This is a phase 1, dose-escalation, and multidose study, aiming to investigate the tolerability, safety and pharmacokinetics of Anfibatate in healthy subjects. The study is divided into 2 intravenous single groups and 3 continuous administration groups. The dose of Anfibatate from 5 IU/60kg to 7 IU/60kg in intravenous single groups. The dose of Anfibatate from 0.002 IU/kg/h, 0.004 IU/kg/h to 0.008 IU/kg/h in continuous administration groups.

开始日期2020-09-01

申办/合作机构

李氏大药厂控股有限公司

NCT04021173 / Unknown status临床2期

A Multicenter, Randomized, Double-blind, Placebo-parallel, Phase II Clinical Trial of the Efficacy and Safety of Anfibatide in Treating Patients With Acquired Thrombotic Thrombocytopenic Purpura (TTP)

This is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study. It is planned to recruit 74 patients with acquired thrombotic thrombocytopenic purpura (TTP). To evaluate the efficacy and safety of Anfibatide as an adjuvant therapy for plasma exchange in patients with acquired TTP.

开始日期2019-07-01

申办/合作机构

李氏大药厂控股有限公司

CTR20180962 / Recruiting临床1期

注射用抗血小板溶栓素Ⅰ期临床人体耐受性与药代动力学研究

1.考察健康受试者静脉推注本品单次用药和连续给药的安全性及耐受性；2.考察药效学特征指标，血小板聚集抑制率；3.初步考察心脏安全指标，为将来试验对患者心脏安全评估提供指导；4.探索5IU和7IU单次给药可以达到的血小板聚集抑制率及5IU和7IU连续给药可以维持的血小板聚集抑制率。

开始日期2019-01-28

申办/合作机构

兆科药业（合肥）有限公司

100 项与安菲博肽相关的临床结果

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100 项与安菲博肽相关的转化医学

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100 项与安菲博肽相关的专利（医药）

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项与安菲博肽相关的文献（医药）

2024-05-28·Blood Advances

Targeting neutrophil extracellular trap accumulation under flow in patients with immune-mediated thrombotic thrombocytopenic purpura

Article

作者: Gralnek, Sarah H. ; Zheng, Liang ; Zheng, X. Long ; Bignotti, Antonia ; Zhang, Quan ; Sosnovske, Dennis ; Ye, Zhan ; Yada, Noritaka ; Hogan, Keenan

AbstractNeutrophil NETosis is a unique form of cell death, characterized by the release of decondensed chromatin and antimicrobial contents to the extracellular space, which is involved in inflammation and thrombosis. However, the role of NETosis in the pathogenesis of immune-mediated thrombotic thrombocytopenic purpura (iTTP) and how a targeted therapy affects the accumulation of neutrophil extracellular traps (NETs) under flow remain unknown. Flow cytometry demonstrated that the percentage of neutrophils undergoing NETosis in whole blood from patients with iTTP on admission was significantly increased, with a concurrent decrease in the capacity of inducible NETosis by shigatoxin. After therapy, the percentage of H3Cit+MPO+ neutrophils was significantly reduced, with an improvement in inducible NETosis in these patients. Additionally, little to no NET and thrombus formation was detected underflow in the whole blood from patients with iTTP when platelet counts were very low, but the NET and thrombus formation was dramatically increased following therapy when platelet counts rose to ≥50 × 109/L or were restored to normal with donor platelets. Similarly, there was no thrombus or NET accumulation under flow in the whole blood from vwf-/- mice, but NET accumulation was significantly higher in Adamts13-/- mice than in wild-type mice. Finally, recombinant ADAMTS13 or caplacizumab (or anfibatide) prevented NET and thrombus formation under flow in whole blood from patients with iTTP or from Adamts13-/- mice. These results indicate that neutrophil NETosis and NET formation depend on platelets and von Willebrand factor (VWF) in iTTP, and a targeted therapy such as recombinant ADAMTS13 or caplacizumab may prevent NET and thrombus formation under flow in iTTP.

