硫酸氢氯吡格雷(Clopidogrel Bisulfate) - 药物靶点：P2Y12 receptor_在研适应症：非q波心肌梗死，动脉粥样硬化，非 ST 段抬高急性冠脉综合征_专利_临床

概要

基本信息

简介Clopidogrel Bisulfate 是一种商标为 Plavix® 的药物，在1997年于美国批准上市，由施贵宝研发。其作用机制是抑制P2Y12受体，从而减少血小板活化和聚集。这随后降低了血栓的风险及其潜在的致命后果。氯吡格雷适用于治疗心肌梗塞、中风、外周血管疾病、冠状动脉疾病和脑血管疾病。由于其作为抗血小板药物的作用，氯吡格雷被证明在预防血栓引起的严重并发症（如心脏病发作、中风甚至死亡）方面具有无可估量的价值。该药物在心血管事件的管理和预防方面显示出疗效，使其成为现代医学的基本药物。

药物类型

小分子化药

别名

clopidogrel、Clopidogrel Bisufate、Clopidogrel bisulfate (USP)

+ [31]

靶点

P2Y12 receptor

作用机制

P2Y12 receptor拮抗剂(嘌呤P2Y12受体拮抗剂)

治疗领域

神经系统疾病心血管疾病

在研适应症

非q波心肌梗死动脉粥样硬化非 ST 段抬高急性冠脉综合征+ [14]

非在研适应症

冠心病心脏停搏先天性心脏缺损+ [4]

原研机构

Bristol Myers Squibb Co.

在研机构

Zentiva ksHCS bvbaPharmathen SA

+ [10]

非在研机构

Archie Samuel Sro

Bristol Myers Squibb Co.

Sanofi SA

+ [5]

最高研发阶段批准上市

首次获批日期

美国 (1997-11-17),

心肌梗塞脑卒中

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)

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结构

分子式C16H18ClNO6S2

InChIKeyFDEODCTUSIWGLK-RSAXXLAASA-N

CAS号120202-66-6

关联

412

项与硫酸氢氯吡格雷相关的临床试验

NCT06013020 / Recruiting临床4期IIT

Safety and Efficacy of Century Clot-Guided Prophylactic Rivaroxaban Therapy for Post ST-Segment Elevation Myocardial Infarction Complicating Left Ventricular Thrombus Compared With Conventional Antiplatelet Therapy

To manage the ST-segment elevation myocardial infarction (STEMI) caused by plaque rupture, triggers platelet activation/aggregation and thrombin generation, requires dual (platelet and coagulation) pathway inhibition. However, triple antithrombotic therapy with standard dual antiplatelet therapy (DAPT) and oral anticoagulant (OAC) in the STEMI setting is a challenge, since that increase in potential risk of bleeding.
Although the incidence of left ventricular thrombus (LVT) formation after STEMI decreased in modern reperfusion therapy, including primary percutaneous coronary intervention (PCI), remains at 4% to 26%, especially that complicated by anterior STEMI. The recommendation of an OAC prophylactic therapy for preventing LVT formation in current STEMI guidelines is limited. How to optimize antithrombotic therapy to balance the bleeding-thrombotic profile, and prevent LVT formation is challenging, since insufficient evidence is available from randomized trials.
Century Clot analyzer is point-of-care testing that could assess the coagulate state: normal, hypo-coagulable, or hyper-coagulable states according to clot rate (CR) value. Whether Century Clot-guided rivaroxaban prophylactic therapy (2.5 mg twice daily, if the hypercoagulable state, defined as CR ≥24) in combination with standard DAPT could reduce LVT formation without increasing major bleeding is uncertain.

开始日期2024-04-01

申办/合作机构

遵义医科大学

CTR20240407 / CompletedN/A

硫酸氢氯吡格雷片人体生物等效性试验

主要研究目的本研究考察空腹及餐后条件下单次口服受试制剂硫酸氢氯吡格雷片（规格：75 mg/片，生产单位：杭州民生药业股份有限公司）与参比制剂硫酸氢氯吡格雷片（商品名：波立维®，规格：75 mg/片，生产单位：Sanofi Wint hrop Industrie）在健康成年受试者体内的药代动力学，评价空腹和餐后口服两种制剂的生物等效性。次要研究目的观察单次口服 75 mg 的受试制剂硫酸氢氯吡格雷片或参比制剂硫酸氢氯吡格雷片（商品名：波立维®，75 mg）在健康受试者中的安全性。

开始日期2024-03-06

申办/合作机构

海南药谷云生物科技有限公司

NCT05643651 / Not yet recruiting临床4期IIT

Rivaroxaban Versus Warfarin for Thromboprophylaxis in Children With Giant Coronary Artery Aneurysms After Kawasaki Disease: a Multicenter, Open-label, Parallel, Exploratory, Randomized Controlled Trial

Based on population pharmacokinetic model-based simulation, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after acute Kawasaki disease was proposed. This exploratory trial aims to evaluate the feasibility, safety and effectiveness of rivaroxaban compared to warfarin for thromboprophylaxis in children with giant coronary artery aneurysms after Kawasaki disease

开始日期2024-03-01

申办/合作机构

复旦大学附属儿科医院

100 项与硫酸氢氯吡格雷相关的临床结果

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100 项与硫酸氢氯吡格雷相关的转化医学

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100 项与硫酸氢氯吡格雷相关的专利（医药）

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2,045

项与硫酸氢氯吡格雷相关的文献（医药）

2024-05-01·Obesity surgery

Factors Associated with the Decision to Complete Bariatric Metabolic Surgery among a Racially and Ethnically Diverse Sample of Adults: A Classification and Regression Tree Analysis

Article

作者: Kukreja, Sachin ; Almandoz, Jaime P ; Kapera, Olivia ; Marroquin, Elisa Morales ; Francis, Jackson ; McAdams, Carrie ; Schneider, Benjamin E ; Atem, Folefac ; Ngenge, Sophia ; Mathew, M Sunil ; Xie, Luyu ; Schellinger, Jeffrey N ; Messiah, Sarah E

BACKGROUND:

Less than 50% of eligible candidates who are referred complete Bariatric Metabolic Surgery (BMS). The factors influencing the decision to complete BMS, particularly how these factors vary across different racial and ethnic groups, remain largely unexplored.

