The study team proposes a randomized, double-blind, RCT to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic ondansetron. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs. Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time. The outcome for the efficacy analysis will be no need for additional medication to treat nausea and vomiting within 2 hours of investigational medication administration. The primary outcome for the tolerability analysis will be the development of any new symptom within 2 hours of medication administration.

开始日期2024-10-01

申办/合作机构

Montefiore Medical Center

ChiCTR2400088071 / Suspended临床4期IIT

The Effect of Fosaprepitant on Postoperative Delirium and Sleep Quality in Elderly Gynecological Laparoscopic Surgery Patients: A Prospective Randomized Controlled Study

开始日期2024-08-10

申办/合作机构-

CTRI/2023/12/060941 / Not yet recruiting临床3期

Anti-Emetic Prophylaxis for Chemotherapy-Induced Nausea and Vomiting with Fosaprepitant for Children and Adolescents Receiving Moderately Emetogenic Chemotherapy: An Investigator-Initiated, Double-blinded, Superiority, Phase III Randomized Controlled Trial. - CIVIC MAN

开始日期2024-02-01

申办/合作机构

Cancer Institute (WIA)

100 项与福沙匹坦双葡甲胺相关的临床结果

登录后查看更多信息

100 项与福沙匹坦双葡甲胺相关的转化医学

登录后查看更多信息

100 项与福沙匹坦双葡甲胺相关的专利（医药）

登录后查看更多信息

246

项与福沙匹坦双葡甲胺相关的文献（医药）

2024-11-01·JOURNAL OF PHARMACOLOGICAL SCIENCES

Effect of antiemetics on zolbetuximab-induced gastric injury and emesis in ferrets

Article

作者: Nagata, Masanori ; Nakazawa, Taisuke ; Ugawa, Tohru ; Yamanaka, Yosuke ; Kinugasa, Fumitaka ; Kajikawa, Satoru ; Akuzawa, Shinobu ; Haggerty, Gillian ; Weng, Jane ; Fushiki, Hiroshi ; Sawamoto, Taiji ; Suzuki, Hiroshi

Claudin-18 splice variant 2 (CLDN18.2), a tight junction protein, is a highly cell type-specific antigen that is expressed by differentiated gastric mucosa cells. The expression of CLDN18.2 in gastric mucosa cells may be retained upon malignant transformation and is displayed on the surface of several tumors, including gastric/gastroesophageal junction adenocarcinoma. Zolbetuximab is a genetically engineered, highly purified chimeric (mouse/human IgG1) antibody directed against CLDN18.2. Nausea and vomiting were observed as adverse events of zolbetuximab. To investigate the mechanism of nausea and vomiting in humans, we evaluated emesis (retching and vomiting) and conducted histopathologic assessment in ferrets after the administration of zolbetuximab. Emesis was frequently observed in all ferrets treated with zolbetuximab in the first hour after administration. Histopathologic assessment revealed the surface of the gastric mucosa was the primary site of emesis-associated tissue damage. The effect of antiemetics (dexamethasone, ondansetron, fosaprepitant, and olanzapine) on emesis induced by zolbetuximab was investigated. Fosaprepitant showed suppressive effects on emesis, and use of dexamethasone or concomitant use of fosaprepitant with other antiemetics tended to alleviate gastric tissue damage. The onset of emesis in humans receiving zolbetuximab may be associated with damage in the gastric mucosa, and antiemetics may mitigate gastrointestinal adverse events.

2024-11-01·TOXICOLOGY AND APPLIED PHARMACOLOGY

Fosaprepitant improves cyclophosphamide-induced bladder damage by alleviating inflammatory response in mice

Article

作者: Yesilbas Aksel, Yaren ; Aksel, Yaren Yeşilbaş ; Barut, Elif Nur ; Engin, Seckin

