Onyx ONE Clear Study: A Single Arm Study with Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients who are considered One-Month Clear - Onyx ONE Clear Study: A Single Arm Study with Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients who are considered One-Month Clear

开始日期2018-12-10

申办/合作机构

Medtronic Japan Co. Ltd.

NCT03316833

/ SuspendedN/A

The ROLEX Registry (Revascularization Of LEft Main With Resolute onyX) A Multicenter Prospective Registry of the Onyx Resolute Stent for the Treatment of Unprotected Left Main Coronary Artery Disease.

The primary objective of this study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent Resolute Onyx in the treatment of unprotected left main coronary artery disease (ULMCAD), both isolated or in association with two- or three-vessel coronary artery disease.

开始日期2017-11-01

申办/合作机构

University of Padua

NCT02508714

/ Unknown statusN/AIIT

Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX): A Randomized Trial With Stent Evaluation in All-comers IV (TWENTE IV)

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with bioresorbable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.

开始日期2016-10-07

申办/合作机构-

100 项与佐他莫司相关的临床结果

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100 项与佐他莫司相关的转化医学

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100 项与佐他莫司相关的专利（医药）

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项与佐他莫司相关的文献（医药）

2025-04-01·LANCET

Outcomes after fractional flow reserve-guided percutaneous coronary intervention versus coronary artery bypass grafting (FAME 3): 5-year follow-up of a multicentre, open-label, randomised trial

Article

作者: Kharbanda, Rajesh ; Miner, Steven E S ; MacCarthy, Philip ; Desai, Manisha ; Al-Attar, Nawwar ; Woo, Y Joseph ; Piroth, Zsolt ; Witt, Nils ; Jagic, Nikola ; Wendler, Olaf ; Tonino, Pim A L ; Aminian, Adel ; Yeung, Alan C ; Engstrøm, Thomas ; Zimmermann, Frederik M ; Ding, Victoria Y ; Takahashi, Kuniaki ; Mavromatis, Kreton ; Davidavičius, Giedrius ; Dambrink, Jan-Henk E ; Hlatky, Mark A ; Pijls, Nico H J ; Szekely, Laszlo ; Kobayashi, Yuhei ; Reardon, Michael J ; Mansour, Samer ; De Bruyne, Bernard ; Oldroyd, Keith G ; Mahaffey, Kenneth W ; Sarma, Jaydeep ; Östlund-Papadogeorgos, Nikolaos ; Otsuki, Hisao ; Kalinauskas, Gintaras ; van Straten, Albert H M ; Casselman, Filip ; Kala, Petr ; Angerås, Oskar ; Christiansen, Evald H ; Fearon, William F

BACKGROUND:

Long-term outcomes following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) might be changing because of improved techniques and better medical therapy. This final prespecified analysis of the Fractional Flow Reserve (FFR) versus Angiography for Multivessel Evaluation (FAME) 3 trial aimed to reassess their comparative effectiveness at 5 years.

METHODS:

FAME 3 was a multicentre, randomised trial comparing FFR-guided PCI using current-generation zotarolimus-eluting stents versus CABG in patients with three-vessel coronary artery disease not involving the left main coronary artery. 48 hospitals in Europe, USA and Canada, Australia, and Asia participated in the trial. Patients (aged ≥21 years with no cardiogenic shock, no recent ST segment elevation myocardial infarction, no severe left ventricular dysfunction, and no previous CABG) were randomly assigned to either PCI or CABG using a web-based system. At 1 year, FFR-guided PCI did not meet the prespecified threshold for non-inferiority for the outcome of death, stroke, myocardial infarction, or repeat revascularisation versus CABG. The primary endpoint for this intention-to-treat analysis was the 5-year incidence of the prespecified composite outcome of death, stroke, or myocardial infarction. The trial was registered at ClinicalTrials.gov, NCT02100722, and is completed; this is the final report.

