A bio-equivalence study of a randomized, open label, 4-period, 2-treatment, 2-sequence, fully replicate, crossover study of EPA NIKP Soft Cap 900 mg relative to EPADEL S900 (Original Ethyl Icosapentate 900 mg) in healthy Thai participants under fed condition

开始日期2026-08-11

申办/合作机构

Bio-innova Co., Ltd

NCT07680829

/ Not yet recruiting临床3期

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of DR10624 Added to Standard Icosapent Ethyl Therapy in Adults With Severe Hypertriglyceridemia

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial for adults with severe hypertriglyceridemia whose lipid levels remain uncontrolled under standard Icosapent Ethyl background treatment plus lifestyle management. Eligible participants complete a screening run-in period, then randomize equally to three treatment groups: two active DR10624 subcutaneous injection groups and one placebo group. All subjects maintain fixed oral background lipid therapy throughout long-term double-blind treatment, followed by a short safety follow-up period. The primary objective is to evaluate the triglyceride-lowering effect of DR10624 versus placebo. Secondary assessments include other lipid indicators, liver fat content, overall safety, and anti-drug antibody status. Independent committees monitor interim data and adjudicate key clinical events to ensure participant safety.

开始日期2026-08-01

申办/合作机构

浙江道尔生物科技有限公司

NCT07648342

/ Not yet recruitingN/AIIT

Evaluation of Pupillometry as a Predictor of Pain Intensity Upon Withdrawal of Sedation in the Postoperative Period Following Cardiac Surgery: A Prospective Cohort Study

Postoperative pain is a significant issue following surgery, and pain that is either inadequately treated or, conversely, overtreated can increase morbidity. For example, severe chest pain following cardiac or pulmonary surgery impairs the patient's respiratory rehabilitation, which can lead to fluid retention and, consequently, pneumonia. Conversely, overtreatment through excessive use of opioids can cause drowsiness and respiratory depression. Currently, planning postoperative pain management for intubated, ventilated, and sedated patients relies on indirect signs of pain assessed using scales, and on the clinician's subjective judgment. It is only after sedation is discontinued that the actual level of pain can be assessed, once the patient becomes communicative, which then allows analgesic treatment to be adjusted to the pain. This approach inevitably results in a period of discomfort and pain for the patient. In addition to semi-quantitative and subjective scales, a number of analgesia monitoring tools have been developed.
Among these, the use of pupillometry and the Pupillary Pain Index (PPI) during surgeries (gynecological, pediatric, cardiac) has been associated with a reduction in intraoperative opioid doses and a decrease in postoperative pain. In our department, pupillometry is routinely used to assess analgesia in intubated, ventilated, and sedated patients undergoing painful procedures. This method is integrated into standard care in the operating room in accordance with the PUCCAR study algorithm, as well as in the intensive care unit according to a specific departmental protocol, in addition to standard assessment scores. We hypothesize that performing pupillometry with a PPI score is predictive of pain intensity at extubation. If our hypothesis is confirmed, this would allow us to tailor analgesic management for each patient prior to discontinuing sedation.

开始日期2026-07-01

申办/合作机构

Centre Hospitalier Universitaire de Dijon

100 项与二十碳五烯酸乙酯相关的临床结果

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100 项与二十碳五烯酸乙酯相关的转化医学

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100 项与二十碳五烯酸乙酯相关的专利（医药）

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829

项与二十碳五烯酸乙酯相关的文献（医药）

2026-07-01·CLINICAL MEDICINE

Lipid lowering in coronary artery disease – not just statins

Review

作者: Wang, Timothy ; Masmanian, Eva ; Chua, Tuan Peng ; Han, Jennie

Coronary artery disease has a high degree of morbidity and mortality internationally and, after a cardiovascular event, patients require intensified management of modifiable risk factors, with optimal lipid control being an important cornerstone of secondary prevention. This is both a primary and a secondary care responsibility. Familiarity with indications for and prescription of non-statin medications, including injectables, is vital for patient outcomes. Fewer than 30% of patients reach LDL-c targets with statins alone. This is a public health matter, and non-statin therapies that all clinicians need to be aware of are oral therapies such as ezetimibe and bempedoic acid, and injectable therapies such as inclisiran and PCKS9 inhibitors. Icosapent ethyl is also available in those with high fasting triglycerides with specific LDL-c values. Understanding when to refer to the lipid clinic enables patients to be managed appropriately in the correct setting. Future therapies under development include cholesterol ester transfer protein inhibitors, oral PCSK9 inhibitors, and gene editing therapy targeting ANGPTL3 and PCSK9. Lipid optimisation leads to significant reduction in major adverse cardiac events, and familiarity with all available treatment options - including non-statins and injectables - will facilitate best primary and secondary care.

2026-07-01·American Journal of Cardiovascular Drugs

Formulation-Specific Cardiovascular Outcomes with High-Dose Eicosapentaenoic Acid: A Systematic Review and Meta-analysis

Review

作者: Muhammad, Tazheen Saleh ; Azeem, Bazil ; Asim, Rabia ; Naveed, Muhammad Abdullah ; Dogar, Mata-E-Alla ; Ali, Talha ; Faheem, Muhammad Anas

BACKGROUND/OBJECTIVE:

Residual cardiovascular risk persists despite intensive statin therapy in patients with established atherosclerotic cardiovascular disease (CVD). Omega-3 fatty acids, particularly high-dose eicosapentaenoic acid (EPA), have been proposed as adjunctive therapy, yet trial results conflict, likely due to formulation differences. We conducted a formulation-focused meta-analysis to determine whether high-dose EPA-dominant supplementation reduces cardiovascular events and to quantify the impact of mixed EPA/docosahexaenoic acid (DHA) regimens on efficacy.

METHODS:

Following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 guidelines, we searched MEDLINE, Embase, CENTRAL, and trial registries through May 2025 for randomized controlled trials, including placebo-controlled and open-label designs, of high-dose EPA-dominant omega-3 (≥ 1.8 g/day; ≥ 50% EPA) in adults with established CVD or other high-risk settings. Six trials (n = 42,738; 31-85% male) were eligible. Random-effects models generated pooled risk ratios (RRs), with I² assessing heterogeneity; sensitivity analyses excluded mixed EPA/DHA formulations. Imaging surrogate outcomes were summarized narratively when study modalities were not directly comparable.

RESULTS:

EPA-based therapy significantly reduced hospitalizations for unstable angina (RR 0.75, 95% CI 0.66-0.87; I² = 0%). Overall effects on recurrent myocardial infarction and revascularization were not statistically significant, but both became significant after exclusion of STRENGTH, the only mixed EPA/DHA cardiovascular outcomes trial. No significant effect was observed for ischemic stroke, cardiovascular death, or high-sensitivity C-reactive protein (hs-CRP). CHERRY and EVAPORATE both suggested attenuation of plaque progression, but these imaging studies were not pooled because intravascular ultrasound and coronary computed tomography angiography-derived measures were not directly comparable.

CONCLUSION:

High-dose EPA-dominant therapy was associated with fewer unstable angina hospitalizations, and formulation appeared to modify clinical benefit. Among blinded, placebo-controlled, cardiovascular outcomes trials, 4 g/day icosapent ethyl is the only formulation independently associated with reduced cardiovascular events. Larger formulation-specific trials are needed to clarify the roles of purified EPA, mixed EPA/DHA regimens, and patient selection.

