The objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice.

开始日期2016-07-15

申办/合作机构

Bayer AG

EUCTR2012-000938-19-IT / Not yet recruitingN/A

Safety and Efficacy of tablets containing extract of Hibiscus Sabdariffa (HS) and Propoli versus placebo in the treatment of the cystitis with Ciproxin

开始日期2012-06-11

申办/合作机构

Novintethical Pharma SA

NCT01561794 / Completed临床3期

A Prospective, Non-randomized, Open-label, Non-controlled, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics/ Pharmacodynamics of BAYQ3939 (400 mg BID and TID) in Hospitalized Patients With Bacterial Pneumonia or Secondary Infection of Chronic Respiratory Disease With Severe Disease or a Poor Response to Other Antimicrobials

The main objective of this study is to investigate the safety, pharmacokinetics (PK) and the relationship between PK and pharmacodynamics (Minimum Inhibitory Concentration [MIC] and Mutant Prevention Concentration [MPC]) of intravenous BAYQ3939 (400 mg BID and 400 mg TID) in hospitalized patients with bacterial pneumonia or secondary infection of chronic respiratory disease with severe disease or a poor response to other antimicrobials. In addition, the efficacy of the ciprofloxacin, in terms of clinical response and microbiological response, will be investigated, but as a secondary endpoint.

开始日期2012-05-01

申办/合作机构

Bayer AG

100 项与乳酸环丙沙星相关的临床结果

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100 项与乳酸环丙沙星相关的转化医学

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100 项与乳酸环丙沙星相关的专利（医药）

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项与乳酸环丙沙星相关的文献（医药）

2020-11-01·European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V2区 · 医学

Dissolution testing of modified release products with biorelevant media: An OrBiTo ring study using the USP apparatus III and IV

2区 · 医学

Article

作者: Etherson, Kelly ; Mistry, Nena ; Karkossa, Frank ; Dressman, Jennifer ; Tomaszewska, Irena ; McAllister, Mark ; Smith, Kieran Lewis ; Schäfer, Kerstin Julia ; Andreas, Cord J ; Rosenblatt, Karin ; Maier, Gerd-Michael ; Williams, James ; Winge, Fredrik ; Klein, Sandra ; Vertzoni, Maria ; Brown, Jonathan ; Karlsson, Eva ; Reppas, Christos ; Vrettos, Napoleon-Nikolaos ; Hanley, Sarah ; Miyaji, Yoshihiro

During the OrBiTo project, our knowledge on the gastrointestinal environment has improved substantially and biorelevant media composition have been refined. The aim of this study was to propose optimized biorelevant testing conditions for modified release products, to evaluate the reproducibility of the optimized compendial apparatus III (USP apparatus III) and compendial apparatus IV (USP apparatus IV, open-loop mode) dissolution methods and to evaluate the usefulness of these methods to forecast the direction of food effects, if any, based on the results of two «ring» studies and by using two model modified release (MR) products, Ciproxin / Cipro XR and COREG CR. Six OrBiTo partners participated in each of the ring studies. All laboratories were provided with standard protocols, pure drug substance, and dose units. For the USP apparatus III, the dissolution methods applied to Ciproxin / Cipro XR, a monolithic MR product of an active pharmaceutical ingredient (API) with moderate aqueous solubility, were robust with low intra- and inter-laboratory data variability. Data from all partners were in line on a qualitative basis with food effect data in humans. For the USP apparatus IV, the dissolution methods applied to COREG CR, a multiparticulate, pH dependent, MR product of an API with low and pH dependent solubility led to high intra- and inter- laboratory data variability. Data from all partners were in line, on a qualitative basis, with the previously observed food effects in humans.