FINDINGS:

Between Aug 25, 2014 and Nov 28, 2019, 757 of 1500 participants were assigned to PCI and 743 to CABG. 5-year follow-up was achieved in 724 (96%) patients assigned to PCI and 696 (94%) assigned to CABG. At 5 years, there was no significant difference in the composite of death, stroke, or myocardial infarction between the two groups, with 119 (16%) events in the PCI group and 101 (14%) in the CABG group (hazard ratio 1·16 [95% CI 0·89-1·52]; p=0·27). There were no differences in the rates of death (53 [7%] vs 51 [7%]; 0·99 [0·67-1·46]) or stroke (14 [2%] vs 21 [3%], 0·65 [0·33-1·28]), but myocardial infarction was higher in the PCI group than in the CABG group (60 [8%] vs 38 [5%], 1·57 [1·04-2·36]), as was repeat revascularisation (112 [16%] vs 55 [8%], 2·02 [1·46-2·79]).

INTERPRETATION:

At the 5-year follow-up, there was no significant difference in a composite outcome of death, stroke, or myocardial infarction after FFR-guided PCI versus CABG, although myocardial infarction and repeat revascularisation were higher with PCI. These results provide contemporary evidence to allow improved shared decision making between physicians and patients.

FUNDING:

Medtronic and Abbott Vascular.

2025-03-01·International Journal of Angiology

A Snapshot on Clinical Trials on Zotarolimus DES: A Repurposing Drug against Myocardial Infarction

Review

作者: Lembhe, Shweta K. ; Undale, Vaishali R. ; Satone, Shital D. ; Hase, Pratiksha

Abstract:

Myocardial infarction is the permanent death (necrosis) of heart muscle caused by a lack of oxygen for an extended period of time (ischemia). Since the very first percutaneous transluminal coronary angioplasty was done 40 years ago, the science of interventional cardiology has advanced dramatically. The above progression began with a balloon catheter attached to a fixed wire, advancing to bare-metal stents, first-generation drug-eluting stents (DES), second- and third-generation biodegradable polymer-based DES. Ultimately, bioabsorbable stents are still in development. Zotarolimus is a new pharmacologic therapy with a similar reprint address; for example, the antirestenosis agent sirolimus has recently been investigated as part of a stent platform combined with a biomimetic phosphorylcholine and BioLINX polymer for its biological activity, as well as its usefulness as an antiproliferative agent. Several clinical trials have been conducted to assess the safety and efficacy of the zotarolimus drug-eluting stent (Z-DES). Medtronic Medical Devices, a global leader in medical technology (United States), and Abbot Global Health Care and Research began clinical trials on the Z-DES in 2002 and will continue through 2021 (INDIA). Endeavor (E-Zes), Resolute (R-Zes), Resolute Integrity (I-Zes), and Resolute Onyx are the different forms of Z-DES that Medtronic has tested in clinical trials. In comparison to other DES, Z-DES was found to be safe in these clinical trials done across multiple nations and in a diverse demographic. This review helps understand the overall clinical trial of Z-DES.

2025-03-01·JACC. Advances

Safety and Efficacy of Different Stent Strategies in Percutaneous Coronary Intervention

Article

作者: Polam, Aravind Reddy ; Ullah, Waqas ; Alraies, M Chadi ; Steyerberg, Ewout W ; Alonso, Mileydis ; Ullah, Irfan ; Zahid, Salman ; Kumar, Arnav ; Zaidi, Syeda Ramsha ; Sandhyavenu, Harigopal ; Khan, Muhammad Atif ; Yasmin, Farah ; Murtaza, Mohammad ; Rade, Jeffrey J

BACKGROUND:

The utility of polymer-permanent, polymer-absorbable, and polymer-free drug-eluting stents (DES) in the context of different eluting drugs in patients undergoing percutaneous coronary intervention (PCI) remains controversial.

OBJECTIVES:

The purpose of this study was to compare the efficacy of different DES strategies in post-PCI patients.

METHODS:

Digital databases were searched to select all randomized control trials. Different combinations of DES were directly compared with permanent-polymer sirolimus-eluting stents. The primary outcome was major adverse cardiovascular events; a composite of cardiovascular mortality, myocardial infarction (MI), and target vessel revascularization. A network meta-analysis was performed to determine the net relative risk (RR) and its 95% CI.

