Ticagrelor

☝ 点击上方 一键预约 ☝   最新最热的医药健康新闻政策前言血栓性疾病作为"隐性健康杀手"，其高发病率、复发率、致残率及致死率的特征，极易引发心梗、中风及静脉栓塞等危重病症，在损害民众健康水平与生存质量的同时，也促进了相关物市场的发展。根据法伯全渠道数据显示，2023年我国总体医疗机构抗血栓药物销售额逾345亿元，主要在两类医院渠道销售，在既往十批国家带量采购（VBP）中累计有13个分子被纳入。补充说明*本分析所述的抗血栓药品市场范围（按照药物解剖学、治疗学及化学分类法ATC编码）：B01。*中国医疗机构：包括两个医院渠道（城市医院、县域医院）和两个基层医疗机构渠道（社区卫生中心、乡镇卫生院）。超345亿市场规模，主要在城市医院销售抗血栓药物是指能在一定程度上阻止血液凝固，实现血栓性疾病防治的药物。根据法伯全渠道数据显示，2023年我国总体医疗机构抗血栓药物销售额达345.4亿元，同比降低3.7%。分渠道来看，城市和县域医院是该类药物的主要销售渠道，且2021-2023年占比较为稳定，此外，近年来社区卫生中心的贡献占比逐渐提升，到2023年达6.0%，且同比增速高于其他渠道（图1）。图1-2021-2023年总体医疗机构抗血栓药销售额及渠道分布数据来源：法伯全渠道数据在抗血栓药市场中，主要包括口服类和注射类，前者如维生素K拮抗剂华法林，血小板凝聚抑制剂氯吡格雷、阿司匹林，和以利伐沙班、阿哌沙班、达比加群酯等为代表的新型口服抗血栓药物（表1），后者如肝素、阿替普酶等。法伯数据显示，2023年在总体医疗机构市场规模较大的类别是血小板凝聚抑制剂和肝素，销售额均破百亿。此外，注射类药物在两类医疗机构渠道占比更高，而口服类抗血栓药则在两类基层医疗机构渠道贡献更大，尤其是社区卫生中心，达88.7%（图2）。图2-抗血栓药主要类别及2023年总体医疗机构销售额、各渠道剂型分布数据来源：法伯全渠道数据2023年销售额排名前十的分子也大多属于上述两个占比较大的类别，合计占总体市场的71.2%。其中，氯吡格雷以超50亿市场规模位居榜首，阿司匹林和依诺肝素分别排名二、三。近年来增速显著的是吲哚布芬，2021-2023年复合增长达58.9%（图3）。图3-2023年总体医疗机构抗血栓药市场TOP10分子及增速数据来源：法伯全渠道数据TOP3企业均为外资，拜耳、赛诺菲领先企业格局方面，在抗血栓药物市场，近年来内资企业的总体市场份额较高，保持在60%以上，但2023年的增速不及外资（-4.6% V.S. -2.1%）（图4）。图4-2021-2023年抗血栓药市场内外资销售额占比及增速数据来源：法伯全渠道数据聚焦该领域2023年TOP10企业，根据法伯全渠道数据显示，前十企业销售额合计占比达53.9%，增速低于总体市场的增长水平。排名前三的均为外资企业，其中，拜耳以超12%市场份额位居榜首；赛诺菲紧随其后，且2021-2023年复合增长3.3%；排名第三的勃林格殷格翰2023年同比增长20.9%。内资企业中华东医药优势显著，不仅排名靠前，且近年来增速喜人（图5）。图5-2023年总体医疗机构抗血栓药市场销售额TOP10企业及增速数据来源：法伯全渠道数据从TOP10企业销售额的渠道分布来看，外资中勃林格殷格翰基本只在两类医院渠道销售相关抗血栓药物，尤其是县域医院贡献较高（41.2%）；社区卫生中心贡献较高的是信立泰和乐普医疗，分别达26.5%和16.5%；整体广阔市场三个渠道占比最高的是石药集团，合计达54.4%（图6）。图6-2023年总体医疗机构抗血栓药市场头部企业渠道销售额分布数据来源：法伯全渠道数据第十一批国采，4个品种初步满足纳入条件根据法伯整理，在已经执行的前十批集采中，抗血栓药市场共有13个分子被纳入，共覆盖5个细分类别，其中替格瑞洛、利伐沙班和达比加群酯有多个规格进入，原研产品中仅赛诺菲的氯吡格雷（商品名：波立维）中标。整体来看，注射剂型主要集中在第七批及之后被纳入。法伯数据显示，所有集采品种2023年在我国总体医疗机构抗血栓药市场合计占比达50.6%（图7）。图7-抗血栓药市场VBP品种及2023年在总体医疗机构销售额占比数据来源：法伯整理；法伯全渠道数据在集采的影响下，不少抗血栓药品的销售额被腰斩。以第四至七批品种为例，根据法伯全渠道数据显示，相较于2021年，2023年比伐芦定、磺达肝葵钠、替罗非班氯化钠、以及依替巴肽的销售额降幅均大于60%；2021年市场规模超36亿元的利伐沙班也在集采后销售额骤减至20亿左右（图8）。图8-部分抗血栓药VBP品种在总体医疗机构销售额变化23V.S.21数据来源：法伯全渠道数据目前，第十批集采已落地，而医保局已明确国家层面将在上半年开展第十一批药品集采。根据易联招采统计，截止到2025年5月9日，在未纳入国采的品种中已有127个满足原研+过评企业≥7家的竞争格局，即初步具备纳入国采的条件。根据法伯进一步整理，其中也包括4抗血栓药品种，分别为吲哚布芬口服常释剂、贝前列素口服常释剂、艾多沙班口服常释剂，以及西洛他唑口服常释剂。法伯数据显示，2023年上述集采候选品种在我国总体医疗机构抗血栓药市场占比达8.9%（图9）。图9-尚未纳入VBP且竞争格局数量≥7家的抗血栓药品种来源：易联招采网；法伯全渠道数据*注：1. 竞争格局符合条件不一定会纳入国采，一切信息以官方为准；2. 统计截止日期2025.5.9，人工统计，仅供参考。抗血栓药物VBP候选品种多渠道发展格局进一步关注抗血栓药VBP候选品种的销售额渠道分布，法伯数据显示，吲哚布芬口服常释剂主要分布在城市医院（69.1%）和县域医院（24.3%）；其余三个品种则基本由城市医院主导，尤其是艾多沙班口服常释剂，超90%销售额来自城市医院（图 10）。图10-抗血栓药第十一批集采候选品种2023年销售额渠道分布数据来源：法伯全渠道数据吲哚布芬独家引入品种，市场增速亮眼在上述四个集采候选品种中，吲哚布芬值得关注。该药物是一种血小板凝聚抑制剂，公开信息显示，吲哚布芬最早是由辉瑞研发的一种外消旋体混合物，此后由意大利Farmitalia Carlo Erba SpA首先研制成功并在意大利及欧盟多国上市。2010年，吲哚布芬由华东医药（西安）博华制药引入开发并独家上市（商品名：辛贝），后由上市公司杭州中美华东制药收购。据悉，传统的抗血小板药物具有固有的出血风险，而吲哚布芬是一种新型抗血小板药物，具有与阿司匹林相似的抗血小板聚集机制，且相较于阿司匹林和氯吡格雷，其副作用和不良反应较低，首选用于老年性外周血管病变药物保守治疗。图11-2021-2023年总体医疗机构吲哚布芬市场规模及增速数据来源：法伯全渠道数据作为中美华东的独家品种，吲哚布芬近年来增速亮眼，根据法伯全渠道数据显示，其在总体医疗机构的市场规模持续扩大，2021-2023年复合增长58.9%，到2023年销售额超19亿元（图11），进入TOP10分子榜单。根据易联招采数据显示，截止至2025年5月9日，吲哚布芬口服常释剂已有包括湖南九典制药、山东京卫制药、山东鲁盛制药等在内的十余家药企过评，初步满足纳入新一批国采的门槛。未来中美华东独占市场的局面何时能被打破，我们拭目以待。艾多沙班第一三共原研，以绝对优势主导市场艾多沙班由第一三共原研（商品名：里先安），是一款可直接作用于凝血因子Xa（FXa）的新型口服抗凝药物。原研药于2018年进入中国市场，并于上市仅两年后的2020年成功进入国家医保药品目录。