2020-08-01·Poultry science2区 · 农林科学

Effects of laying breeder hens dietary β-carotene, curcumin, allicin, and sodium butyrate supplementation on the jejunal microbiota and immune response of their offspring chicks

2区 · 农林科学

ArticleOA

作者: Lan, H N ; Gong, H Z ; Zheng, X ; Li, D ; Lang, W Y ; Wu, M ; Wang, J H ; Wang, T P ; Chu, Q R ; Fan, Y Y

Our long-term goal is to improve chick health and reduce the use of antibiotics in the poultry industry via maternal effects. To link jejunal microbes with chicks' different immune levels and growth performance in our previous research, this study investigated jejunal microbes, jejunal inflammation, and immune responses based on a comparison between different groups. Newly hatched Hy-Line chicks were allotted into 3 groups: a chick control group (cCON), a ciprofloxacin lactate treatment group (Cipro)-the chicks of the cCON and Cipro groups were hatched from laying breeder hens given a basal diet-and a 5-wk β-carotene, curcumin, allicin, and sodium butyrate supplementation group (cCCAB), wherein chicks hatched from laying breeder hens. All groups were fed the same diet for 4 wk; the Cipro group was given ciprofloxacin lactate in drinking water continuously. At the end of the experiment, the results demonstrated that the jejunal microbes of the Cipro group showed significant changes in alpha and beta diversity, and in taxonomy at phylum and genus levels. Statistically, a total of 67 significantly enriched (P < 0.05) taxa were identified between groups by linear discriminant analysis effect size; Firmicutes was significantly enriched (P < 0.05) in the cCCAB group, 65 taxa were significantly enriched (P < 0.05) in the Cipro group, and 32 of the 65 enriched (P < 0.05) taxa were in the Proteobacteria phylum of the Cipro group. Levels of lipopolysaccharide in jejunal content, and nuclear factor kappa-B, and tumor necrosis factor-α in jejunums of the Cipro and cCCAB groups were increased (all P < 0.05) compared to those in the cCON group. There was obvious neutrophil infiltration and upregulated (all P < 0.05) IL-6 mRNA in the Cipro group jejunums compared to the cCON and cCCAB groups. The expression of PSME3 and PSME4 genes was upregulated (all P < 0.05) in the cCCAB group compared to the cCON and Cipro groups. In conclusion, ciprofloxacin lactate administration led to potential hazards in health and growth in chicks via microbial disturbances-induced jejunal inflammation, and laying breeder hens dietary supplementation with β-carotene, curcumin, allicin, and sodium butyrate could enhance jejunal immunity of their offspring via the interaction between host innate immunity selected microbial colonization and microbiota educated adaptive immunity.

2020-01-01·Poultry science2区 · 农林科学

Effects of laying breeder hens dietary β-carotene, curcumin, allicin, and sodium butyrate supplementation on the growth performance, immunity, and jejunum morphology of their offspring chicks

2区 · 农林科学

ArticleOA

作者: Gong, H Z ; Zhang, Y ; Wang, Y Q ; Yang, M ; Zheng, X ; Wang, J H ; Lang, W Y ; Wu, M

This study evaluated the growth performance, immunity, and jejunum morphology of chicks hatched from laying breeder hens given dietary additive supplementation, as well as chicks receiving direct antibiotic supplementation in early life. Hy-line breeder hens were allotted to 2 groups with 3 replicates. A control group (CON) was fed a basal diet, and the treatment group (CCAB) received β-carotene, curcumin, allicin, and sodium butyrate in addition to basal diet for 5 wk. Breeder-hen eggs were collected and hatched. The chicks hatched from the CON group were assigned to 2 treatments: a chick control group (cCON) and a chick treatment group (Cipro) given ciprofloxacin lactate into drinking water; the cCON group, Cipro group, and the chicks hatched from the CCAB group (cCCAB) were fed the same diet for 4 wk. The results demonstrated that there were significant differences between the CON and CCAB groups in the serum levels of IgA, IgG, IgM (triple P < 0.01), lysozyme (P < 0.05), and β-defensin (P < 0.05). The body weights of the cCCAB group's chicks increased at 1, 7, and 28 D of age (P < 0.05, P < 0.05, P < 0.01, respectively), and those of the Cipro group's chicks increased at 7 and 21 D of age (P < 0.01, P < 0.05). The tibial lengths of the cCCAB group's chicks increased at 1, 7, 14, 21, and 28 D of age (P < 0.01, P < 0.05, triple P < 0.01), and the lengths in the Cipro group increased at 7 and 14 D of age (P < 0.01, P < 0.01). Intestinal development, including intestinal length, jejunum morphology, and IgA positive cells, helps to explain these results. The breeder eggs from the CCAB group had higher IgG (P < 0.05) and IgM (P < 0.05) levels in the egg whites and higher IgA, IgG, and IgM levels (triple P < 0.01) in the egg yolks. In conclusion, β-carotene, curcumin, allicin, and sodium butyrate supplementation of laying breeder hen diets produced more advantages in growth performance and intestinal development in offspring than in chicks directly supplemented with antibiotics.