REGISTRATION:

PROSPERO identifier number: CRD420251063069.

2026-06-16·ANALYTICAL CHEMISTRY

Breaking the Cryogenic Sensing Limitation: Solvent-Microenvironment-Programmed Cold-Adaptable Nanozymes Enable Sensitive Volatile Amine Detection at Low Temperature

Article

作者: Liang, Hao ; Chen, Xinyu ; Liu, Shuangquan ; Niu, Xiangheng ; Zou, Ruihan ; Liu, Jinjin ; Wang, Linjie ; Tang, Zheng

Nanozymes, with recognized superiorities over natural enzymes, hold enormous potential in biochemical analysis, while their poor catalytic efficiency and kinetics, particularly under low-temperature conditions, severely limit practical use in cryogenic scenarios. To break the low-temperature sensing limitation, here we propose a solvent-microenvironment-programmed manganese-coordinated polyphosphate (Mn(DTPMP)) with the cold-adaptable oxidase-mimetic feature to achieve the sensitive detection of volatile amines (VAs) in food cold-chain logistics. By employing different solvents during hydrothermal synthesis, both the physical structure and surface chemistry of Mn(DTPMP) were subtly modulated, which contributed to the oxidase-mimicking catalytic characteristics jointly. The nanozyme exhibited robust performance across a temperature range from near-zero to physiological, and such an exceptional feature was proved to originate from the synergistic interplays of unique elemental composition, valence state distribution, extremely low activation energy barrier, and high-spin electron configuration. Leveraging the cold-adaptable nanozyme, a sensitive colorimetric approach was established and validated for accurately monitoring VAs in low-temperature environments, with a detection limit as low as 0.17 ppm. By breaking the temperature barrier, the paradigm of developing high-activity cold-adaptable nanozymes extends their application frontiers in cryogenic measurements. Besides, our study offers fundamental insights into the solvent-microenvironment-mediated regulation of nanozymes and deepens the mechanism understanding of their cold-adaptable effect, both of which can inspire designing advanced enzyme mimics for broader cryogenic science including but not limited to analytical sensing.

373

项与二十碳五烯酸乙酯相关的新闻（医药）

2026-06-30

·柳州市人民医院

2026年第7次药物临床试验伦理委员会审查结果公示

2026年6月12日药物临床试验伦理委员会审查会议结果如下：（一）初始审查：5项 1. 项目评估AHB-137 注射液用于初治慢性乙型肝炎参与者有效性和安全性的随机、双盲、安慰剂对照、多中心II 期临床试验受理号 GCP2026-046-01 研究类型药物II期项目来源杭州浩博医药有限公司主要研究者胡家光主审委员潘柳萍、莫献忠审查决定同意 2. 项目注射用IMM0306（阿沐瑞芙普α）联合来那度胺对比安慰剂联合来那度胺治疗复发/难治滤泡性淋巴瘤受试者的随机、双盲、对照、多中心III期临床研究受理号 GCP2026-047-01 研究类型药物III期项目来源宜明昂科生物医药技术（上海）股份有限公司主要研究者班春梅主审委员刘代华、吴仕华审查决定作必要修正后同意 3. 项目一项在重度高甘油三酯血症试验参与者中评价DR10624 与二十碳五烯酸乙酯比较的有效性和安全性的多中心、随机、双盲双模拟、阳性对照的Ⅲ期临床试验受理号 GCP2026-048-01 研究类型药物III期项目来源浙江道尔生物科技有限公司主要研究者莫秋萍主审委员李俊明、黄华强审查决定同意 4. 项目评价盐酸他喷他多注射液用于骨科术后镇痛的有效性和安全性的随机、双盲、阳性及安慰剂对照、多中心Ⅲ期临床试验受理号 GCP2026-049-01 研究类型药物III期项目来源江苏华泰晨光药业有限公司主要研究者韦新权主审委员王晓龙、莫献忠审查决定同意 5. 项目在肥胖或超重合并或未合并2型糖尿病参与者中评价elecoglipron的有效性和安全性的III期、随机、双盲、安慰剂对照、多中心研究的主方案受理号 GCP2026-050-01 研究类型药物III期项目来源阿斯利康全球研发(中国)有限公主要研究者周玉主审委员蒋忠胜、吴仕华审查决定同意（二）安全性事件审查：3项 1. 项目一项评价sac-TMT（芦康沙妥珠单抗，MK-2870）联合帕博利珠单抗序贯卡铂/紫杉醇联合帕博利珠单抗对比化疗联合帕博利珠单抗作为高危早期三阴性乳腺癌或激素受体低表达/人表皮生长因子受体2阴性乳腺癌的新辅助治疗的有效性和安全性的III期、随机、开放性研究受理号 GCP2025-068-09GCP2025-068-06 研究类型药物III期项目来源默沙东研发（中国）有限公司主要研究者莫军扬主审委员翁映虹、龙入虹审查决定同意研究继续进行 2. 项目一项评价sac-TMT（芦康沙妥珠单抗，MK-2870）联合帕博利珠单抗序贯卡铂/紫杉醇联合帕博利珠单抗对比化疗联合帕博利珠单抗作为高危早期三阴性乳腺癌或激素受体低表达/人表皮生长因子受体2阴性乳腺癌的新辅助治疗的有效性和安全性的III期、随机、开放性研究受理号 GCP2025-068-10 研究类型药物III期项目来源默沙东研发（中国）有限公司主要研究者莫军扬主审委员翁映虹、龙入虹审查决定同意研究继续进行（三）违背方案审查：4项 1. 项目 Exendin-4Fc 融合蛋白（JY09）注射液在二甲双胍治疗后血糖控制不佳成人 2 型糖尿病受试者中的多中心、随机、开放、度拉糖肽阳性对照Ⅲ期临床研究受理号 GCP2025-013-04 研究类型药物III期项目来源北京东方百泰生物科技股份有限公司主要研究者刘纳主审委员潘柳萍、吴仕华审查决定同意研究继续进行 2. 项目评价注射用RF16001局部浸润用于全髋关节置换术后镇痛的疗效、安全性、药代动力学的多中心、随机、双盲、平行、阳性及安慰剂对照、剂量探索Ⅱ期临床试验受理号 GCP2025-107-02 研究类型药物II期项目来源宜昌人福药业有限责任公司主要研究者余相地主审委员蒋忠胜、余洪立审查决定同意研究继续进行 3. 项目一项纳武利尤单抗+Relatlimab固定剂量复方制剂联合化疗对比帕博利珠单抗联合化疗作为非鳞状（NSQ）、IV期或复发性非小细胞肺癌且肿瘤细胞PD-L1表达水平为≥1%的受试者一线治疗的3期、随机、开放标签研究受理号 GCP2024-096-12 研究类型药物III期项目来源百时美施贵宝（中国）投资有限公司主要研究者李竟长主审委员刘代华、余洪立审查决定同意研究继续进行 4. 项目一项评价GR1802注射液在慢性鼻窦炎伴鼻息肉患者中的有效性、安全性和免疫原性的随机、双盲、安慰剂对照、多中心III期临床试验受理号 GCP2024-055-07 研究类型药物III期项目来源重庆智翔金泰生物制药股份有限公司主要研究者李纪辉主审委员翁映虹、吴仕华审查决定同意研究继续进行