Inhibition of inflammatory process is a key therapeutic target for the treatment of interstitial cystitis (IC). Recent reports indicate that neurokinin 1 receptor (NK1R) antagonists have beneficial roles in inflammatory-based diseases. Herein, we investigate the protective effects of fosaprepitant (FOS), a NK1R antagonist, in cyclophosphamide (CP)-induced cystitis. The cystitis model was established multiple CP (80 mg/kg; i.p.) injection one day apart, and mice were treated with FOS (20 and 60 mg/kg/day; i.p.) for seven consecutive days. Detrusor contractility, vesical vascular permeability, myeloperoxidase (MPO) activity and protein expression levels of the TLR4 pathway were evaluated in mice bladder. Carbachol and electric field stimulation-evoked contractions of detrusor strips were significantly increased in CP-treated mice, which was significantly attenuated by FOS (60 mg/kg/day) treatment (p<0.001, p<0.05). Notably, vesical vascular permeability was markedly impaired in CP-induced cystitis, that was restored by FOS (60 mg/kg/day) treatment (p<0.01). MPO activity was significantly increased in cystitis group whereas FOS (20 and 60 mg/kg/day) treatment remarkably suppressed MPO activity in bladder tissue (p<0.001). Although TLR4 expression increased with cystitis, MyD88 and p-NFκB^Ser536/total NFκB did not change, FOS (20 and 60 mg/kg/day) treatment caused a dramatic decrease in TLR4 expression (p<0.001), indicating the anti-inflammatory effect of FOS. In conclusion, FOS improved detrusor overactivity and inflammatory response by inhibiting MPO activity and TLR4 expression, resulting in functional and histological recovery in CP-induced cystitis.

2024-09-01·ECOLOGICAL APPLICATIONS

Functional responses of understory plants to natural disturbance‐based management in eastern and western Canada

Article

作者: Noualhaguet, Marion ; Fenton, Nicole J. ; Nock, Charles A. ; Aubin, Isabelle ; Macdonald, S. Ellen ; Work, Timothy T.

Abstract:

Natural disturbance‐based management (NDBM) is hypothesized to maintain managed forest ecosystem integrity by reducing differences between natural and managed forests. The effectiveness of this approach often entails local comparisons of species composition or diversity for a variety of biota from managed and unmanaged forests. Understory vegetation is regularly the focus of such comparison because of its importance in nutrient cycling, forest regeneration, and for wildlife. However, larger scale comparisons between regions with distinct species assemblages may require a trait‐based approach to better understand understory responses to disturbance. We compared the long‐term effects of retention harvesting on understory vegetation in two large experimental study sites located in eastern and western regions of the Canadian boreal forest. These sites included the Sylviculture en Aménagement Forestier Ecosystémique (SAFE) experiment and the Ecosystem Management Emulating Natural Disturbance (EMEND) experiment, located in the eastern and western regions of Canada, respectively. EMEND and SAFE share common boreal understory species but have distinct tree communities, soils, and climate. Both experiments were designed to evaluate how increasing tree retention after harvest affects biodiversity. Here, we examined taxonomic richness, functional diversity, and functional composition (using community trait mean values) of understory plant communities, and also examine intraspecific trait variability (ITV) for five species common and abundant in both experiments. We observed the limited impacts of retention level on richness, functional diversity, and functional composition of understory plants 20 years postharvest. However, ITV of leaf morphological traits varied between retention levels within each experiment, depending on the species identity. Common species had different functional responses to retention level, showing species‐specific reactions to environmental variation. Our result suggests that understory plant communities in the boreal forest achieve resilience to disturbance both in terms of interspecific and intraspecific functional trait diversity. Such diversity may be key to maintaining understory biodiversity in the face of future disturbances and environmental change. Our results reveal the significance of ITV in plant communities for understanding responses to forest harvesting and the importance of choosing appropriate traits when studying species responses to the environment.