项与乳酸环丙沙星相关的新闻（医药）

2024-08-28

·米内网

【重磅】科伦爆发了！今年28个产品获批过评，39个产品申报

精彩内容 8月27日，国家药监局官网显示，科伦药业申报的3类仿制药布比卡因脂质体注射液获批生产并视同过评，为国内第2家。今年以来，科伦药业有28个品种获批过评/视同过评，目前累计过评品种数超过160个，47个品种在国采中顺利中标；此外，今年以来，公司有39个品种申报：包括33个仿制药和1款2.2类新药报产，5个品种提交一致性评价补充申请等。国内第2家！科伦药业拿下高端注射剂布比卡因是一种酰胺类局部麻醉药，临床上主要用于局部浸润麻醉、外周神经阻滞、椎管内阻滞等。目前国内已获批上市的布比卡因制剂有盐酸布比卡因注射液、布比卡因脂质体注射液两种，其中，布比卡因脂质体注射液仅恒瑞医药、科伦药业拥有生产批文。国内已获批上市的布比卡因制剂来源：米内网一键检索米内网数据显示，近年来布比卡因注射剂在中国城市公立医院、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）终端的销售额均以两位数的增速持续增长，2023年超过2.5亿元，同比增长12.75%。近年来中国公立医疗机构终端布比卡因注射剂销售情况（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布比卡因作为临床常用术后多模式镇痛的局麻药，疗效确切不良反应小，但镇痛疗效仅能维持不足8小时，单次用药无法满足临床需求。布比卡因脂质体注射液采用先进的多囊脂质体缓释技术，众多微小脂质囊泡逐一破裂释放药物，从而实现单次给药即能达到72小时的超长效镇痛效果，弥补了临床对持久安全镇痛且医疗操作简便的术后镇痛需求。近年来，国内手术数量不断增长驱动了术后镇痛药物的需求提升。布比卡因脂质体注射液潜在市场可观，且研发壁垒决定了其良好的竞争格局，商业化前景富有潜力。 28个品种获批过评！累计160余个过评品种亮眼近年来，科伦药业仿制药产品线进入密集收获期，获批产品数呈逐年递增态势，建立起公司在肠外营养、细菌感染及体液平衡等疾病领域产品集群，并逐步强化麻醉镇痛、生殖健康、中枢神经及其他慢病领域的产品管线，涵盖了粉液双室袋、肠外营养液液多室袋、载药脂肪乳等系列特色技术产品。 2024年以来，科伦药业有28个品种过评或视同过评，其中19个品种以新注册分类报产获批而视同过评，9个品种以补充申请方式过评。此外，还有13项原料药获批上市。 2024年以来科伦药业过评情况来源：米内网数据库、公司公告多个品种为国内首批上市，其中注射用美罗培南/氯化钠注射液、ω-3甘油三酯（2%）中/长链脂肪乳/氨基酸（16）/葡萄糖（16%）注射液、艾曲泊帕乙醇胺片为国内首仿，布比卡因脂质体注射液、奥拉帕利片为国产第2家，麦考酚钠肠溶片为国产第3家，复方氨基酸注射液（18AA-Ⅶ）为国产第4家等。注射用美罗培南/氯化钠注射液为科伦药业粉液双室袋平台第7个获批的产品，米内网数据显示，2023年中国三大终端六大市场（统计范围详见本文末）美罗培南注射剂销售额超过33亿元；ω-3甘油三酯（2%）中/长链脂肪乳/氨基酸（16）/葡萄糖（16%）注射液为公司获批的第7款肠外营养三腔袋产品，此前获批的6款产品大多数为国产首个获批；艾曲泊帕是全球首个获批上市的小分子非肽类TPO-R激动剂，2023年原研药全球销售额超过22亿美元。此外，瑞戈非尼片、麦考酚钠肠溶片、盐酸乌拉地尔注射液等品种2023年在中国三大终端六大市场的销售额均超过10亿元。截至目前，科伦药业有超过160个品种过评或视同过评，涵盖12个治疗大类，主要集中在全身用抗感染药物、血液和造血系统药物、抗肿瘤和免疫调节剂、消化系统及代谢药等治疗领域。丰富的过评产品集群让科伦药业在国采中收获颇丰。在已开展的八批九轮化药集采中，公司分别有1个、5个、4个、4个、11个、11个、7个、4个品种成功中选，累计47个品种。随着集采常态化推进，科伦药业已跻身集采头部供应商之列。 33个品种瞄准超140亿市场，10个首仿蓄势待发今年以来，科伦药业在产品申报方面也高歌猛进：33款仿制药以新注册分类报产，2.2类新药布瑞哌唑口溶膜申报上市，3类仿制药布立西坦片申报临床且获批临床，5个品种提交一致性评价补充申请。此外，登记了9项原料药。 2024年以来科伦药业申报上市的品种来源：米内网中国申报进度（MED）数据库以新注册分类报产的33个品种2023年在中国三大终端六大市场的销售额合计超过140亿元，包括罗沙司他胶囊、结构脂肪乳注射液(C6～24)、左氧氟沙星氯化钠注射液、低钙腹膜透析液（乳酸盐-G1.5%）等超10亿大品种。其中，有10个品种暂无首仿（含剂型首仿）获批，包括吗啉硝唑氯化钠注射液、恩扎卢胺片、盐酸纳呋拉啡口崩片、布瑞哌唑口崩片、布瑞哌唑片、枸橼酸西地那非口溶膜、洛索洛芬钠贴剂等。 2.2类新药布瑞哌唑口溶膜是一款口溶膜产品，目前国内暂无企业拥有该产品生产批文。在口溶膜赛道上，科伦药业已有枸橼酸西地那非口溶膜、昂丹司琼口溶膜、布瑞哌唑口溶膜3款产品报产，盐酸鲁拉西酮口溶膜、盐酸达泊西汀口溶膜2款产品获批临床，研发进度及速度在国内靠前。注射用氨曲南、盐酸布比卡因注射液、注射用苯唑西林钠、乳酸环丙沙星氯化钠注射液、硫酸阿米卡星注射液5个品种提交一致性评价补充申请，其中注射用苯唑西林钠2023年在中国三大终端六大市场的销售额超过20亿元，目前仅2家企业过评。结语自2012年转型至今，科伦药业已成功实现了从单纯大输液到全面、综合、内涵发展的蜕变。经过多年布局，公司转型成果显著，产品管线日益丰硕，未来发展值得期待! 资料来源：米内网数据库、国家药监局官网等注：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。数据统计截至8月27日，如有疏漏，欢迎指正！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

