主要目的：在健康男性与女性受试者中于空腹/餐后条件下，评价受试制剂依折麦布片（规格：10 mg，生产商：南京海鲸药业股份有限公司）和MSD Pharma（Singapore）Pte. Ltd.为持证商的参比制剂依折麦布片（益适纯®，规格：10 mg）的生物等效性。次要目的：观察受试制剂依折麦布片与参比制剂依折麦布片（益适纯®）在健康受试者中的安全性。

开始日期2024-08-05

申办/合作机构

南京海鲸药业股份有限公司

NCT06317051 / Not yet recruiting临床3期IIT

A Phase III/IV Factorial Randomized Double-blind Trial to Compare the Addition of Dapagliflozin vs Placebo and Rosuvastatin/Ezetimibe Versus Pitavastatin in Patients With HIV on Integrase Strand Transfer Inhibitor-based Antiretrovirals With Elevated Metabolic Risk

People with HIV are at a higher risk of cardiovascular diseases (CVD) due to the effects of the virus and its treatment. Integrase strand transfer inhibitors (INSTIs), a common HIV treatment, are associated with increased CVD risk and metabolic issues, such as weight gain and high blood pressure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors, however, have been working well in reducing CVD events and hospitalizations due to heart failure, irrespective of diabetes presence. They also help in reducing weight and blood pressure. Pitavastatin has shown to work in lowering CVD events in people with HIV, but its availability is limited. This benefit is thought to be common to all statins, but this has not yet been confirmed. This study will examine the impact of dapagliflozin vs. placebo on metabolic parameters in people with HIV with high metabolic risk who are on INSTI-based ART.

开始日期2024-08-01

申办/合作机构

Kirby Institute

100 项与依折麦布相关的临床结果

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100 项与依折麦布相关的转化医学

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100 项与依折麦布相关的专利（医药）

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3,975

项与依折麦布相关的文献（医药）

2024-06-17·The Journal of clinical endocrinology and metabolism

Comparison of the Efficacy of Ezetimibe Combination Therapy and High-Intensity Statin Monotherapy in Type 2 Diabetes

Article

作者: Ahn, Kyu Jeung ; Park, So Young ; Chung, Ho Yeon ; Hwang, You-Cheol ; Jun, Ji Eun ; Jeong, In-Kyung

Abstract:

Context:

Low-density lipoprotein cholesterol (LDL-C)-lowering therapy is considerably important in preventing cardiovascular disease (CVD) among patients with diabetes. Studies comparing CVD, stroke, and mortality outcomes of low- or moderate-intensity statins with ezetimibe combination therapy and high-intensity statin monotherapy in patients with diabetes remain lacking.

Objective:

This study compared the primary prevention effect of myocardial infarction (MI), stroke, and all-cause death between combination therapy of low- or moderate-intensity statins and ezetimibe and high-intensity statin monotherapy in patients with diabetes using the Korean National Health Insurance claims database.

Methods:

Patients aged ≥20 years with type 2 diabetes and dyslipidemia were enrolled. The combination therapy of low- or moderate-intensity statin and ezetimibe was compared with high-intensity statin monotherapy after a propensity score–matched analysis. The incidence of composite outcomes consisting of MI, stroke, and all-cause death and each component were analyzed.

Results:

In moderate-intensity statin therapy with ezetimibe combination therapy, LDL-C (74 ± 37.9 mg/dL vs 80.8 ± 38.8 mg/dL, P < .001) and the incidence of composite outcomes were lower (hazard ratio 0.85, 95% CI 0.74-0.98) than those in high-intensity statin monotherapy. Meanwhile, no significant difference was observed in the LDL-C levels and composite outcomes between low-intensity statins with ezetimibe combination therapy and high-intensity statin monotherapy.

Conclusion:

Adding ezetimibe to a moderate-intensity statin in patients with type 2 diabetes has a greater LDL-C–lowering effect and greater primary prevention of composite outcomes than that of high-intensity statin monotherapy.

