The study team proposes a double-blind, comparative effectiveness, randomized controlled trial (RCT) to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic metoclopramide. 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 emergency departments (EDs). Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time.

开始日期2025-06-01

申办/合作机构

Montefiore Medical Center

NCT06931119

/ Not yet recruiting临床1期

Aprepitant in the Management of Immune Checkpoint Inhibitors Pruritus: Pilot Study in Solid Cancer Patients

Pruritus, commonly known as itching, is an unpleasant sensation that triggers the urge to scratch, which may provide temporary relief. Pruritus can be intermittent or persistent, localized or widespread, and may be associated with medication use. Chronic pruritus, defined as lasting more than six weeks, can significantly affect sleep and quality of life.
Dermatologic toxicities are among the most common immune-related adverse events (irAEs), reported in 43-45% of patients receiving ipilimumab and approximately 34% of those treated with nivolumab or pembrolizumab. Combination therapies (ipilimumab+ nivolumab or pembrolizumab) tend to elevate the incidence of potential irAEs to 41%. These toxicities typically emerge within the first few weeks of treatment, though delayed-onset cases have been documented. Cutaneous irAEs occur more rapidly in patients receiving combination therapy compared to anti-PD1 monotherapy.
Pruritus is one of the most frequently observed cutaneous irAEs. Current treatments for pruritus are often inadequate, leaving many patients suffering from persistent and debilitating symptoms. Despite available therapies, a significant number of individuals continue to experience chronic itch that negatively impacts their quality of life. Substance P (SP) functions as a neurotransmitter and neuromodulator in the central and peripheral nervous systems of mammals. It is produced by both neuronal and non-neuronal cells and plays a role in various physiological responses, including nausea, depression, vomiting, pain, neurogenic inflammation, and, more recently, pruritus. SP exerts its biological effects primarily through neurokinin receptors (NKRs), also known as tachykinin receptors. When SP binds to NK1R in the skin, it triggers mast cell degranulation, leading to the release of pruritogenic and proinflammatory mediators such as histamine, interferon-γ, leukotriene B4, vascular endothelial growth factor (VEGF), and nerve growth factor (NGF). This results in vasodilation and neurogenic inflammation, manifesting clinically as pruritus, erythema, and edema. NK1R antagonists are a class of drugs with antiemetic, antidepressant, anxiolytic, and antipruritic properties, though they have not been effective as analgesics in humans. These drugs act centrally by crossing the blood-brain barrier and selectively blocking NK1R activation by SP in the central nervous system, particularly in vomiting centers. Aprepitant has also demonstrated efficacy in treating pruritus induced by anticancer therapies.
This study is a pilot, single-center open label study evaluating the safety and efficacy of single course of EMEND® (aprepitant) capsules (80mg +125mg) in treating pruritus (new onset and/or refractory) induced by immune checkpoint inhibitors in patients with solid tumors.

开始日期2025-05-30

申办/合作机构

Rabin Medical Center Beilinson

NCT06382012

/ Recruiting临床2/3期IIT

Antiemetic Fosaprepitant To Remedy Nausea and Vomiting

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2024-11-13

申办/合作机构

Montefiore Medical Center

100 项与福沙匹坦双葡甲胺相关的临床结果

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100 项与福沙匹坦双葡甲胺相关的转化医学

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100 项与福沙匹坦双葡甲胺相关的专利（医药）

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336

项与福沙匹坦双葡甲胺相关的文献（医药）

2025-07-01·LANCET ONCOLOGY

Overall efficacy and safety of olanzapine 5 mg added to triplet antiemetics for an anthracycline-containing regimen in patients with breast cancer: a phase 3, double-blind, randomised, placebo-controlled trial

Article

作者: Tanaka, Kenichiro ; Ozeki, Rie ; Mukohara, Toru ; Nakai, Katsuya ; Shimokawa, Mototsugu ; Yanagisawa, Naotake ; Udagawa, Ryoko ; Ogata, Hideaki ; Hosoya, Keiko ; Ikuta, Tomoki ; Uomori, Toshitaka ; Saito, Mitsue ; Bando, Hiroko ; Ishida, Kazushige ; Kutomi, Goro ; Shima, Hiroaki ; Futamura, Manabu ; Ishikawa, Yuko ; Iihara, Hirotoshi ; Tsuneizumi, Michiko ; Kawate, Takahiko

BACKGROUND:

The addition of 10 mg olanzapine to the standard triplet antiemetic therapy has shown superiority in controlling chemotherapy-induced nausea and vomiting compared with triplet therapy alone for highly emetogenic chemotherapy, albeit with sedative side-effects. We aimed to investigate if administering 5 mg of olanzapine at home after anthracycline plus cyclophosphamide chemotherapy, rather than before chemotherapy, can maintain efficacy in controlling chemotherapy-induced nausea and vomiting while minimising sedative side-effects and associated risks.