一致性评价上市批准

2024-06-24

·信狐药迅

仿制药申请12个品规、进口上市4个品规发通知件；临床申请品种均默示许可| 新获批（6.17-6.23）

每周药品注册获批数据，分门别类呈现，一目了然。(6.17-6.23）新药上市申请药品名称企业注册分类受理号TQ-B3139胶囊正大天晴药业集团南京顺欣制药有限公司1CXHS2200026国;CXHS2200026TQ-B3139胶囊正大天晴药业集团南京顺欣制药有限公司1CXHS2200025国;CXHS2200025TQ-B3139胶囊正大天晴药业集团南京顺欣制药有限公司1CXHS2200024国;CXHS2200024甲磺酸奥瑞替尼片南京圣和药业股份有限公司1CXHS2101058国;CXHS2101058 新药临床申请药品名称企业注册分类受理号HRS-9813片广东恒瑞医药有限公司1CXHL2400397HRS-9813片广东恒瑞医药有限公司1CXHL2400396PZH2113 胶囊漳州片仔癀药业股份有限公司1CXHL2400372PZH2113 胶囊漳州片仔癀药业股份有限公司1CXHL2400371WD-890片浙江文达医药科技有限公司1CXHL2400361WD-890片浙江文达医药科技有限公司1CXHL2400360WD-890片浙江文达医药科技有限公司1CXHL2400359WD-890片浙江文达医药科技有限公司1CXHL2400358ZX-8177片南京征祥医药有限公司1CXHL2400347ZX-8177片南京征祥医药有限公司1CXHL2400346西奥罗尼胶囊深圳微芯生物科技股份有限公司1CXHL2400342西奥罗尼胶囊深圳微芯生物科技股份有限公司1CXHL2400341RS-C1001片青岛睿森生物科技有限公司1CXHL2400340RS-C1001片青岛睿森生物科技有限公司1CXHL2400339PH009-1片苏州浦合医药科技有限公司1CXHL2400336PH009-1片苏州浦合医药科技有限公司1CXHL2400335CS060304片凯思凯迪(上海)医药科技有限公司1CXHL2400334CS060304片凯思凯迪(上海)医药科技有限公司1CXHL2400333CS060304片凯思凯迪(上海)医药科技有限公司1CXHL2400332CS060304片凯思凯迪(上海)医药科技有限公司1CXHL2400331HRS-7249注射液上海拓界生物医药科技有限公司1CXHL2400329BC-007默化(无锡)生物科技有限公司1CXHL2400326GFH375片劲方医药科技(上海)有限公司1CXHL2400328GFH375片劲方医药科技(上海)有限公司1CXHL2400327注射用WP1302百明信康生物技术(浙江)有限公司1CXHL2400318洛索洛芬钠凝胶贴膏海南赛立克药业有限公司4CYHL2400073注射用BL-M17D1成都百利多特生物药业有限责任公司1CXSL2400237重组抗HER3人源化单抗注射液上海生物制品研究所有限责任公司1CXSL2400232注射用LM-2417礼新医药科技(上海)有限公司1CXSL2400223AK129注射液康方汇科(上海)生物有限公司1CXSL2400220CM355北京天诺健成医药科技有限公司1CXSL2400217IMC-002宜明凯尔生物医药技术(上海)有限公司1CXSL2400219IMC-002宜明凯尔生物医药技术(上海)有限公司1CXSL2400216注射用SKB518四川科伦博泰生物医药股份有限公司1CXSL2400215注射用MK-2870默沙东研发(中国)有限公司1CXSL2400214司美格鲁肽注射液正大天晴药业集团股份有限公司3.3CXSL2400241司美格鲁肽注射液正大天晴药业集团股份有限公司3.3CXSL2400240LPS-001注射液乐普药业股份有限公司3.3CXSL2400231QL2108注射液齐鲁制药有限公司3.3CXSL2400221泰它西普注射液荣昌生物制药(烟台)股份有限公司2.1;2.2CXSL2400213 