100

项与福沙匹坦双葡甲胺相关的新闻（医药）

2024-10-28

·米内网

【重磅】50亿注射剂，人福医药出手了

精彩内容 10月26日，人福医药发布公告称，控股子公司宜昌人福药业的司美格鲁肽注射液获批临床，注册分类为化学药品2.2类，目前全球尚无化学合成的司美格鲁肽产品上市。2023年在中国三大终端六大市场，原研的司美格鲁肽注射液（生物制品）销售额超过54亿元。表1：获批产品的情况来源：公司公告，米内网整理司美格鲁肽是一种长效人胰高血糖素样肽-1(GLP-1)受体激动剂，能够刺激胰岛素的生成，并抑制胰高血糖素分泌，同时降低食欲和食物摄入量，从而在治疗2型糖尿病和辅助体重管理方面发挥重要作用。本次人福医药获批临床的适应症为适用于成人2型糖尿病患者的血糖控制：在饮食控制和运动基础上，接受二甲双胍和/或磺脲类药物治疗血糖仍控制不佳的成人2型糖尿病患者；适用于降低伴有心血管疾病的2型糖尿病成人患者的主要心血管不良事件（心血管死亡、非致死性心肌梗死或非致死性卒中）风险。图1：司美格鲁肽注射液的销售情况（单位：万元）来源：米内网格局数据库原研的司美格鲁肽注射液由诺和诺德开发，为生物制品，2021年获批进入中国市场，同年谈判成功进入国家医保目录。 2023年在中国三大终端六大市场（统计范围见文末），司美格鲁肽注射液的销售额涨至54亿元以上，2024上半年该产品在公立医院终端（城市公立医院+县级公立医院）的销售额超过20亿元，在零售药店终端（城市实体药店+网上药店）的销售额也在10亿元以上，而在公立基层医疗终端（城市社区中心+乡镇卫生院）也有2亿元的销售额。目前全球尚无化学合成的司美格鲁肽产品上市，人福医药在该项目上的累计研发投入约为900万元。图2：人福医药已上市的糖尿病用药来源：米内网中国上市药品（MID）数据库米内网数据显示，人福医药已有1个糖尿病中成药和2个糖尿病化药获批上市，均为口服药，司美格鲁肽注射液有望成为公司在糖尿病领域首款注射剂，具有积极意义。表2：人福医药今年以来获批的新产品（按批文号统计）来源：米内网中国申报进度（MED）数据库今年以来，人福医药收获不断，已累计有14款新品获批，其中中药3.1类新药芍药甘草颗粒目前为独家产品，恩扎卢胺软胶囊是公司首款内分泌治疗用药，注射用福沙匹坦双葡甲胺是公司首款止吐药和止恶心药。 2022年至今，人福医药报产在审的产品还有37个，均为化药仿制药，随着新产品陆续获批进入市场，公司的产品矩阵将不断丰富，同时助力公司不断提升市场竞争力。资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；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10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 ●温馨提示● 因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下：【分享、点赞、在看】点一点不失联哦

上市批准医药出海

2024-10-10

·PRNewswire

Heron Therapeutics Reaffirms Availability and Ample Supply of CINVANTI®, SUSTOL®, and APONVIE® as Alternatives During the Potential Shortage of Intravenous Fluids

SAN DIEGO, Oct. 10, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today reaffirmed the Company's ability to supply CINVANTI® (aprepitant) injectable emulsion and SUSTOL® (granisetron) extended-release injection for Chemotherapy Induced Nausea and Vomiting ("CINV") prevention and APONVIE® for Postoperative Nausea and Vomiting ("PONV") prevention given the temporary shortage of intravenous ("IV") fluids which is expected as the result of Hurricane Helene. As alternatives to products that require dilution with IV fluids, CINVANTI, SUSTOL, and APONVIE are supplied in ready-to-administer formulations that do not require additional dilution with IV fluids in what may be a time of critical shortage. As widely reported, the potential disruption in the supply of intravenously administered fluids is a result of the temporary closure of a major suppliers' manufacturing site in Marion, North Carolina which was impacted by Hurricane Helene. The Marion facility is believed to supply up to 60% of the IV fluid market in the U.S. "In the wake of Hurricane Helene, and with the recently announced potential supply disruption for IV fluids, Heron has received outreach from several health systems preparing to maintain continuity of care," said Craig Collard, Chief Executive Officer of Heron. "Our team is committed to ensuring timely delivery of our products throughout the U.S. during the potential shortage of IV fluids as we understand the importance of preventing CINV and PONV for both patients and providers." CINVANTI, SUSTOL, and APONVIE are available through major wholesalers and specialty distributors, and further information can be obtained by calling the Company's information line at 844-HERON11 (844-437-6611). About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection. Please see full prescribing information at . About SUSTOL for CINV Prevention SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron's Biochronomer® drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL's efficacy and safety in more than 2,000 patients with cancer. SUSTOL's efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy). Please see full prescribing information at . About APONVIE for Postoperative Nausea and Vomiting (PONV) APONVIE is a substance NK1 Receptor Antagonist (RA), indicated for the prevention of PONV in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron's approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023. Please see full prescribing information at . About Heron Therapeutics, Inc. Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit . Forward-looking Statements This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the potential market opportunities for APONVIE®, CINVANTI® and SUSTOL®. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law. Investor Relations and Media Contact: Ira Duarte Executive Vice President, Chief Financial Officer Heron Therapeutics, Inc. [email protected] 858-251-4400 SOURCE Heron Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期上市批准临床结果