RESULTS:

A total of 314 randomized control trials comprising 345,749 patients with coronary artery disease undergoing PCI were included. Compared with polymer-permanent sirolimus-eluting stent, polymer-free titanium-nitride-oxide (RR: 0.68; 95% CI: 0.53-0.87), polymer-permanent everolimus (RR: 0.89; 95% CI: 0.82-0.96), and zotarolimus stents (RR: 0.89; 95% CI: 0.79-0.99) had a lower risk of major adverse cardiovascular events at 5 years. Polymer-free titanium-nitride-oxide stents also had a significantly lower incidence of stent thrombosis (RR: 0.28; 95% CI: 0.13-0.59) and MI (RR: 0.41; 95% CI: 0.27-0.62) at 1 year. Bare metal stents had a significantly higher 1-year risk of MI (RR: 1.52; 95% CI: 1.25-1.86), and need for target vessel revascularization (RR: 2.26; 95% CI: 1.93-2.64).

CONCLUSIONS:

In comparison with polymer-permanent sirolimus, the newer stents including polymer-free titanium-nitride-oxide, polymer-permanent everolimus, and zotarolimus stents significantly reduce the risk of long-term ischemic events.

项与佐他莫司相关的新闻（医药）

2025-05-10

·循因缉药

10x Genomics CEO 炮轰美国联邦政府

全球视野，深度视角各位亲爱的股东，大家早上好中午好晚上好！星球首发，加入方法如下。小编在这里！星球在这里！2025年5月8日，开完财报会的10x Genomics CEO Serge Saxonov没有忍住在Linkedin上发了个帖子炮轰美国联邦政府。他说，通常情况下，我们 10x 不会对当前事件、政策或社会问题发表评论。但是...我们确实正处于一个黄金时代的门槛上，但我们却在本应踩下油门的时候，却在自我设限。以下是帖子原文和翻译。原文：As a general rule, at 10x, we don’t comment on current events, policies or social issues. Our mission is to accelerate the mastery of biology to advance human health. We take the primacy of the mission very seriously and believe it’s critical not to be distracted by other imperatives or issues. Sometimes the centrality of our mission works the other way. Here is how I finished our prepared remarks on our earnings call earlier today - As we wrap up, I’d like to end on a personal note. I wasn’t born in this country, but I love America. In fact, I love America, especially because I didn’t grow up here. In no other country in the world could I have dreamed of the opportunities that came my way, of being given the chance to make a dent in the universe. There is no other place we could have started 10x. No other place has such a welcoming culture of boundless innovation and positive ambition. No other place has this concentration of insanely talented people, incredibly sophisticated capital markets and the remarkable ecosystem across academia and industry supporting scientific innovation. We are living in a time of incredible progress in life sciences. The mysteries of biology are right in front of us, ready to be unlocked. Scientific progress in the coming years has the potential to bring cures to many, many diseases and completely transform the human condition. We are indeed on the threshold of a golden age, but we are shooting ourselves in the foot, right when we should be pressing on the accelerator.Recent U.S. federal actions are massively