2026-06-30

·BioSpace

Amarin Reaffirms the Proven, Guideline-Recommended Role of VASCEPA® (Icosapent Ethyl) in an Evolving Triglyceride Treatment Landscape

Clinically Validated, Increasingly Prescribed, Widely Reimbursed, and Affordable, VASCEPA Expected to Benefit from Increased Attention to Patients with Severely Elevated Triglycerides DUBLIN, Ireland and BRIDGEWATER, N.J., June 30, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) , a company committed to advancing the science of cardiovascular disease worldwide, applauds the recent FDA approval of injectable apolipoprotein C-III (APOC3) therapies for the treatment of severe hypertriglyceridemia (sHTG), defined as triglycerides (TG) greater than or equal to 500 mg/dL. i These injectable therapies represent meaningful progress for patients at high risk for serious, sometimes life-threatening diseases associated with sHTG, including acute pancreatitis. “The renewed attention triglycerides generated by the introduction of innovative therapies is welcome, as they help to drive patient–physician conversations and bring critical awareness to the dangers of very high triglyceride levels,” said Aaron Berg, CEO of Amarin. “We recognize the important therapeutic advancement that APOC3 therapies represent and are optimistic about their potential benefit in patients at high risk of acute pancreatitis. For many years, clinicians have managed sHTG with proven, foundational therapies like VASCEPA, which remains a critical, first-line option for millions of individuals who have taken control of their lipid management. We remain mindful that issues such as cost, coverage, and accessibility may influence how and when patients are able to benefit from innovative, yet high-cost therapies. Therefore, we are confident that VASCEPA will continue to deliver strong clinical and economic value for a broad segment of patients with severe hypertriglyceridemia.” Mr. Berg noted the following: Robust Reductions in sHTG Without LDL-C Increases: VASCEPA has been shown to deliver a 33% median reduction in TG levels in patients with sHTG as compared to placebo, with approximately 50% of patients achieving TG levels below 500 mg/dL at 12 weeks. ii , iii These reductions were achieved without the increases in LDL cholesterol observed with certain other triglyceride-lowering agents in patients with sHTG. iv , v , vi Lower Cost, Proven Efficacy, and Broad Access : There is a stark contrast in cost between VASCEPA and recently introduced injectable APOC3 therapies, the most recent of which carries an annual wholesale acquisition cost (WAC) of $40,000 per patient. By comparison, the annual wholesale acquisition cost for VASCEPA is approximately $4,200 per patient. Reflecting this cost differential, many payers, pharmacy benefit managers (PBMs), and managed care organizations may follow a well-established pattern of managing utilization of premium priced therapies through judicious prior authorization and step-therapy requirements. vii Elevated Triglyceride Patients are at Increased Risk for Cardiovascular Disease: VASCEPA has been prescribed more than 30 million times globally for patients with elevated triglycerides and remains the first and only FDA-approved therapy proven to reduce the risk of cardiovascular events by 25% when added to a statin in high-risk patients with elevated triglycerides and other cardiovascular risk factors. viii Global Guideline Support Recently Reaffirmed : 70+ leading medical societies recognize the importance of icosapent ethyl based on the strength of the clinical data. The 2026 American College of Cardiology / American Heart Association / Multisociety Dyslipidemia Guideline reaffirmed the role of established triglyceride-lowering therapies, including VASCEPA, in the management of patients with elevated triglycerides. i Mr. Berg concluded, “We fully appreciate the potential benefits of recently introduced therapies for the segment of sHTG patients who are at high risk of acute pancreatitis. However, for the majority of the sHTG patient population, and for the broader global population of patients with elevated triglycerides at risk for cardiovascular events, significant clinical and economic value will be derived from prioritizing treatments such as VASCEPA that are proven, safe, commonly prescribed, affordable, and widely reimbursed.” About Amarin Amarin is a global pharmaceutical company committed to reducing the cardiovascular disease (CVD) burden for patients and communities and to advancing the science of cardiovascular care around the world. We own and support a global branded product approved by multiple regulatory authorities based on a track record of proven efficacy and safety and backed by robust clinical trial evidence. Our commercialization model includes a direct sales approach in the U.S. and an indirect distribution strategy internationally, through a syndicate of reputable and well-established partners with significant geographic expertise, covering close to 100 markets worldwide. Our success is driven by a dedicated, talented, and highly skilled team of experts passionate about the fight against the world’s leading cause of death, CVD. About VASCEPA ® /VAZKEPA ® (icosapent ethyl) Capsules VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than thirty million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA was granted in the United Kingdom (applying to England, Scotland, Wales, and Northern Ireland). VAZKEPA is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy, Denmark and Austria. United States Indications and Limitation of Use VASCEPA is indicated: As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease. As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Important Safety Information VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur. VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin. Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%). Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%). Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088. Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding. FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM . Europe For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA ® in Europe, please visit: Globally, prescribing information varies; refer to the individual country product label for complete information. Forward-Looking Statements This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s outlook for achievements in 2026 and beyond; Amarin’s overall efforts to expand access and reimbursement to VASCEPA/VAZKEPA across global markets; expectations regarding potential market dynamics, payer behavior, and the competitive landscape; and the overall potential and future success of VASCEPA/VAZKEPA and Amarin that are based on the beliefs and assumptions and information currently available to Amarin. All statements other than statements of historical fact contained in this press release are forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the fiscal year ended 2025 and subsequent quarterly reports on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin Contact Information Media Inquiries:  Tegan Berry  Amarin Corporation plc  PR@amarincorp.com Investor Inquiries: Devin Sullivan & Conor Rodriguez  The Equity Group on Behalf of Amarin   devin.sullivan.ext@amarincorp.com  or  conor.rodriguez.ext@amarincorp.com Investor.relations@amarincorp.com i Blumenthal RS, Morris PB, Gaudino M, et al. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol . 2026 Mar 13:S0735-1097(25)10254-4. doi: 10.1016/j.jacc.2025.11.016. Epub ahead of print ii Bays HE, et al. Am J Cardiol. 2011;108(5):682-90. doi: 10.1016/j.amjcard.2011.04.015. iii Chowdhury IN. Medical Review(s): Vascepa (Icosapent Ethyl) . Silver Spring, MD: US Food and Drug Administration; 2012:50. Application No. 202057Orig1s000. Accessed December 17, 2025. iv v vi Marston NA, Bergmark BA, Alexander VJ, et al.; CORE-TIMI 72a and CORE2-TIMI 72b Investigators. Olezarsen for managing severe hypertriglyceridemia and pancreatitis risk. N Engl J Med. 2025 Nov 8. doi: 10.1056/NEJMoa2512761. vii Annual wholesale acquisition cost: published WAC pricing / data on file. [Medi-Span ® Price Rx Pro ® ”] viii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22. DOI: 10.1056/NEJMoa1812792

