Comparison of Intensive Lipid-Lowering Therapy With a Statin-Ezetimibe Combination (Without Aspirin) vs. Statin Monotherapy (With Aspirin) In Asymptomatic Patient With Coronary Artery Calcification

A Multicenter, randomized trial comparing the efficacy and safety of intensive lipid-lowering therapy using a statin-ezetimibe combination without aspirin versus statin monotherapy with aspirin in asymptomatic patients with coronary artery calcification

开始日期2025-06-01

申办/合作机构

Asan Medical Center

NCT06933459

/ Not yet recruiting临床1期

An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AJU-C714 Compared to C714R in Healthy Adult Volunteers

To evaluate the safety and pharmacokinetic characteristics of AJU-C714 and C714R in healthy adults

开始日期2025-05-25

申办/合作机构

Aju Pharm Co. Ltd.

KCT0010331

/ Not yet recruiting临床4期IIT

Comparing the Moderate Intensity STatin with Ezetimibe COmbination TheraPy with High Intensity Statin Monotherapy on Coronary PLAQUE Stablization (STOP-PLAQUE trial)

开始日期2025-03-31

申办/合作机构

Korea University Anam Hospital

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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6,376

项与依折麦布相关的文献（医药）

2025-08-01·INTERNATIONAL JOURNAL OF CARDIOLOGY

LDL-cholesterol levels and lipid lowering therapy in secondary prevention. Baseline data from the BRING-UP prospective registry

Article

作者: Abrignani, Maurizio Giuseppe ; Maffei, Simone ; Barbato, Emanuele ; Aloia, Antonio ; Alonzo, Alessandro ; Navazio, Alessandro ; Arca, Marcello ; Oliva, Fabrizio ; Calò, Leonardo ; La Rosa, Giuseppe ; Di Lenarda, Andrea ; Riccio, Carmine ; Temporelli, Pier Luigi ; Catapano, Alberico Luigi ; Bertoli, Daniele ; Calabrò, Paolo ; Scicchitano, Pietro ; Pavan, Daniela ; Aschieri, Daniela ; Fabbri, Gianna ; Ceseri, Martina ; Carugo, Stefano ; Fattirolli, Francesco ; Colivicchi, Furio ; Averna, Maurizio ; Maggioni, Aldo Pietro ; Di Fusco, Stefania Angela ; Gabrielli, Domenico ; Themistoclakis, Sakis ; Scelza, Nicola ; Gonzini, Lucio ; Gulizia, Michele Massimo ; Crisci, Vincenzo

AIMS:

To narrow the gap between guidelines recommendation for secondary cardiovascular prevention and clinical practice, we designed a national project based on educational programs and patient data collection.

METHODS:

BRING-UP Prevention is an observational, prospective, multicentre study on patients with an atherothrombotic event enrolled in 2 phases: an educational intervention followed by two 3-months data collection, followed by 6 and 12-month follow-up, when the primary, secondary and exploratory endpoints will be evaluated. Clinical characteristics, treatments and target achievement for LDL cholesterol and other modifiable risk factors at baseline are reported in this manuscript.

RESULTS:

From September 2023 to February 2024, 189 cardiology centers included 4790 patients, 2500 hospitalized, and 2290 managed as outpatients. Of the 4790 patients, 98 % had CAD, 6.1 % CVD, and 6.9 % PAD. Mean age was 67 ± 11 years, 20 % were females. Patients with LDL-C levels <55 mg/dL were 32.6 %. Patients at target for blood pressure were 39.2 %. Diabetic patients were 27.5 %, HbA1c <7 % was reported in 43.5 % of them. Statins prescription increased from 69 % at entry to 96 % at discharge/end of visit. In 74.5 % of patients, statins were prescribed in combination with ezetimibe. PCSK9-i or inclisiran were prescribed in a low rate of patients.

CONCLUSION:

These data show that a low percentage of patients was at goal for LDL-C level and blood pressure. The 6-month follow-up visit will allow us to evaluate the changes in modifiable risk factors.