METHODS:

This was a phase 3, double-blind, randomised, placebo-controlled trial, done in 15 hospitals and cancer centres in Japan. Eligible patients were female adults aged 20 years or older with stage I-III breast cancer and an Eastern Cooperative Oncology Group performance status of 0-1, who were scheduled to receive intravenous anthracycline plus cyclophosphamide-based chemotherapy, and were naive to chemotherapy or had never received moderately to highly emetogenic chemotherapy. Eligible patients were randomly assigned 1:1 to oral olanzapine 5 mg or placebo via the central registration system. Randomisation was performed using blocked stratification, with age (≥55 years vs <55 years) and institution as stratification factors and a block size of two. Allocation was concealed and masking was achieved by using tablets with identical appearance. Treatment was administered at home within 5 h after the end of anthracycline plus cyclophosphamide administration and before the patient's evening meal on day 1 to minimise the risk of sedation during hospital visits and transportation, and on the next 3 days after their evening meal, both with pre-chemotherapeutical application of intravenous dexamethasone 9·9 mg, intravenous palonosetron 0·75 mg, and oral aprepitant 125 mg on day 1 followed by an additional dose of aprepitant 80 mg on days 2 and 3 or intravenous fosaprepitant 150 mg as a premedication on day 1. The primary endpoint was the proportion of patients with a complete response, defined as no vomiting and no rescue medication during the overall phase (0-120 h after the initiation of anthracycline plus cyclophosphamide) based on patient diary. The primary analysis was done by modified intention-to-treat, including all patients who received at least one dose of the study treatment and had at least one efficacy evaluation. Safety was analysed in all patients who received any treatment. This trial was registered with the Japan Registry of Clinical Trials, jRCT1031200134, and is complete.

FINDINGS:

Between Oct 26, 2020 and Nov 2, 2022, 500 female patients from 15 medical institutions in Japan were randomly assigned to receive olanzapine (n=251) or placebo (n=249). Median age at enrolment was 52 years (IQR 45-60) in the olanzapine group and 51 years (46-60) in the placebo group. Data on gender and race or ethnicity were not collected. The median follow-up was 168 h (IQR 168-168). 480 participants (246 in the olanzapine group and 234 in the placebo group) received at least one dose of study medication and were eligible for the efficacy analysis. The complete response rate in the olanzapine group (58·1%, n=143) was significantly higher than in the placebo group (35·5%, n=83; difference 22·7%, 95% CI 14·0-31·4%; p<0·0001) during the overall phase. The most frequently reported severe or very severe symptoms based on the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) version 1.0 were anorexia (33 [13%] of 246 patients in the olanzapine group vs 89 [38%] of 235 in the placebo group) and constipation (30 [12%] vs 37 [16%]). Severe or very severe concentration impairment was reported in 25 (10%) of 246 patients in the olanzapine group and 34 (14%) of 235 patients in the placebo group. Experimental drug-related grade 3-4 adverse events according to the Common Terminology Criteria for Adverse Events version 5.0 included somnolence (four [2%] of 246 patients in the olanzapine group vs none of 235 in the placebo group), and concentration impairment (two [1%] vs none). There were no deaths.

INTERPRETATION:

Post-chemotherapy administration of 5 mg olanzapine in combination with triplet antiemetic therapy before anthracycline plus cyclophosphamide-based chemotherapy significantly improved the complete response rate for chemotherapy-induced nausea and vomiting during the overall phase compared with placebo in female patients with breast cancer receiving outpatient chemotherapy, with an acceptable level of safety. The findings represent a substantial advancement in managing chemotherapy-induced nausea and vomiting and provide assurance that the safe and effective administration of olanzapine can be achieved at a dosage of 5 mg.

FUNDING:

The Capture of Outstanding Clinical Research and Evolution (CORE) project at Juntendo University.

2025-05-01·Journal of the Pediatric Orthopaedic Society of North America

Fosaprepitant Use as an Antiemetic to Prevent Postoperative Nausea and Vomiting in Pediatric Spinal Fusion Patients May Be Associated With More Rapid Transition to Oral Pain Medication and Reduced Length of Stay

Article

作者: Vitale, Michael ; Roye, Benjamin ; Schechter, William ; Louie, Aaron ; Crotty, Jennifer ; Lin, Albert ; Malka, Matan ; Busse, Jennifer ; Muratova, Zarema ; Givens, Ritt

Background:

Significant postoperative nausea and vomiting (PONV) in pediatric patients undergoing posterior spinal fusion is common and limits recovery, prolonging hospital stay. Fosaprepitant is a long-acting antiemetic and works by blocking substance P binding to the neurokinin-1 (NK₁) receptor. There is evidence that its perioperative use substantially reduces PONV in adults, but there is a dearth of literature on its use in pediatric PONV. We seek to elucidate whether a postoperative dose of fosaprepitant in pediatric posterior instrumentation and fusion (PSIF) patients decreases PONV, thus improving recovery and decreasing the length of hospital stay.

Methods:

This is a retrospective chart review of 173 pediatric patients with idiopathic scoliosis undergoing PSIF. The anesthetic methodology was standardized among both groups. The cohort was divided into two groups according to the use of fosaprepitant intraoperatively (or within four hours postoperatively) or no use. We examined patient characteristics, fosaprepitant dose, incidence of PONV, time to transition from parenteral to oral opioids, and length of hospital stay.

