主要目的：评估中国健康成年受试者单次皮下注射（SC）BION-1301的药代动力学（PK）特征次要目的：评估中国健康成年受试者单次SC BION-1301后对免疫球蛋白的药效学（PD）影响；评估中国健康成年受试者单次SC BION-1301的免疫原性；评估中国健康成年受试者单次SC BION-1301的安全性和耐受性

开始日期2023-04-17

申办/合作机构

Chinook Therapeutics, Inc.

[+3]

100 项与 Zigakibart 相关的临床结果

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100 项与 Zigakibart 相关的专利（医药）

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项与 Zigakibart 相关的文献（医药）

2024-05-01·DRUGS

Drugs in Development to Treat IgA Nephropathy

Review

作者: Del Vecchio, Lucia ; Comolli, Stefania ; Allinovi, Marco ; Locatelli, Francesco ; Rimoldi, Chiara ; Peiti, Silvia

IgA nephropathy is a common glomerulonephritis consequent to the autoimmune response to aberrant glycosylated immunoglobulin (Ig) A antibodies. Although it has historically been considered a benign disease, it has since become clear that a substantial percentage of patients reach end-stage kidney failure over the years. Several therapeutic attempts have been proposed, with systemic steroids being the most prevalent, albeit burdened by possible serious adverse events. Thanks to the more in-depth knowledge of the pathogenesis of IgA nephropathy, new treatment targets have been identified and new drugs developed. In this narrative review, we summarise the molecules under clinical development for the treatment of IgA nephropathy. As a search strategy, we used PubMed, Google, ClinicalTrials.gov and abstracts from recent international congresses. TRF budesonide and sparsentan are the two molecules at a more advanced stage, just entering the market. Other promising agents are undergoing phase III clinical development. These include anti-APRIL and anti-BLyS/BAFF antibodies and some complement inhibitors. Other new possible strategies include spleen tyrosine kinase inhibitors, anti-CD40 ligands and anti-CD38 antibodies. In an era increasingly characterised by 'personalised medicine' and 'precision therapy' approaches and considering that the potential therapeutic armamentarium for IgA nephropathy will be very broad in the near future, the identification of biomarkers capable of helping the nephrologist to select the right drug for the right patient should be the focus of future studies.

2023-12-04·Clinical kidney journal

The contribution of a proliferation-inducing ligand (APRIL) and other TNF superfamily members in pathogenesis and progression of IgA nephropathy

Review

作者: Barratt, Jonathan ; Yeo, See Cheng

ABSTRACT:

Advances in our understanding of the pathogenesis of immunoglobulin A nephropathy (IgAN) have led to the identification of novel therapeutic targets and potential disease-specific treatments. Specifically, a proliferation-inducing ligand (APRIL) has been implicated in the pathogenesis of IgAN, mediating B-cell dysregulation and overproduction of pathogenic galactose-deficient IgA1 (Gd-IgA1). Animal and clinical studies support the involvement of APRIL in the pathogenesis and progression of IgAN. An elevated level of APRIL is found in IgAN when compared with controls, which correlates with the level of Gd-IgA1 and associates with more severe disease presentation and worse outcomes. Conversely, anti-APRIL therapy reduces pathogenic Gd-IgA1 and IgA immune complex formation and ameliorates the severity of kidney inflammation and injury. Genome-wide association studies in IgAN have identified TNFSF13 and TNFRSF13B, a cytokine ligand-receptor gene pair encoding APRIL and its receptor, respectively, as risk susceptibility loci in IgAN, further supporting the causal role of the APRIL signalling pathway in IgAN. Several novel experimental agents targeting APRIL, including atacicept, telitacicept, zigakibart and sibeprenlimab, are currently under investigation as potential therapies in IgAN. Preliminary results suggest that these agents are well-tolerated, and reduce levels of Gd-IgA1, with corresponding improvement in proteinuria. Further studies are ongoing to confirm the safety and efficacy of anti-APRIL approaches as an effective therapeutic strategy in IgAN.