2025-08-01·INTERNATIONAL JOURNAL OF CARDIOLOGY

Impact of a personalized, strike early and strong approach on non-HDL-cholesterol levels and outcome in patients with acute myocardial infarction

Article

作者: Marengo, Alessandra ; D'Amario, Domenico ; Grisafi, Leonardo ; Patti, Giuseppe ; Solli, Martina ; Mennuni, Marco ; Bosco, Manuel ; Cumitini, Luca

AIMS:

We retrospectively evaluated the impact on non-HDL-cholesterol (non-HDL-C) levels of the systematic introduction in our institution of an individualized, pre-defined, strike early and strong (SES) strategy for lipid-lowering therapy (LLT) in patients with acute myocardial infarction (MI).

METHODS:

We analyzed data from 500 consecutive patients admitted across three periods: Period A (N = 198, January-June 2019), when the non-HDL-C goal was <100 mg/dL and a stepwise LLT approach was indicated; Period B (N = 180, January-June 2021), when the non-HDL-C goal was <85 mg/dL and a stepwise approach was recommended; Period C (N = 122, January-June 2023), when the SES protocol was introduced. Primary endpoints were the percentage of patients reaching the non- HDL-C goal during follow-up and the incidence of major adverse cardiovascular events (MACE) at one year.

RESULTS:

Compared to the other periods, the prevalence of prescription at discharge of potent statins, alone or in combination with ezetimibe, and PCSK9 inhibitors was greater in Period C. The achievement of the non-HDL-C goal in Period C was higher (87 % vs 67 % and 58 % in Periods A and B, respectively; p < 0.001). This achievement was associated with a lower occurrence of MACE (7 % vs. 13 % in patients not at target; log-rank p = 0.027). MACE incidence was the lowest in patients with early and sustained non-HDL-C < 85 mg/dL during follow-up.

CONCLUSION:

The systematic introduction of an individualized, SES approach for LLT in patients with acute MI led to higher achievement of the non-HDL-C goal and this translated into a lower risk of MACE.

2025-06-01·CLINICAL THERAPEUTICS

A Phase III Randomized, Double-Blind, Active-Controlled, Multicenter Study on the Efficacy and Safety of Ezetimibe/Atorvastatin/Amlodipine Combination in Patients With Comorbid Primary Hypercholesterolemia and Essential Hypertension

Article

作者: Lee, Chan Joo ; Choi, Jung Hyun ; Han, Seung Hwan ; Choi, Jin-Oh ; Shin, Jinho ; Kim, Eung Ju ; Yoon, Young Won ; Kim, Kye Hun ; Hwang, Byung-Hee ; Sung, Jung-Hoon ; Choi, Ji Yong ; Lee, Pil Hyung ; Kang, Seok-Min

PURPOSE:

This study aimed to evaluate the efficacy and safety of triple combination of ezetimibe (Eze)/atorvastatin (Ato) 10/40 mg + amlodipine (Aml) 10 mg therapy for lowering the low-density lipoprotein cholesterol (LDL-C) and blood pressure compared with either Eze/Ato 10/40 mg or Aml 10 mg therapies in patients with comorbid primary hypercholesterolemia and essential hypertension.

METHODS:

This was a randomized, multicenter, double-blind, active-controlled, Phase III clinical trial. Participants underwent a wash-out period (2 weeks for nonfibrate medications, 6 weeks for fibrates) followed by 4 weeks of therapeutic lifestyle changes. Subsequently, 109 participants were randomly assigned to 3 groups: (1) Eze/Ato 10/40 mg + Aml 10 mg, (2) Eze/Ato 10/40 mg, and (3) Aml 10 mg. The coprimary end points were percentage change in LDL-C and change in mean sitting systolic blood pressure (SBP) compared with baseline at week 8.

FINDINGS:

A total of 109 participants were enrolled in the study, and there were no statistically significant differences in the baseline characteristics of participants across the 3 groups. After 8 weeks of treatment, the least-square (LS) mean (SE) of percent change from baseline in LDL-C was -57.95% (3.52%) for the Eze/Ato 10/40 mg + Aml 10 mg group and 8.93% (3.54%) for the Aml 10 mg group. The LS mean difference (SE) between these 2 groups was statistically significant at -66.88 (4.95) (95% CI, -76.77% to -56.99%) (P < 0.0001). Furthermore, at week 8, the LS mean (SE) change in mean sitting SBP between the Eze/Ato 10/40 mg + Aml 10 mg group and the Eze/Ato 10/40 mg group was -19.24 (2.42) mm Hg and -4.43 (2.56) mm Hg, respectively. The LS mean difference (SE) between the 2 groups was statistically significant -14.81 (3.53) (95% CI, -21.87 to -7.74) mm Hg (P < 0.0001). No serious adverse drug reactions occurred in any of the study groups.