2024-03-01·Journal of pharmaceutical and biomedical analysis

A study on cholesterol-cholesteryl ester metabolic homeostasis and drug intervention in hyperlipidemic hamsters using UHPLC-MS/MS

Article

作者: Wang, Zhiquan ; Zheng, Bowen ; Wang, Zhe ; Zhang, Jinlan ; Lin, Miao

Hyperlipidemia is a global metabolic disorder characterized by dysregulation of lipid metabolism. This dysregulation is closely associated with the altered homeostasis of cholesterol-cholesteryl ester (CE) metabolism in systemic circulation, and some organs. Additionally, the relationship between oxidized cholesteryl ester (oxCE) and the disease has also gained attention. Currently, there is a lack of comprehensive research on the alterations in cholesterol-CE metabolism in the context of hyperlipidemia, as well as the characteristics of lipid-lowering agents in regulating this metabolic state. Therefore, 40 oxCEs were identified in the hamster liver sample, and novel ultrahigh performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) methods were established for simultaneous analysis of cholesterol, 57 CEs, and 40 oxCEs in the serum, liver, adipose tissue, and intestine of hyperlipidemic hamsters. This study investigated the metabolic alterations between cholesterol-CE/oxCE in hyperlipidemic hamsters and those treated with lipid-lowering agents, including the Niemann-Pick-C1 like-1 protein (NPC1L1) inhibitor ezetimibe and the acyl coenzyme A: cholesterol acyltransferase (ACAT) inhibitor avasimibe. The study findings demonstrate metabolic disorders in cholesterol-CE/oxCE homeostasis in hyperlipidemic hamsters. Lipid-lowering agent therapy can improve the metabolic dysregulation caused by hyperlipidemia, with distinct characteristics: ezetimibe is more effective in reducing cholesterol, while avasimibe is more effective in reducing CEs/oxCEs. Eight potential biomarkers indicating the dysregulation of cholesterol-CE metabolism caused by hyperlipidemia and its improvement by lipid-lowering agents have been identified in the serum. This study offers new insights into the hyperlipidemia pathophysiology and the mechanisms of lipid-lowering agents from a novel perspective on cholesterol-CE/oxCE metabolic homeostasis.

2024-03-01·Indian heart journal

Traditional and novel non-statin lipid-lowering drugs

Review

作者: Jain, Peeyush

Non-statin drugs find utility in the management of dyslipidaemia in mixed dyslipidaemia, patients with statin intolerance, and when guidelines directed low-density lipoprotein cholesterol (LDL-C) target cannot be achieved despite maximally tolerated statin. The most definite indication of fenofibrate monotherapy is fasting serum triglyceride >500 mg/dl to reduce the risk of acute pancreatitis It offers a modest reduction in cardiovascular events. The statin-ezetimibe combination is commonly used for lipid lowering particularly after ACS. Fish oils reduce serum triglycerides by about 25 %. EPA (and not DHA) seems to have cardioprotective effects. Despite cardiovascular outcome benefits, bile-exchange resins have limited use due to poor tolerance. Bempedoic acid added to maximally tolerated statin therapy is approved to lower LDL-C in adults with primary hypercholesterolemia or mixed dyslipidaemias, HeFH, in patients with ASCVD who require additional lowering of LDL-C, and in patients who are statin-intolerant. Inclisiran is a long-acting double-stranded small interfering RNA (siRNA) that inhibits the transcription of PCSK-9 leading to a decrease in PCSK9 generation in hepatocytes and an increase in LDL receptor expression in the liver cell membrane leading to about 50 % reduction in serum LDL-C levels. Lomitapide lowers plasma levels of all ApoB-containing lipoproteins, including VLDL, LDL, and chylomicrons by inhibiting the enzyme microsomal triglyceride transfer protein (MTP) and approved for the treatment of adult patients with homozygous familial hypercholesterolemia (HoFH). Close monitoring for hepatotoxicity is required. Mipomersen is a single-stranded synthetic antisense oligonucleotide (ASO) that affects the production and secretion of apoB-containing lipoproteins with demonstrated efficacy in both homozygous and heterozygous FH patients. It is approved for restricted use due to risk of hepatotoxicity. Pelacarsen is an antisense oligonucleotide that reduces the production of apo(a) in the liver.