2023-12-01·Clinical rheumatology

A narrative review of potential drug treatments for nephritis in children with IgA vasculitis (HSP)

Review

作者: Lamond, Megan ; Chetwynd, Andrew J ; Marro, Julien ; Oni, Louise ; Williams, Chloe E C

Abstract:

Immunoglobulin A (IgA) vasculitis (IgAV, also known as Henoch-Schoenlein purpura, HSP) is the most common vasculitis of childhood. It usually presents with a simple, self-limiting disease course; however, a small subset of patients may develop kidney involvement (IgAV-N) which occurs 4–12 weeks after disease onset and is the biggest contributor to long-term morbidity. Treatment currently targets patients with established kidney involvement; however; there is a desire to work towards early prevention of inflammation during the window of opportunity between disease presentation and onset of significant nephritis. There are no clinical trials evaluating drugs which may prevent or halt the progression of nephritis in children with IgAV apart from the early use of corticosteroids which have no benefit. This article summarises the latest scientific evidence and clinical trials that support potential therapeutic targets for IgAV-N that are currently being developed based on the evolving understanding of the pathophysiology of IgAV-N. These span the mucosal immunity, B-cell and T-cell modulation, RAAS inhibition, and regulation of complement pathways, amongst others. Novel drugs that may be considered for use in early nephritis include TRF-budesonide; B-cell inhibiting agents including belimumab, telitacicept, blisibimod, VIS649, and BION-1301; B-cell depleting agents such as rituximab, ofatumumab, and bortezomib; sparsentan; angiotensin converting enzyme inhibitors (ACE-Is); and complement pathway inhibitors including avacopan, iptacopan, and narsoplimab. Further clinical trials, as well as pre-clinical scientific studies, are needed to identify mechanistic pathways as there may be an opportunity to prevent nephritis in this condition.Key Points• Kidney involvement is the main cause of long-term morbidity and mortality in IgA vasculitis despite the current treatment recommendations.• The evolving understanding of the pathophysiology of IgA vasculitis is allowing exploration of novel treatment options which target underlying immune pathways.• Novel treatments currently being trialled in IgA nephropathy may have benefit in IgA vasculitis due to the similarities in the underlying pathophysiology, such as TRF-budesonide, B-cell modulators, and complement inhibitors.• Further studies, including clinical trials of novel drugs, are urgently needed to improve the long-term outcomes for children with IgA vasculitis nephritis.