IMPLICATIONS:

Triple combination therapy with Eze/Ato + Aml has effectively reduced the LDL-C and SBP independently, compared with either Eze/Ato or Aml therapies over 8 weeks of treatment period. In terms of safety, there were no significant differences among the 3 treatment groups. This research lays the groundwork for the development of a triple fixed-dose combination in the future, which could improve patient convenience and adherence by reducing pill burden. Clinical Research Information Service (CRIS), Republic of Korea: KCT0006283.

437

项与依折麦布相关的新闻（医药）

2025-05-29

·医脉通

江西、安徽两省发文，启动医保执法大排查 | 医脉3分钟

今天的医疗圈发生了哪些与你有关的大事？更新、更全的医学动态3分钟一网打尽********今日关键词：新冠疫情趋缓，严查药师“挂证”，医保执法大排查来源 | 医脉通作者 | 晚报君新闻60秒➤国家医保局发布公告：对定点零售药店药师“挂证”开展核查@国家医保局近期，国家医保局对全国定点零售药店4月份以来的医保结算数据进行筛查分析发现，部分药师姓名（对应同一身份证号）出现在多家定点零售药店的药品费用明细中，可能存在药师信息被假冒或药师“挂证”的违规情况。这既威胁了人民群众用药安全和医保基金安全，也损害了正规注册药师的合法权益，共涉及24个省份、23997家定点零售药店、9563名药师。针对这种情况，国家医保局28日发布公告，要求对定点零售药店药师“挂证”等情况开展核查，以维护人民群众用药安全、维护医保基金安全、维护广大注册药师合法权益。➤全球“最大医院”原院长阚全程接受调查@河南省纪委监委 5月29日，据河南省纪委监委网站，河南省政协人口资源环境委员会主任阚全程涉嫌严重违纪违法，目前正接受河南省纪委监委纪律审查和监察调查。阚全程于2008年开始担任郑州大学第一附属医院院长院长，将该院打造成业界熟悉万张床位的全球超级医院。2018年，阚全程任河南省卫计委主任，2018年11月任河南省卫生健康委员会党组书记、主任。期间，阚全程主导将河南改制医院收回公立。➤国家疾控局：全国新冠疫情上升趋势减缓@新华社 5月28日，从国家疾控局处获悉，目前，全国新冠疫情上升趋势减缓，大多数省份疫情已达高点或呈下降趋势。优势流行株为XDV变异株的第六代亚分支NB.1.8.1，致病力未发生明显变化，疾病临床严重程度未发生明显变化。据新冠等呼吸道传染病监测结果，2025年3月以来，全国流感等其他急性呼吸道传染病疫情处于低水平，新冠疫情呈现逐渐上升态势。目前，全国大多数省份疫情已达高点或呈下降趋势。政策60秒➤江西、安徽两省发文，启动医保执法大排查@赛柏蓝器械江西、安徽等多地医保局发文，对过往违规问题进行大起底。根据医保局发布的公告，江西省此次重点征集2023年以来全省各级医保部门在涉企行政执法中存在线索，包括乱收费、乱罚款、乱检查、乱查封等问题；安徽省此次对医疗保障部门在医疗保障领域行政执法工作中可能存在的违规执法、过度执法、粗暴执法、随意检查等相关问题开展大排查、大起底、大整治。➤山东推广三明医改：财政投入年均增25%，医耗价格降幅最高达75%@国家卫生健康委 5月27日，山东省卫生健康委主任马立新表示，山东认真学习推广三明医改经验，在保障公益性上下功夫。近5年，全省财政对公立医院补助投入年均增长25%。落实药品和高值医用耗材集中带量采购政策，分别落地824种、40类，价格显著下降。例如，人工耳蜗类耗材单套价格从平均20余万元降至5万元左右，降幅达75%。再以济南市历下区高血压、糖尿病、心脑血管疾病患者用药为例，集采后药品价格平均降幅超60%。医药60秒➤君实生物抗PCSK9单抗获批两项新适应症@君实生物 5月27日，君实生物宣布，其自主研发的昂戈瑞西单抗注射液君适达（重组人源化抗PCSK9单克隆抗体注射液）的新适应症上市申请获得中国国家药监局（NMPA）批准，用于杂合子型家族性高胆固醇血症（HeFH）的成人患者；在他汀类药物不耐受或禁忌使用的患者中，单独或与依折麦布联合用药用于非家族性高胆固醇血症和混合型血脂异常的成人患者。➤我国首个ARNI类原研降压药获批上市@信立泰药业近日，信立泰宣布，高血压新药信超妥（沙库巴曲阿利沙坦钙片）获得国家药品监督管理局签发的药品注册证书。据悉，沙库巴曲阿利沙坦钙片为该公司自主研发的ARNI（血管紧张素受体脑啡肽酶抑制剂）类药物，本次获批的适应症为原发性高血压。责编｜阿泰封面图来源｜医脉通新规：未经报备，医务人员禁止擅自科普！医护：以后连自媒体都不能做吗？出生10天后就查出了肾结石，甚至还可能一辈子伴有腹泻……他得的到底是什么病？丨医起推理吧医脉通是专业的在线医生平台，“感知世界医学脉搏，助力中国临床决策”是平台的使命。医脉通旗下拥有「临床指南」「用药参考」「医学文献王」「医知源」「e研通」「e脉播」等系列产品，全面满足医学工作者临床决策、获取新知及提升科研效率等方面的需求。☟戳这里，更有料！