Results:

78 (45%) patients received fosaprepitant and 95 (55%) did not. There were no statistically significant differences between groups based on demographics or intraoperative management. No significant difference was found in the incidence of PONV between the groups, but there was a reduction in the number of rescue antiemetics required and a quicker transition from parenteral to oral opioids in the fosaprepitant group. There was also a significantly decreased length of stay.

Conclusions:

While fosaprepitant did not significantly decrease PONV in pediatric PSIF patients, it was associated with decreased use of additional antiemetics. The patients also demonstrated a more rapid transition to oral from parenteral opioids and a shorter length of hospital stay. A larger study may show a statistically significant reduction in PONV in patients who received fosaprepitant. Future studies are needed to elucidate the optimal dose and timing needed to treat PONV in pediatrics.

Key Concepts:

(1)Spinal fusion surgery patients are at risk of having significant postoperative nausea and vomiting.(2)Fosaprepitant is an effective agent to treat postoperative nausea and vomiting in adults, but has not been extensively studied in pediatrics for this purpose.

Level of Evidence:

The level of evidence is a 3 as it is a cohort study looking at the relationship between an exposure and an outcome.

2025-05-01·DRUG METABOLISM AND DISPOSITION

In vitro assessment of ATP-binding cassette transporters and their functional genetic polymorphisms on fluoroquinolone accumulation in human embryonic kidney 293 recombinant cell lines

Article

作者: Mahieu, Gwenaëlle ; Elens, Laure ; Van Bambeke, Françoise ; Haufroid, Vincent

Fluoroquinolone tissue distribution and cellular accumulation are hindered by efflux transporters, including ATP-binding cassette subfamily B member 1 (ABCB1), ATP-binding cassette subfamily G member 2 (ABCG2), and ATP-binding cassette subfamily C member 4 (ABCC4). Genetic polymorphisms (single-nucleotide polymorphisms) can impact transporter activity, leading to interindividual variability in the systemic and cellular pharmacokinetics of their substrates. This study assesses the impact of these transporters on moxifloxacin and ciprofloxacin (CIP) cellular accumulation in vitro, and the effect of common single-nucleotide polymorphisms in ABCB1 [c.1199G>A (rs2229109); common haplotype c.1236C>T (rs1128503), c.2677G>T/A (rs2032582), and c.3435C>T (rs1045642)] and ABCG2 [c.421C>A (rs2231142)]. Recombinant human embryonic kidney (HEK) cell lines overexpressing wild-type or variant transporters were generated via stable plasmid transfection. The impact of transporter overexpression on fluoroquinolone cell disposition was assessed through accumulation experiments in the presence of specific inhibitors to establish the link between transporter expression and differential accumulation. Results indicated that ABCB1 overexpression reduced moxifloxacin cellular concentration by 30% but inconsistently with that of CIP and that zosuquidar or elacridar reversed these effects. ABCG2 had no impact. ABCC4 markedly reduced CIP accumulation by 25%, even at the basal level, an effect reversed by MK517. Contrarily to the wild-type and the c.1199A carriers, ABCB1 CGT and TTT variants did not reduce antibiotic accumulation. In conclusion, moxifloxacin and CIP are substrates of the wild-type and 1199G>A ABCB1, while CGT and TTT haplotypes had a marginal impact on fluoroquinolone transport by ABCB1. CIP is a preferential ABCC4 substrate. Because of the large body distribution of these transporters, our findings may help rationalize their role and the impact of their polymorphisms in fluoroquinolone disposition in tissues and cells. SIGNIFICANCE STATEMENT: This study demonstrates that moxifloxacin and ciprofloxacin are substrates of ABCB1, with ciprofloxacin also transported by ABCC4. Specific ABCB1 polymorphisms (CGT and TTT haplotypes) reduce the ABCB1 transport capacity toward fluoroquinolones. These findings highlight the importance of considering ABCB1 and ABCC4 inducers or inhibitors, which may affect fluoroquinolone disposition in tissues and cells, as well as ABCB1 polymorphisms that could explain interindividual variability in pharmacokinetic profiles.