172

项与 Zigakibart 相关的新闻（医药）

2024-12-10

·戊戌数据

【注册报告】2024年11月药品注册审评审批报告

一 2024年11月药品受理情况 1.2024年11月受理总况 2024年11月，国家药品监督管理局药品审评中心（以下称药审中心）共计受理1606个受理号，比去年同期增加6.4%。图一 2023和2024年药审中心药品受理情况受理的药品中，化药占比73%，生物制品12%，中药15%。图二 2024年11月各药品类型受理情况 2.化药受理情况 2024年11月化药受理总数为1170个。图三 2024年11月化药各申请类型受理情况化药1类创新药申报共计133个受理号，包含国产和进口品种。图四 2024年11月化药各注册分类受理情况备注：注册分类统计只包含新药、进口、仿制药。本月新申报的1类化药共计31个品种，涉及30个企业。表1 11月首次申报临床的化药创新药本月共有2个1类新药提交了上市申请。盐酸阿曲生坦片 Atrasentan是由Chinook Therapeutics开发的ETA受体拮抗剂，可选择性阻断内皮素A（ETA）受体，通过阻断肾小球系膜细胞活化，直接的抗炎和抗纤维化，降低球囊内压力和肾小球滤过屏障大分子通透性来减少免疫球蛋白A肾病(IgAN) 患者的尿蛋白。 2023年6月，诺华宣布以35亿美元的总金额收购加拿大公司Chinook Therapeutics，并获得2款临床后期慢性肾病药物（Atrasentan和Zigakibart)。力胜克拉片 APG-2575（lisaftoclax）是亚盛医药在研的Bcl-2选择性抑制剂，通过选择性抑制Bcl-2蛋白来恢复肿瘤细胞程序性死亡机制（细胞凋亡），从而诱导肿瘤细胞凋亡，达到治疗肿瘤的目的。 2024年11月，亚盛医药自主研发的新型口服Bcl-2选择性抑制剂力胜克拉片（Lisaftoclax，APG-2575）提交上市申请获得受理，制剂生产合作伙伴是宣泰药业。适应症为用于治疗难治或复发性慢性淋巴细胞白血病/小淋巴细胞淋巴瘤患者。 2.生物制品受理情况 2024年11月生物制品共计受理187个，治疗用生物制品160个，预防用生物制品23个。本月生物类创新药共计25家企业新申报了25个1类生物药（表2）。表2 11月新注册临床的治疗用生物创新本月共有4个1类新药申报上市。注射用维拉苷酶β CAN103是一种酶替代治疗药物，由北海康成开发，用于成人和儿童I型和III型戈谢病患者的长期治疗。重组抗IL-17A人源化单克隆抗体注射液 2024年11月，三生国健的重组抗IL-17A人源化单克隆抗体注射液SSGJ-608上市申请已获得CDE受理，用于治疗成人中重度斑块状银屑病。伊诺格鲁肽注射液 XW-003是一种允许每周给药一次注射的GLP-1类似物，作为治疗2型糖尿病、肥胖症的有效工具，在治疗NASH方面也同样显示出临床潜力。 IM19嵌合抗原受体T细胞注射液 IM19 CAR-T细胞注射液是一种自体CD19(B细胞表面的一种白细胞分化抗原)靶向CAR-T细胞(嵌合抗原受体T细胞)产品，它是通过慢病毒转导T细胞产生的。 2024年8月2日，北京艺妙神州医药科技有限公司宣布与华东医药股份有限公司全资子公司华东医药（杭州）有限公司，就其靶向CD19的自体CAR-T候选产品IM19嵌合抗原受体T细胞注射液，达成在中国大陆地区的商业化合作。表3 11月新注册的生物类似药 3.中药受理情况本月，中药受理256个受理号，其中补充申请244个，3个1.1类新药临床试验申请，1个1.3类新药临床试验申请，1个2.2类新药临床试验申请，3个3.1类新药上市申请。 1.1中药复方制剂，系指由多味饮片、提取物等在中医药理论指导下组方而成的制剂。 