2024-09-25

·米内网

奥赛康破局重生！首仿药大涨454%，5款重磅新品获批，9个爆款新药全力冲刺

精彩内容 2024上半年，奥赛康的净利润同比增长了147.71%，有券商预计公司全年有望扭亏为盈。近几年奥赛康加快了产品结构调整，猛攻创新药和高技术壁垒的新型仿制药，2021年获批的首仿药泊沙康唑注射液和地拉罗司分散片2024年Q1在重点省市公立医院终端大涨69.59%、453.9%，成绩喜人。目前，公司首款抗肿瘤化药1类新药利厄替尼片正在抓紧冲刺，首款生物药1类新药ASKB589注射液已在III期临床，奥赛康将进入新药丰收期。首仿药大涨454%，5款重磅新品获批了奥赛康是一家创新与研发驱动的医药制造企业，公司的药物治疗领域主要覆盖抗肿瘤、抗感染、慢性病及消化四大领域，据公司2024半年报数据显示，公司的抗肿瘤类占营收比例为36.23%，毛利率达92.08%，抗感染类占28.08%，毛利率达81.66%，慢性病类占16.84%，毛利率达73.97%，消化类占15.79%，毛利率达72.07%。表1：奥赛康2024年Q1产品TOP20中正增长的产品来源：米内网重点省市公立医院药品终端竞争格局米内网数据显示，2024年Q1在重点省市公立医院终端，奥赛康TOP20产品中有13个呈正增长态势：抗肿瘤和免疫调节剂占了5个，其中多西他赛注射液和甲磺酸仑伐替尼胶囊分别增长了80.28%、97.42%；消化系统及代谢药占了4个，其中沙格列汀片和注射用多黏菌素E甲磺酸钠（国产第二家获批）分别增长了56.83%、72.16%；全身用抗感染药物占了2个，2021年获批的泊沙康唑注射液为国内首仿，2024年Q1增长了69.59%；同在2021年获批的地拉罗司分散片也是国内首仿，2024年Q1增长了453.90%。图1：2024年以来奥赛康获批的新产品来源：米内网中国上市药品（MID）数据库近几年，奥赛康优选首批首仿、独家品种、高壁垒复杂制剂进行开发，不断丰富公司传统优势领域抗肿瘤、消化道治疗用药和新崛起的抗感染和慢性病用药，构建并强化了公司特色的仿制药产品组群。今年以来，公司有1款新药及4款仿制药新品获批，注射用右兰索拉唑是公司首个获批的2类改良型新药，是公司在PPI优势产品组群基础上的升级产品，进一步增强公司在消化领域的市场竞争力。在首仿药方面，注射用硫酸艾沙康唑用于成人侵袭性毛霉病患者和侵袭性曲霉病患者治疗，进一步丰富公司抗感染产品组群，艾曲泊帕乙醇胺片用于治疗既往对糖皮质激素、免疫球蛋白等治疗反应不佳的慢性免疫性（特发性）血小板减少症（ITP）。首款抗肿瘤化药1类新药冲刺，8款新药全力推进 2024上半年奥赛康的研发投入超过1.8亿元，同比有所减少，主要由于部分新药已完成研发投入较大的关键性临床研发阶段，无需继续进行大规模研发投入。表2：奥赛康申报上市并在审的仿制药新品来源：米内网中国申报进度（MED）数据库今年以来，奥赛康陆续提交了3个仿制药新品的上市申请，目前共有6个高端仿制药报产在审。德拉沙星是新一代广谱氟喹诺酮抗菌素，用于急性细菌性皮肤及皮肤结构感染（ABSSSI）和社区获得性细菌性肺炎（CABP），该品种相关产品暂未在国内市场上市销售。据悉，早前奥赛康对原研企业梅琳塔申请了三篇中国制剂专利提起专利无效请求，并于2021年10月获得国家知识产权局判定专利无效的审查决定。奥赛康是首家提交注射用德拉沙星仿制上市申请的国内药企，如能顺利拿下首仿，有望享有一定的市场独占期，也为公司的抗感染产品组群再添一员猛将。表3：奥赛康部分在研的重磅新药来源：米内网中国临床试验数据库、公司半年报奥赛康的创新药布局涉及化学药和生物药，抢攻抗肿瘤、抗贫血、眼科、抗菌、关节和肌肉痛等热门领域。利厄替尼是具有全新分子结构的第三代EGFR抑制剂，目前第三代EGFR抑制剂已成为T790M突变的非小细胞肺癌的主流治疗方案。