264

项与依折麦布相关的新闻（医药）

2024-09-19

·米内网

方盛制药开挂了！独家中成药暴涨430%，入局30亿贴膏剂，6款1类新药、3大新品来袭

精彩内容近日，方盛制药的中药1类新药养血祛风止痛颗粒提交NDA获受理。2024上半年，公司实现营收9.1亿元（+6.44%），归母净利润1.37亿元（+28.23%），其中创新中药快速放量，玄七健骨片销售收入同比增长超430%，小儿荆杏止咳颗粒销售收入同比增长超150%等。方盛制药坚持创新驱动，2024上半年研发费用大增66.68%，6款1类新药、3大新品在路上。创新中药大爆发！2大独家品种涨逾150% 方盛制药始创于2002年，2014年成功登陆上交所，是一家集制药工业、大健康产业、医疗服务于一体的健康产业集团。目前公司拥有142个药品注册批件（含已转让未办理完变更手续生产批件），聚焦心脑血管、骨伤科、儿科、妇科、呼吸系统、抗感染等治疗领域。 8月29日，方盛制药公布2024上半年业绩，报告期内实现营业收入9.1亿元，同比增长6.44%；归母净利润1.37亿元，同比增长28.23%。其中，制药工业实现营业收入8.37亿元，同比增长9.12%，主要系“338大产品打造计划”中核心产品尤其是慢病用药呈现稳健增长态势。从细分类别收入情况看，心脑血管疾病用药营业收入2.38亿元，同比增长37.57%，主要得益于依折麦布片集采后快速放量；骨骼肌肉系统用药营业收入1.93亿元，同比增长3.62%，主要系玄七健骨片纳入医保后快速放量；呼吸系统用药营业收入1.46亿元，同比增长12.09%，推测主要得益于强力枇杷膏（蜜炼）解决原料问题后稳步放量；此外，儿童用药营业收入0.94亿元，妇科疾病用药营业收入0.43亿元，抗感染用药营业收入0.33亿元等。 2024H1方盛制药分系列收入情况（单位：元）来源：公司公告 3大拳头产品稳步增长，2024上半年藤黄健骨片销售量同比增长近5%，累计覆盖等级医院近2300家，基层医院约5600家；强力枇杷膏（蜜炼）营业收入同比增长约26%，累计覆盖9500多家公立医疗机构，其中等级医院超1500家；依折麦布片销售额约1.44亿元，同比增长超110%。创新中药实现快速放量，有望成为公司未来新的利润增长点。2024上半年玄七健骨片销售收入突破5000万元，同比增长超430%，报告期内新增覆盖超300家公立医疗机构，累计覆盖900多家公立医疗机构，其中等级医院超500家；小儿荆杏止咳颗粒销售收入约4500万元，同比增长超150%，报告期内新增覆盖超260家公立医疗机构，累计覆盖1500多家公立医疗机构，其中等级医院超1000家。 6款1类新药来袭，入局2大超10亿贴膏剂方盛制药以中药创新药为发展方向，持续加大研发投入，2024上半年研发费用同比增长66.68%。目前公司有多个研发项目稳步推进，未来将在化药、中药、生物药三大领域实现共同发展。米内网数据显示，目前方盛制药有6款1类新药（按新版药品注册管理办法，不含已有批文品种开展新适应症）处于获批临床及以上阶段，涵盖中成药、化学药、生物药三大药品类型。方盛制药部分在研新药来源：米内网综合数据库中药创新药方面，养血祛风止痛颗粒已提交NDA，该新药是基于中国近代著名中医大家张锡纯先生的代表性方剂“升陷汤”的加减配方而成，能够直接升提气血至头部，改善脑供血不足情况，迅速缓解头痛、头晕症状，用于治疗频繁阵发性紧张型头痛；健胃祛痛微丸处于III期临床，用于慢性非萎缩性胃炎脾胃气虚兼湿热瘀滞所致胃脘疼痛、神疲倦怠、口苦口干、纳差、胃脘胀满等；益气消瘤颗粒于今年7月获批临床，用于气虚血瘀所致子宫肌瘤无手术指征者。