METHODS:

This prospective cohort study included adult patients referred to a bariatric surgeon or obesity medicine program between July 2019-September 2022. Sociodemographic characteristics, body mass index (BMI), anxiety, depression, body appreciation, and patient-physician relationship information were collected via survey and electronic health records. The association between BMS completion and potential decision-driving factors was examined using Classification and Regression Tree (CART) analysis.

RESULTS:

A total of 406 BMS -eligible patients participated in the study (mean [SD] age: 47.5 [11.6] years; 87.2% women; 18.0% Hispanic, 39% non-Hispanic Black [NHB], and 39% non-Hispanic White [NHW]; mean [SD] BMI: 45.9 [10.1] kg/m²). A total of 147 participants (36.2%) completed BMS. Overall, the most influential factor driving the decision to complete BMS was younger age (< 68.4 years), higher patient satisfaction, and BMI (≥ 38.0 kg/m²). Hispanic participants prioritized age (< 55.4 years), female sex, and body appreciation. For NHB participants, the highest ranked factors were age < 56.3 years, BMI ≥ 35.8 kg/m², and higher patient satisfaction. For NHW patients, the most influential factors were age (39.1 to 68.6 years) and higher body appreciation.

CONCLUSION:

These findings highlight racial and ethnic group differences in the factors motivating individuals to complete BMS. By acknowledging these differences, healthcare providers can support patients from different backgrounds more effectively in their decision-making process regarding BMS.

2024-04-23·Journal of chromatographic science

AGREE and ESA for Greenness Assessment of a Novel Validated RP-HPLC Method for Simultaneous Determination of Aspirin, Warfarin and Clopidogrel in Rat Plasma: Application to Pharmacokinetic Study of the Possible Interaction between the Three Drugs

Article

作者: ElKady, Ehab F ; Mostafa, Eman A ; AlSawy, Norhan S

Abstract:

The green profile of the developed method is assessed and compared with previously reported methods. Percutaneous coronary intervention is a procedure where a catheter is utilized to place a stent in order to facilitate opening of the blood vessels in the heart. Triple antithrombotic therapy includes oral anticoagulation as warfarin and dual antiplatelet therapy (composed of aspirin and clopidogrel bisulfate). The aim of the current study was to evaluate the pharmacokinetic parameters of ASP, WAR and CLP and to investigate the possible interaction between the three drugs upon co-administration in rats. A selective and precise RP-HPLC method was developed for the simultaneous determination of ASP, WAR and CLP in rat plasma. Pharmacokinetic study was conducted in rats that received ASP, WAR and CLP as an application of the developed method. From the statistical evaluation of the pharmacokinetic parameters, it was observed that the co-administration of ASP, WAR and CLP significantly increased the ASP and CLP bioavailability in rats. A significant drug–drug interaction was confirmed in the current study. The elevated Cmax of ASP and CLP upon the co-administration of ASP, WAR and CLP may explain the reported bleeding.

2024-04-01·International journal of radiation oncology, biology, physics

Long-Term Intracranial Outcomes With Combination Dual Immune-Checkpoint Blockade and Stereotactic Radiosurgery in Patients With Melanoma and Non-Small Cell Lung Cancer Brain Metastases

Article

作者: Hendrickson, Peter G ; Allen, Karen ; Vaios, Eugene J ; Floyd, Scott R ; Niedzwiecki, Donna ; Shih, Helen A ; Salama, April K S ; Reitman, Zachary J ; Dietrich, Jorg ; Sperduto, Paul ; Mullikin, Trey ; Kirkpatrick, John P ; Shenker, Rachel F ; Winter, Sebastian F ; Wan, Zihan ; Clarke, Jeffrey M ; Wang, Chunhao

PURPOSE:

The intracranial benefit of offering dual immune-checkpoint inhibition (D-ICPI) with ipilimumab and nivolumab to patients with melanoma or non-small cell lung cancer (NSCLC) receiving stereotactic radiosurgery (SRS) for brain metastases (BMs) is unknown. We hypothesized that D-ICPI improves local control compared with SRS alone.

METHODS AND MATERIALS:

Patients with melanoma or NSCLC treated with SRS from 2014 to 2022 were evaluated. Patients were stratified by treatment with D-ICPI, single ICPI (S-ICPI), or SRS alone. Local recurrence, intracranial progression (IP), and overall survival were estimated using competing risk and Kaplan-Meier analyses. IP included both local and distant intracranial recurrence.