该新药是奥赛康首款申报上市的抗肿瘤化药1类新药，用于既往经EGFR-TKI治疗时或治疗后出现疾病进展，并且经检测确认存在EGFR T790M突变阳性的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的二线治疗于2021年申报上市，第二个适应症用于具有EGFR外显子19缺失或外显子21（L858R）置换突变的局部晚期或转移性NSCLC成人患者的一线治疗在今年8月申报上市，目前两个受理号均在审评审批中，值得期待。生物药1类新药方面，ASKB589注射液进展最快，该新药是一种抗体依赖性细胞毒性（ADCC）增强型第二代抗CLDN18.2人源化单克隆抗体，目前已进入III期临床阶段，2024年1月该项临床研究完成了中国首例患者给药，有券商预测该新药未来有望成为30亿级的大品种。进口新药方面，麦芽酚铁胶囊是奥赛康引进的口服补铁产品，用于治疗成人铁缺乏。该新药是近年来国际市场上市获批的唯一一款新型口服铁剂，临床研究证实该新药的补铁作用强，不良反应发生率低，生物利用度高且不易发生铁过载，对于现有口服铁制剂不耐受或治疗效果不佳的患者，麦芽酚铁胶囊是理想的替代药物。目前麦芽酚铁胶囊的国内临床已到了III期，有望成为公司业绩的新宠儿。 ASKG712注射液是同时靶向VEGF与ANG-2的双功能融合蛋白，该新药治疗新生血管性年龄相关性黄斑变性（nAMD）适应症正在开展IIa期临床研究，而治疗糖尿病性黄斑水肿（DME）也在I期临床阶段。 ASKC202片是一种新型、强效且高选择性的口服小分子c-Met抑制剂，拟与利厄替尼片联合用于治疗既往经EGFR-TKI治疗时或治疗后耐药，经检测确认存在MET基因异常或蛋白过表达的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的治疗。据悉，随着第三代EGFR-TKI治疗NSCLC的广泛应用，耐药现象日益凸显，ASKC202片与ASK120067片两药联合可能为EGFR-TKI耐药提供有效解决方案，延长非小细胞肺癌患者的生存期。 32个产品已过评，5个“光脚产品”备战第十批国采截至2024年9月24日，奥赛康已过评（含视同过评）的产品有32个，公司积极参与国家集中带量采购，从第四批到第九批国采（不含第六批胰岛素专项）已有13个产品中标。表4：奥赛康国采中标产品2024年Q1的市场情况来源：米内网重点省市公立医院药品终端竞争格局在重点省市公立医院终端，奥赛康已成为了沙格列汀片和注射用地西他滨的TOP1企业，成为了注射用艾司奥美拉唑钠、注射用替加环素、注射用替莫唑胺和盐酸左布比卡因注射液的TOP2企业，成为了注射用泮托拉唑钠和多西他赛注射液的TOP3企业。表5：竞争企业≥5家的产品来源：米内网中国公立医疗机构药品终端竞争格局目前奥赛康已过评且暂未纳入国采的产品中，有6个产品的竞争企业（原研+过评）≥5家。泊沙康唑注射液、哌柏西利胶囊、注射用盐酸罗沙替丁醋酸酯、艾曲泊帕乙醇胺片和注射用福沙匹坦双葡甲胺5个产品均为公司在2021-2024年按新分类获批的“光脚”产品，潜力大有可为。结语随着集采利空逐渐见底，创新转型不断迎来收获，奥赛康的业绩在今年迎来了重要的转折，2024年Q1公司营业收入达4.48亿元、净利润增长了145.99%，上半年营业收入达9.23亿元、净利润增长了147.71%，券商预计公司2024年全年营业收入将达16亿元，净利润增长有望超过120%，实现扭亏为盈。资料来源：米内网数据库、公司公告及半年报等注：米内网重点省市公立医院化学药终端竞争格局数据库是以20+省市，近700家样本省市公立医院的化学药采购数据为基础，对化学药全品类进行连续监测的样本省市样本医院数据库。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9月24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