129

项与福沙匹坦双葡甲胺相关的新闻（医药）

2025-07-11

·E药经理人

认识齐鲁制药“欧氏家族”，告别放化疗、术后恶心呕吐

说起肿瘤化疗后的不良反应，大家首先想到的可能是掉头发或免疫力下降，其实最常见的是恶心呕吐，化疗相关性恶心呕吐(CINV)发生率高达60%-80%，顺铂等化疗药物导致的恶心呕吐发生率甚至超过90%。那种胃里“翻江倒海”甚至脱水的感觉让很多患者恐惧化疗，治疗依从性降低，会严重影响生活质量。这样的烦恼还出现在放疗和部分手术后，放疗相关恶心呕吐（RINV）发生率高达50%-80%，影响治疗进展和效果。术后恶心呕吐(PONV)发生率也普遍较高，达20%-30%，高风险人群的发生率可达80%，PONV可导致多种并发症，影响患者预后。根据作用机制，预防和治疗CINV、RINV和PONV的药物主要有5-羟色胺(5-HT3)受体拮抗剂、神经激肽-1（NK-1）受体拮抗剂、多巴胺受体拮抗剂、糖皮质激素等类型。其中，5-HT3受体拮抗剂是防治CINV和RINV的基石药物。对于CINV和RINV，用药根据治疗方案的致吐作用的高、中、低和轻微强度风险以及患者的自身情况进行选择，CINV防治可两种、三种、或四种药物联合使用，RINV防治中联合用药的效果优于单一用药。对于PONV，指南推荐存在1-2个风险因素的患者，给与两种不同药物预防，存在3-4个风险因素的高危患者建议联合3-4项预防；所以临床上常考虑联合用药。为了满足临床需求，让患者获益，齐鲁制药在放化疗和术后止吐领域广泛布局，并深耕多年，已上市8款产品，为肿瘤支持治疗和外科手术PONV防治提升用药的可选择性。坐拥多元化产品线，多个产品市场份额位列前茅，布局有潜力改良型新药和新剂型产品，齐鲁制药以优异成绩领跑止吐赛道。齐鲁止吐产品线覆盖5-HT3受体拮抗剂、NK-1受体拮抗剂、多巴胺受体拮抗剂，包括助力填补PONV防治无高效安全多巴胺受体拮抗剂空白的氨磺必利注射液（欧可止®）、全球销量可观的止吐产品昂丹司琼——盐酸昂丹司琼片（欧贝®）和盐酸昂丹司琼注射液（欧贝®）、国内首家上市的亚微乳制剂阿瑞匹坦注射液（欧瑞贝®），以及首仿阿瑞匹坦胶囊（欧可平®）、盐酸帕洛诺司琼注射液（欧赛®）、注射用福沙匹坦双葡甲胺（欧得安®）、盐酸托烷司琼注射液（欣贝®）和盐酸格拉司琼注射液。齐鲁制药“欧氏家族”为化疗、放疗和术后所致恶心、呕吐的全程管理提供了更强有力的武器，为患者带来更高效、更安全的用药新选择。01应用最广泛：5-HT3受体拮抗剂5-HT3受体拮抗剂是目前应用最为广泛的止吐药物，通过阻断肠道和中枢神经的5-HT3受体，抑制恶心呕吐反应，适用于化疗、放疗或术后引起的恶心呕吐。司琼类药物种类多，齐鲁制药拥有5款产品。盐酸昂丹司琼片是全球首个上市的5-HT3受体拮抗剂类止吐药，也是最常用的5-HT3受体拮抗剂。1994年，齐鲁制药盐酸昂丹司琼片获批上市，2019年，该产品通过一致性评价，为国内首家过评，进入国家基药目录。盐酸昂丹司琼注射液是化疗、放疗及术后止吐的全周期解决方案“金标准”药物。齐鲁制药盐酸昂丹司琼注射液于1994年国内首仿获批上市，一直稳居国内市场占有率前列，并在2021年国内首家过评。该产品在2014年获得美国FDA批准上市，同样在美国市场拥有较高的市场占有率。盐酸帕洛诺司琼注射液属于第二代5-HT3受体拮抗剂，与第一代相比，具有与受体结合效力更高、血浆半衰期延长、止吐作用效果更好等优势临床上主要用于预防中重度致吐化疗引起的恶心、呕吐。2008年齐鲁制药盐酸帕洛诺司琼注射液国内首家上市，并于2021年国内首家过评，上市以来一直保持着较大的市场份额优势。盐酸格拉司琼注射液是一种高效、高选择性的5-HT3受体抑制剂，不良反应少，对恶心呕吐高风险患者预防作用突出。齐鲁制药盐酸格拉司琼注射液于2005年国内获批上市，并于2021年国内首家过评。盐酸托烷司琼注射液是第一代5-HT3受体拮抗剂，作用快速且耐受性较好，曾经的国内市场“止吐一哥”。齐鲁制药盐酸托烷司琼注射液于2005年获批上市。02新型中枢止吐药：NK-1受体拮抗剂NK-1受体拮抗剂是一种新型作用机制的止吐药物，通过与中枢神经系统的NK-1受体紧密结合，阻断P物质的作用点，预防化疗或术后引起的恶心呕吐。阿瑞匹坦胶囊是全球第一个高度选择性NK-1受体拮抗剂，为预防肿瘤化疗后引起的急性和迟发性恶心呕吐的一线用药/推荐用药。该产品销售额在全球止吐市场稳居第一梯队。2020年，齐鲁制药阿瑞匹坦胶囊国内首仿上市并首家过评。阿瑞匹坦注射液是将阿瑞匹坦包裹于大豆油中制成的亚微乳制剂，相比于口服制剂，可显著提高生物利用度和用药顺应性，同时有效降低同类注射制剂过敏反应的发生率。2022年，齐鲁制药阿瑞匹坦注射液获批上市，成为国内首款获批和过评的阿瑞匹坦亚微乳注射剂。福沙匹坦是阿瑞匹坦的前体药物，能在体内迅速发生水解，代谢生成阿瑞匹坦。注射用福沙匹坦双葡甲胺为国内外指南一致推荐用于高度/中度致吐性化疗方案的止吐药物，相较于口服阿瑞匹坦，注射给药能提供更大的灵活性和便利性。齐鲁制药注射用福沙匹坦双葡甲胺于2021年获批上市并视同过评。03开拓新选择：多巴胺受体拮抗剂多巴胺受体拮抗剂通过阻断中枢或胃肠道的多巴胺受体，抑制催吐化学感受区的兴奋，从而发挥止吐作用。传统多巴胺受体拮抗剂的不良反应严重，PONV防治受限，作为一种高选择性拮抗多巴胺D2/D3受体拮抗剂，氨磺必利注射液弥补PONV防治无高效安全的多巴胺受体拮抗剂空白。今年6月，齐鲁制药氨磺必利注射液国内首家获批上市，用于预防成人术后PONV，单药预防可显著改善患者中重度恶心及呕吐症状，联合用药预防PONV安全增效。说明：本文仅供医学药学专业人士阅读，具体应用请咨询专业人员。一审| 黄佳二审| 李芳晨三审| 李静芝