此外，小儿荆杏止咳颗粒成人适应症正在开展II期临床，有望于2025年报产。化药/生物药新药方面，2款1类新药均处于I期临床，注射用迪安替康钠是一种抗结直肠癌的治疗药物，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）抗肿瘤药（化学药+生物药）销售额超过1400亿元；重组人角质细胞生长因子-2滴眼液为眼科用药，用于角膜擦伤、轻中度化学烧伤、角膜手术及术后愈合不良和干眼引起的角膜上皮缺损等。仿制药方面，方盛制药以新注册分类提交了6个品种的上市申请，其中厄贝沙坦氢氯噻嗪片、依折麦布片已获批生产并视同过评，吲哚布芬片、洛索洛芬钠凝胶贴膏、氟比洛芬凝胶贴膏等品种还在审评审批中。方盛制药新分类报产的品种来源：米内网中国申报进度（MED）数据库洛索洛芬钠凝胶贴膏、氟比洛芬凝胶贴膏均为贴膏剂产品，2023年在中国三大终端六大市场的销售额分别超过14亿元、30亿元。上述2款产品目前均仅有1家国内企业拥有生产批文，且均未通过一致性评价。营利双增占比不足3成！中药企业业绩分化日前，A股医药企业2024年半年报已披露完毕。中药板块72家上市企业中，7家企业营业收入超50亿元，分别为白云山（410.4亿元）、云南白药（204.6亿元）、华润三九（141.1亿元）、同仁堂（97.63亿元）、太极集团（78.17亿元）、片仔癀（56.51亿元）、步长制药（54.32亿元）；6家企业归母净利润超10亿元，分别为云南白药（31.89亿元）、白云山（25.5亿元）、华润三九（23.98亿元）、片仔癀（17.22亿元）、济川药业（13.38亿元）、同仁堂（10.21亿元）。从业绩增长情况看，72家企业中仅23家企业营业收入实现同比增长，31家企业归母净利润实现同比增长，营收、净利润双增长的企业仅有17家，占比不足3成。其中，片仔癀、东阿阿胶、马应龙、羚锐制药、佐力药业、贵州三力、莱茵生物、华森制药8家企业的营收、净利润均实现两位数增长。 2024H1业绩双增长的A股中药企业来源：东方财富网，米内网整理分析中药企业业绩分化的原因，除了集采降价、医保政策调整等政策因素外，近年来一路飙涨的中药材价格也对行业产生影响。中药材价格的上涨，使一些企业的中药材种植或中药饮片业务取得增长，但与此同时，在集采降价的背景下，也有众多中成药企业面临成本上升的压力。在这样的市场环境下，中药行业的整合并购趋势可能会加速，部分企业会通过并购重组来强化自身的市场地位和竞争力，如华润医药、国药集团在今年上半年的多次并购活动。行业整合提速是产业升级的必然步骤，有助于优化资源配置，提高行业集中度。此外，创新转型也将成为中药行业发展的核心旋律，同时也是中药企业摆脱经营困境、实现突破的重要策略。如天士力、以岭药业、康缘药业、方盛制药等中药企业均在积极布局创新药研发，寻找新的增长点。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9月18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