财报临床3期上市批准

100 项与福沙匹坦双葡甲胺相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D06597	福沙匹坦双葡甲胺	A04AD12	DB06717

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
恶心	中国	江苏豪森药业集团有限公司	2019-09-29
呕吐	中国	江苏豪森药业集团有限公司	2019-09-29
化疗引起的恶心和呕吐	欧盟	Merck Sharp & Dohme BV	2008-01-11
化疗引起的恶心和呕吐	冰岛	Merck Sharp & Dohme BV	2008-01-11
化疗引起的恶心和呕吐	列支敦士登	Merck Sharp & Dohme BV	2008-01-11
化疗引起的恶心和呕吐	挪威	Merck Sharp & Dohme BV	2008-01-11

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
脑积水，心内膜纤维弹性增生和白内障	临床3期	中国	江苏豪森药业集团有限公司	2015-02-06
恶心和呕吐	临床3期	中国	江苏豪森药业集团有限公司	2015-02-06
术后恶心呕吐	临床3期	-	Merck Sharp & Dohme Corp.	2005-07-01
非小细胞肺癌	临床2期	美国	Merck Sharp & Dohme Corp.	2015-04-01
转移性黑色素瘤	临床2期	美国	Merck Sharp & Dohme Corp.	2013-09-01
转移性肾细胞癌	临床2期	美国	Merck Sharp & Dohme Corp.	2013-09-01
生殖细胞和胚胎肿瘤	临床2期	美国	Merck Sharp & Dohme Corp.	2013-01-01