2026-06-28

·信狐药迅

五款1类新药获批上市：培来加南、琥珀八氢氨吖啶、沃诺拉赞、BL-B01D1、舒瑞基奥仑赛、斯乐韦米单抗| 新获批(6.22-6.28）

每周药品注册获批数据，分门别类呈现，一目了然。(6.22-6.28）新药上市申请药品名称企业注册分类受理号艾玛昔替尼软膏江苏恒瑞医药股份有限公司 1 CXHS2500018 培来加南喷雾剂普莱医药(江苏)股份有限公司 1 CXHS2400130 琥珀八氢氨吖啶片通化金马药业集团股份有限公司 1 CXHS2400085 琥珀八氢氨吖啶片通化金马药业集团股份有限公司 1 CXHS2400084 醋酸沃诺拉赞注射液江苏柯菲平医药股份有限公司 2.1;2.2;2.4 CXHS2500023 水合氯醛口服液成都诺和晟鸿生物制药有限公司 2.2 CXHS2400098 注射用醋酸曲普瑞林微球长春金赛药业有限责任公司 2.2 CXHS2400028 枸地氯雷他定口服液合肥恩瑞特药业有限公司 2.2;2.4 CXHS2500017 SHR8028滴眼液成都盛迪医药有限公司 2.2;2.4 CXHS2300039 注射用BL-B01D1 成都百利多特生物药业有限责任公司 1 CXSS2500124 舒瑞基奥仑赛注射液恺兴生命科技(上海)有限公司 1 CXSS2500068 斯乐韦米单抗注射液重庆智翔金泰生物制药股份有限公司 1 CXSS2500004 阿得贝利单抗注射液上海盛迪医药有限公司 2.2 CXSS2500099 新药临床申请药品名称企业注册分类受理号 YKYY033注射液北京悦康科创医药科技股份有限公司 1 CXHL2600610 BGB-43395片百济神州(苏州)生物科技有限公司 1 CXHL2600454 BGB-43395片百济神州(苏州)生物科技有限公司 1 CXHL2600453 BGB-43395片百济神州(苏州)生物科技有限公司 1 CXHL2600452 BGB-43395片百济神州(苏州)生物科技有限公司 1 CXHL2600451 注射用甲磺酸普依司他成都赜灵生物医药科技股份有限公司 1 CXHL2600456 注射用莱古杉醇上海亲合力生物医药科技股份有限公司 1 CXHL2600450 注射用莱古杉醇上海亲合力生物医药科技股份有限公司 1 CXHL2600449 IPG1094片南京艾美斐生物医药科技股份有限公司 1 CXHL2600440 IPG1094片南京艾美斐生物医药科技股份有限公司 1 CXHL2600439 IPG1094片南京艾美斐生物医药科技股份有限公司 1 CXHL2600438 IPG1094片南京艾美斐生物医药科技股份有限公司 1 CXHL2600437 HRS-8797片成都盛迪医药有限公司 1 CXHL2600434 HRS-8797片成都盛迪医药有限公司 1 CXHL2600433 HRS-8797片成都盛迪医药有限公司 1 CXHL2600432 盐酸艾司氯胺酮口颊粘膜溶液宜昌人福药业有限责任公司 2.2 CXHL2600442 猴痘mRNA疫苗江苏中慧元通生物科技股份有限公司 1.2 CXSL2600362 HH160注射液华辉安健(北京)生物科技有限公司 1 CXSL2600564 QT-019B细胞注射液杭州启函生物科技有限公司 1 CXSL2600533 注射用HDM2017 杭州中美华东制药有限公司 1 CXSL2600414 SHR-4610注射液上海盛迪医药有限公司 1 CXSL2600425 注射用SHR-A2009 苏州盛迪亚生物医药有限公司 1 CXSL2600422 注射用SHR-1826 苏州盛迪亚生物医药有限公司 1 CXSL2600418 注射用FH-006 江苏恒瑞医药股份有限公司 1 CXSL2600417 注射用SKB500 四川科伦博泰生物医药股份有限公司 1 CXSL2600411 MRG007 乐普生物科技股份有限公司 1 CXSL2600409 注射用KGX105 北京康抗生物技术有限公司 1 CXSL2600408 注射用6MW5311 迈威(上海)生物科技股份有限公司 1 CXSL2600410 BBT002皮下注射液杉竹曜(北京)生物医药科技有限公司 1 CXSL2600407 BBT002皮下注射液杉竹曜(北京)生物医药科技有限公司 1 CXSL2600406 重组人源化抗白介素-6受体单抗注射液北京伟德杰生物科技有限公司 1 CXSL2600404 注射用HDM2005 杭州中美华东制药有限公司 1 CXSL2600401 注射用HWS113 湖北生物医药产业技术研究院有限公司 1 CXSL2600402 9MW5211注射液迈威(上海)生物科技股份有限公司 1 CXSL2600376 普那利单抗注射液天境生物药业(杭州)股份有限公司 1 CXSL2600373 GT101注射液苏州沙砾生物科技有限公司 1 CXSL2600365 注射用瑞康曲妥珠单抗苏州盛迪亚生物医药有限公司 2.2 CXSL2600426 SHR-8068注射液苏州盛迪亚生物医药有限公司 2.2 CXSL2600419 注射用SIM0692 山东先声再明生物制药有限公司 2.2 CXSL2600398 仿制药申请药品名称企业注册分类受理号乙酰半胱氨酸颗粒江西仁齐制药有限公司 3 CYHS2503020 磷/碳酸氢钠血滤置换液(4mmol/L钾、1.25mmol/L钙) 成都青山利康药业股份有限公司 3 CYHS2500563 碳酸氢钠/葡萄糖2mmol/l钾电解质血滤置换液成都青山利康药业股份有限公司 3 CYHS2500549 聚普瑞锌口腔崩解片海南金瑞宝医药科技有限公司 3 CYHS2500438 坎地氢噻片华益药业科技(安徽)有限公司 3 CYHS2500414 吡格列酮二甲双胍片(15mg/500mg) 宁波美舒药业有限公司 3 CYHS2500407 己酮可可碱缓释片福建海西新药创制股份有限公司 3 CYHS2500310 盐酸曲唑酮片安徽万邦医药科技股份有限公司 3 CYHS2500203 盐酸丙卡特罗口服溶液广州一品红制药有限公司 3 CYHS2500095 硫酸阿托品注射液烟台万润药业有限公司 3 CYHS2404615 复方电解质注射液(V) 湖南科伦制药有限公司 3 CYHS2404500 苯磺贝他斯汀口腔崩解片漯河市汇创医药有限公司 3 CYHS2404404 吸入用盐酸丙卡特罗溶液合肥国药诺和药业有限公司 3 CYHS2404418 吸入用盐酸丙卡特罗溶液合肥国药诺和药业有限公司 3 CYHS2404417 苯磺酸氨氯地平口服溶液四川奥邦古得药业有限公司 3 CYHS2404396 盐酸伐地那非口崩片哈尔滨三联药业股份有限公司 3 CYHS2404392 醋酸特利加压素注射液武汉华龙生物制药有限公司 3 CYHS2404363 吸入用盐酸丙卡特罗溶液石家庄四药有限公司 3 CYHS2404384 复方电解质醋酸钠注射液浙江高跖医药科技股份有限公司 