2024-09-06

·GlobeNewswire-Health Care

NewAmsterdam Pharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

NAARDEN, the Netherlands and MIAMI, Sept. 06, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that the Compensation Committee of NewAmsterdam’s Board of Directors approved the grant of inducement share options covering an aggregate of 111,000 of NewAmsterdam’s ordinary shares to three non-executive new hires. The share options were granted as an inducement material to the employees acceptance of employment with NewAmsterdam pursuant to the NewAmsterdam Pharma Company N.V. 2024 Inducement Plan (the “2024 Inducement Plan”) and in accordance with Nasdaq Listing Rule 5635(c)(4). The share options have an exercise price per share equal to $15.91, which represents the closing market price on the Nasdaq Stock Market of the Company’s ordinary shares on, September 3, 2024 the grant date. The shares subject to the options will vest over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the shares vesting in a series of 36 equal monthly installments thereafter, subject to each employee’s continued service with NewAmsterdam on such vesting dates. The options are subject to the terms and conditions of the 2024 Inducement Plan and the terms and conditions of an option award agreement covering the grant. About NewAmsterdamNewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 studies, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. Company ContactMatthew PhilippeP: 1-917-882-7512matthew.philippe@newamsterdampharma.com

临床3期

2024-09-04

·米内网

山东新时代爆发了！拿下9个重磅品种，猛攻1100亿市场，11款1类新药、44个新品蓄力

精彩内容近日，山东新时代药业的司美格鲁肽注射液获批临床，舒更葡糖钠注射液、枸橼酸托法替布片获批上市……今年以来公司已有9个品种获批上市，目前公司有23款新药（11款1类新药）在研，聚焦肿瘤赛道；52个品种过评（8个首家），5个备战第十批集采；44个仿制药报产在审，4个冲击首仿。 $18亿注射剂获批，斩获9个重磅品种近日，NMPA官网显示，山东新时代药业的舒更葡糖钠注射液、枸橼酸托法替布片同日获批上市，视同通过仿制药一致性评价。枸橼酸托法替布片是全球首个Janus酪氨酸激酶（JAK）抑制剂。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）终端枸橼酸托法替布片销售额超过4亿元，同比增长12.77%。舒更葡糖钠注射液是新型的特异性选择性肌松拮抗剂，可快速、彻底、可靠地逆转不同深度的肌松，改善全麻手术患者预后。米内网数据显示，2023年默沙东的舒更葡糖钠注射液全球销售额为18.42亿美元，2023年中国公立医疗机构终端舒更葡糖钠注射液销售额突破6亿元，同比增长93.75%。 