2022年9月，先声药业拿下该品种国内首仿。根据法伯全渠道数据显示，2021-2023年艾多沙班口服常释剂的销售额复合大涨146.5%，到2023年达2.6亿元。目前，原研第一三共依旧占绝对优势，份额高达98.3%（图12）。据易联招采截至2025年5月9日数据统计，艾多沙班口服常释剂已形成“8+1”的企业竞争格局。图12-总体医疗机构艾多沙班口服常释剂市场规模及企业格局数据来源：法伯全渠道数据贝前列素获批上市多年，竞争格局“8+1”公开信息显示，贝前列素钠片的参比制剂为原研进口的贝前列素钠片（商品名：德纳），由东丽株式会社（Toray Industries, Inc.）研究开发，于1992年1月在日本批准上市。2003年08月，德纳在中国获批进口。2008年，北京泰德制药的贝前列素钠片（商品名：凯那）获批上市。法伯数据显示，近年来我国总体医疗机构贝前列素市场由泰德制药主导，到2023年市场份额达86.4%（图13）。目前，该品种过评企业已达9家，整体形成“8+1”的竞争格局，能否纳入新一批集采，值得关注。图13-总体医疗机构贝前列素口服常释剂市场规模及企业格局数据来源：法伯全渠道数据西洛他唑原研稳定占据超七成市场另一款集采候选抗血栓品种是西洛他唑口服常释剂，该药物由大冢制药原研（商品名：培达），是一种具有血管扩张作用的新型抗血小板抑制剂，于1988年在日本上市；1999年美国FDA批准西洛他唑作为治疗稳定性间歇性跛行的药物上市；2015年，西洛他唑进入中国市场。根据法伯全渠道数据显示，2021-2023年西洛他唑超过70%的市场持续由原研大冢制药占据，内资企业中占比最高的是华森制药（图14）。若该品种纳入新一批国采，未来其市场格局或将被重塑。图14-总体医疗机构西洛他唑口服常释剂市场规模及企业格局数据来源：法伯全渠道数据(来源：法伯科技）药闻康策新媒体矩阵微信公众号点击下方  一键关注  【免责声明】1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看

Real-World Analysis Shows Statistically Significant Reduction in Severe Bleeding and Transfusion Needs in CABG Patients on the Blood Thinner, Ticagrelor, with CytoSorbents Therapy PRINCETON, N.J., May 22, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announced today's presentation at EuroPCR 2025 of a new contemporary real-world data analysis highlighting the intraoperative use of its technology to significantly reduce the severity of bleeding in urgent coronary artery bypass grafting (CABG) patients on the blood thinner, ticagrelor (Brilinta®, AstraZeneca) who had not completed the recommended drug washout period. Presented by Professor Robert F. Storey, Academic Director and Honorary Consultant Interventional Cardiologist for the Cardiology and Cardiothoracic Surgery Directorate, Sheffield Teaching Hospitals NHS Foundation Trust (U.K.) and co-Principal Investigator of the international STAR (Safe and Timely Antithrombotic Removal) Registry, the findings were shared during the session titled, "Ticagrelor Removal to Reduce Bleeding after Urgent CABG: Comparative Analysis of Real-world Data." Key Study Insights The analysis compared two patient populations undergoing urgent CABG surgery on ticagrelor before completing the guideline-recommended 3-day washout period. The device group consisted of an updated cohort of 150 patients from the STAR Registry who were all operated on with the use of CytoSorbents' device, while the control group comprised 644 similar patients from a recent publication who were all operated on without the use of the device. The results showed statistically significant and clinically meaningful reductions in severe bleeding complications with device use, including: Reductions in the rate of BARC-4 (validated measure of severe bleeding after CABG) severe bleeding: 10.7% vs. 33% control, p<0.001) Reduction in large transfusion events (≥5 units of blood): 6% vs. 27% control, p<0.001) Reduction in the need for re-operations to control bleeding (4% vs. 9.6% control, p=0.02) Importantly, no device-related adverse events or device deficiencies were reported by participating centers, underscoring the device's ease-of-use and safety in real-world clinical practice. Professor Storey concluded his