3 CYHS2404375 咪达唑仑口服溶液成都倍特药业股份有限公司 3 CYHS2404337 帕拉米韦注射液嘉亨(珠海横琴)医药科技有限公司 3 CYHS2404329 法莫替丁注射液杭州民生药物研究院有限公司 3 CYHS2404291 硫酸阿托品注射液江苏润恒制药有限公司 3 CYHS2404301 盐酸丙卡特罗颗粒浙江恒研医药科技有限公司 3 CYHS2404185 格隆溴铵新斯的明注射液瑞阳制药股份有限公司 3 CYHS2404162 维生素B6注射液山西九康医药科技有限公司 3 CYHS2404161 钠钾镁钙注射用浓溶液成都欣捷高新技术开发股份有限公司 3 CYHS2404135 盐酸纳布啡注射液国药集团工业有限公司廊坊分公司 3 CYHS2404011 复方硫酸钠片山东华铂凯盛生物科技有限公司 3 CYHS2404007 盐酸尼卡地平氯化钠注射液浙江国镜药业有限公司 3 CYHS2404016 无水乙醇注射液成都倍特药业股份有限公司 3 CYHS2403977 普瑞巴林口服溶液盖天力医药控股集团制药股份有限公司 3 CYHS2403917 普瑞巴林口服溶液盖天力医药控股集团制药股份有限公司 3 CYHS2403916 普瑞巴林口服溶液盖天力医药控股集团制药股份有限公司 3 CYHS2403915 碳酸氢钠注射液北京民康百草医药科技有限公司 3 CYHS2403899 酮咯酸氨丁三醇片山东朗诺制药有限公司 3 CYHS2403892 维生素B6注射液康普药业股份有限公司 3 CYHS2403905 盐酸氟西汀口服溶液安徽四环科宝制药有限公司 3 CYHS2403883 盐酸氟西汀口服溶液安徽四环科宝制药有限公司 3 CYHS2403882 盐酸氟西汀口服溶液安徽四环科宝制药有限公司 3 CYHS2403881 盐酸氟西汀口服溶液安徽四环科宝制药有限公司 3 CYHS2403880 门冬氨酸钾注射液山东齐都药业有限公司 3 CYHS2403844 拉米夫定替诺福韦片石家庄龙泽制药股份有限公司 3 CYHS2403711 己酮可可碱缓释片广州仁恒医药科技股份有限公司 3 CYHS2403696 盐酸甲氧氯普胺注射液江西科为制药有限公司 3 CYHS2403635 美索巴莫注射液山东百诺医药股份有限公司 3 CYHS2403582 注射用硫酸多黏菌素B 广州艾奇西新药研究有限公司 3 CYHS2403540 氨己烯酸口服溶液用散上海上药信谊药厂有限公司 3 CYHS2403515 聚乙二醇3350散马应龙药业集团股份有限公司 3 CYHS2403471 氯化钙注射液广州大光制药有限公司 3 CYHS2403421 西格列汀二甲双胍缓释片江苏谦仁生物科技有限公司 3 CYHS2403411 西格列汀二甲双胍缓释片江苏谦仁生物科技有限公司 3 CYHS2403408 盐酸维拉帕米注射液扬州中宝药业股份有限公司 3 CYHS2403234 维生素B6注射液亚邦医药股份有限公司 3 CYHS2403199 福多司坦口服溶液珠海市汇通达医药有限公司 3 CYHS2403192 硝普钠注射液嘉实(湖南)医药科技有限公司 3 CYHS2403150 米诺地尔搽剂上海理想制药有限公司 3 CYHS2403058 米诺地尔搽剂上海理想制药有限公司 3 CYHS2403057 盐酸甲氧氯普胺注射液华夏生生药业(北京)有限公司 3 CYHS2403018 复方聚乙二醇(3350)电解质口服溶液黑龙江中桂制药有限公司 3 CYHS2403033 盐酸左西替利嗪口服溶液安徽四环科宝制药有限公司 3 CYHS2403025 盐酸左西替利嗪口服溶液安徽四环科宝制药有限公司 3 CYHS2403024 盐酸左西替利嗪口服溶液安徽四环科宝制药有限公司 3 CYHS2403023 维生素B12注射液华夏生生药业(北京)有限公司 3 CYHS2402959 依托泊苷注射液海南倍特药业有限公司 3 CYHS2402672 氯化钾口服溶液浙江领创优品药业有限公司 3 CYHS2402475 氯化钾口服溶液浙江领创优品药业有限公司 3 CYHS2402474 复方聚乙二醇(3350)电解质散华润双鹤药业股份有限公司 3 CYHS2402386 依巴斯汀口服溶液山东如至生物医药科技有限公司 3 CYHS2402348 二硫化硒洗剂浙江鼎泰药业股份有限公司 3 CYHS2402301 米诺地尔搽剂江西海尔思药业股份有限公司 3 CYHS2402125 盐酸甲氧氯普胺注射液四川美大康华康药业有限公司 3 CYHS2401972 琥乙红霉素片呋欧医药科技(湖州)有限公司 3 CYHS2401930 盐酸甲氧氯普胺注射液江苏瑜兴医药科技有限公司 3 CYHS2401815 米诺地尔搽剂西安德立生物化工有限公司 3 CYHS2401338 利那洛肽胶囊陕西汉唐制药有限公司 4 CYHS2504067 哌柏西利胶囊广州科锐特药业有限公司 4 CYHS2503483 哌柏西利胶囊广州科锐特药业有限公司 4 CYHS2503482 哌柏西利胶囊广州科锐特药业有限公司 4 CYHS2503481 氧(液态) 准格尔旗鼎承气体有限责任公司 4 CYHS2502980 甲磺酸沙非胺片浙江兄弟药业有限公司 4 CYHS2502648 甲磺酸沙非胺片浙江兄弟药业有限公司 4 CYHS2502647 复方氨基酸注射液(18AA-VII) 山东豪瑞恩制药有限公司 4 CYHS2502611 碳酸司维拉姆片江苏中天药业有限公司 4 CYHS2502575 蔗糖羟基氧化铁咀嚼片丽彩甘肃西峰制药有限公司 4 CYHS2502566 艾拉莫德片璟济生物医药科技(泰州)股份有限公司 4 CYHS2502487 依西美坦片浙江亚瑟医药有限公司 4 CYHS2501983 盐酸二甲双胍缓释片山东济坤生物制药有限公司 4 CYHS2501330 盐酸二甲双胍缓释片山东济坤生物制药有限公司 4 CYHS2501329 聚多卡醇注射液苏州朗科生物技术股份有限公司 4 CYHS2501225 聚多卡醇注射液苏州朗科生物技术股份有限公司 4 CYHS2501224 聚多卡醇注射液苏州朗科生物技术股份有限公司 4 CYHS2501223 阿帕他胺片正大天晴药业集团南京顺欣制药有限公司 4 CYHS2501181 盐酸曲唑酮缓释片山东京卫制药有限公司 4 CYHS2501106 沙库巴曲缬沙坦钠片江苏万高药业股份有限公司 4 CYHS2501071 沙库巴曲缬沙坦钠片江苏万高药业股份有限公司 4 CYHS2501070 沙库巴曲缬沙坦钠片江苏中邦制药有限公司 4 CYHS2500963 沙库巴曲缬沙坦钠片江苏中邦制药有限公司 4 CYHS2500962 瑞舒伐他汀依折麦布片(I) 浙江京新药业股份有限公司 4 CYHS2500959 巴瑞替尼片广州绿十字制药股份有限公司 4 CYHS2500931 巴瑞替尼片广州绿十字制药股份有限公司 4 CYHS2500930 甲硝唑凝胶湖北舒邦药业有限公司 