仿制药申请药品名称企业注册分类受理号盐酸异丙肾上腺素注射液成都欣捷高新技术开发股份有限公司3CYHS2301346盐酸异丙肾上腺素注射液成都欣捷高新技术开发股份有限公司3CYHS2301345甲硫酸新斯的明注射液陕西丽彩药业有限公司3CYHS2300705甲硫酸新斯的明注射液陕西丽彩药业有限公司3CYHS2300704美索巴莫注射液南京赛瑞谱顿制药有限公司3CYHS2300368盐酸非索非那定干混悬剂济川药业集团有限公司3CYHS2201943国;CYHS2201943盐酸非索非那定干混悬剂济川药业集团有限公司3CYHS2201942国;CYHS2201942盐酸氨溴索滴剂丽彩甘肃西峰制药有限公司3CYHS2201844国;CYHS2201844盐酸氨溴索滴剂丽彩甘肃西峰制药有限公司3CYHS2201843国;CYHS2201843盐酸左沙丁胺醇雾化吸入溶液宏越科技(湖州)有限公司3CYHS2201800国;CYHS2201800盐酸左沙丁胺醇雾化吸入溶液宏越科技(湖州)有限公司3CYHS2201799国;CYHS2201799己酮可可碱注射液江西和盈药业有限公司3CYHS2201773国;CYHS2201773铝碳酸镁混悬液杭州民生健康药业股份有限公司3CYHS2201508国;CYHS2201508利伐沙班细粒剂浙江恒研医药科技有限公司3CYHS2201485国;CYHS2201485利伐沙班细粒剂浙江恒研医药科技有限公司3CYHS2201484国;CYHS2201484人纤维蛋白原广东双林生物制药有限公司3.4CXSS2300008醋酸阿托西班注射液湖南科伦制药有限公司4CYHS2303412醋酸阿托西班注射液湖南科伦制药有限公司4CYHS2303411氟比洛芬凝胶贴膏河北鼎泰制药有限公司4CYHS2302482氢溴酸伏硫西汀片石家庄龙泽制药股份有限公司4CYHS2302355磷酸奥司他韦胶囊安徽省先锋制药有限公司4CYHS2302241磷酸奥司他韦胶囊安徽省先锋制药有限公司4CYHS2302239注射用甲泼尼龙琥珀酸钠海南倍特药业有限公司4CYHS2302171鲑降钙素注射液海南紫程众投生物科技有限公司4CYHS2302116罗库溴铵注射液陕西金思铭生物技术有限公司4CYHS2302031罗库溴铵注射液陕西金思铭生物技术有限公司4CYHS2302030黄体酮阴道缓释凝胶浙江爱生药业有限公司4CYHS2301662硫酸氨基葡萄糖胶囊山东朗诺制药有限公司4CYHS2300975硫酸氨基葡萄糖胶囊药大制药有限公司4CYHS2300757乳酸环丙沙星氯化钠注射液江苏长江药业有限公司4CYHS2300644盐酸艾司洛尔氯化钠注射液石家庄四药有限公司4CYHS2300581左卡尼汀口服溶液浙江北生药业汉生制药有限公司4CYHS2300528麦考酚钠肠溶片四川科伦药业股份有限公司4CYHS2300453复方电解质注射液广东科伦药业有限公司4CYHS2300379复方电解质注射液广东科伦药业有限公司4CYHS2300378尼莫地平注射液四川汇宇制药股份有限公司4CYHS2300281布南色林片合肥英太制药有限公司4CYHS2300237富马酸喹硫平缓释片山东京卫制药有限公司4CYHS2300181左西孟旦注射液海南倍特药业有限公司4CYHS2300170精氨酸布洛芬颗粒海南葫芦娃药业集团股份有限公司4CYHS2300159氯苯唑酸葡胺软胶囊齐鲁制药有限公司4CYHS2300076尼莫地平注射液北京柏雅联合药物研究所有限公司4CYHS2300056利托那韦片海南先声药业有限公司4CYHS2300046骨化三醇注射液成都国为生物医药有限公司4CYHS2201941国;CYHS2201941他达拉非片河南比福制药股份有限公司4CYHS2201830国;CYHS2201830磷酸奥司他韦胶囊山东新时代药业有限公司4CYHS2201767国;CYHS2201767磷酸奥司他韦胶囊山东新时代药业有限公司4CYHS2201766国;CYHS2201766磷酸奥司他韦胶囊山东新时代药业有限公司4CYHS2201765国;CYHS2201765罗库溴铵注射液江苏正大清江制药有限公司4CYHS2201743国;CYHS2201743甲泼尼龙片辰欣药业股份有限公司4CYHS2201704国;CYHS2201704贝前列素钠片重庆药友制药有限责任公司4CYHS2201706国;CYHS2201706孟鲁司特钠咀嚼片海南葫芦娃药业集团股份有限公司4CYHS2201672国;CYHS2201672孟鲁司特钠咀嚼片海南葫芦娃药业集团股份有限公司4CYHS2201671国;CYHS2201671注射用氯诺昔康广州曼翔医药有限公司4CYHS2201418国;CYHS2201418普瑞巴林胶囊江苏恩华药业股份有限公司4CYHS2201265国