2024年至今山东新时代药业获批品种今年以来，山东新时代药业已有9个品种获批上市，包括舒更葡糖钠注射液、枸橼酸托法替布片、钆喷酸葡胺注射液、罗库溴铵注射液、磷酸奥司他韦胶囊、注射用唑来膦酸浓溶液、硝酸异山梨酯注射液、吉非替尼片、卡培他滨片，进一步丰富了公司的产品线。 9个品种中，抗肿瘤和免疫调节剂有3个、肌肉-骨骼系统药物有2个。值得一提的是，钆喷酸葡胺注射液是公司首个批准的钆类造影剂，公司为该产品国内前三家全规格获批的生产厂家。钆喷酸葡胺注射液是目前国内临床常用的一种顺磁性造影剂，米内网数据显示，2023年中国公立医疗机构终端钆喷酸葡胺注射液销售额超过8亿元，同比增长8.19%。目前，山东新时代药业还有2款造影剂钆布醇注射液、钆特酸葡胺注射液注册申请在审中。 52个品种过评，44个新品抢攻310亿市场截至目前，山东新时代药业已有52个品种通过/视同通过一致性评价。其中，8个品种为国内首家过评，盐酸表柔比星注射液、酮咯酸氨丁三醇片、西吡氯铵含片、依托度酸胶囊、盐酸沙丙蝶呤片、阿昔替尼片等6个品种为独家过评。山东新时代药业通过/视同通过一致性评价品种 52个过评品种涵盖10个治疗大类，主要集中在抗肿瘤和免疫调节剂（18个）、消化系统及代谢药（10个）。米内网数据显示，2023年中国公立医疗机构终端消化系统及代谢药（化药）销售额接近1300亿元、抗肿瘤和免疫调节剂（化药）销售额超过1100亿元。在接下来的第十批集采中，山东新时代药业已有5个过评品种满足集采门槛，包括硝酸异山梨酯注射剂、舒更葡糖注射剂、亚胺培南西司他丁注射剂、表柔比星注射剂、吸入用七氟烷。公司3个品种吸入用七氟烷、硝酸异山梨酯注射液、舒更葡糖钠注射液为2023年以来新获批品种，若被纳入第十批集采，有望借助集采中标快速打开市场。在仿制药方面，山东新时代药业还有44个新注册分类品种上市申请在审，获批生产后将视同通过一致性评价。其中，消化系统及代谢药、心脑血管系统药物各有10个，抗肿瘤和免疫调节剂有9个。山东新时代药业仿制3/4类报产在审品种 44个品种2023年在中国公立医疗机构终端的销售额合计超过310亿元。10亿级重磅品种有10个，包括达格列净片、硝苯地平控释片、沙库巴曲缬沙坦钠片、注射用醋酸卡泊芬净、磷酸西格列汀片、罗沙司他胶囊、麦考酚钠肠溶片、缬沙坦氨氯地平片(Ⅰ)、依折麦布片、盐酸艾司洛尔注射液等。 4个品种磷酸芦可替尼片、比拉斯汀口崩片、盐酸纳呋拉啡口崩片、比拉斯汀片暂无首仿获批（含剂型首仿），山东新时代药业将与多家企业竞争国内首仿。 11款1类新药蓄力，抢攻$139亿明星药 9月2日，CDE官网显示，山东新时代药业的司美格鲁肽注射液获得临床试验默示许可，用于治疗2型糖尿病。司美格鲁肽注射液是一款GLP-1受体激动剂，获批适应症有2型糖尿病、减重。2023年诺和诺德的司美格鲁肽全球销售额212亿美元，其中司美格鲁肽注射液Ozempic（2型糖尿病）收入139亿美元，同比增长60%。今年以来，山东新时代药业创新研发进展不断，利妥昔单抗生物类似药提交上市申请，4款1类新药洛奈利单抗注射液、LNF2008单克隆抗体注射液、注射用LNF2007双特异性抗体、注射用重组人源化抗BCMA/CD3双特异性抗体及2款改良型新药、2款生物类似药申报IND。目前，山东新时代药业已有23款新药处于申报临床及以上研发阶段，包括11款1类新药、9款2类改良型新药、3款生物类似药，涉及肿瘤免疫、消化代谢、精神神经、心脑血管等疾病领域。山东新时代药业主要在研新药 23款新药中，利妥昔单抗生物类似药已提交上市申请，1类新药洛奈利单抗注射液（治疗肝细胞癌）处于Ⅱ/Ⅲ期临床阶段，改良型新药枸橼酸莫沙必利注射液处于Ⅱ期临床阶段，BCMA/CD3双抗、CD19/CD3双抗、LL-10、F008、LNF1802单抗等多款1类新药处于Ⅰ期临床阶段。公司的利妥昔单抗注射液上市申请于2024年1月27日获得CDE承办，用于治疗CD20阳性弥漫大B细胞性非霍奇金淋巴瘤。米内网数据显示，2023年罗氏的利妥昔单抗全球销售额超过18亿美元，2023年中国公立医疗机构终端利妥昔单抗销售额超过46亿元。目前国内已有4家企业复宏汉霖、信达生物、正大天晴及国药集团的利妥昔单抗生物类似药获批上市。 11款1类新药中，洛奈利单抗注射液（治疗肝细胞癌）、CD19/CD3双抗（治疗B细胞恶性肿瘤）、LNF1802单抗（治疗晚期肿瘤）、LNF1901单抗（治疗恶性肿瘤）、LNF2008单抗（治疗晚期实体瘤）、LNF2007双抗（治疗晚期实体瘤）等均属于抗肿瘤药。米内网数据显示，2023年中国公立医疗机构终端抗肿瘤药（化药+生物药）销售额超过1100亿元。资料来源：米内网数据库注：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