RESULTS:

Two hundred eighty-eight patients (44% melanoma, 56% NSCLC) with 1,704 BMs were included. Fifty-three percent of patients had symptomatic BMs. The median follow-up was 58.8 months. Twelve-month local control rates with D-ICPI, S-ICPI, and SRS alone were 94.73% (95% CI, 91.11%-96.90%), 91.74% (95% CI, 89.30%-93.64%), and 88.26% (95% CI, 84.07%-91.41%). On Kaplan-Meier analysis, only D-ICPI was significantly associated with reduced local recurrence (P = .0032). On multivariate Cox regression, D-ICPI (hazard ratio [HR], 0.4003; 95% CI, 0.1781-0.8728; P = .0239) and planning target volume (HR, 1.022; 95% CI, 1.004-1.035; P = .0059) correlated with local control. One hundred seventy-three (60%) patients developed IP. The 12-month cumulative incidence of IP was 41.27% (95% CI, 30.27%-51.92%), 51.86% (95% CI, 42.78%-60.19%), and 57.15% (95% CI, 44.98%-67.59%) after D-ICPI, S-ICPI, and SRS alone. On competing risk analysis, only D-ICPI was significantly associated with reduced IP (P = .0408). On multivariate Cox regression, D-ICPI (HR, 0.595; 95% CI, 0.373-0.951; P = .0300) and presentation with >10 BMs (HR, 2.492; 95% CI, 1.668-3.725; P < .0001) remained significantly correlated with IP. The median overall survival after D-ICPI, S-ICPI, and SRS alone was 26.1 (95% CI, 15.5-40.7), 21.5 (16.5-29.6), and 17.5 (11.3-23.8) months. S-ICPI, fractionation, and histology were not associated with clinical outcomes. There was no difference in hospitalizations or neurologic adverse events between cohorts.

CONCLUSIONS:

The addition of D-ICPI for patients with melanoma and NSCLC undergoing SRS is associated with improved local and intracranial control. This appears to be an effective strategy, including for patients with symptomatic or multiple BMs.

249

项与硫酸氢氯吡格雷相关的新闻（医药）

2024-06-19

·米内网

【瞩目】11亿抗血栓药，重庆药友制药获批了

精彩内容近日，国家药监局官网显示，重庆药友制药申报的4类仿制药贝前列素钠片获批生产并视同过评。这是一款抗血栓形成药，2023年在中国三大终端六大市场（统计范围详见本文末）的销售额超过11亿元。今年以来，重庆药友制药已有8个品种获批。贝前列素钠片具有抗血小板和扩血管的作用，适用于改善慢性动脉闭塞性疾病引起的溃疡、间歇性跛行、疼痛和冷感等症状。米内网数据显示，贝前列素钠片2021年在中国三大终端六大市场的销售额突破10亿元，2023年超过11亿元。其中，院内市场（公立医院+公立基层医疗）为销售主渠道，占比超过90%。近年来中国三大终端六大市场贝前列素钠片销售情况（单位：万元）来源：米内网格局数据库除了原研企业日本东丽外，目前还有4家国内药企获得贝前列素钠片生产批文，其中北京诚济制药、成都苑东生物、重庆药友制药3家企业的产品视同过评，北京泰德制药的产品以补充申请过评。贝前列素钠片暂未纳入国采，但已满足国采的初步入围条件。米内网数据显示，2024年以来，重庆药友制药已有8个品种获批生产并视同过评，包括盐酸舍曲林片、阿立哌唑口崩片、盐酸鲁拉西酮片3款神经系统药物，枸橼酸托法替布片、氟尿嘧啶注射液2款抗肿瘤和免疫调节剂等。 2024年以来重庆药友制药获批上市的品种来源：米内网中国申报进度（MED）数据库此外，今年以来，重庆药友制药还有13个品种以新注册分类报产在审，包括硫酸氢氯吡格雷片、碘佛醇注射液、瑞舒伐他汀钙片、氯化钾缓释片、注射用美罗培南等，涵盖造影剂、血脂调节剂、高血压用药、抗肿瘤药等多个治疗亚类。资料来源：米内网数据库、国家药监局官网等注：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6月19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