;CYHS2201265结构脂肪乳注射液(C6-24)四川国瑞药业有限责任公司4CYHS2201238国;CYHS2201238富马酸丙酚替诺福韦片温岭市创新生物医药科技股份有限公司4CYHS2200916国;CYHS2200916醋酸奥曲肽注射液四川汇宇制药股份有限公司4CYHS2200889国;CYHS2200889普瑞巴林胶囊山东新华制药股份有限公司4CYHS2200880国;CYHS2200880普瑞巴林胶囊山东新华制药股份有限公司4CYHS2200879国;CYHS2200879富马酸伏诺拉生片宜昌人福药业有限责任公司4CYHS2200735国;CYHS2200735富马酸伏诺拉生片宜昌人福药业有限责任公司4CYHS2200734国;CYHS2200734磷酸西格列汀片苏州天马医药集团天吉生物制药有限公司4CYHS2200560国;CYHS2200560磷酸西格列汀片苏州天马医药集团天吉生物制药有限公司4CYHS2200559国;CYHS2200559磷酸西格列汀片苏州天马医药集团天吉生物制药有限公司4CYHS2200558国;CYHS2200558左乙拉西坦口服溶液湖南嘉恒制药有限公司4CYHS2200388国;CYHS2200388 进口申请药品名称企业注册分类受理号磷酸芦可替尼片Novartis Pharma Schweiz AG5.1JXHS2300054盐酸卡马替尼片Novartis Pharma Schweiz AG5.1JXHS2300024盐酸卡马替尼片Novartis Pharma Schweiz AG5.1JXHS2300023亚甲蓝肠溶缓释片Alfasigma S.p.A.5.1JXHS2300021爱塔乐伦颗粒口服干混悬剂PTC Therapeutics International Limited5.1JXHS2200031国;JXHS2200031爱塔乐伦颗粒口服干混悬剂PTC Therapeutics International Limited5.1JXHS2200030国;JXHS2200030爱塔乐伦颗粒口服干混悬剂PTC Therapeutics International Limited5.1JXHS2200029国;JXHS2200029地拉罗司颗粒MSN Laboratories Private Limited5.2JYHS2200036国;JYHS2200036地拉罗司颗粒MSN Laboratories Private Limited5.2JYHS2200035国;JYHS2200035注射用多黏菌素E甲磺酸钠Xellia Pharmaceuticals ApS5.2JYHS2101061国;JYHS2101061利奈唑胺葡萄糖注射液北京费森尤斯卡比医药有限公司5.2JYHS2000050国;JYHS2000050BAY 2862789口服溶液Bayer AG1JXHL2400081Bomedemstat胶囊Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.1JXHL2400080Bomedemstat胶囊Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.1JXHL2400079Bomedemstat胶囊Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.1JXHL2400078Bomedemstat胶囊Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.1JXHL2400077Capivasertib片AstraZeneca AB2.4JXHL2400087Capivasertib片AstraZeneca AB2.4JXHL2400086VAY736注射液Novartis Pharma AG1JXSL2400070BAY 3018250Bayer AG1JXSL2400068帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSL2400074Ravulizumab注射液Alexion Pharmaceuticals Inc.3.1JXSL2400075 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