登录后查看更多信息

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


ASCO2024	N/A	-	-	Fosaprepitant	鏇遞憲廠觸壓願襯簾鹹(糧憲衊淵蓋艱獵鑰鹹襯) = 艱艱積淵襯獵鏇艱夢壓廠憲獵鏇憲鏇顧蓋選壓 (糧衊範鹽積鹹鬱齋糧艱 )	不佳	2024-05-24
NCT03237611 (CTgov)	临床2期	化疗引起的恶心和呕吐	15	Ondansetron 16 MG+Aprepitant 125 mg+Dexamethasone+Fosaprepitant 115 MG	繭淵鹽鏇獵衊夢廠窪願(製選構鬱艱鹹糧選蓋鬱) = 製網範積廠夢觸遞夢鹽餘製憲鬱憲糧簾廠鬱願 (夢構餘製獵淵鬱鑰簾淵, 淵遞鏇壓齋淵製醖鹹襯 ~ 遞範鑰網積廠獵廠觸網) 更多	-	2023-11-13
NCT05564286 (Pubmed \| Support Care Cancer)	临床3期	-	116	Fosaprepitant, tropisetron, and dexamethasone	繭選獵築構築夢築顧夢(網醖鏇鑰鹹襯鹹壓繭鏇) = Fosaprepitant was well tolerated as the incidences of adverse events in the two groups were comparable 襯繭夢簾窪齋糧窪窪繭 (顧膚艱積鏇鑰壓憲鏇觸 ) 更多	积极	2023-11-01
				Tropisetron plus dexamethasone
FDA 人工标引	N/A	化疗引起的恶心和呕吐	2,322	FOCINVEZ+ondansetron+dexamethasone (Intravenous)	製蓋膚艱鬱艱積壓願獵(窪繭顧簾繭築憲鏇簾憲) = 鏇壓鏇窪鑰衊顧廠製選範憲觸襯製簾築選壓艱 (鏇構壓繭遞繭鏇糧範衊 ) 更多	积极	2023-08-22
				Aprepitant+ondansetron+dexamethasone (Oral)	製蓋膚艱鬱艱積壓願獵(窪繭顧簾繭築憲鏇簾憲) = 餘觸艱鏇艱鬱鏇夢顧鑰範憲觸襯製簾築選壓艱 (鏇構壓繭遞繭鏇糧範衊 ) 更多
FDA 人工标引	N/A	化疗引起的恶心和呕吐	1,000	FOCINVEZ+ondansetron+dexamethasone (Intravenous)	膚觸廠鏇獵淵窪簾繭餘(窪簾獵憲襯壓蓋糧願遞) = 齋遞選醖網製選築糧膚鑰顧膚衊製蓋選鑰鑰窪 (遞壓顧觸鹽鹽膚齋繭窪 ) 更多	积极	2023-08-22
				ondansetron+dexamethasone	膚觸廠鏇獵淵窪簾繭餘(窪簾獵憲襯壓蓋糧願遞) = 鏇鑰鑰壓餘襯製鏇願積鑰顧膚衊製蓋選鑰鑰窪 (遞壓顧觸鹽鹽膚齋繭窪 ) 更多
NCT03578081 (CTgov)	临床3期	恶心 \| 化疗引起的恶心和呕吐 \| 肿瘤 ... 更多	690	Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone+Fosaprepitant Dimeglumine (Arm I (Fosaprepitant Dimeglumine, Olanzapine))	壓簾糧膚艱範憲憲製構(淵鑰鹹糧襯齋積繭願構) = 艱選襯糧築鏇遞襯蓋繭範鏇積鏇鏇廠遞壓繭壓 (衊鏇鑰簾夢蓋蓋製鑰蓋, 製鏇衊築繭構壓夢製憲 ~ 鬱醖鹹網網淵壓糧顧鹹) 更多	-	2023-05-08
				Placebo+Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone (Arm II (Placebo, Olanzapine))	壓簾糧膚艱範憲憲製構(淵鑰鹹糧襯齋積繭願構) = 範觸夢顧範製遞膚觸網範鏇積鏇鏇廠遞壓繭壓 (衊鏇鑰簾夢蓋蓋製鑰蓋, 壓窪醖願製鬱獵願齋網 ~ 襯憲鏇鏇顧範鬱襯醖襯) 更多
NCT03197064 (CTgov)	临床4期	术后恶心呕吐	11	Fosaprepitant 150 mg	簾選蓋鏇糧醖衊鹹襯製(遞鬱鑰鹽餘繭範繭獵網) = 鏇襯憲窪膚範鹽鏇範製夢廠襯構蓋壓蓋糧鑰獵 (壓獵壓夢積遞壓構繭鹽, 餘齋膚積艱壓鏇壓糧膚 ~ 製網衊鹹遞蓋壓衊鬱衊) 更多	-	2022-07-18
NCT04054193 (0517-045 \| MK-0517-045, CTgov)	临床4期	恶心 \| 化疗引起的恶心和呕吐 \| 呕吐	103	5-HT3 antagonist+Dexamethasone+Fosaprepitant Dimeglumine	醖鏇願廠網積顧築淵製(獵網壓築餘醖鑰憲鬱網) = 繭製鏇夢構繭鹽觸鑰鹽構遞淵簾餘築簾積獵淵 (選衊獵網鏇艱鹽簾餘鹹, 顧窪願夢窪願鏇餘獵築 ~ 鏇襯窪鬱選顧獵糧選鹽) 更多	-	2021-09-23
CTRI/2017/02/007925 (ASCO2018)	临床3期	化疗引起的恶心和呕吐	135	Fosaprepitant	鹽鹹繭繭築糧糧壓壓獵(範夢顧襯願願繭艱憲廠) = 鹽餘顧淵選襯糧網鑰壓觸鏇餘獵鹽範鏇憲艱鬱 (鏇願膚餘膚鏇鏇築憲選 ) 更多	积极	2018-06-01
				Placebo	鹽鹹繭繭築糧糧壓壓獵(範夢顧襯願願繭艱憲廠) = 鏇簾簾選艱醖糧膚鹽餘觸鏇餘獵鹽範鏇憲艱鬱 (鏇願膚餘膚鏇鏇築憲選 ) 更多
NCT01874119 (HDIL2/Emend, CTgov)	临床2期	转移性肾细胞癌 \| 化疗引起的恶心和呕吐 \| 转移性黑色素瘤	13	Fosaprepitant (Fosaprepitant)	製構淵選窪廠範壓製網(襯艱網壓醖醖窪觸襯鹽) = 窪鏇膚蓋遞醖淵鬱網遞選選鏇積製鏇構選餘淵 (網淵糧選窪蓋廠膚窪憲, 製選網範壓範壓鹽衊鹽 ~ 夢製鬱餘憲鑰蓋製選鹽) 更多	-	2018-05-04
				Fosaprepitant (Placebo)	製構淵選窪廠範壓製網(襯艱網壓醖醖窪觸襯鹽) = 願製簾窪憲襯夢艱齋艱選選鏇積製鏇構選餘淵 (網淵糧選窪蓋廠膚窪憲, 繭鏇遞鹹窪構鹹夢壓簾 ~ 觸窪鹽襯鏇壓築顧願製) 更多