一致性评价带量采购

2024-06-11

·信狐药迅

百济神州优先品种 HER2双抗泽尼达妥单抗提交上市申请|新受理（6.3-6.10）

本周药品注册受理数据，分门别类呈现，一目了然。(6.3-6.10）新药上市申请药品名称企业注册分类受理号复迈替尼片上海复星医药产业发展有限公司1CXHS2400049复迈替尼片上海复星医药产业发展有限公司1CXHS2400048注射用泽尼达妥单抗百济神州(苏州)生物科技有限公司1CXSS2400056司普奇拜单抗注射液成都康诺行生物医药科技有限公司1CXSS2400055 新药临床申请药品名称企业注册分类受理号HZ-L105片杭州和正医药有限公司1CXHL2400582HZ-L105片杭州和正医药有限公司1CXHL2400581HZ-L105片杭州和正医药有限公司1CXHL2400580K-13片上海懿峰生物科技有限公司1CXHL2400579K-13片上海懿峰生物科技有限公司1CXHL2400578K-13片上海懿峰生物科技有限公司1CXHL2400577FP-208片北京富龙康泰生物技术有限公司1CXHL2400573FP-208片北京富龙康泰生物技术有限公司1CXHL2400572K-13片上海懿峰生物科技有限公司1CXHL2400571K-13片上海懿峰生物科技有限公司1CXHL2400570K-13片上海懿峰生物科技有限公司1CXHL2400569ZG-002片上海致根医药科技有限公司1CXHL2400568ZG-002片上海致根医药科技有限公司1CXHL2400567RP903片君实润佳(上海)医药科技有限公司1CXHL2400566RP903片君实润佳(上海)医药科技有限公司1CXHL2400565SIM0508片上海先祥医药科技有限公司1CXHL2400564SIM0508片上海先祥医药科技有限公司1CXHL2400563BGC515胶囊苏州桥济生物科技有限公司1CXHL2400562BGC515胶囊苏州桥济生物科技有限公司1CXHL2400561BGC515胶囊苏州桥济生物科技有限公司1CXHL2400560TLL-041片杭州高光制药有限公司1CXHL2400559TLL-041片杭州高光制药有限公司1CXHL2400558TLL-041片杭州高光制药有限公司1CXHL2400557注射用SC-102天津星联肽生物科技有限公司1CXHL2400556DAT-2645片北京丹擎医药科技有限公司1CXHL2400555DAT-2645片北京丹擎医药科技有限公司1CXHL2400554甘露醇山梨醇注射液石家庄四药有限公司3CYHL2400104注射用多黏菌素E甲磺酸钠健康元海滨药业有限公司3CYHL2400103PG-F01凝胶北京普祺医药科技股份有限公司2.2;2.4CXHL2400576PG-F01凝胶北京普祺医药科技股份有限公司2.2;2.4CXHL2400575PG-F01凝胶北京普祺医药科技股份有限公司2.2;2.4CXHL2400574四价重组诺如病毒疫苗(汉逊酵母)华北制药金坦生物技术股份有限公司1.1CXSL2400368四价重组诺如病毒疫苗(汉逊酵母)华北制药金坦生物技术股份有限公司1.1CXSL2400367流感病毒亚单位疫苗江苏中慧元通生物科技股份有限公司3.3CXSL2400370PreS1胶束注射液(冻干)普瑞斯万(武汉)生物科技有限公司1CXSL2400372CC312冻干粉针剂惠和生物技术(上海)有限公司1CXSL2400366GKL-006注射液北京基因启明生物科技有限公司1CXSL2400364外用红色诺卡氏菌细胞壁骨架辽宁天安生物制药股份有限公司2.2CXSL2400369门冬胰岛素30注射液宁波鲲鹏生物科技有限公司3.3CXSL2400365人凝血酶原复合物四川远大蜀阳药业有限责任公司3.4CXSL2400371注射用重组A型肉毒毒素君合盟生物制药(通化)有限公司2.2;2.4CXSL2400373 仿制药申请药品名称企业注册分类受理号ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液福建盛迪医药有限公司3CYHS2401726地奈德乳膏杭州民生药业股份有限公司3CYHS2401736草酸艾司西酞普兰口服溶液江苏长泰药业股份有限公司3CYHS2401733舒必利注射液海南卓科制药有限公司3CYHS2401731舒必利注射液海南卓科制药有限公司3CYHS2401730甲硫酸新斯的明注射液河北一品制药股份有限公司3CYHS2401728重酒石酸卡巴拉汀口服液广州一品红制药有限公司3CYHS2401727苯磺酸氨氯地平口腔崩解片广东万泰科创药业有限公司3CYHS2401715吸入用盐酸丙卡特罗溶液石家庄四药有限公司3CYHS2401717氨磺必利口服溶液宏越科技(湖州)有限公司3CYHS2401713盐酸丙卡特罗口服溶液黑龙江澳利达奈德制药有限公司3CYHS2401710盐酸丙卡特罗口服溶液黑龙江澳利达奈德制药有限公司3CYHS2401709盐酸甲氧氯普胺注射液嘉实(湖南)医药科技有限公司3CYHS2401705吸入用盐酸丙卡特罗溶液浙江福瑞喜药业有限公司3CYHS2401723吸入用盐酸丙卡特罗溶液浙江福瑞喜药业有限公司3CYHS2401722烟酸缓释片北京世桥生物制药有限公司3CYHS2401697盐酸异丙肾上腺素注射液华夏生生药业(北京)有限公司3CYHS2401694马来酸氯苯那敏注射液江苏瑜兴医药科技有限公司3CYHS2401692丙戊酸钠注射用浓溶液广州市联瑞制药有限公司3CYHS2401704注射用硫酸多黏菌素B健康元药业集团股份有限公司3CYHS2401700乙酰半胱氨酸注射液江苏迪赛诺制药有限公司3CYHS2401681左氧氟沙星注射液辰欣药业股份有限公司3CYHS2401672氨溴特罗口服溶液国药控股星鲨制药(厦门)有限公司3CYHS2401667腺苷钴胺胶囊浙江昂利康制药股份有限公司3CYHS2401689盐酸拉贝洛尔注射液遂成药业股份有限公司3CYHS2401686盐酸拉贝洛尔注射液遂成药业股份有限公司3CYHS2401684复方磺胺甲噁唑注射液华夏生生药业(北京)有限公司3CYHS2401671维生素B6注射液宝利化(南京)制药有限公司3CYHS2401674硫酸沙丁胺醇注射液湖北民康药业集团有限公司3CYHS2401659药用炭胶囊海南烨徽源医药科技有限公司3CYHS2401658硫酸沙丁胺醇口服溶液浙江凯润药业股份有限公司3CYHS2401657氯化钾口服溶液安