4 CYHS2500906 二甲双胍恩格列净片(I) 南昌立健药业有限公司 4 CYHS2500858 二甲双胍恩格列净片(VI) 南昌立健药业有限公司 4 CYHS2500857 马立巴韦片齐鲁制药(海南)有限公司 4 CYHS2500815 盐酸西替利嗪滴剂福建大谱生物医药有限公司 4 CYHS2500755 盐酸西替利嗪滴剂福建大谱生物医药有限公司 4 CYHS2500754 阿帕他胺片浙江诺得药业有限公司 4 CYHS2500670 帕利哌酮缓释片北大医药股份有限公司 4 CYHS2500647 帕利哌酮缓释片北大医药股份有限公司 4 CYHS2500646 罗沙司他胶囊浙江贝得药业有限公司 4 CYHS2500663 罗沙司他胶囊浙江贝得药业有限公司 4 CYHS2500662 注射用尼可地尔锦州九泰药业有限责任公司 4 CYHS2500633 玻璃酸钠滴眼液国药集团三益药业(芜湖)有限公司 4 CYHS2500590 玻璃酸钠滴眼液国药集团三益药业(芜湖)有限公司 4 CYHS2500589 硫酸氨基葡萄糖胶囊辽宁康博士制药有限公司 4 CYHS2500571 磷酸奥司他韦胶囊江西泰吉立生物医药科技有限公司 4 CYHS2500552 美阿沙坦钾片北京民康百草医药科技有限公司 4 CYHS2500517 美阿沙坦钾片北京民康百草医药科技有限公司 4 CYHS2500516 恩扎卢胺软胶囊正大天晴药业集团股份有限公司 4 CYHS2500542 盐酸乙哌立松片大桐制药(中国)有限责任公司 4 CYHS2500532 富马酸伏诺拉生片四川梓橦宫药业股份有限公司 4 CYHS2500525 富马酸伏诺拉生片四川梓橦宫药业股份有限公司 4 CYHS2500524 甲苯磺酸艾多沙班片华北制药股份有限公司 4 CYHS2500450 甲苯磺酸艾多沙班片华北制药股份有限公司 4 CYHS2500449 美阿沙坦钾片山西德元堂药业有限公司 4 CYHS2500473 美阿沙坦钾片山西德元堂药业有限公司 4 CYHS2500472 艾拉莫德片安徽省先锋制药有限公司 4 CYHS2500466 盐酸达泊西汀片浙江莎普爱思药业股份有限公司 4 CYHS2500426 盐酸达泊西汀片浙江莎普爱思药业股份有限公司 4 CYHS2500425 盐酸曲唑酮缓释片浙江赛默制药有限公司 4 CYHS2500424 盐酸曲唑酮缓释片浙江赛默制药有限公司 4 CYHS2500423 富马酸伏诺拉生片陕西白鹿制药股份有限公司 4 CYHS2500418 富马酸伏诺拉生片陕西白鹿制药股份有限公司 4 CYHS2500417 瑞舒伐他汀依折麦布片(I) 江苏利泰尔药业有限公司 4 CYHS2500379 米库氯铵注射液江西远超医药科技有限公司 4 CYHS2500340 米库氯铵注射液江西远超医药科技有限公司 4 CYHS2500339 注射用磷酸特地唑胺珠海优润医药科技有限公司 4 CYHS2500314 枸橼酸西地那非口腔崩解片东莞松山湖美健生物技术有限公司 4 CYHS2500293 培哚普利氨氯地平片(I) 杭州和泽坤元药业有限公司 4 CYHS2500289 枸橼酸西地那非口腔崩解片南京康川济医药科技有限公司 4 CYHS2500283 比索洛尔氨氯地平片山东朗诺制药有限公司 4 CYHS2500241 盐酸达泊西汀片山东百诺医药股份有限公司 4 CYHS2500224 盐酸达泊西汀片山东百诺医药股份有限公司 4 CYHS2500223 硝酸异山梨酯注射液珠海润都制药股份有限公司 4 CYHS2500234 瑞舒伐他汀依折麦布片(I) 山东齐都药业有限公司 4 CYHS2500236 培哚普利氨氯地平片(Ⅱ) 杭州仟源保灵药业有限公司 4 CYHS2500170 瑞舒伐他汀依折麦布片(I) 杭州沐源生物医药科技股份有限公司 4 CYHS2500106 硫酸羟氯喹片国药集团川抗制药有限公司 4 CYHS2500074 瑞舒伐他汀依折麦布片(I) 常州市阳光药业有限公司 4 CYHS2500076 富马酸伏诺拉生片哈药集团制药六厂 4 CYHS2500010 苯磺酸左氨氯地平片河北山姆士药业有限公司 4 CYHS2500033 苯磺酸左氨氯地平片河北山姆士药业有限公司 4 CYHS2500032 普拉洛芬滴眼液海南回元堂药业有限公司 4 CYHS2500003 富马酸伏诺拉生片地奥集团成都药业股份有限公司 4 CYHS2404666 富马酸伏诺拉生片地奥集团成都药业股份有限公司 4 CYHS2404665 罗沙司他胶囊浙江百代医药科技有限公司 4 CYHS2404480 罗沙司他胶囊浙江百代医药科技有限公司 4 CYHS2404479 甲磺酸沙非胺片石家庄四药有限公司 4 CYHS2404435 盐酸伐昔洛韦片浙江车头制药股份有限公司 4 CYHS2404440 甲磺酸沙非胺片石家庄四药有限公司 4 CYHS2404436 妥布霉素滴眼液江苏宝东医药科技有限公司 4 CYHS2404383 腺苷注射液广州大光制药有限公司 4 CYHS2404334 富马酸伏诺拉生片海南广升誉制药有限公司 4 CYHS2404293 富马酸伏诺拉生片海南广升誉制药有限公司 4 CYHS2404292 丙戊酸钠缓释片(I) 浙江普洛康裕制药有限公司 4 CYHS2404274 比索洛尔氨氯地平片上海衡山药业有限公司 4 CYHS2404263 富马酸伏诺拉生片北京北陆药业股份有限公司 4 CYHS2404253 富马酸伏诺拉生片北京北陆药业股份有限公司 4 CYHS2404252 甲钴胺片山东丹红制药有限公司 4 CYHS2404182 环孢素软胶囊浙江美迪深生物医药有限公司 4 CYHS2404167 他达拉非片以岭万洲国际制药有限公司 4 CYHS2404114 卡贝缩宫素注射液常州四药制药有限公司 4 CYHS2404104 瑞巴派特片安徽省先锋制药有限公司 4 CYHS2404036 注射用氯诺昔康开封明仁药业有限公司 4 CYHS2403982 盐酸米托蒽醌注射液海南倍康医药科技有限公司 4 CYHS2403988 阿达帕林凝胶浙江普利药业有限公司 4 CYHS2403860 注射用氯诺昔康浙江尖峰药业有限公司 4 CYHS2403867 盐酸阿莫罗芬乳膏苏州高迈药业有限公司 4 CYHS2403740 地夸磷索钠滴眼液广东南国药业有限公司 4 CYHS2403731 米库氯铵注射液舒美奇成都生物科技有限公司 4 CYHS2403685 注射用盐酸美法仑兆科(广州)肿瘤药物有限公司 4 CYHS2403667 非布司他片湖南状元制药有限公司 4 CYHS2403637 非布司他片湖南状元制药有限公司 4 CYHS2403636 氨氯地平阿托伐他汀钙片翎耀生物科技(上海)有限公司 4 CYHS2403520 盐酸屈他维林注射液江苏润恒制药有限公司 4 CYHS2403505 注射用醋酸西曲瑞克常州四药制药有限公司 4 CYHS2403480 