presentation, stating, "A device that removes free ticagrelor from blood and is easily integrated into the CPB circuit appears safe and effective in mitigating excess bleeding in ticagrelor-treated patients undergoing CABG surgery before completing the 3-day washout," Dr. Efthymios Deliargyris, MD, Chief Medical Officer of CytoSorbents stated, "Today's presentation in Paris is a vital addition to the growing evidence base of blood thinner removal with our technology. The data show that device use is simple and safe but more importantly establish that patients on ticagrelor undergoing urgent CABG at heart centers using our device as part of their standard care, experience significantly lower bleeding complications compared to patients operated without the device. We are thrilled with these new data that support routine use of our device as an effective solution to address the major unmet medical need of patients on blood thinners like ticagrelor requiring urgent cardiac surgery." Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, noted, "We are proud to see the updated STAR Registry data presented alongside one of the largest and most recent meta-analyses of non-device treated CABG patients on Brilinta®. With growing adoption of our technology by cardiac surgery centers worldwide, this important real-world evidence from our registry reinforces the clinical value of our therapy that we hope to bring to all countries and patients around the world." Additional Presentation and Study Details In today's oral presentation titled "Ticagrelor Removal to Reduce Bleeding after Urgent CABG: Comparative Analysis of Real-world Data" at the 2025 EuroPCR conference in Paris, France, the world-leading course in interventional cardiovascular medicine with over 12,000 attendees, Professor Robert Storey presented the results of a comparative analysis in patients on ticagrelor undergoing CABG surgery before completing the recommended three-day washout period with or without the intraoperative use of the CytoSorb® device. Device group: 150 patients from the STAR Registry that is actively enrolling at 28 sites in 6 European countries (Germany, United Kingdom, Austria, Belgium, Sweden and Switzerland) who were all operated with the use of the device Control group: 644 similar patients from the recently published individual patient data meta-analysis in the peer-reviewed journal, European Journal of Cardiothoracic Surgery, who were all operated without the use of the device Key Data Highlights: There were no significant differences in baseline characteristics between the two groups (device vs. control), including age (65 vs. 67 years), acute coronary syndrome presentation (90.5% vs. 89.1%) and overall perioperative risk according to Euroscore II (2.5 vs. 2.8%). Most importantly, the two groups had near identical distribution of the time of CABG relative to the last dose of ticagrelor, a very strong factor determining bleeding risk (within 1 day of last dose 41.4% vs. 41.9%, more than 1 but less than 3 days 58.6% vs. 58.1%). The primary outcome of the analysis was incidence of the composite of severe bleeding