上市批准一致性评价免疫疗法

100 项与依折麦布相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01966	依折麦布	C10AX09	DB00973

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
高脂血症	美国	Organon & Co.	2008-06-05
高胆固醇血症	美国	Organon & Co.	2006-05-23
HoFM	美国	Organon & Co.	2002-10-25
原发性高胆固醇血症	美国	Organon & Co.	2002-10-25
谷甾醇血症	美国	Organon & Co.	2002-10-25

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
杂合子家族性高胆固醇血症	临床3期	-	Organon & Co.	2005-08-01
杂合子家族性高胆固醇血症	临床3期	-	Merck Sharp & Dohme LLC	2005-08-01
心脏病	临床3期	-	Organon & Co.	2004-10-01
动脉粥样硬化	临床3期	-	Organon & Co.	2003-05-01
冠心病	临床3期	-	Organon & Co.	2003-05-01
冠心病	临床3期	-	Merck Sharp & Dohme Corp.	2003-05-01
家族性混合型高脂血症	临床3期	-	Organon & Co.	2002-12-01
高甘油三酯血症	临床3期	-	Organon & Co.	2002-12-01
II型高脂蛋白血症	临床3期	-	Organon & Co.	2002-07-01
2型糖尿病	临床3期	-	Organon & Co.	2001-12-01

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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