2023-01-01·Computational and Structural Biotechnology Journal

Assembly of an active microbial consortium by engineering compatible combinations containing foreign and native biocontrol bacteria of kiwifruit

Article

作者: Li, Li ; Zhong, Caihong ; Zhou, Longteng ; Lin, Long ; Wang, Bozhen ; Qian, Guoliang ; Wang, Limin ; Shao, Xiaolong ; Tao, Min ; Wu, Qianhua

Assembling functional bacterial biocontrol consortia is expected to expand the scope and efficiency of biocontrol agents. Generally, bacterial interspecies interactions lead to incompatibility events, as bacteria can produce antibacterial compounds and/or assemble contact-dependent killing (CDK) devices. Here, we aimed to assemble a bacterial consortium comprising Lysobacter enzymogenes OH11 and Bacillus safensis ZK-1 for the synergistic control of bacterial and fungal diseases of kiwifruit. ZK-1, a native kiwifruit biocontrol bacterium, is effective against Pseudomonas syringae pv. actinidiae (Psa) that causes bacterial kiwifruit canker, but has weak antifungal activity. OH11 is a foreign kiwifruit biocontrol agent with strong antifungal activity. While OH11 was unable to produce anti-Gram-negative metabolites, this strain could utilize type IV secretion system as an antibacterial CDK weapon. We first observed that OH11 could inhibit growth of ZK-1 by generating diffusible anti-Gram-positive antibiotic WAP-8294A2, whereas ZK-1 failed to generate diffusible antibacterial compound to inhibit growth of OH11. To disrupt this interspecies incompatibility, we generated a transgenic OH11-derived strain, OH11W, by deleting the WAP-8294A2 biosynthetic gene and found that OH11W did not kill ZK-1. We further observed that when OH11W and ZK-1 were co-inoculated on agar plates, no CDK effect was observed between them, whereas co-culture of OH11W or ZK-1 with Psa on agar plates resulted in Psa killing, suggesting L. enzymogenes and B. safensis assemble antibacterial CDK weapons against bacterial pathogens, and these CDK weapons did not affect the compatibility between OH11W and ZK-1. Based on these findings, we assembled an OH11W/ZK-1 dependent consortium that was shown to be functional in controlling bacterial canker and several representative fungal diseases of kiwifruit.

2022-07-01·European Journal of Pharmacology3区 · 医学

Anfibatide alleviates inflammation and apoptosis via inhibiting NF-kappaB/NLRP3 axis in ischemic stroke

3区 · 医学

Article

作者: Li, Rui ; Ma, Zheng ; Gong, Peng ; Dai, Xiang-Rong ; Luo, Sheng-Yong ; Jia, Hui-Yu ; Li, Xin-Wei ; Si, Min ; Li, Xiao-Yi

Recent evidence suggests that Nod-like receptor protein-3 (NLRP3) inflammasome is a key mediator of inflammatory response and can induce the activation of apoptosis signaling pathways in ischemic stroke. In this research, we assessed the effects of anfibatide (ANF) on inflammatory and apoptosis in cerebral ischemic injury and the potential mechanisms. Middle cerebral artery occlusion (MCAO) model was established on male Sprague-Dawley rats to induce cerebral ischemia/reperfusion (I/R) injury in vivo. Primary cortical neurons (PCN) cells were exposed to oxygen-glucose deprivation and reintroduction (OGD/R) to mimic cerebral I/R injury in vitro. The results showed that ANF markedly alleviated infarct volume, neurological deficit and neurobehavioral impairment in MCAO/R rats, enhanced cell viability and decreased LDH release in PCN after OGD/R. The number of TUNEL-positive cells, Bax, cleaved-caspase-3, p-IκBα, p-p65, NLRP3, ASC, cleaved caspase-1, IL-β and IL-18 proteins expression were significantly upregulated in the cortex of MCAO/R rats and PCN exposed to OGD/R, NLRP3 and caspase-1 mRNA levels were also evidently elevated. Bcl-2 protein expression significantly decreased in the cortex of MCAO/R rats. Treatment with ANF obviously inhibited the expression of p-IκBα, p-p65, NLRP3, ASC, cleaved caspase-1, Bax and cleaved-caspase-3, promoted the expression of Bcl-2, then decreased the TUNEL-positive cell number and the level of inflammatory cytokines (IL-β and IL-18) in cerebral ischemia reperfusion in vito and in vitro. Our findings suggest that ANF exerts effects of alleviating inflammation and apoptosis through inhibiting NF-kappaB/NLRP3 axis. ANF is a potential candidate for treating cerebral I/R injury.