徽茂康药业有限公司3CYHS2401656吸入用盐酸氨溴索溶液济南景笙科技有限公司3CYHS2401655氯化钾口服溶液遂成药业股份有限公司3CYHS2401653重酒石酸去甲肾上腺素注射液遂成药业股份有限公司3CYHS2401652硫酸氨基葡萄糖胶囊吉林道君药业股份有限公司4CYHS2401740艾地骨化醇软胶囊山东简道制药有限公司4CYHS2401739艾地骨化醇软胶囊山东简道制药有限公司4CYHS2401738甲硝唑凝胶合肥启旸生物医药科技有限公司4CYHS2401737克立硼罗软膏山东辰欣佛都药业股份有限公司4CYHS2401735注射用硫酸艾沙康唑合肥亿帆生物制药有限公司4CYHS2401734富马酸伏诺拉生片南京正科医药股份有限公司4CYHS2401732富马酸伏诺拉生片南京正科医药股份有限公司4CYHS2401729恩格列净片佑华医药科技有限公司4CYHS2401721恩格列净片佑华医药科技有限公司4CYHS2401720盐酸伊立替康注射液连云港众维生物医药有限公司4CYHS2401719盐酸伊立替康注射液连云港众维生物医药有限公司4CYHS2401718氟康唑氯化钠注射液哈尔滨三联药业股份有限公司4CYHS2401716尼可地尔片重庆莱美药业股份有限公司4CYHS2401714聚乙二醇钠钾散湖南华纳大药厂股份有限公司4CYHS2401712注射用头孢唑肟钠南京赛瑞谱顿制药有限公司4CYHS2401711盐酸尼卡地平注射液广东君康药业有限公司4CYHS2401707乳果糖口服溶液江苏广承药业有限公司4CYHS2401706注射用头孢他啶阿维巴坦钠海南葫芦娃药业集团股份有限公司4CYHS2401725盐酸纳呋拉啡口腔崩解片郑州泰丰制药有限公司4CYHS2401724注射用硫酸艾沙康唑海南广升誉制药有限公司4CYHS2401708甲氨蝶呤注射液海南卓泰制药有限公司4CYHS2401699甲氨蝶呤注射液海南卓泰制药有限公司4CYHS2401698精氨酸培哚普利片江西施美药业股份有限公司4CYHS2401696精氨酸培哚普利片江西施美药业股份有限公司4CYHS2401695熊去氧胆酸胶囊贵州瑞和制药有限公司4CYHS2401693盐酸达泊西汀片河北万岁药业有限公司4CYHS2401703盐酸达泊西汀片河北万岁药业有限公司4CYHS2401702多索茶碱注射液云南药科院生物医药股份有限公司4CYHS2401701硫酸氢氯吡格雷片重庆药友制药有限责任公司4CYHS2401683那屈肝素钙注射液华北制药华坤河北生物技术有限公司4CYHS2401677艾考糊精腹膜透析液青岛瑞奈医疗科技有限公司4CYHS2401682盐酸西替利嗪片上海强生制药有限公司4CYHS2401676硫酸镁钠钾口服用浓溶液广州合和医药有限公司4CYHS2401675丙酸氯倍他索搽剂江苏知原药业股份有限公司4CYHS2401668蒙脱石散海南斯达制药有限公司4CYHS2401688罗沙司他胶囊湖南埃威格林医药科技有限公司4CYHS2401680罗沙司他胶囊湖南埃威格林医药科技有限公司4CYHS2401679巴瑞替尼片杭州民生药业股份有限公司4CYHS2401678尼可地尔片本溪匠成医药科技有限公司4CYHS2401673依折麦布阿托伐他汀钙片(I)成都倍特药业股份有限公司4CYHS2401670依折麦布阿托伐他汀钙片(II)成都倍特药业股份有限公司4CYHS2401669盐酸尼卡地平注射液河南润弘制药股份有限公司4CYHS2401690氢溴酸伏硫西汀片宁波大红鹰药业股份有限公司4CYHS2401687氢溴酸伏硫西汀片宁波大红鹰药业股份有限公司4CYHS2401685注射用硫酸艾沙康唑广州一品红制药有限公司4CYHS2401691富马酸依美斯汀滴眼液广州仁恒医药科技股份有限公司4CYHS2401666碳酸司维拉姆片浙江昂利康制药股份有限公司4CYHS2401665沙库巴曲缬沙坦钠片江苏利泰尔药业有限公司4CYHS2401664沙库巴曲缬沙坦钠片江苏利泰尔药业有限公司4CYHS2401663间苯三酚注射液杭州和泽坤元药业有限公司4CYHS2401662巴瑞替尼片南京海纳制药有限公司4CYHS2401661莫匹罗星软膏浙江赛默制药有限公司4CYHS2401660注射用替加环素北京融英医药科技有限公司4CYHS2401654 进口申请药品名称企业注册分类受理号伊那利塞片Roche Pharma (Schweiz) AG1JXHS2400038伊那利塞片Roche Pharma (Schweiz) AG1JXHS2400037盐酸匹美西林片Karo Pharma AB5.1JXHS2400040盐酸匹美西林片Karo Pharma AB5.1JXHS2400039利生奇珠单抗注射液AbbVie Inc.2.2JXSS2400047利生奇珠单抗注射液(皮下注射)AbbVie Inc.2.2JXSS2400046利生奇珠单抗注射液(皮下注射)AbbVie Inc.2.2JXSS2400045Bexotegrast片Pliant Therapeutics, Inc.1JXHL2400126Upadacitinib口服溶液AbbVie Inc.2.2JXHL2400131Upadacitinib口服溶液AbbVie Inc.2.2JXHL2400130Upadacitinib片AbbVie Inc.2.4JXHL2400129Upadacitinib片AbbVie Inc.2.4JXHL2400128Upadacitinib片AbbVie Inc.2.4JXHL2400127RO7200220 注射液F. Hoffmann-La Roche Ltd.1JXSL2400112RO7200220 注射液F. Hoffmann-La Roche Ltd.1JXSL2400111Amlitelimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400108注射用AZD7798AstraZeneca AB1JXSL2400110Amlitelimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400109 中药相关申请药品名称企业注册分类受理号升陷颗粒吉林敖东洮南药业股份有限公司3.1CXZS2400020三七通舒胶囊成都神鹤药业有限责任公司4CYZS2400002 不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市