疫苗高管变更

2025-05-28

·EINPresswire

SCYNEXIS Resumes Patient Dosing in Phase 3 MARIO Study

First new patient dosed in Phase 3 MARIO study following the lifting of the FDA clinical hold Resumption of dosing in this study triggers a $10M milestone payment from GSK plus an additional $20M milestone due in six months; as previously disclosed GSK disputes these milestone payments, and SCYNEXIS vigorously disagrees with their position JERSEY CITY, N.J., May 28, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that patient dosing has resumed in the Phase 3 MARIO study, which is an innovative study to investigate oral ibrexafungerp as a potential step-down antifungal therapy following IV echinocandin for invasive candidiasis, a life-threatening infection. The study had been on hold due to concerns about potential cross-contamination in light of draft U.S. Food and Drug Administration (FDA) guidance regarding manufacturing a non-antibiotic beta-lactam (ezetimibe) at the same site as ibrexafungerp. The study has resumed following the manufacture of new clinical supplies at another site and the lifting of the clinical hold by the FDA. If the study is successful and approval for this indication is granted by the FDA, it will give healthcare providers the opportunity to step-down their patients to a non-azole oral therapy that retains the Mechanism of Action (glucan synthase inhibition) of the IV-only echinocandins, which are the gold standard for treatment of invasive Candida infections. SCYNEXIS’s position is that the dosing of this first new patient triggers a $10 million payment from partner GSK, with another $20 million payment to be triggered by the six-month anniversary of dosing. As previously disclosed, there is a disagreement between SCYNEXIS and GSK regarding the resumption of the MARIO Study and GSK’s responsibility for paying these milestones. SCYNEXIS is working to resolve the disagreement. “We are pleased to announce the dosing of the first new patient in the Phase 3 MARIO study following the lifting of the clinical hold by the FDA in April,” said David Angulo, M.D., President and Chief Executive Officer. “The rapid resumption of patient enrollment, just a few days after the investigational sites were re-activated in the study, reflects the eagerness of the scientific community to have new treatment options for this life-threatening infection.” SCYNEXIS is thankful to the investigators participating in this trial for their support and patience during the clinical hold period, and for their continued commitment to the successful completion of this important study, which has already enrolled approximately 25% of the projected patients. “I’m happy to see this important study restarted, and glad that we have been able to contribute by enrolling a new patient,” said Barbara D. Alexander, MD, MHS, FIDSA Professor of Medicine and Pathology at Duke University and the Director of the Transplant Infectious Diseases Service. “We need additional treatment options for patients with invasive fungal diseases, and we are looking forward to the completion of this study evaluating oral ibrexafungerp in this area of significant unmet need.” “There is substantial need for new treatments for invasive candidiasis, particularly for Candida strains resistant to the currently approved antifungals,” added Dr. Luis Ostrosky-Zeichner, MD, Professor of Medicine and Epidemiology and Chief at the Division of Infectious Diseases of the McGovern Medical School (UTHealth Houston). “Ibrexafungerp could play an important role in improving the outcome of patients with these life-threating infections, and I am glad to see this important study reinitiated in our institution.” About Triterpenoid Antifungals Triterpenoid antifungals (also known as “fungerps”) are a novel class of structurally distinct glucan synthase inhibitors that combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. They have demonstrated broad-spectrum antifungal activity against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. Ibrexafungerp is the first representative of this novel class of antifungal agents. Ibrexafungerp, formerly known as SCY-078, is currently approved in the U.S. for the treatment of vulvovaginal candidiasis and is in late-stage development for invasive candidiasis. The next generation fungerp, SCY-247, is currently in the late stages of a Phase 1 clinical study. About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps.” Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional antifungal assets from this novel class are currently in clinical, pre- clinical and discovery phases, including the compound SCY-247. For more information, visit www.scynexis.com . CONTACT : Investor Relations Irina Koffler LifeSci Advisors Tel: (646) 970-4681 ikoffler@lifesciadvisors.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床3期上市批准合格传染病产品