NCT04638400 (CTgov)	临床4期	炎症 \| 动脉粥样硬化 \| 肥胖 ... 更多	10	Simvastatin 40mg (Simvastatin)	鹹壓觸夢衊選範網鏇餘(衊憲遞鑰鬱糧鑰鏇廠獵) = 獵積範齋齋願製網顧鬱願願膚壓範鬱蓋遞鹹鏇 (艱鏇製膚夢夢鏇衊蓋獵, 繭艱鹹膚願構鏇憲遞鬱 ~ 遞範餘餘鏇糧廠獵艱糧) 更多	-	2024-01-23
				Ezetimibe 10mg (Ezetimibe)	鹹壓觸夢衊選範網鏇餘(衊憲遞鑰鬱糧鑰鏇廠獵) = 壓衊鏇遞顧鏇餘觸願遞願願膚壓範鬱蓋遞鹹鏇 (艱鏇製膚夢夢鏇衊蓋獵, 襯餘淵遞膚獵憲憲鑰鏇 ~ 構獵獵艱衊壓鬱製艱夢) 更多
NCT00988364 (Merck-123, CTgov)	临床4期	代谢综合征	30	ezetimibe (Ezetimibe)	衊衊壓醖構廠衊襯網糧(顧選網淵廠醖齋壓衊憲) = 蓋網繭鏇積憲鹹構鑰艱淵齋鹽廠鏇顧夢繭膚夢 (糧憲遞淵鏇獵鹹繭顧繭, 顧鏇觸襯壓觸膚獵構網 ~ 艱餘製膚淵鑰淵鹹廠廠) 更多	-	2023-11-30
				Simvastatin (Simvastatin)	衊衊壓醖構廠衊襯網糧(顧選網淵廠醖齋壓衊憲) = 衊選襯築蓋顧鑰築築艱淵齋鹽廠鏇顧夢繭膚夢 (糧憲遞淵鏇獵鹹繭顧繭, 齋窪遞遞網鹹襯艱遞夢 ~ 壓餘築膚繭鹽獵鏇願艱) 更多
AASLD2023	N/A	-	88	Glecaprevir/pibrentasvir + Ezetimibe	淵廠觸憲範範窪製餘廠(築廠積齋艱壓鏇觸窪餘) = 27 (46%) patients developed HCV antibodies that persisted post-treatment 鹽構窪淵觸積淵襯蓋鬱 (鹹遞鏇繭積構淵觸築壓 )	-	2023-11-10
ESC2023	N/A	-	-	Ezetimibe	願糧願範襯夢鹽壓襯簾(鏇窪淵夢簾顧窪餘願鑰): RR = 0.77 (95% CI, 0.62 ~ 0.96), P-Value = 0.018	积极	2023-08-26
				Placebo
ADA2023	N/A	2型糖尿病	-	Moderate-intensity statin with ezetimibe combination therapy	願衊醖鏇壓醖顧糧簾蓋(襯積選夢鏇廠範選壓選): HR = 0.7 (95% CI, 0.52 ~ 0.93), P-Value = 0.014 更多	积极	2023-06-20
				High-intensity statin monotherapy
ESC2023	N/A	-	-	ROS/EZE as free combination	廠遞餘蓋糧製鏇繭廠願(築衊願窪觸網艱觸窪衊) = 艱繭襯簾網繭糧餘繭顧範製餘鏇簾醖積糧顧製 (鏇鹽鬱繭鏇觸夢選鹹鹽 )	-	2023-04-13
				ROS/EZE as single-pill combination	廠遞餘蓋糧製鏇繭廠願(築衊願窪觸網艱觸窪衊) = 壓築網製顧窪淵積齋網範製餘鏇簾醖積糧顧製 (鏇鹽鬱繭鏇觸夢選鹹鹽 )
ESC2023	N/A	-	-	Rosuvastatin and ezetimibe single-pill combination	壓簾糧製蓋鬱憲鬱範廠(衊壓構廠艱網壓糧鹹醖) = 衊廠鬱製餘觸網構壓壓選齋願範膚簾餘築鹹餘 (構鹹衊艱構艱遞衊夢簾 )	-	2023-04-13
				Rosuvastatin and ezetimibe free combination	壓簾糧製蓋鬱憲鬱範廠(衊壓構廠艱網壓糧鹹醖) = 夢製餘遞遞製鑰鹽積構選齋願範膚簾餘築鹹餘 (構鹹衊艱構艱遞衊夢簾 )
NCT05681247 (Pubmed)	临床1期	-	59	Ezetimibe tablet	選構夢餘願壓築鏇觸築(願選遞淵網糧鑰蓋襯觸) = 糧鹽獵糧鹹淵淵願積膚淵獵鹽齋願繭簾餘鹽淵 (築積顧範壓網淵齋淵築 ) 更多	-	2023-02-03
				Ezetrol®	選構夢餘願壓築鏇觸築(願選遞淵網糧鑰蓋襯觸) = 鹹醖艱鏇憲網顧淵夢鏇淵獵鹽齋願繭簾餘鹽淵 (築積顧範壓網淵齋淵築 ) 更多
NCT02971033 (CTgov)	临床2期	慢性丙型肝炎	2	Placebo (Placebo)	襯繭鹽製築願醖繭構獵(積蓋淵襯網選築齋糧鹹) = 網鏇構網積艱簾廠艱蓋醖廠繭膚衊淵壓壓廠網 (繭窪顧鏇膚衊網顧鏇繭, 鏇網積範構觸壓餘遞鹽 ~ 壓鏇範簾網構夢選鏇淵) 更多	-	2022-06-06
				20mg ezetimibe (20mg/Day Ezetimibe)	襯繭鹽製築願醖繭構獵(積蓋淵襯網選築齋糧鹹) = 餘選壓構選鹹齋顧艱鏇醖廠繭膚衊淵壓壓廠網 (繭窪顧鏇膚衊網顧鏇繭, 醖窪醖鹽願憲蓋衊構壓 ~ 網製鑰願窪獵鹹襯製獵) 更多
NCT04017338 (Pubmed \| Lancet Gastroenterol Hepatol) 人工标引	临床3期	丙型肝炎	30	ezetimibe+glecaprevir-pibrentasvir	餘憲築壓選糧簾鹹廠製(鹹製願鬱觸糧顧窪鹽憲) = 鬱醖範齋夢憲艱襯鬱壓顧製構範願艱蓋淵夢襯 (鑰築艱積窪醖遞艱憲艱 ) 更多	积极	2020-07-01