1.2从单一植物、动物、矿物等物质中提取得到的提取物及其制剂。 3.1按古代经典名方目录管理的中药复方制剂。表3 11月注册的中药新药桃红四物颗粒桃红四物颗粒源自桃红四物汤（《妇科冰鉴》（清.柴得华）），“血多有块，色紫稠粘者，有瘀停也，桃红四物汤随其流以逐之”。目前已有6家企业提交了上市申请。表4 桃红四物颗粒注册情况五味消毒颗粒五味消毒颗粒源自五味消毒饮（《医宗金鉴》（清.吴谦）），“夫疔疮者，乃火证也。……初起俱宜服蟾酥丸汗之；毒势不尽，憎寒壮热仍作者，宜服五味消毒饮汗之。” 枇杷清肺颗粒枇杷清肺颗粒源自枇杷清肺饮（《医宗金鉴》（清.吴谦）），“此证由肺经血热而成。每发于面鼻，起碎疙瘩，形如黍屑，色赤肿痛，破出白粉汁，日久皆成白屑，形如黍米白屑。宜内服枇杷清肺饮。” 目前已有4家企业提交了上市申请，其中2家已获批上市。表5 枇杷清肺颗粒注册情况二 2024年11月药品上市情况本月国家药品监督管理局新批准上市药品共计245个（以批准文号计，包含新药、进口、仿制药），其中包含仿制药226个，新药15个，进口原研药4个。表4 11月新批准上市的创新药格索雷塞片 D-1553是益方生物自主研发的一种高效和高选择性的KRAS G12C抑制剂。 2023年8月，正大天晴与益方生物就后者临床期KRAS G12C抑制剂D-1553达成合作协议，获得该新药在中国大陆地区开发、注册、生产和商业化的独家许可权。根据协议，益方生物将获得最高不超过5.5亿元人民币的首付款及里程碑款，以及产品的销售分成。 2024年11月，国家药品监督管理局通过优先审评审批程序附条件批准上海正大天晴医药科技开发有限公司申报的1类创新药格索雷塞片（商品名：安方宁）上市，该药适用于治疗至少接受过一种系统性治疗的鼠类肉瘤病毒癌基因（KRAS）G12C突变型的晚期非小细胞肺癌（NSCLC）成人患者。盐酸佐利替尼片 Zorifertinib（AZD3759）是晨泰医药科技有限公司（Alpha Biopharma）主导在研产品，为新一代以表皮生长因子受体为作用靶点的小分子酪氨酸激酶抑制剂（EGFR-TKI），可以100%透过血脑屏障，达到药物在血液、脑组织和脑脊液的浓度一致，专门用于治疗表皮生长因子受体（EGFR）基因突变阳性的非小细胞肺癌（NSCLC）伴中枢神经系统（CNS）转移患者。晨泰医药成立于2017年，成立当年，晨泰医药便与阿斯利康（AstraZeneca）签订了合作协议，以期通过先导候选药物zorifertinib（AZD3759）精准切入肺癌脑转移领域。 2024年11月，国家药品监督管理局批准江苏晨泰医药科技有限公司申报的1类创新药盐酸佐利替尼片（商品名：泽瑞尼）上市，该药适用于具有表皮生长因子受体（EGFR）19号外显子缺失或外显子21（L858R）置换突变，并伴中枢神经系统（CNS）转移的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。注射用芦康沙妥珠单抗 SKB264为科伦博泰拥有自主知识产权的靶向TROP2的人源化单克隆抗体、可酶促裂解的Linker连接着新型拓扑异构酶I抑制剂组合而成的抗体-偶联药物（TROP2- ADC）。 2022年5月，SKB264有偿独家许可给MERCK SHARP & DOHME LLC.（MSD）进行中国以外（中国包括中国大陆，香港、澳门和台湾）区域范围内的研究、开发、生产制造和商业化。 2024年11月，国家药品监督管理局批准四川科伦博泰生物医药股份有限公司申报的注射用芦康沙妥珠单抗（商品名：佳泰莱）上市，用于既往至少接受过2种系统治疗（其中至少1种治疗针对晚期或转移性阶段）的不可切除的局部晚期或转移性三阴性乳腺癌成人患者。 END ★ 点击下方卡片，发现更多精彩