2025-05-28

·美通社

君实生物宣布君适达®(抗PCSK9单抗）新增两项适应症在中国获批

上海 2025年5月28日 /美通社/ -- 北京时间2025年5月27日，君实生物（1877.HK，688180.SH）宣布，由公司自主研发的昂戈瑞西单抗注射液（重组人源化抗PCSK9单克隆抗体注射液，商品名：君适达 ® ）用于：1）杂合子型家族性高胆固醇血症（HeFH）的成人患者；2）在他汀类药物不耐受或禁忌使用的患者中，单独或与依折麦布联合用药用于非家族性高胆固醇血症和混合型血脂异常的成人患者的两项新适应症上市申请近日获得国家药品监督管理局（NMPA）批准。此次获批包括2种规格，分别为150mg（1ml）/支（预充式注射器）、150mg（1ml）/支（预充式自动注射器）。昂戈瑞西单抗成为首个获批用于他汀不耐受人群的国产PCSK9靶点药物。《中国血脂管理指南（2023年）》 [1] 指出，心血管疾病是我国城乡居民第一位死因，其中以动脉粥样硬化性心血管疾病（ASCVD）为主。低密度脂蛋白胆固醇（LDL-C）水平升高是ASCVD的致病性危险因素，通过降低LDL-C水平可显著减少ASCVD的发病及死亡危险。 HeFH是家族性高胆固醇血症的常见类型，估测患病率1/250~1/200，主要临床特征为LDL-C水平显著升高和早发冠心病 [1] 。与非家族性高胆固醇血症患者相比，HeFH患者基础LDL-C水平更高且指南推荐的控制目标水平更低，若使用他汀类药物等治疗后LDL-C未能达标，将导致患者处于高心血管风险。此外，尽管目前他汀类药物已成为降脂治疗的基础，但临床上约有9.1%的患者存在他汀不耐受，且在亚洲人群中该比例更高 [2] 。对于他汀不耐受患者，停用或仅使用可耐受剂量的他汀类药物可能导致LDL-C水平不达标，从而无法达到降低患者ASCVD风险的目的。 PCSK9抑制剂作为强效降低LDL-C水平的新型降脂药物，已得到国内外血脂管理指南的推荐，并得到临床医生的广泛认可。昂戈瑞西单抗的显著降脂作用已在多项Ⅲ期临床研究中获得证明，并已于2024年10月获得NMPA批准用于治疗原发性高胆固醇血症（非家族性）和混合型血脂异常的成人患者。此次两项新适应症的获批主要基于JS002-005（NCT05325203）和JS002-007（NCT05621070）两项注册临床试验。其中，JS002-005是在HeFH成人患者中进行的一项随机、双盲、安慰剂对照的Ⅲ期临床研究，由首都医科大学附属北京安贞医院马长生教授和蔺洁教授担任主要研究者，共入组135例HeFH患者。该研究是首个抗PCSK9单抗用于中国确诊HeFH患者（DLCN分值＞8分）的Ⅲ期临床研究。 JS002-005的最新数据已全文发表于《动脉粥样硬化》（Atherosclerosis），结果显示 [3] ，与安慰剂相比，昂戈瑞西单抗150mg每2周一次（Q2W）或450mg每4周一次（Q4W）皮下注射治疗24周时，可显著降低LDL-C水平分别达69.4%和80.6%（p˂0.0001），且在治疗期间维持稳定降幅。同时，昂戈瑞西单抗对其他血脂参数也有明显的改善作用，非高密度脂蛋白胆固醇（non-HDL-C）、载脂蛋白B（ApoB）、总胆固醇（TC）和脂蛋白(a)[Lp(a)]水平较基线显著降低，其中Lp(a)较基线降幅达50%。整体安全性良好，治疗期间出现的不良事件（TEAE）发生率与安慰剂相当。 JS002-007是在他汀类药物不耐受的原发性高胆固醇血症和混合型血脂异常成人患者中完成的一项随机、双盲、安慰剂对照的Ⅲ期临床研究，由北京大学第三医院唐熠达教授担任主要研究者。