布瑞哌唑片扬子江药业集团南京海陵药业有限公司 4 CYHS2403466 左卡尼汀口服溶液南京恒道医药科技股份有限公司 4 CYHS2403462 达沙替尼片北京双鹭药业股份有限公司 4 CYHS2403437 达沙替尼片北京双鹭药业股份有限公司 4 CYHS2403436 达沙替尼片北京双鹭药业股份有限公司 4 CYHS2403435 盐酸达泊西汀片河南中帅医药科技股份有限公司 4 CYHS2403388 盐酸伐地那非片烟台鲁银药业有限公司 4 CYHS2403384 盐酸伐地那非片烟台鲁银药业有限公司 4 CYHS2403383 富马酸伏诺拉生片江苏中邦制药有限公司 4 CYHS2403380 富马酸伏诺拉生片江苏中邦制药有限公司 4 CYHS2403379 夫西地酸乳膏江苏知原药业股份有限公司 4 CYHS2403346 二十碳五烯酸乙酯软胶囊北京民康百草医药科技有限公司 4 CYHS2403335 注射用醋酸西曲瑞克南京海辰药业股份有限公司 4 CYHS2403340 布洛芬混悬液湖南九典制药股份有限公司 4 CYHS2403325 硫酸镁钠钾口服用浓溶液北京双鹭药业股份有限公司 4 CYHS2403324 他达拉非片河南中帅医药科技股份有限公司 4 CYHS2403269 注射用头孢他啶阿维巴坦钠哈药集团制药总厂 4 CYHS2403239 吗啉硝唑氯化钠注射液南京恒道医药科技股份有限公司 4 CYHS2403153 匹维溴铵片郑州泰丰制药有限公司 4 CYHS2403081 注射用生长抑素中寰医药有限公司 4 CYHS2402870 注射用硫酸艾沙康唑湖北午时医药研究院有限公司 4 CYHS2402731 黄体酮软胶囊山西晋新双鹤药业有限责任公司 4 CYHS2402698 黄体酮软胶囊山西晋新双鹤药业有限责任公司 4 CYHS2402697 利那洛肽胶囊四川国为制药有限公司 4 CYHS2402190 丙酸氟替卡松鼻喷雾剂齐鲁制药有限公司 4 CYHS2402147 丙泊酚乳状注射液南京健友生化制药股份有限公司 4 CYHS2401982 注射用卡非佐米扬子江药业集团有限公司 4 CYHS2301669 注射用卡非佐米扬子江药业集团有限公司 4 CYHS2301668 地舒单抗注射液泰州迈博太科药业有限公司 3.3 CXSS2500019 甘精胰岛素利司那肽注射液(II) 赛诺菲(北京)制药有限公司 3.4 CXSS2500063 甘精胰岛素利司那肽注射液(I) 赛诺菲(北京)制药有限公司 3.4 CXSS2500062 东莨菪碱透皮贴片亚宝药业集团股份有限公司 3 CYHL2600045 氟轻松氢醌维A酸乳膏杭州倍特生物医药有限公司 3 CYHL2600042 进口申请药品名称企业注册分类受理号 Imlunestrant片 Eli Lilly Nederland B.V. 1 JXHS2500045 Imlunestrant片 Eli Lilly Nederland B.V. 1 JXHS2500044 甲磺酸奥希替尼片 AstraZeneca AB 2.4 JXHS2500108 甲磺酸奥希替尼片 AstraZeneca AB 2.4 JXHS2500107 阿贝西利片 Eli Lilly Nederland B.V. 2.4 JXHS2500096 阿贝西利片 Eli Lilly Nederland B.V. 2.4 JXHS2500095 阿贝西利片 Eli Lilly Nederland B.V. 2.4 JXHS2500094 尼拉帕利阿比特龙片 Janssen-Cilag International NV 2.4 JXHS2500089 尼拉帕利阿比特龙片 Janssen-Cilag International NV 2.4 JXHS2500088 氘丁苯那嗪缓释片 Teva Neuroscience, Inc. 5.1 JXHS2400093 氘丁苯那嗪缓释片 Teva Neuroscience, Inc. 5.1 JXHS2400092 氘丁苯那嗪缓释片 Teva Neuroscience, Inc. 5.1 JXHS2400091 氘丁苯那嗪缓释片 Teva Neuroscience, Inc. 5.1 JXHS2400090 氘丁苯那嗪缓释片 Teva Neuroscience, Inc. 5.1 JXHS2400089 氘丁苯那嗪缓释片 Teva Neuroscience, Inc. 5.1 JXHS2400088 帕博利珠单抗注射液 MSD International Business GmbH 2.2 JXSS2500122 美泊利珠单抗注射液 GlaxoSmithKline Trading Services Limited 3.1 JXSS2500125 美泊利珠单抗注射液 GlaxoSmithKline Trading Services Limited 3.1 JXSS2500124 注射用阿帕达酶α Takeda Pharmaceuticals U.S.A., Inc. 3.1 JXSS2500044 注射用阿帕达酶α Takeda Pharmaceuticals U.S.A., Inc. 3.1 JXSS2500043 非诺贝特酸胆碱缓释胶囊 Aurobindo Pharma Limited 5.2 JYHS2400045 非诺贝特酸胆碱缓释胶囊 Aurobindo Pharma Limited 5.2 JYHS2400044 氨甲环酸注射液 Maxmind Pharmaceutical S.L 5.2 JYHS2400038 氨甲环酸注射液 Maxmind Pharmaceutical S.L 5.2 JYHS2400037 硫酸瑞美吉泮口崩片 Pfizer Inc. 2.4 JXHL2600096 Belantamab (GSK2857914) 注射液 GlaxoSmithKline Research & Development Limited 1 JXSL2600119 古塞奇尤单抗/戈利木单抗(JNJ-78934804)注射液 Janssen Research & Development, LLC 2.3 JXSL2600098 中药相关申请药品名称企业注册分类受理号椿乳凝胶株洲千金药业股份有限公司 2.3 CXZL2600034 龙丹颗粒青岛颐圣康和生物科技有限公司其他情形 CYZL2600001 芍药甘草颗粒河北万邦复临药业有限公司 3.1 CXZS2500039 一贯煎颗粒江苏康缘药业股份有限公司 3.1 CXZS2500036 清肺汤颗粒江西药都樟树制药有限公司 3.1 CXZS2500032 芍药甘草颗粒山东润中药业有限公司 3.1 CXZS2500004 清金化痰颗粒山东齐都药业有限公司 3.1 CXZS2500001 苏黄止咳胶囊杨凌科森生物制药有限责任公司 4 CYZS2500009 注：橙色字体部分结论为不批准或收到通知件；