申请上市

2025-07-05

·赛柏蓝

第十一批国采，11个药「迎战」

编者按：本文来自米内网，作者苍穹；赛柏蓝授权转载，编辑相宜11个消化系统及代谢化药迎战第十一批集采，齐鲁、华海、倍特等企业多个品种在列。01第十一批集采11个品种备战超50亿畅销药被盯上11个拟纳入第十一批国采的品种均满足7家及以上的竞争格局，2024年在中国公立医疗机构终端的销售额合计超过105亿元。其中，达格列净片2024年销售额在50亿元以上，2025Q1拿下超16亿元的销售佳绩；4个品种2024-2025Q1销售额增速均达两位数，具体为硫酸镁钠钾口服用浓溶液、富马酸伏诺拉生片、二甲双胍恩格列净片(Ⅰ)/(Ⅲ)/(Ⅵ)和达格列净片。从竞争格局上看，法莫替丁注射液为热门选手，目前已有近40家企业（按集团计，下同）符合条件；达格列净片、二甲双胍恩格列净片(Ⅰ)/(Ⅲ)/(Ⅵ)/(Ⅴ)、富马酸伏诺拉生片符合条件企业均在20家及以上；注射用福沙匹坦双葡甲胺、阿瑞匹坦胶囊等品种竞争相对缓和，各有7家企业符合条件。过评品种上看，齐鲁制药、正大制药、华海药业在数量上领跑，均涉及4个及以上过评品种；倍特药业、石药集团、山东新时代药业、福安药业、江苏万高药业、山东朗诺制药、江苏德源药业、浙江诺得药业、东阳祥昇医药等企业分别有3个过评品种在列。拟纳入第十一批国采的消化系统及代谢化药注：根据网传清单整理，一切信息以官方为准02消化系统及代谢化药市场跌跌不休TOP20品牌出炉数据显示，2024年中国公立医疗机构终端消化系统及代谢化药销售额约1250亿元，同比下滑2.95%，2025Q1其销售额再度下滑1.67%至约310亿元。2022年至今该品类销售市场已现“4连跌”。近年来中国公立医疗机构终端消化系统及代谢化药销售趋势（单位：万元）从渠道格局上看，城市公立医院一马当先，市占比超45%，县级公立医院、城市社区医院和乡镇卫生院分别占约16%、6%和5%。治疗亚类方面，糖尿病用药、治疗与胃酸分泌相关疾病的药物各以超20%的份额位列第一和第二；胆、肝疾病治疗药和维生素类的市场份额均超10%，先后排名第三和第四；矿物质补充剂、胃肠解痉药/抗胆碱药和胃动力药、止吐药和止恶心药等10个类别位列其后。2025Q1中国公立医疗机构终端消化系统及代谢化药亚类格局临床在售剂型上，消化系统及代谢化药主要涉及12种剂型（以一级剂型计），包括片剂、注射剂、胶囊剂、溶液剂、散剂/颗粒剂、凝胶剂、栓剂等。其中片剂和注射剂销售额均在100亿元以上，稳居TOP1和TOP2之位；胶囊剂名列TOP3，销售额超过40亿元。消化系统及代谢化药TOP20品牌中，阿斯利康的达格列净片继续高居榜首，2025Q1销售额已突破14亿元；正大天晴药业的异甘草酸镁注射液和默沙东的磷酸西格列汀片分别位居第二、第三，销售额均超5亿元；默克的盐酸二甲双胍片、北京协和药厂的双环醇片、勃林格殷格翰的利格列汀片、山西普德药业的注射用多种维生素(12)、丽珠集团丽珠制药的注射用艾普拉唑钠销售额均在3亿元以上，先后位列TOP4-TOP8。此外，8个品牌销售额实现正增长，其中通化金马药业集团的复方嗜酸乳杆菌片、丽珠集团丽珠制药的注射用艾普拉唑钠、成都天台山制药的多烯磷脂酰胆碱注射液、阿斯利康的达格列净片和武田药品的富马酸伏诺拉生片同比增速均达两位数。2025Q1中国公立医疗机构终端消化系统及代谢化药品牌TOP20注：增长率不足3%用*表示END内容沟通：郑瑶（13810174402）