该研究是首个抗PCSK9单抗用于他汀不耐受的中国原发性高胆固醇血症和混合型血脂异常患者的Ⅲ期临床研究，研究结果将于近期在国际学术期刊上发表。君实生物总经理兼首席执行官邹建军博士表示："截至目前，昂戈瑞西单抗已累计获批3项适应症，包括杂合子型家族性高胆固醇血症以及非家族性高胆固醇血症和混合型血脂异常，同时覆盖了他汀类药物不耐受或禁忌使用的非家族性高胆固醇血症和混合型血脂异常成人患者。这不仅标志着我们在心血管疾病领域取得了重要突破，也代表着中国心血管疾病患者将拥有更多的治疗选择。未来，我们将继续‘立足中国'，围绕国人临床未尽之需，致力通过创新药物探索攻克更多疾病领域并加速创新药物的可及性。" 【参考文献】 1. 中国血脂管理指南（2023年）. 中国循环杂志. 2023 38;3:237-271. 2. Bytyçi I, et al. Prevalence of statin intolerance: a meta-analysis. Eur Heart J. 2022;43(34):3213-3223. 3. Lin J, Ji Y, Wang G, et al. Efficacy and safety of ongericimab in Chinese patients with heterozygous familial hypercholesterolemia: a randomized, double-blind, placebo-controlled phase 3 trial[J]. Atherosclerosis, 2025: 119120. 1. 本材料旨在传递前沿信息，无意向您做任何产品的推广，不作为临床用药指导。 2. 若您想了解具体疾病诊疗信息，请遵从医疗卫生专业人士的意见与指导。 —— 完 —— 关于昂戈瑞西单抗注射液（君适达 ® ）昂戈瑞西单抗注射液（君适达 ® ）是君实生物自主研发的注射用重组人源化抗PCSK9单克隆抗体注射液，于2024年10月获NMPA批准上市，目前已在中国内地获批3项适应症，用于治疗：1）原发性高胆固醇血症（非家族性）和混合型血脂异常的成人患者；2）杂合子型家族性高胆固醇血症的成人患者；3）在他汀类药物不耐受或禁忌使用的患者中，单独或与依折麦布联合用药用于非家族性高胆固醇血症和混合型血脂异常的成人患者。获批规格为150mg（1ml）/支（预充式注射器）、150mg（1ml）/支（预充式自动注射器）。 2023年10月，君实生物与重庆博创医药有限公司（博创医药）达成合作，授予博创医药在中国大陆和许可用途内研发、生产、商业化昂戈瑞西单抗的独占许可。关于君实生物君实生物（688180.SH，1877.HK）成立于2012年12月，是一家以创新为驱动，致力于创新疗法的发现、开发和商业化的生物制药公司。依托全球一体化源头创新研发能力，公司已构建起涵盖超过50款创新药物的多层次产品管线，覆盖恶性肿瘤、自身免疫、慢性代谢类、神经系统、感染性疾病五大治疗领域，已有5款产品在国内或海外上市，包括我国首个自主研发、在中美欧等地超过35个国家和地区获批上市的PD-1抑制剂特瑞普利单抗（拓益 ® ）。疫情期间，君实生物还参与开发了埃特司韦单抗、民得维 ® 等多款预防和治疗新冠的创新药物，积极承担本土创新药企的责任。君实生物以"用世界一流、值得信赖的创新药普惠患者"为使命，立足中国，布局全球。目前，公司在全球拥有约2500名员工，分布在美国马里兰，中国上海、苏州、北京、广州等。官方网站： www.junshipharma.com 官方微信：君实生物