hampering the ability of our universities and our government agencies to pursue their goals of advancing science. I’d be the first to tell you that many of these institutions are in need of reform; that the current system often suffers from too much process, too much politicization and too much bureaucracy; that younger scientists and unusual ideas face more challenges than they did in the past. But overall, these institutions are incredibly valuable and productive. Our university system is the global engine of scientific discovery and the envy of the world. The NIH is the foundational jewel of biomedical progress. We should certainly endeavor to reform and make these organizations ever more effective. But recent federal actions are not doing that. Instead, they are severely undermining these enterprises and run the risk of fundamentally dismantling their ability to support research. And that would be a tragedy.America is the greatest country in the history of the world, the beacon of hope for all of mankind. My exhortation to those who are listening, let’s not squander our great inheritance. Let’s work to defend and improve our greatest institutions.Overall, despite the current turbulence, I remain optimistic. The progress of science and technology just holds so much promise to improve the human condition and create massive value. As always, we are deeply committed to helping that progress and to always be great partners with our customers. We are focused on disciplined execution as we navigate the current environment while always keeping our eye on the long-term mission.翻译（by Kimi，微调）通常情况下，我们 10x 不会对当前事件、政策或社会问题发表评论。我们的使命是加速掌握生物学以推进人类健康。我们非常重视这一使命的首要性，并相信至关重要的是不要被其他任务或问题分散注意力。但有时，我们使命的核心性会起到相反的作用。以下是我今天早些时候在财报电话会议准备发言的结尾部分——在结束时，我想以个人的名义说几句话。我并非出生在这个国家，但我热爱美国。事实上，我正是因为我没有在这里长大，才更热爱美国。世界上没有其他国家能像美国这样让我获得摆在我面前的梦想的机会，能让我有机会在宇宙中留下印记。10x 只能在美国创立。没有其他地方拥有如此欢迎创新和积极进取的文化。没有其他地方拥有如此集中的人才、复杂成熟的资本市场以及支持科学创新的卓越生态系统。我们生活在一个生命科学取得巨大进步的时代。生物学的奥秘就在我们眼前，等待着被解锁。未来几年的科学进步有潜力为许多疾病带来治愈方法，并彻底改变人类的状况。我们确实正处于一个黄金时代的门槛上，但我们却在本应踩下油门的时候，却在自我设限。最近美国联邦政府的一些行动极大地阻碍了我们的大学和政府机构实现推进科学的目标。我首先要告诉大家的是，这些机构中的许多确实需要改革；当前的体系常常存在过多的流程、过度的政治化和过多的官僚主义；年轻科学家和不寻常的想法面临着比过去更多的挑战。但总体而言，这些机构是极其宝贵且富有成效的。我们的大学体系是全球科学发现的引擎，令世界羡慕。NIH（美国国立卫生研究院）是生物医学进步的基石。我们当然应该努力改革并使这些组织更加有效。但最近的联邦行动并没有做到这一点。相反，它们严重削弱了这些机构，并有可能从根本上破坏它们支持研究的能力。那将是一场悲剧。美国是世界历史上最伟大的国家，是全人类的希望灯塔。我对那些正在聆听的人的呼吁是：让我们不要浪费我们伟大的遗产。让我们努力捍卫和改进我们最伟大的机构。总体而言，尽管当前形势动荡，我仍然保持乐观。科学和技术的进步有着如此巨大的潜力，可以改善人类的状况并创造巨大的价值。一如既往，我们致力于推动这一进步，并始终成为我们客户的优秀合作伙伴。我们在应对当前环境时保持纪律性的执行力，同时始终着眼于长期使命。相关资料：Serge Saxonov出生于1976年12月，父母是塔吉克斯坦大学的教授。1999年 Saxonov毕业于哈佛大学应用数学专业，2006年获得斯坦福大学博士学位。2006年他成为23andMe的首位员工，2010年加入QuantaLife（后被Bio-Rad收购）。2012年，Saxonov创立10x Genomics并担任CEO。END小编在这里！星球在这里！各位股东看了么？赞了么？转发了么？别忘了点赞。谢谢！所有内容均不作为投资建议，信息均来自公开资料，星球更新更快。近期文章：StandardBioTools 2025Q1：不是，你们多看看未来嘛HLI选定的胰腺癌早筛产品是个啥？Twist 2025Q2：小子看好了，我只教一次WGS+蛋白组？这个真没有但是可以有圣湘2024财报：老板，我想跟你干