according to the Bleeding Academic Research Consortium (BARC)-4 definition that includes: intracranial bleeding; re-operation for bleeding; transfusion ≥ 5 units of packed red blood cells (pRBC) and 24-hour chest tube drainage of ≥ 2 liters. Additional individual outcomes included the rate of large transfusion events (≥ 5 units of pRBC) and the rate of re-operation for bleeding. BARC-4 bleeding was significantly reduced with the use of the device (10.7% vs. 33% control, p<0.001) as were large transfusion events (6% vs. 27% control, p<0.001) and re-operations for bleeding (4% vs. 9.6% control, p=0.02). Mortality at 30 days was not different between the 2 groups (4.4% vs. 6.5%, p=ns). Importantly, there were no device deficiencies or device-related adverse events reported by participating centers, underscoring the ease and safety of the use of the device in the real world. About CytoSorbents Corporation (NASDAQ: CTSO) CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with more than a quarter million devices used cumulatively to date. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. CytoSorb is not yet approved or cleared in the United States. In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. In September 2024, the Company submitted a De Novo Request to the U.S. FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. On April 25, 2025, the FDA issued a denial letter regarding the Company's De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. The Company believes these items can be most effectively and expeditiously resolved through the formal appeal process, which facilitates engagement with FDA senior leadership and our external surgical experts. Given the expedited timelines associated with the appeal process, the Company believes that a final regulatory decision can be achieved in 2025. In November 2024, the Company received its MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada. CytoSorbents' DrugSorb-ATR application with Health Canada remains under advanced review. While Health Canada has indicated that application reviews are currently delayed beyond their target Market Authorization Times (MAT) due to a backlog, they have reaffirmed their commitment to issuing a decision at the earliest opportunity. The Company remains confident in receiving a final regulatory decision in 2025. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company's website at or follow us on Facebook and X. Forward-Looking Statements This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our restructuring of our direct sales team and strategy in Germany, our ability to resolve deficiencies in the FDA denial letter through a successfully appeal the FDA's decision, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws. Please Click to Follow Us on Facebook and X U.S. Company Contact: Peter J. Mariani, Chief Financial Officer 305 College Road East Princeton, NJ 08540 [email protected] Investor Relations Contact: Aman Patel, CFA & Adanna G. Alexander, PhD ICR Healthcare [email protected] SOURCE Cytosorbents Corp WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED