4CYHS2303636达格列净片福元药业有限公司4CYHS2303637酮咯酸氨丁三醇注射液江苏明圣康源药业有限公司3CYHS2303616醋酸去氨加压素注射液华夏生生药业(北京)有限公司4CYHS2303667醋酸去氨加压素注射液华夏生生药业(北京)有限公司4CYHS2303668重酒石酸间羟胺注射液武汉久安药业有限公司3CYHS2303676阿加曲班注射液陕西天宇制药有限公司4CYHS2303629阿奇霉素滴眼液南京恒道医药科技股份有限公司3CYHL2300168非洛地平缓释片辰欣药业股份有限公司4CYHS2303670麦考酚钠肠溶片山东新时代药业有限公司4CYHS2303659进口申请药品名称企业名称分类受理号AZD9829AstraZeneca AB1JXSL2300234Benralizumab注射液AstraZeneca AB2.2JXSL2300235BI1569912 片Boehringer Ingelheim International GmbH1JXHL2300327BI1569912 片Boehringer Ingelheim International GmbH1JXHL2300328cemiplimabRegeneron Ireland Designated Activity Company (DAC)2.2JXSL2300237EtavopivatNovo Nordisk A/S1JXHL2300326M1774胶囊Merck Healthcare KGaA1JXHL2300329M1774胶囊Merck Healthcare KGaA1JXHL2300330注射用CU-20101CKD BiO Corporation3.4JXSL2300236瑞利珠单抗注射液Alexion Europe SAS3.1JXSS2300094瑞利珠单抗注射液Alexion Europe SAS3.1JXSS2300095磷酸芦可替尼乳膏Incyte Biosciences Distribution B.V.5.1JXHL2300331一致性评价申请药品名称企业名称受理号注射用磷霉素钠厦门宝瑞药业有限公司CYHB2350981注射用磷霉素钠厦门宝瑞药业有限公司CYHB2350982注射用磷霉素钠厦门宝瑞药业有限公司CYHB2350983丙氨酰谷氨酰胺注射液费森尤斯卡比华瑞制药有限公司CYHB2350976克林霉素磷酸酯注射液重庆莱美药业股份有限公司CYHB2350984克林霉素磷酸酯注射液重庆莱美药业股份有限公司CYHB2350985枸橼酸铋钾胶囊山西德元堂药业有限公司CYHB2350975注射用头孢他啶广州白云山天心制药股份有限公司CYHB2350965注射用头孢他啶广州白云山天心制药股份有限公司CYHB2350966注射用头孢哌酮钠舒巴坦钠广州白云山天心制药股份有限公司CYHB2350978注射用头孢哌酮钠舒巴坦钠广州白云山天心制药股份有限公司CYHB2350979注射用头孢唑肟钠金鸿药业股份有限公司CYHB2350970注射用头孢唑肟钠金鸿药业股份有限公司CYHB2350971注射用头孢噻肟钠广州白云山天心制药股份有限公司CYHB2350967注射用头孢噻肟钠广州白云山天心制药股份有限公司CYHB2350968碘海醇注射液福安药业集团宁波天衡制药有限公司CYHB2350977腹膜透析液(乳酸盐-G1.5%)成都青山利康药业股份有限公司CYHB2350972腹膜透析液(乳酸盐-G2.5%)成都青山利康药业股份有限公司CYHB2350973腹膜透析液(乳酸盐-G4.25%)成都青山利康药业股份有限公司CYHB2350974葡萄糖酸钙注射液国药集团容生制药有限公司CYHB2350980西咪替丁注射液山东鲁抗医药集团赛特有限责任公司CYHB2350969中药相关申请药品名称企业名称分类受理号椒七麝凝胶贴膏湖南九典制药股份有限公司1.1CXZS2300028铁皮石斛咀嚼片杭州丹鹤医药有限公司1.1CXZL2300075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。推荐关注：注射用磷霉素钠是同属于医保甲类和国家基药的、耐药性低的广谱抗生素；本品虽批文较多，但实际生产企业少，且暂无任何企业通过一致性评价。东北制药和宝瑞药业先后提交注射用磷霉素钠一致性评价补充申请，两企业很有可能同时通过评价。

疫苗申请上市一致性评价

2022-11-29

·米内网

【市场】过亿注射剂，哈三联第2家过评

精彩内容近日，哈三联公告称，公司注射用甲磺酸加贝酯通过了仿制药一致性评价，为国内第2家过评。米内网数据显示，2021年中国公立医疗机构终端注射用甲磺酸加贝酯销售额约1.6亿元，同比增长9.37%。注射用甲磺酸加贝酯主要适用于急性轻型（水肿型）胰腺炎的治疗，也可用于急性出血坏死型胰腺炎的辅助治疗。米内网数据显示，2021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）终端注射用甲磺酸加贝酯销售额约1.6亿元，同比增长9.37%；2022年上半年其销售额超过8000万元，同比增长8.20%，其中成都天台山制药、山西普德药业占据的市场份额均超过30%。中国公立医疗机构终端注射用甲磺酸加贝酯销售情况（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目前国内共有15家企业拥有注射用甲磺酸加贝酯生产批文，重庆华森制药该产品为国内首家过评，哈三联为第2家过评。哈三联过评品种来源：米内网新版数据库截至目前，哈三联已有10个品种过评，包括米氮平片、盐酸氨溴索注射液、奥氮平口崩片、依达拉奉注射液、盐酸昂丹司琼注射液、注射用奥美拉唑钠、甲钴胺注射液、甲硝唑氯化钠注射液、克林霉素磷酸酯注射液、注射用甲磺酸加贝酯。数据来源：米内网数据库、公司公告本文为原创稿件，转载请注明来源和作者，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

一致性评价

100 项与甲磺酸加贝酯相关的药物交易

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