财报

2025-05-01

·药明康德

深耕「创新海岸」，药明康德圣地亚哥基地的生态圈回馈 | Bilingual

在生物医药领域，创新如海岸线上翻涌不息的浪潮一般，奔腾向前。坐落在美国加利福尼亚州南部的圣地亚哥，正是行业浪潮的引领地之一，是当之无愧的“生物医药创新海岸（Biotech Beach）”。这里的产业生态圈汇聚着超过1000家生物医药技术公司，以及80多所相关科研机构和高等学府。学术和产业创新的成果在这里碰撞出火花，衍生出一款又一款新兴疗法，造福人类健康。深耕这片创新海岸多年，药明康德圣地亚哥基地不仅为当地的医药健康产业创新作出了积极贡献，也以更多实际行动回馈圣地亚哥生态圈，共同打造一个更为绿色和健康的社区。▲药明康德圣地亚哥基地员工及其亲友参加“世界地球日”公益活动在刚刚过去的周末，药明康德圣地亚哥基地的员工和亲友一起，于圣地亚哥泻湖（San Dieguito Lagoon）共同组织公益活动，清理塑料、玻璃瓶等人造垃圾。该活动也广受当地居民关注，多人携子女一道前来参加。正如本活动的合作伙伴、非营利组织“我想要一个干净的圣地亚哥”（ILACSD）所言，这些大大小小的垃圾如果不及时清理，可能会通过溪流和雨水渠流到海边，破坏当地生物的生存环境。与此同时，药明康德圣地亚哥的员工也在基地自发组织电子设备等回收活动，进一步兑现我们的全球绿色承诺。作为负责任的企业公民，不管是守护生命健康，帮助全球合作伙伴加速研发、为患者带来好药新药，还是守护我们的家园，与社群共生共长，都是我们为自身所扎根的创新热土作出的积极贡献。▲药明康德美国圣地亚哥基地的合全药业（上）和辉源生物（下）园区事实上，早在成立之初，药明康德就与圣地亚哥结下了不解之缘——当地蓬勃发展的生物技术产业，与药明康德“一体化、端到端”的新药研发和生产服务平台有着天生的契合。“药明康德是一个值得信赖的合作伙伴，我们已经合作了20年。”圣地亚哥的行业老兵John Hood博士曾在采访中说道。他在当地先后任职于多家明星生物医药公司，2021年，其创立的Impact Biomedicines被Celgene公司以70亿美元收购。他随后创立了Endeavor Biomedicines，并于2024年拿到1.32亿美元的C轮融资。▲John Hood博士参加药明康德圣地亚哥园区扩建庆典为了更好地赋能北美乃至全球的客户，药明康德圣地亚哥研发基地于2016年投入运营，为小分子API和制剂提供从工艺研发到生产的一体化服务，以及以生物学为中心的一系列临床前药物研发服务。“药明康德团队一直是一个稳定、高效且富有成效的合作伙伴，在我们努力为癌症患者创造有意义新疗法的过程中，我们深深感谢他们的支持。”原Mirati Therapeutics高级副总裁、药物发现负责人Matt Marx博士曾多次感谢药明康德过去10年间对KRAS抑制剂研发的支持。2022年，美国FDA批准该公司的KRAS抑制剂上市。2024年，这家在圣地亚哥起步的公司以48亿美元被百时美施贵宝收购。这一切只是药明康德做对的事、为社区和产业贡献的一个缩影。今后的日子里，我们将继续与社会各界一道，践行绿色运营的道路，并持续助力全球医药健康产业创新、为全球病患带去希望。我们深信，只有在可持续发展的环境中，科学创新才能生生不息，人类未来的生命质量才能获得持久的提升。Known as the "Biotech Beach," San Diego, located in the United States, is home to a thriving life sciences ecosystem, with over 1,000 biotech companies and 80 research institutes fueling breakthroughs in human health. Since its foundation, WuXi AppTec has been proud to contribute to this vibrant innovation hub through integrated API development and manufacturing, drug product development and manufacturing, and biology-focused preclinical drug discovery services.Our long-standing collaborations with local industry leaders—including support for KRAS inhibitor research that led to FDA approval—reflect our deep commitment to advancing science from San Diego to the world.Beyond our work in the lab, we are equally dedicated to giving back. This past weekend, employees and their families organized a volunteer clean-up at San Dieguito Lagoon, collecting waste to protect local ecosystems. Internally, our team also led a site-wide recycling initiative, reinforcing our global commitment to sustainable operations.At WuXi AppTec, we believe that scientific innovation and environmental stewardship go hand in hand—laying the foundation for a healthier future for both people and the planet.免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