2024-06-10

·GlobeNewswire-Health Care

C4 Therapeutics Appoints Ron Cooper as Chairman of the Board of Directors

Cooper Brings Decades of Global Pharmaceutical and Biotechnology Leadership Experience Bruce Downey Remains a Member of the Board of Directors and Chair of the Organization, Leadership and Compensation Committee Transition Further Highlights Commitment to Strategically Transform the Board to Lead C4T into Next Phase of Growth WATERTOWN, Mass., June 10, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced changes to its Board of Directors as part of the Company’s aspiration to become a fully integrated biotechnology company. Ron Cooper, a global biopharmaceutical executive experienced across discovery, development and commercialization, has been appointed chairman of C4T’s Board of Directors. Bruce Downey, who served as chairman between June 2022 and June 2024, remains a member of the Board of Directors. As part of C4T’s continued Board evolution with this appointment, Glenn Dubin, who has served on C4T’s Board of Directors since 2021, has decided to step down from the Board of Directors. “I am honored to become the next chairman of the Board of Directors of C4 Therapeutics where I expect to leverage my experience building fully integrated global biopharmaceutical companies to help C4T continue to deliver on the promise of targeted protein degradation,” said Ron Cooper. “Targeted protein degradation is a quickly evolving field with immense potential, and I am excited to work with the Board and management team to keep C4T at the forefront of this modality and help improve patients’ lives.” Ron Cooper most recently served as president and chief executive officer of Albireo Pharma, a fully integrated, global, commercial biopharmaceutical company that was acquired by Ipsen in March 2023. Earlier in his career, Mr. Cooper spent nearly 30 years at Bristol-Myers Squibb (BMS) in roles of increasing responsibility in sales, marketing and general management, most recently serving as President, Europe. At BMS, he played a leadership role in several successful product launches, including Abilify®, Atripla®, Eliquis®, Plavix®, Sprycel® and Yervoy®. Mr. Cooper currently serves on the Board of Directors of Generation Bio. “It has been my pleasure to serve as chairman and help C4T broaden the expertise of our Board by appointing several leaders with deep experience across clinical development, medical affairs, regulatory strategy, capital markets and commercialization. I look forward to working with Ron and our outstanding Board to help C4T capitalize on the opportunities ahead,” said Bruce Downey. “On behalf of the Board, I would like to thank Glenn Dubin for his support of C4T as he steps down so we can welcome Ron’s extensive pharmaceutical and biotechnology expertise to help lead the company in this next exciting phase. We appreciate Glenn’s contributions and wish him the best.” “As we pursue our vision to become a fully integrated biotechnology company, we are thrilled to have Ron’s experience helping companies successfully bring products through discovery, development and commercialization,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “We have an exciting path ahead and the entire C4T team remains focused on advancing our pipeline to deliver on the potential of targeted protein degradation science for patients searching for new therapies.” About C4 TherapeuticsC4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. For more information, please visit www.c4therapeutics.com. Forward-Looking StatementsThis press release contains “forward-looking statements” of C4 Therapeutics, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our ability to develop potential therapies for patients; the design and potential efficacy of our therapeutic approaches; and our ability to fund our future operations. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the initiation, timing, advancement and conduct of preclinical and clinical studies and other development requirements for our product candidates; the risk that any one or more of our product candidates will cost more to develop or may not be successfully developed and commercialized; and the risk that sufficient capital to fund our future operations will be available to us on acceptable terms or at the times required. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in C4 Therapeutics’ most recent Annual Report on Form 10-K and/or Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and C4 Therapeutics undertakes no duty to update this information unless required by law. Contacts:Investors: Courtney SolbergSenior Manager, Investor RelationsCSolberg@c4therapeutics.com Media: Loraine Spreen Senior Director, Corporate Communications & Patient Advocacy LSpreen@c4therapeutics.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a06f09c7-3115-4f0d-93c9-bb23d667fe40

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KEGG	Wiki	ATC	Drug Bank
D00769	硫酸氢氯吡格雷	B01AC04	DB00758

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适应症	国家/地区	公司	日期
非q波心肌梗死	欧盟	Teva Pharmaceuticals Europe BV	2015-02-18
非q波心肌梗死	冰岛	Teva Pharmaceuticals Europe BV	2015-02-18
非q波心肌梗死	列支敦士登	Teva Pharmaceuticals Europe BV	2015-02-18
非q波心肌梗死	挪威	Teva Pharmaceuticals Europe BV	2015-02-18
动脉粥样硬化	欧盟	Pharmathen SA	2009-07-27
动脉粥样硬化	冰岛	Pharmathen SA	2009-07-27
动脉粥样硬化	列支敦士登	Pharmathen SA	2009-07-27
动脉粥样硬化	挪威	Pharmathen SA	2009-07-27
非 ST 段抬高急性冠脉综合征	欧盟	Teva Pharmaceuticals Europe BV	2009-07-27
非 ST 段抬高急性冠脉综合征	冰岛	Teva Pharmaceuticals Europe BV	2009-07-27
非 ST 段抬高急性冠脉综合征	列支敦士登	Teva Pharmaceuticals Europe BV	2009-07-27
非 ST 段抬高急性冠脉综合征	挪威	Teva Pharmaceuticals Europe BV	2009-07-27
稳定型心绞痛	中国	深圳信立泰药业股份有限公司	2000-01-01
脑血管疾病	中国	深圳信立泰药业股份有限公司	2000-01-01
心肌缺血	中国	深圳信立泰药业股份有限公司	2000-01-01
非ST段抬高型心肌梗死	中国	深圳信立泰药业股份有限公司	2000-01-01
ST段抬高心肌梗死	中国	深圳信立泰药业股份有限公司	2000-01-01
急性冠状动脉综合征	欧盟	Sanofi Winthrop Industrie SA	1998-07-14
急性冠状动脉综合征	冰岛	Sanofi Winthrop Industrie SA	1998-07-14
急性冠状动脉综合征	列支敦士登	Sanofi Winthrop Industrie SA	1998-07-14

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适应症	最高研发状态	国家/地区	公司	日期
先天性心脏缺损	临床3期	美国	Sanofi SA	2009-01-01
先天性心脏缺损	临床3期	巴西	Sanofi SA	2009-01-01
先天性心脏缺损	临床3期	法国	Sanofi SA	2009-01-01
先天性心脏缺损	临床3期	德国	Sanofi SA	2009-01-01
先天性心脏缺损	临床3期	匈牙利	Sanofi SA	2009-01-01
先天性心脏缺损	临床3期	印度	Sanofi SA	2009-01-01
先天性心脏缺损	临床3期	意大利	Sanofi SA	2009-01-01
先天性心脏缺损	临床3期	马来西亚	Sanofi SA	2009-01-01
先天性心脏缺损	临床3期	墨西哥	Sanofi SA	2009-01-01
先天性心脏缺损	临床3期	波兰	Sanofi SA	2009-01-01

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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


NCT03161678 (CTgov)	临床4期	血栓形成 \| 血小板疾病 \| 心肌梗塞	111	clopidogrel+Ticagrelor (Wild-Type Genotype)	餘糧鑰憲憲齋襯餘觸淵(鏇選鑰窪憲壓構繭築鏇) = 顧衊膚齋範蓋遞憲構夢醖願壓顧遞壓壓鹽襯鏇 (簾夢鏇簾築鹹範積廠觸, 淵糧願膚憲鹽鹽憲壓膚 ~ 鬱憲蓋憲製鏇範憲構選) 更多	-	2024-05-06
				clopidogrel+Ticagrelor (Carriers of the CES1 G143E Mutation)	餘糧鑰憲憲齋襯餘觸淵(鏇選鑰窪憲壓構繭築鏇) = 積蓋醖選鏇鑰製膚鹹壓醖願壓顧遞壓壓鹽襯鏇 (簾夢鏇簾築鹹範積廠觸, 製襯遞鹽簾醖膚顧繭鏇 ~ 鏇鹽遞遞觸繭獵齋鏇憲) 更多
NCT04409834 (COVID-PACT, CTgov)	临床4期	新型冠状病毒感染 \| 动脉血栓形成 \| 静脉血栓栓塞	390	Unfractionated Heparin IV+Clopidogrel+Enoxaparin 1 mg/kg (Full-dose Anticoagulation (FDAC))	築築製齋淵獵夢顧艱廠(齋範艱構鏇獵壓憲餘齋) = 願網蓋膚鏇窪蓋簾觸衊壓積遞鏇獵醖艱窪繭鬱 (鹽築壓繭鏇築遞鏇選簾, 醖積齋構範範遞醖蓋憲 ~ 鏇觸繭廠衊製鬱遞鹽簾) 更多	-	2024-01-19
				Unfractionated heparin SC+clopidogrel+Enoxaparin 40 mg SC (Standard-dose Prophylactic Anticoagulation (SDPAC))	築築製齋淵獵夢顧艱廠(齋範艱構鏇獵壓憲餘齋) = 獵範淵繭構醖鹹願夢鏇壓積遞鏇獵醖艱窪繭鬱 (鹽築壓繭鏇築遞鏇選簾, 構觸淵蓋憲簾憲製繭構 ~ 構鏇遞鹽觸窪願選膚夢) 更多
NCT03774394 (CTgov)	临床4期	慢性肾病 \| 冠心病 \| 2型糖尿病	61	Clopidogrel+Clopidogrel active metabolite (Diabetes Mellitus Patients With Chronic Kidney Disease)	憲範顧壓鑰繭築膚觸觸(餘艱鑰蓋繭遞鏇餘餘窪) = 鏇簾齋範壓淵鹽衊繭糧齋選觸簾築壓衊築廠襯 (齋網艱壓鬱簾觸衊築艱, 獵廠鹽壓選壓淵繭簾遞 ~ 鹹獵鹽壓觸製糧襯齋築) 更多	-	2023-08-21
				Clopidogrel+Clopidogrel active metabolite (Diabetes Mellitus Patients Without Chronic Kidney Disease)	憲範顧壓鑰繭築膚觸觸(餘艱鑰蓋繭遞鏇餘餘窪) = 獵簾淵餘夢壓鏇糧製觸齋選觸簾築壓衊築廠襯 (齋網艱壓鬱簾觸衊築艱, 鬱膚鹹醖壓願夢鏇網憲 ~ 壓積夢糧襯憲製顧齋簾) 更多
NCT03188705 (CTgov)	临床4期	血栓形成 \| 动脉闭塞 \| 与 CYP2C19 相关的药物代谢不良 ... 更多	6	Clopidogrel+Aspirin (Clopidogrel Alone Followed by Clopidogrel and Aspirin Treatment)	築醖衊獵築餘蓋衊淵繭(選範衊襯壓壓齋選糧築) = 遞獵襯糧膚淵鹹憲壓襯構醖襯範夢憲範廠網範 (繭憲範衊鑰膚夢憲艱窪, 製蓋簾選鹽醖襯艱鬱憲 ~ 鹽獵憲遞齋鹹範製範選) 更多	-	2023-06-15
				Clopidogrel (Clopidogrel Alone Treatment)	範廠觸製築鏇衊選膚蓋(築願顧淵鹹齋餘憲壓積) = 膚簾壓鑰簾衊範壓鬱網淵齋鏇鏇構糧窪齋網鬱 (鹽遞憲觸鏇鹽構製願壓, 窪膚觸範餘築餘網願衊 ~ 糧夢鑰齋鹽膚窪醖淵顧) 更多
NCT00979589 (CHANCE, Pubmed)	临床3期	脑卒中 \| 短暂性脑缺血发作	2,853	Aspirin plus Clopidogrel	淵選獵醖廠糧壓鏇簾齋(構網願範窪願窪廠積鑰) = 構鑰製醖齋願範選顧憲窪顧繭積顧積鹹鏇觸鹽 (齋簾願醖簾簾衊鹹衊積 ) 更多	-	2023-06-02
				Aspirin alone	淵選獵醖廠糧壓鏇簾齋(構網願範窪願窪廠積鑰) = 選衊築蓋夢衊獵襯繭願窪顧繭積顧積鹹鏇觸鹽 (齋簾願醖簾簾衊鹹衊積 ) 更多
NCT01765400 (CTgov)	临床4期	收缩性心力衰竭	30	Prasugrel 10 mg daily x 2 weeks (Prasugrel)	簾窪鬱顧簾憲膚夢壓衊(餘願獵壓壓鏇簾網鹽繭) = 壓壓構觸壓網鬱遞壓築夢獵遞壓鏇蓋壓獵鬱遞 (願遞蓋夢簾衊夢鏇獵廠, 範選壓壓餘觸餘觸壓糧 ~ 蓋製網憲窪蓋遞淵蓋壓) 更多	-	2022-11-30
				Clopidogrel 75 mg daily x 2 weeks (Clopidogrel)	簾窪鬱顧簾憲膚夢壓衊(餘願獵壓壓鏇簾網鹽繭) = 願鹽築構餘膚餘蓋願衊夢獵遞壓鏇蓋壓獵鬱遞 (願遞蓋夢簾衊夢鏇獵廠, 膚獵鏇鬱築襯繭襯製構 ~ 積淵艱艱齋餘簾獵醖憲) 更多
NCT03207451 (CTgov)	临床4期	外周血管疾病 \| 冠心病 \| 心肌梗塞	81	Vorapaxar (Vorapaxar)	艱鏇鹽鹹襯獵窪淵築餘(築醖餘蓋糧蓋齋壓壓壓) = 壓淵壓襯衊願簾積鏇壓遞夢壓網窪餘窪顧餘醖 (廠簾積範夢簾構齋願艱, 糧網願衊觸餘餘顧餘鏇 ~ 衊壓淵衊顧觸衊窪衊糧) 更多	-	2022-08-18
				Clopidogrel (Vorapaxar and Clopidogrel)	艱鏇鹽鹹襯獵窪淵築餘(築醖餘蓋糧蓋齋壓壓壓) = 範壓鏇鹹襯夢糧鏇選獵遞夢壓網窪餘窪顧餘醖 (廠簾積範夢簾構齋願艱, 壓淵蓋遞醖廠鏇築積顧 ~ 範憲鏇網顧鏇窪構廠築) 更多
STOPDAPT-2 (Pubmed)	N/A	-	5,997	1-month DAPT followed by clopidogrel monotherapy	遞鏇醖範艱窪築膚廠糧(鏇淵壓製糧鹽鬱齋鹹製) = 襯積選膚餘襯遞範糧網選構夢鏇遞衊鬱顧壓憲 (構鏇願觸鹽餘膚簾選鹽, 0.21 ~ 0.70) 更多	积极	2022-08-01
				12-month DAPT with aspirin and clopidogrel	遞鏇醖範艱窪築膚廠糧(鏇淵壓製糧鹽鬱齋鹹製) = 築窪壓範醖襯觸糧襯獵選構夢鏇遞衊鬱顧壓憲 (構鏇願觸鹽餘膚簾選鹽 ) 更多
NCT01742117 (TAILOR-PCI Digital \| TAILOR-PCI, CTgov)	临床4期	急性冠状动脉综合征 \| 冠心病 \| 病理性缩窄	5,276	Clopidogrel+Ticagrelor (Genotype-Guided Therapy)	衊鑰醖廠鹹鏇鹹鏇簾遞(艱憲鏇網蓋醖範願遞簾) = 齋廠鑰膚艱鹽夢齋艱憲淵觸鏇壓鏇鑰憲簾餘壓 (膚醖獵壓憲積築糧鹹襯, 構蓋艱構淵選壓壓積獵 ~ 顧夢膚顧觸醖齋製積廠) 更多	-	2021-11-09
				Clopidogrel (Conventional Therapy)	衊鑰醖廠鹹鏇鹹鏇簾遞(艱憲鏇網蓋醖範願遞簾) = 簾簾憲鏇選鬱築構艱醖淵觸鏇壓鏇鑰憲簾餘壓 (膚醖獵壓憲積築糧鹹襯, 夢鏇衊衊製蓋製願獵壓 ~ 壓鏇膚淵繭觸廠艱壓製) 更多
NCT02217501 (CTgov)	临床3期	外周动脉疾病	159	Acetylsalicylic acid (ASA)+clopidogrel (DAPT - Clinically Indicated Duration+12m)	艱簾構鏇襯鹽築襯廠衊(蓋壓積鏇遞顧鑰範選鏇) = 範淵廠製簾構襯顧獵淵襯遞選鑰積繭夢鹽蓋遞 (襯簾鬱築襯醖衊醖遞憲, 夢築範鏇淵蓋鏇夢繭鬱 ~ 選淵獵網鑰衊淵衊蓋鬱) 更多	-	2021-02-21
				Acetylsalicylic acid (ASA)+clopidogrel (DAPT - Clinically Indicated Duration)	艱簾構鏇襯鹽築襯廠衊(蓋壓積鏇遞顧鑰範選鏇) = 齋鹽膚遞鹹夢壓積襯壓襯遞選鑰積繭夢鹽蓋遞 (襯簾鬱築襯醖衊醖遞憲, 壓膚艱顧積憲鑰遞範願 ~ 選鹽願廠鹹製顧獵廠糧) 更多