上市批准临床3期临床结果

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
心血管疾病	澳大利亚	Organon Pharma Pty Ltd.	2003-06-23
杂合子家族性高胆固醇血症	澳大利亚	Organon Pharma Pty Ltd.	2003-06-23
纯合子家族性高胆固醇血症	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,

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适应症	最高研发状态	国家/地区	公司	日期
冠心病	临床3期	美国	Merck Sharp & Dohme Corp.	2009-09-01
糖尿病	临床3期	-	Organon & Co.	2006-09-01
稳定型心绞痛	临床3期	-	Organon & Co.	2005-07-12
稳定型心绞痛	临床3期	-	Schering-Plough Corp.	2005-07-12
不稳定型心绞痛	临床3期	-	Organon & Co.	2005-07-12
不稳定型心绞痛	临床3期	-	Schering-Plough Corp.	2005-07-12
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
动脉粥样硬化	临床3期	-	Organon & Co.	2002-06-01
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

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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


Pubmed 人工标引	N/A	心血管疾病	-	Statins + Ezetimibe	艱範衊窪築衊選艱網憲(壓積鏇壓鹹顧糧憲鹹膚) = 餘膚糧廠襯鑰膚構築構鬱範繭膚觸觸齋網夢積 (遞積糧獵壓鑰觸憲廠襯 ) 更多	积极	2025-03-20
				Statins	-
NCT04826354 (SaveSAMS, Pubmed) 人工标引	临床4期	动脉粥样硬化	561	Moderate-intensity statin with ezetimibe combination therapy (rosuvastatin 5 mg with ezetimibe 10 mg)	積鏇衊憲壓醖醖醖窪壓(顧齋鑰網鑰鑰範製築糧) = 餘製繭壓鏇鏇壓艱築淵衊鹽醖獵醖簾廠鏇遞顧 (憲網網鏇範壓鏇壓築獵 ) 更多	积极	2024-12-22
				High-intensity statin monotherapy (rosuvastatin 20 mg)	積鏇衊憲壓醖醖醖窪壓(顧齋鑰網鑰鑰範製築糧) = 鬱壓鹹簾壓襯網膚構遞衊鹽醖獵醖簾廠鏇遞顧 (憲網網鏇範壓鏇壓築獵 ) 更多
NCT04369664 (CHORD, CTgov)	临床4期	2型糖尿病	151	PCSK9 inhibitor+Ezetimibe 10mg+Statin (Type 2 Diabetes Group)	網衊構鹹鬱選選窪膚餘(網觸鏇獵壓廠餘衊憲鹹) = 構網衊製艱積簾艱齋糧遞蓋鬱鬱獵鹽製艱鹽壓 (蓋衊鹽鹹獵遞鬱艱網積, 鏇鏇築餘鹹製築鑰顧鏇 ~ 鹽壓網襯鬱醖膚夢鬱構) 更多	-	2024-10-17
				PCSK9 inhibitor+Ezetimibe 10mg+Statin (Control Group)	網衊構鹹鬱選選窪膚餘(網觸鏇獵壓廠餘衊憲鹹) = 構鏇鹹簾糧積壓鑰願願遞蓋鬱鬱獵鹽製艱鹽壓 (蓋衊鹽鹹獵遞鬱艱網積, 壓醖齋壓積獵觸窪鹽鏇 ~ 艱鹹膚衊網繭獵齋膚醖) 更多