项与安菲博肽相关的新闻（医药）

2024-10-15

·李氏大药厂

研发快讯 | 李氏大药厂(00950)：重组安菲博肽注射液临床试验药物申请获受理

10月14日，李氏大药厂控股有限公司（简称“李氏大药厂”或“集团”，股份编号：00950）发布公告：9月25日，中国国家药品监督管理局（“国家药监局”）已正式受理重组安菲博肽注射液的临床试验申请，受理号为CXSL2400638和CXSL2400639。本次为该药物的首次临床试验注册申报，提交的临床方案包括Ⅰ期（单次给药和多次给药）及Ⅱ期的临床方案。重组安菲博肽注射液是一种由本集团全资附属公司兆科药业（合肥）有限公司发现及拥有的一类治疗用生物制品，符合中国国家药监局发布的药品生产品质管制规范。关于重组安菲博肽重组安菲博肽是在尖吻蝮蛇蛇毒天然蛋白Agkisacutacin（抗血小板溶栓素）序列基础上进行优化，以CHO细胞为宿主细胞进行重组表达的蛋白，作用于血小板膜糖蛋白GPIb。该药物为全新结构、全新靶点的创新药物。试验表明该药物是一个有效的GPIb抑制剂，通过与GP1bα结合，抑制GP1b-vWF相互作用，该靶点对抑制血栓的形成、预防心肌梗塞及血栓性血小板低下紫斑症均有作用。本集团拥有该药物全球知识产权。往期回顾 ◆ 金风菊韵话重阳 ◆ 精彩会议回顾 | 中欧病例魔方宫颈癌专题第三期——肿瘤免疫治疗毒性管理策略 ◆ 寒露轻降，秋韵悠长 ◆ 李氏快讯｜ 9月要闻速览关于李氏大药厂 - 亞太地區最具創新力的上市企業 - 李氏大药厂控股有限公司（简称“李氏大药厂”或“集团”, 股份编号: 00950）成立于1994年，是一家结合了研发驱动和市场导向的生物医药集团公司，总部位于香港。李氏大药厂于2002年7月在香港联合交易所（简称：“港交所”）创业板上市，并于2010年5月成功转至港交所主板上市。李氏大药厂在中国大陆拥有两大综合性生产研发基地，即：兆科合肥基地（位于安徽省合肥市高新区）和兆科广州基地（位于广东省广州市南沙区），目前员工总数超过1100人。李氏大药厂立足中国大陆，放眼国际，通过坚实和稳固的投入建设，全面覆盖整合了药物研发、临床研究、药政注册、生产制造、销售与市场推广等各个环节。集团集中于心血管科、妇科与产科、儿科、罕见病、肿瘤科、皮肤科、精神科等多个重要疾病领域开发不同阶段的专利新药和高端仿制药。李氏大药厂与20余家国际公司建立了广泛的合作关系，目前在中国大陆、香港、澳门及台湾地区推广及销售25种包含专利新药、仿制药物及授权引进的国外已上市进口药品。李氏大药厂现有超过40个处于不同开发阶段的产品，既有自主研发产品，也有通过来自美国、欧洲及日本等公司通过授权引进进行研发、生产以及商业化的产品。李氏大药厂的使命是通过提供治疗各种疾病的创新产品，以改善患者健康及提高生活质量，成为亚洲一家成功的生物医药集团。下滑查看更多免责声明：本公众号发布或转载企业宣传资讯，仅供读者参考之用，并不构成收购、购买或认购依据，并不构成任何个人化的投资劝诱或建议。因本公布全部或任何部分内容而产生或因倚赖该等内容而引致的任何损失不承担任何责任。企业文化公共关系部出品文章来源：集团官网排版：樊扬波审核：黄思伽与“李”同行招商热线 020-39062882

临床2期临床3期临床1期

100 项与安菲博肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
急性冠状动脉综合征	临床2期	中国	兆科药业（合肥）有限公司	2016-01-14
血栓形成	临床1期	中国香港	李氏大药厂控股有限公司	2013-11-15
血栓形成	临床1期	加拿大	St. Michael's Hospital	2013-11-15
血栓形成	临床1期	中国	兆科药业（合肥）有限公司	2013-11-15
获得性血栓性血小板减少性紫癜	药物发现	中国	李氏大药厂控股有限公司	2019-07-01
ST段抬高心肌梗死	药物发现	中国	李氏大药厂控股有限公司	2015-08-01
非ST段抬高型心肌梗死	药物发现	中国	李氏大药厂控股有限公司	2012-07-01
凝血障碍	药物发现	-	李氏大药厂控股有限公司	2010-09-01
冠状动脉疾病	药物发现	-	李氏大药厂控股有限公司	2010-09-01