并购

2025-03-24

·上海和誉生物医药科技有限公司

和誉医药口服PD-L1小分子抑制剂ABSK043与艾力斯医药KRAS-G12C抑制剂枸橼酸戈来雷塞片达成联合用药临床研究合作协议

2025年3月24日，上海和誉生物医药科技有限公司（以下简称“和誉医药”，港交所代码：02256）宣布，已与上海艾力斯医药科技股份有限公司达成协议，（以下简称“艾力斯”，上交所代码：688578）其在研的口服小分子PD-L1抑制剂ABSK043即将与KRAS-G12C抑制剂戈来雷塞片开展联合用药治疗KRASG12C突变的非小细胞肺癌的临床研究。此前，ABSK043还与艾力斯自主研发的甲磺酸伏美替尼片进行联合用药，用于治疗晚期非小细胞肺癌，并于2024年11月完成首例患者给药。 ABSK043治疗晚期实体瘤患者的最新1期研究结果展示出ABSK043具有良好的安全性和抗肿瘤活性，PD-L1高表达组、EGFR突变组和KRAS突变组的有效率更高。关于ABSK043 ABSK043为一款全新的具备优异活性及高度选择性的口服小分子PD-L1抑制剂。癌细胞可以利用PD-1及其配体PD-L1这些免疫检查点来逃避免疫监管和清除，抑制或限制T细胞应答。ABSK043可与PD-L1受体特异性结合并诱导其从细胞表面内吞，有效地抑制PD-1/PD-L1的相互作用，解除PD-L1介导的T细胞活化抑制作用。ABSK043在多个临床前模型中展现出与已获批PD-L1抗体相当的抗肿瘤功效。截止目前，全球已有多款PD-1/PD-L1抗体药物获批上市，但并无PD-1/PD-L1小分子药物获批。ABSK043目前正在澳大利亚和中国开展针对晚期实体肿瘤的I期临床试验。关于戈来雷塞枸橼酸戈来雷塞片是一款KRAS G12C抑制剂，目前已在中国、美国及欧洲多国启动多项针对晚期实体瘤患者的临床试验，包括与SHP2抑制剂AST-24082联用治疗非小细胞肺癌，以及单药治疗胰腺癌的注册性临床研究等。其中，胰腺癌适应症在美国获得孤儿药认定，并在中国获得突破性治疗药物认定。关于艾力斯上海艾力斯医药科技股份有限公司成立于2004年3月，是一家以全球医药市场需求为导向，专注于肿瘤治疗领域，集新药研发、生产和商业化为一体的创新型制药企业。艾力斯医药以科技关爱生命为发展理念，以开发首创药物和同类最佳药物为首要目标。历经20年坚持不懈的努力，艾力斯已经成功自主研发，获批两款创新药，具备持续创制具有自主产权的疗效确切、市场最优的抗肿瘤新药之综合实力。2020年12月2日，上海艾力斯医药科技股份有限公司正式在上海证券交易所科创板挂牌上市（股票代码：688578）。 Abbisko Therapeutics and Allist Pharmaceuticals Enter into a Cooperation Agreement to Explore ABSK043 in Combination Glecirasib for the Treatment of NSCLC 24 March 2025, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) today announced it has entered into a cooperation agreement with Shanghai Allist Pharmaceuticals Co., Ltd. ("Allist" hereafter, SSE code: 688578) to explore the combination of Abbisko’s investigational oral PD-L1 inhibitor, ABSK043, with Allist’s KRAS-G12C inhibitor, glecirasib, for the treatment of NSCLC patients with KRAS-G12C mutation. The parties previously disclosed a separate collaboration to explore the combination of ABSK043 and furmonertinib (IVESA), developed by Allist, for the treatment of advanced non-small cell lung cancer. First-patient dosing for this study occurred in December 2024. Results from an updated Phase 1 study showed that ABSK043 demonstrated a favorable safety profile and impressive anti-tumor activity as a single agent, with response rates higher in the subset of patients with high PD-L1 expression, and EGFR or KRAS mutations. About ABSK043 ABSK043 is a novel, orally bioavailable, highly selective small molecule PD-L1 inhibitor wholly-owned by Abbisko Therapeutics. Tumor cells can exploit immune checkpoints such as PD-1 and its ligand PD-L1 to evade immune detection and clearance, thereby suppressing or limiting T-cell responses. ABSK043 selectively binds to the PD-L1 receptor and induces its internalization from the cell surface, effectively inhibiting the PD-1/PD-L1 interaction and alleviating PD-L1-mediated suppression of T-cell activation. In preclinical models, ABSK043 has demonstrated anti-tumor efficacy comparable to approved PD-L1 antibodies. While several PD-1/PD-L1 monoclonal antibodies have been approved worldwide, there are currently no approved orally bioavailable PD-1/PD-L1 small molecule drugs. ABSK043 is currently being explored in an ongoing Phase I clinical trial for advanced solid tumors in Australia and China. About Glecirasib Glecirasib (AST-24081) is a KRAS G12C inhibitor. A number of clinical trials are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include combination therapy trials with SHP2 inhibitor AST-24082 in NSCLC and monotherapy trials in pancreatic cancer. Additionally, the pancreatic cancer indication has received orphan drug designation in the United States and breakthrough therapy designation in China. About Allist Shanghai Allist Pharmaceuticals Co., Ltd, founded in March, 2004, is an innovative pharmaceutical company with a fully integrated system for research and development, manufacturing, and commercialization of novel oncology drugs with a purpose to meet with medical needs across the globe. In accordance with its development concept“Advancing Long Life with Innovation of Science and Technology”, Allist is dedicated to self-develop First-in-class and Best-in-class drug candidates. After 20 years of endeavor, Allist has successfully developed and received approvals of two innovative drugs by its own. On December 2nd, 2020, Shanghai Allist Pharmaceuticals Co., Ltd. was officially listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange (stock number: 688578). 关于和誉和誉医药（香港联交所代码：02256）成立于2016年，是一家立足中国，着眼全球的创新药研发公司。公司的创始人和管理团队拥有多年顶尖跨国药企的研发和管理经验，并参与了多个临床及上市新药的研发。和誉医药专注于肿瘤新药研发，以小分子肿瘤精准治疗和小分子肿瘤免疫治疗药物为核心，着眼病患及医药市场的需求，秉承国际新药开发的理念和标准，致力于开发新颖及高潜力药物靶点的潜在first-in-class或best-in-class创新药物，用于改善中国及全球病人的生活质量。自成立以来，和誉医药已经建立了丰富的创新产品管线，涵盖肿瘤精准治疗领域以及肿瘤免疫治疗领域。更多信息，欢迎访问 www.abbisko.com。