带量采购一致性评价医药出海核酸药物

2025-06-29

·米内网

千亿市场4连跌！第十一批集采11个品种迎战，43个新药大放异彩，恒瑞、石药、信达火力全开

精彩内容近日，信达开发的国产首款GLP-1减重创新药玛仕度肽注射液获批上市；11个消化系统及代谢化药迎战第十一批集采，齐鲁、华海、倍特等企业多个品种在列。米内网数据显示，2025Q1中国公立医疗机构终端消化系统及代谢化药销售额约310亿元，同比下滑1.67%；品牌TOP20中，阿斯利康的达格列净片、正大天晴药业的异甘草酸镁注射液和默沙东的磷酸西格列汀片高居前三。43款消化系统及代谢化药新药强势来袭，恒瑞、石药、人福等火力全开。消化系统及代谢化药市场跌跌不休！TOP20品牌出炉米内网数据显示，2024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）终端消化系统及代谢化药销售额约1250亿元，同比下滑2.95%，2025Q1其销售额再度下滑1.67%至约310亿元。2022年至今该品类销售市场已现“4连跌”。近年来中国公立医疗机构终端消化系统及代谢化药销售趋势（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从渠道格局上看，城市公立医院一马当先，市占比超45%，县级公立医院、城市社区医院和乡镇卫生院分别占约16%、6%和5%。治疗亚类方面，糖尿病用药、治疗与胃酸分泌相关疾病的药物各以超20%的份额位列第一和第二；胆、肝疾病治疗药和维生素类的市场份额均超10%，先后排名第三和第四；矿物质补充剂、胃肠解痉药/抗胆碱药和胃动力药、止吐药和止恶心药等10个类别位列其后。2025Q1中国公立医疗机构终端消化系统及代谢化药亚类格局来源：米内网中国公立医疗机构药品终端竞争格局临床在售剂型上，消化系统及代谢化药主要涉及12种剂型（以一级剂型计），包括片剂、注射剂、胶囊剂、溶液剂、散剂/颗粒剂、凝胶剂、栓剂等。其中片剂和注射剂销售额均在100亿元以上，稳居TOP1和TOP2之位；胶囊剂名列TOP3，销售额超过40亿元。消化系统及代谢化药TOP20品牌中，阿斯利康的达格列净片继续高居榜首，2025Q1销售额已突破14亿元；正大天晴药业的异甘草酸镁注射液和默沙东的磷酸西格列汀片分别位居第二、第三，销售额均超5亿元；默克的盐酸二甲双胍片、北京协和药厂的双环醇片、勃林格殷格翰的利格列汀片、山西普德药业的注射用多种维生素(12)、丽珠集团丽珠制药的注射用艾普拉唑钠销售额均在3亿元以上，先后位列TOP4-TOP8。此外，8个品牌销售额实现正增长，其中通化金马药业集团的复方嗜酸乳杆菌片、丽珠集团丽珠制药的注射用艾普拉唑钠、成都天台山制药的多烯磷脂酰胆碱注射液、阿斯利康的达格列净片和武田药品的富马酸伏诺拉生片同比增速均达两位数。2025Q1中国公立医疗机构终端消化系统及代谢化药品牌TOP20来源：米内网中国公立医疗机构药品终端竞争格局注：增长率不足3%用*表示第十一批集采11个品种备战，超50亿畅销药被盯上日前，一份关于征求《#第十一批国家组织药品集中采购拟采购药品清单》意见的函在业内流出，75个品种在列。从治疗大类上看，消化系统及代谢化药为本批集采的主力之一，11个品种或有望纳入。拟纳入第十一批国采的消化系统及代谢化药来源：米内网综合数据库注：根据网传清单整理，一切信息以官方为准11个拟纳入第十一批国采的品种均满足7家及以上的竞争格局，2024年在中国公立医疗机构终端的销售额合计超过105亿元。其中，达格列净片2024年销售额在50亿元以上，2025Q1拿下超16亿元的销售佳绩；4个品种2024-2025Q1销售额增速均达两位数，具体为硫酸镁钠钾口服用浓溶液、富马酸伏诺拉生片、二甲双胍恩格列净片(Ⅰ)/(Ⅲ)/(Ⅵ)和达格列净片。从竞争格局上看，法莫替丁注射液为热门选手，目前已有近40家企业（按集团计，下同）符合条件；达格列净片、二甲双胍恩格列净片(Ⅰ)/(Ⅲ)/(Ⅵ)/(Ⅴ)、富马酸伏诺拉生片符合条件企业均在20家及以上；注射用福沙匹坦双葡甲胺、阿瑞匹坦胶囊等品种竞争相对缓和，各有7家企业符合条件。过评品种上看，齐鲁制药、正大制药、华海药业在数量上领跑，均涉及4个及以上过评品种；倍特药业、石药集团、山东新时代药业、福安药业、江苏万高药业、山东朗诺制药、江苏德源药业、浙江诺得药业、东阳祥昇医药等企业分别有3个过评品种在列。43个新药大放异彩，恒瑞、石药、信达......火力全开在消化系统及代谢化药领域，今年以来已有5款1类新药获批上市，分别是恒瑞医药的注射用磷罗拉匹坦帕洛诺司琼和瑞格列汀二甲双胍片(Ⅰ)/(Ⅱ)、石药集团的普卢格列汀片、信达生物的玛仕度肽注射液。其中，注射用磷罗拉匹坦帕洛诺司琼是国内首个超长效原研复方止吐针剂，瑞格列汀二甲双胍片(Ⅰ)/(Ⅱ)为DPP-4抑制剂联合二甲双胍固定复方制剂，普卢格列汀片属于新型口服DPP-4抑制剂，信达生物的玛仕度肽注射液为国产首款GLP-1减重创新药。3款2类改良型新药提交上市在审，分别是南京海纳制药的兰索拉唑碳酸氢钠干混悬剂、江苏柯菲平医药的醋酸伏诺拉生注射液以及长春澜江医药的LJ01003。其中，兰索拉唑碳酸氢钠干混悬剂属于新型质子泵抑制剂（PPI），是兰索拉唑碳酸氢钠胶囊的改良新剂型，可用于胃溃疡、十二指肠溃疡、反流性食管炎、卓-艾综合征、吻合口溃疡等。2025年至今获批上市的消化系统及代谢化药新药来源：米内网中国申报进度（MED）数据库此外，今年以来，已有36款消化系统及代谢化药新药获批临床，包括22款1类新药和14款2类改良型新药，涉及石药集团的SYH2067胶囊、翰森制药的HS-10501-2、远大健康的HDM1005注射液、人福医药的HW201877胶囊等；按治疗亚类统计，糖尿病用药以12个产品在数量上遥遥领先，胆/肝疾病治疗药、减肥药（食品除外）、治疗与胃酸分泌相关疾病的药物分别占5个及以上席位。今年以来消化系统及代谢化药新药获批临床情况来源：米内网中国申报进度（MED）数据库从最高研发进度看，19个品种处于Ⅰ期临床及以上阶段。其中，常山生化的艾本那肽注射液（GLP-1RA激动剂）已报产在审，恒瑞医药的HRS9531注射液（GLP-1/GIP双受体激动剂）、苏州闻泰医药的VCT220片（GLP-1R激动剂）已进入Ⅲ期临床，远大健康的HDM1005注射液（GLP-1/GIP双受体激动剂）、罗欣药业的注射用LX22001（P-CAB药物）、联邦制药的UBT251注射液（GLP-1/GIP/GCG三靶点受体激动剂）、奥立泰医药的MT2004胶囊（FXR激动剂）等处于Ⅱ期临床研究阶段。资料来源：米内网数据库等注：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6月27日，如有疏漏，欢迎指正！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

带量采购上市批准

100 项与福沙匹坦双葡甲胺相关的药物交易

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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	江苏豪森医药研究院有限公司	2015-02-06
恶心和呕吐	临床3期	中国	江苏豪森医药研究院有限公司	2015-02-06
多发性骨髓瘤	临床3期	德国	Merck Sharp & Dohme Corp.	2005-07-01
术后恶心呕吐	临床3期	-	Merck Sharp & Dohme Corp.	2005-07-01
晚期非小细胞肺癌	临床2期	美国	Merck Sharp & Dohme Corp.	2015-04-01
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
肉瘤	临床阶段不明	美国	Merck Sharp & Dohme Corp.	2012-05-01

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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


ASCO2024	N/A	-	-	Fosaprepitant	糧窪願獵鹹糧獵獵艱襯(願鏇範鹽廠觸積簾齋醖) = 膚範構構壓願積簾積淵壓選鬱簾選網蓋構顧襯 (構構範艱窪窪鑰壓糧憲 )	不佳	2024-05-24
NCT03237611 (CTgov)	临床2期	化疗引起的恶心和呕吐	15	Dexamethasone+Ondansetron 16 MG+Aprepitant 125 mg+Fosaprepitant 115 MG	觸窪憲簾製憲壓顧範獵 = 襯壓選艱壓齋鹽鹽構鹹膚齋蓋衊簾築遞鹽鬱膚 (築積廠蓋觸遞鬱鹹繭積, 簾網鏇選鏇壓膚鹽構鏇 ~ 範艱願夢顧積選憲鏇艱) 更多	-	2023-11-13
NCT05564286 (Pubmed \| Support Care Cancer)	临床3期	化疗引起的恶心和呕吐	116	Fosaprepitant, tropisetron, and dexamethasone	衊淵齋製襯廠廠鹹獵鹽(鏇蓋淵憲顧選艱選齋憲) = Fosaprepitant was well tolerated as the incidences of adverse events in the two groups were comparable 醖鏇觸鏇襯觸淵餘構襯 (獵觸繭壓夢衊顧網廠餘 ) 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)	淵齋夢衊艱遞遞齋選襯(鹽繭鹽簾願襯鏇艱構鑰) = 醖製網窪範衊艱蓋窪構鬱顧觸壓鏇鹽積糧築網 (網網繭積衊窪簾齋艱鏇 ) 更多	积极	2023-08-22
				Aprepitant+ondansetron+dexamethasone (Oral)	淵齋夢衊艱遞遞齋選襯(鹽繭鹽簾願襯鏇艱構鑰) = 窪襯鹹糧積醖構淵觸鬱鬱顧觸壓鏇鹽積糧築網 (網網繭積衊窪簾齋艱鏇 ) 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)	積觸餘繭憲淵鹽積顧鹹(壓襯襯鬱壓築構餘簾築) = 鬱衊鏇膚簾壓醖衊鑰鑰鹹網餘築壓鑰選蓋壓蓋 (積鬱艱獵廠繭願齋廠鏇 ) 更多	积极	2023-08-22
				ondansetron+dexamethasone	積觸餘繭憲淵鹽積顧鹹(壓襯襯鬱壓築構餘簾築) = 範鏇顧齋壓壓糧憲製廠鹹網餘築壓鑰選蓋壓蓋 (積鬱艱獵廠繭願齋廠鏇 ) 更多
NCT03578081 (CTgov)	临床3期	化疗引起的恶心和呕吐 \| 恶心 \| 肿瘤 ... 更多	690	Olanzapine+Dexamethasone+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Fosaprepitant Dimeglumine (Arm I (Fosaprepitant Dimeglumine, Olanzapine))	齋蓋鑰製憲醖鑰壓鏇鑰 = 壓繭積醖鹽衊製製憲糧積鹹簾鹽積鏇築範齋壓 (繭選餘構鹹蓋膚壓鏇顧, 積選鏇襯積餘鬱繭網築 ~ 鏇糧襯蓋繭觸壓繭蓋鏇) 更多	-	2023-05-08
				Placebo+Olanzapine+Dexamethasone+Palonosetron Hydrochloride+Ondansetron Hydrochloride (Arm II (Placebo, Olanzapine))	齋蓋鑰製憲醖鑰壓鏇鑰 = 繭顧壓鹽願製壓鏇積鹹積鹹簾鹽積鏇築範齋壓 (繭選餘構鹹蓋膚壓鏇顧, 夢衊齋範顧鬱廠鏇築廠 ~ 鏇淵觸鏇範繭鹽襯膚積) 更多
ACAAI2022	N/A	过敏	-	Fosaprepitant 150mg	選鏇蓋壓積積觸廠鏇製(廠構網鹽夢鑰窪觸衊網) = A tryptase level was drawn 3 hours after symptom onset and was elevated to 13.2 mcg/L (baseline 6.7 mcg/L) 鹽膚築淵鑰製顧壓壓網 (憲觸膚網觸遞鹹膚廠鏇 ) 更多	-	2022-11-10
NCT03197064 (CTgov)	临床4期	术后恶心呕吐	11	Fosaprepitant 150 mg	繭願製選艱鑰鹽網觸繭(糧醖夢鹹築餘製糧範廠) = 廠淵鬱膚鹽衊製窪鹽範遞選獵蓋醖淵鹽網鏇壓 (網淵選衊鹹鹹積願壓鬱, 1.49) 更多	-	2022-07-18
NCT04054193 (0517-045 \| MK-0517-045, CTgov)	临床4期	化疗引起的恶心和呕吐 \| 恶心 \| 呕吐	103	5-HT3 antagonist+Dexamethasone+Fosaprepitant Dimeglumine	齋製構鹽鏇廠齋窪網鑰 = 選糧淵鏇憲觸鬱鏇範蓋構簾鹽淵糧範繭膚鏇願 (網廠壓鹽憲遞餘壓膚淵, 齋鬱構鹽憲鏇膚網獵觸 ~ 淵膚餘壓壓襯鏇蓋衊願) 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	積遞顧衊淵築艱鏇憲蓋(鹽壓選鹽鬱衊鏇鬱膚醖) = 廠餘鑰淵獵蓋廠繭觸壓顧膚蓋醖膚淵夢鹽積艱 (衊積壓獵鑰衊製範膚鬱 ) 更多	积极	2018-06-01
				Placebo	積遞顧衊淵築艱鏇憲蓋(鹽壓選鹽鬱衊鏇鬱膚醖) = 願遞願鏇憲醖積鑰醖鹹顧膚蓋醖膚淵夢鹽積艱 (衊積壓獵鑰衊製範膚鬱 ) 更多