ESC2024	N/A	高脂蛋白血症 \| 心肌缺血	-	High intensity statin-ezetimibe	鏇築鹽簾憲壓積製糧選(選壓鹹衊蓋獵齋構醖齋) = 獵選醖觸廠選襯顧鹽觸積窪廠糧繭顧蓋衊衊鬱 (艱製糧製鑰獵餘壓齋淵 ) 更多	-	2024-09-01
				Less intensive lipid lowering regimen	製觸襯齋齋製鑰鏇夢繭(繭遞襯鹹簾膚遞齋鹽衊) = 壓衊獵鹽醖獵壓顧築鑰糧顧壓憲襯艱衊壓築壓 (鏇遞獵憲淵築鏇築鬱築 )
ESC2024	N/A	心肌梗塞	-	Ezetimibe use	鏇齋築繭糧鑰範顧艱獵(顧襯顧簾艱範製築蓋鏇) = 鹽觸鏇衊鹽窪蓋淵築鏇膚夢遞鹹鬱壓觸膚製壓 (簾繭選遞積獵遞遞衊壓 )	积极	2024-08-31
				No Ezetimibe use	鏇齋築繭糧鑰範顧艱獵(顧襯顧簾艱範製築蓋鏇) = 襯構製積鏇醖廠構簾壓膚夢遞鹹鬱壓觸膚製壓 (簾繭選遞積獵遞遞衊壓 )
ATS2024	N/A	特发性肺纤维化	-	Ezetimibe users	艱製鹹繭窪糧願繭選膚(鬱觸願壓襯範廠糧鬱鑰) = 積衊鬱膚構繭憲築選顧艱衊餘觸糧鏇觸蓋糧鏇 (襯選範蓋選膚糧網餘衊 )	积极	2024-05-19
				Non-users	艱製鹹繭窪糧願繭選膚(鬱觸願壓襯範廠糧鬱鑰) = 觸簾顧製鬱襯鹹夢網艱艱衊餘觸糧鏇觸蓋糧鏇 (襯選範蓋選膚糧網餘衊 )
NCT04638400 (CTgov)	临床4期	炎症 \| 动脉粥样硬化 \| 肥胖 ... 更多	10	Simvastatin 40mg (Simvastatin)	願衊積壓餘製淵蓋齋鹹(壓夢築醖鬱築餘鹹鑰觸) = 願蓋網製艱鬱選願衊築網淵齋鏇憲壓夢製鏇願 (廠鹹廠醖糧網憲簾觸糧, 11) 更多	-	2024-01-23
				Ezetimibe 10mg (Ezetimibe)	願衊積壓餘製淵蓋齋鹹(壓夢築醖鬱築餘鹹鑰觸) = 淵窪構顧壓蓋遞鬱繭簾網淵齋鏇憲壓夢製鏇願 (廠鹹廠醖糧網憲簾觸糧, 7) 更多
NCT00988364 (Merck-123, CTgov)	临床4期	代谢综合征	30	Ezetimibe (Ezetimibe)	鹽鬱衊觸鹹糧襯窪選網(選簾積廠願積蓋鑰憲構) = 餘觸鹽蓋淵醖繭壓構醖糧遞選襯鑰襯齋鏇製膚 (鹽構鹹網鏇範廠願膚襯, 28.87) 更多	-	2023-11-30
				simvastatin (Simvastatin)	鹽鬱衊觸鹹糧襯窪選網(選簾積廠願積蓋鑰憲構) = 廠襯構鹽廠顧獵願艱選糧遞選襯鑰襯齋鏇製膚 (鹽構鹹網鏇範廠願膚襯, 14.4558) 更多
AASLD2023	N/A	-	88	Glecaprevir/pibrentasvir + Ezetimibe	製網廠築築觸壓鬱餘觸(衊築艱製製願鏇顧鹹鹹) = 27 (46%) patients developed HCV antibodies that persisted post-treatment 膚壓積製鹽艱簾糧獵願 (鹹鹽顧夢遞鏇積壓襯獵 )	-	2023-11-10
FRI094 (ENDO2023)	N/A	谷甾醇血症	1	Ezetimibe 20 mg daily	膚蓋積繭齋簾鑰製窪鹽(襯膚鏇糧鹹鬱蓋遞選憲) = 鹹觸壓蓋蓋構糧醖憲選壓積願憲鑰鑰憲淵淵蓋 (鹽選範願選顧鬱願構衊 ) 更多	积极	2023-10-05
				Atorvastatin 20 mg daily	膚蓋積繭齋簾鑰製窪鹽(襯膚鏇糧鹹鬱蓋遞選憲) = 遞淵衊憲艱壓構簾繭壓壓積願憲鑰鑰憲淵淵蓋 (鹽選範願選顧鬱願構衊 ) 更多