临床1期孤儿药突破性疗法上市批准AACR会议

100 项与佐他莫司相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06669	佐他莫司	L04AA	-

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
冠状动脉再狭窄	加拿大	AbbVie AS	2008-05-16

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
勃起功能障碍	临床1期	美国	Medtronic Plc	-
血管再狭窄	临床1期	美国	AbbVie AS	-
纤维化	临床前	中国	中南大学	2024-12-01
纤维化	临床前	中国	Medchemexpress LLC	2024-12-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00660478 (SORT OUT III, Pubmed \| JACC Cardiovasc Interv)	临床3期	冠状动脉再狭窄	2,342	Zotarolimus-eluting stent (ZES)	簾遞觸蓋蓋願夢鹽簾壓(壓夢餘夢積構鹹築齋鹹) = 鏇廠艱窪淵膚糧廠夢壓網糧鹹製襯鹹積顧廠鬱 (夢鬱艱夢窪繭獵積廠衊 ) 更多	-	2012-08-01
NCT00660478 (SORT OUT III, Pubmed \| JACC Cardiovasc Interv)	临床3期	冠状动脉再狭窄	2,342	Sirolimus-eluting stent (SES)	簾遞觸蓋蓋願夢鹽簾壓(壓夢餘夢積構鹹築齋鹹) = 選顧膚積築糧願鬱齋範網糧鹹製襯鹹積顧廠鬱 (夢鬱艱夢窪繭獵積廠衊 ) 更多	-	2012-08-01
E-Five Registry (Pubmed \| Catheter Cardiovasc Interv)	N/A	-	-	Endeavor zotarolimus-eluting stent	窪壓憲鏇願簾網鏇窪夢(衊網膚餘膚淵積獵壓衊) = 獵簾憲鬱範膚艱構觸糧蓋廠遞廠淵醖範襯憲鑰 (憲蓋醖膚顧鹹製構襯顧 ) 更多	-	2011-06-01
Pubmed \| JACC Cardiovasc Interv	N/A	冠心病	401	Zotarolimus	簾廠鹽衊範壓蓋壓簾窪(壓鏇衊襯觸襯窪構製醖) = 鏇積窪壓製糧觸醖製遞鹹壓醖獵獵遞繭鏇衊築 (鏇蓋網顧壓觸廠構簾衊 ) 更多	不佳	2008-10-01
Pubmed \| JACC Cardiovasc Interv	N/A	冠心病	401	Zotarolimus	簾廠鹽衊範壓蓋壓簾窪(壓鏇衊襯觸襯窪構製醖) = 鑰鑰醖鹽襯膚製鹽築齋鹹壓醖獵獵遞繭鏇衊築 (鏇蓋網顧壓觸廠構簾衊 ) 更多	不佳	2008-10-01
E-Five Registry (Pubmed \| Am J Cardiol)	N/A	-	-	Endeavor Zotarolimus-Eluting Stent	範夢鏇夢淵鹽蓋顧鏇鏇(壓醖構齋壓觸衊範獵衊) = 製齋憲鏇鹹選遞蓋網壓夢鹽網選積衊壓選繭繭 (網齋餘醖積繭範構鬱範 )	积极	2007-10-01