信使RNA上市批准疫苗临床1期

100 项与二十碳五烯酸乙酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01892	二十碳五烯酸乙酯	C10AX	DB08887

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
糖尿病	欧盟	Recordati SpA	2022-10-21
糖尿病	冰岛	Recordati SpA	2022-10-21
糖尿病	列支敦士登	Recordati SpA	2022-10-21
糖尿病	挪威	Recordati SpA	2022-10-21
疼痛	韩国	RP Bio, lnc.	2022-02-21
溃疡	韩国	RP Bio, lnc.	2022-02-21
心血管疾病	美国	Amarin Pharmaceuticals Ireland Ltd.	2019-12-13
高甘油三酯血症	美国	Amarin Pharmaceuticals Ireland Ltd.	2012-07-26
动脉硬化闭塞症	日本	Mochida Pharmaceutical Co., Ltd.	1998-10-15
高脂血症	日本	Mochida Pharmaceutical Co., Ltd.	1994-10-05

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
结肠癌	临床3期	英国	Amarin Pharma, Inc.	2018-05-02
肝转移	临床3期	英国	Amarin Pharma, Inc.	2018-05-02
亨廷顿舞蹈病	临床3期	美国	Amarin Neuroscience Ltd.	2005-09-01
亨廷顿舞蹈病	临床3期	加拿大	Amarin Neuroscience Ltd.	2005-09-01
代谢功能障碍相关脂肪性肝炎	临床2期	美国	Mochida Pharmaceutical Co., Ltd.	2010-06-01

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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


NCT01492361 (REDUCE-IT, Pubmed \| Eur J Prev Cardiol)	临床3期	高甘油三酯血症	8,174	Icosapent Ethyl 4g daily	獵艱窪糧醖憲蓋範鬱鹹(鹹獵遞衊獵淵鏇簾鹹醖): HR = 0.55 (95.0% CI, 0.3 ~ 1.01), P-Value = 0.05 更多	积极	2025-09-22
				Placebo
NCT01492361 (REDUCE-IT, Pubmed \| J Am Heart Assoc) 人工标引	临床3期	心血管疾病 LDL-C	8,175	Icosapent Ethyl 2g twice dailyIcosapent Ethyl 2g twice daily (LDL‐C <55 mg/dL)	糧鹽願願窪鏇鏇鬱壓遞(齋膚築築壓觸鬱衊鹹鑰) = 鏇淵齋築鹽壓襯製範餘壓醖簾鏇憲淵積繭選餘 (鬱醖鹽積願觸鏇鬱範鏇 )	积极	2025-02-19
				Placebo (LDL‐C <55 mg/dL)	糧鹽願願窪鏇鏇鬱壓遞(齋膚築築壓觸鬱衊鹹鑰) = 選製獵築廠觸製膚壓獵壓醖簾鏇憲淵積繭選餘 (鬱醖鹽積願觸鏇鬱範鏇 )
NCT02719327 (BRAVE-EPA, CTgov)	临床2/3期	阿尔茨海默症	131	icosapent ethyl (Icosapent Ethyl (IPE))	衊願窪夢夢顧艱願憲壓(襯鏇醖蓋築築範構夢構) = 製鏇鹹膚範淵鬱壓糧膚範選衊鬱築鹹構淵膚積 (衊構繭壓艱選製鑰顧壓, 14.6) 更多	-	2024-11-26
				gel cap placebo (Placebo)	衊願窪夢夢顧艱願憲壓(襯鏇醖蓋築築範構夢構) = 糧廠築遞鹽鹹艱糧願願範選衊鬱築鹹構淵膚積 (衊構繭壓艱選製鑰顧壓, 14.1) 更多
NCT05198843 (CTgov)	临床1/2期	转移性乳腺癌 \| 转移性三阴性乳腺癌	1	Dasatinib+EPA	鹽膚繭簾襯衊選窪範醖(簾積積獵艱鹽艱願淵餘) = 醖醖憲鬱憲願蓋製願範鑰遞獵窪選糧襯願淵構 (衊餘簾糧壓簾遞製醖蓋, 憲衊窪夢願簾蓋網製觸 ~ 窪鬱餘鹽廠襯簾構製願) 更多	-	2024-09-04
NCT01492361 (REDUCE-IT, GlobeNewswire) 人工标引	临床3期	心血管疾病	-	Icosapent Ethyl (IPE) (Lp(a) ≥50 mg/dL)	醖夢獵醖獵願積廠襯餘(網醖衊簾憲繭繭壓顧衊) = 鬱構鹽憲鹽膚糧衊願糧蓋構襯網構鹹顧鏇願壓 (膚醖鹽積觸襯壓網齋繭 ) 更多	积极	2024-04-06
				Icosapent Ethyl (IPE) (Lp(a) <50 mg/dL)	醖夢獵醖獵願積廠襯餘(網醖衊簾憲繭繭壓顧衊) = 積窪糧繭選廠窪膚築築蓋構襯網構鹹顧鏇願壓 (膚醖鹽積觸襯壓網齋繭 ) 更多
NCT01492361 (REDUCE-IT USA, Pubmed \| J Am Heart Assoc)	临床3期	-	3,146	Icosapent Ethyl	構糧壓願醖醖餘鏇願艱(網鹹遞構範顧廠鑰蓋餘) = 願網壓齋鑰觸觸廠鏇遞鹽遞製蓋獵艱鬱壓觸壓 (築衊齋淵糧鏇鏇淵鹽醖 ) 更多	-	2024-01-02
NCT01492361 (REDUCE-IT, GlobeNewswire) 人工标引	临床3期	心血管疾病 \| 代谢综合征	2,866	VASCEPA	鬱範艱獵膚糧願糧鑰壓(艱顧鹽願壓繭鏇遞窪衊): relative risk reduction = 29, P-Value = <0.0001; absolute risk reduction = 5.9 更多	积极	2023-11-12
				placebo
NCT01492361 (REDUCE-IT, Pubmed \| Eur Heart J Open)	临床3期	代谢综合征	8,179	Icosapent ethyl 4 g/day	獵廠餘餘簾齋鏇壓簾艱(膚簾選願廠遞鹹窪蓋蓋) = 齋觸衊膚繭簾網構願糧網築顧夢醖糧簾選艱獵 (糧築選夢醖膚範艱夢廠 )	积极	2023-11-03
NCT01492361 (REDUCE-IT, ESC2023)	临床3期	-	-	Icosapent ethyl	積鏇夢鹽顧築網遞構鹽(繭淵選憲糧遞鹽鹹觸鹹) = 願壓醖齋鏇夢鹽餘觸醖簾獵夢襯鑰願廠淵獵淵 (願願艱積糧網鹽鹹齋壓, 1.8 ~ 8.7)	-	2023-08-27
				Placebo	積鏇夢鹽顧築網遞構鹽(繭淵選憲糧遞鹽鹹觸鹹) = 艱糧衊觸網糧窪獵夢糧簾獵夢襯鑰願廠淵獵淵 (願願艱積糧網鹽鹹齋壓, 1.9 ~ 9.4)
NCT01492361 (REDUCE-IT, Pubmed)	临床3期	心房颤动	8,179	Icosapent Ethyl	鹽簾觸選遞鹽構襯壓觸(獵網構齋糧鹽遞鑰齋廠) = 憲齋鹹壓醖構獵顧顧鏇衊遞顧齋鏇鏇艱繭窪積 (糧簾選廠艱構網遞蓋廠 )	-	2023-02-21
				Placebo	鹽簾觸選遞鹽構襯壓觸(獵網構齋糧鹽遞鑰齋廠) = 衊襯遞鹹襯觸膚鬱鑰選衊遞顧齋鏇鏇艱繭窪積 (糧簾選廠艱構網遞蓋廠 )