2024-04-17

·米内网

【瞩目】10亿注射剂，四川药企获批了

精彩内容4月16日，NMPA官网显示，四川美大康佳乐药业的盐酸乌拉地尔注射液获批上市并视同过评。盐酸乌拉地尔注射液为静脉降压药，2022年在中国公立医疗机构终端销售额超过10亿元。乌拉地尔是由武田研发的一种选择性α1受体阻滞剂，具有外周和中枢双重降压作用。盐酸乌拉地尔注射液主要适用于高血压危象以及控制围手术期高血压，在临床上应用甚广，是急诊室常备急救药品之一。米内网数据显示，2022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）终端盐酸乌拉地尔注射液销售额超过10亿元，2023年上半年其销售额超过5亿元，同比增长8.77%。中国公立医疗机构终端盐酸乌拉地尔注射液销售情况（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此前国内已有16家企业获得了盐酸乌拉地尔注射液的生产批文，包括西安利君制药、罗欣药业、河北一品制药、锦州奥鸿药业、石家庄四药、青峰药业等，四川美大康佳乐药业为该药国产第17家。该药还有科伦药业、正大丰海、天方药业等20家企业的上市申请在审中。四川美大康佳乐药业于2001年在成都市高新技术开发区西区注册成立，是一家以新药研发、液体制剂生产销售为主的综合性现代制药企业。四川美大康佳乐药业过评品种来源：米内网一致性评价进度数据库目前，四川美大康佳乐药业已有9款注射剂过评，包括盐酸乌拉地尔注射液、甘油果糖氯化钠注射液、甲磺酸帕珠沙星氯化钠注射液、伊班膦酸钠注射液、盐酸替罗非班氯化钠注射液、利奈唑胺葡萄糖注射液、多西他赛注射液、乳酸环丙沙星氯化钠注射液、碳酸氢钠林格注射液等。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。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

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