申请上市细胞疗法免疫疗法临床3期ASH会议

2024-11-26

·生物制品圈

今日，诺华「阿曲生坦」在国内报上市，治疗IgA 肾病

11 月 26 日，CDE 官网显示，诺华的盐酸阿曲生坦片在国内报上市，适应症为用于降低有疾病进展风险的原发性免疫球蛋白 A 肾病（IgAN）成人患者的蛋白尿，此前已纳入优先审评。截图来源：CDE 官网阿曲生坦是一种在研的强效选择性口服 ETA（内皮素 A）受体拮抗剂，ETA 受体的激活会导致蛋白尿升高，这与 IgAN 中的肾脏损伤、纤维化和肾功能丧失有关。阿曲生坦有可能添加到目前的支持疗法中，以减少持续性蛋白尿并保护广大患者群体的肾功能。临床前模型也表明阿曲生坦可以减少 IgAN 中的炎症和纤维化。 5 月 25 日，诺华公布了阿曲生坦治疗 IgA 肾病 (IgAN) 患者的 III 期 ALIGN 研究的预定中期分析结果，与接受支持治疗（最大耐受剂量和稳定剂量的肾素-血管紧张素系统 [RAS] 抑制剂）的患者相比，接受阿曲生坦治疗的患者在 36 周时蛋白尿（以 24 小时尿蛋白与肌酐比率 [UPCR] 衡量）减少了 36.1% (p<0.0001)。研究还显示，阿曲生坦具有良好的安全性，与前期报道的数据一致。今年 7 月，阿曲生坦刚在 FDA 首次提交上市申请，目前全球都没有国家获批。本次在国内报上市，最快有望明年底获批。我们也注意到，阿曲生坦在中国的化合物专利已经在 2017 年到期（公开/公告号：CN1091768C）。值得注意的是，诺华另一款新药盐酸伊普可泮胶囊近期也在国内递交了用于 IgAN 的新适应症上市申请（JXHS2400053），该药是目前全球首款获批用于降低有快速进展风险的原发性 IgA 肾病（IgAN）蛋白尿的补体旁路途径抑制剂，并有望在中国已获批的阵发性睡眠性血红蛋白（PNH）适应症基础上，加速拓展 IgAN 及其他肾脏领域适应症，为中国 IgAN 患者带来更加具有针对性的治疗方案。此外，诺华还有一款靶向增殖诱导配体（APRIL）的IgA肾病新药（Zigakibart），目前正处于 III 期临床阶段。诺华上述产品组合旨在针对不同的 IgA 肾病驱动因素，为这类群体提供多样化的治疗选择。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床3期优先审批申请上市

2024-11-19

·PipelineReview

Otsuka Provides Update on Sibeprenlimab, an Investigational Monoclonal Antibody for the Treatment of IgA Nephropathy in Adults

PRINCETON, NJ, USA & TOKYO, Japan I November 19, 2024 I Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce the decision to submit a Biologics License Application (BLA) in the U.S. for sibeprenlimab, an investigational drug for the treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults, in the first half of 2025. The update follows a recent meeting with the U.S. Food & Drug Administration to discuss the positive interim analysis results from the Phase 3 VISIONARY study (NCT05248646). Sibeprenlimab is an investigational, anti-APRIL monoclonal antibody ( A PR oliferation- I nducing L igand) that blocks a key initiating step in the immune pathogenic cascade of IgA nephropathy by limiting aberrant IgA1 (Gd-IgA1) production and immune complex formation. IgA nephropathy is a progressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over the lifetime of most patients. 1,2,3,4 Otsuka was previously granted Breakthrough Therapy designation for sibeprenlimab following favorable results of the Phase 2 ENVISION clinical trial. 3 “We greatly appreciated the opportunity to discuss the positive interim data from the Phase 3 sibeprenlimab trial with the FDA and plan to incorporate the Agency’s feedback as we prepare the BLA filing,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “Otsuka is committed to the nephrology community and looks forward to bringing this innovative targeted therapy to people living with IgA nephropathy. We want to thank the patients, caregivers and healthcare professionals who continue to be such an important part of this process.” In October, Otsuka announced positive interim results from the Phase 3 sibeprenlimab trial. The ongoing Phase 3 study continues in a blinded manner to evaluate the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed in early 2026. Further prespecified and exploratory analyses of the data will be conducted to determine the full potential of sibeprenlimab for the treatment of IgA nephropathy and will be shared. About Sibeprenlimab Sibeprenlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary of Otsuka. Pre-clinical and early-stage trials of sibeprenlimab were also conducted by Visterra. Sibeprenlimab is an investigational monoclonal antibody that blocks the action of APRIL (A PR oliferation- I nducing L igand), that plays a key role in IgA nephropathy’s four-hit pathogenic cascade. APRIL is an important sustaining factor in IgA nephropathy progression by promoting the production of pathogenic Gd-IgA1 and immune complex formation. By binding and neutralizing APRIL, sibeprenlimab may help reduce the amount of immunoglobulin A (IgA) and Gd-IgA1. Lower levels of Gd-IgA1 may then result in reduced auto-antibody production, which in turn may result in fewer immune complexes, decreased immune complex deposits in the kidney, and reduced proteinuria and kidney inflammation. By reducing the production of Gd-IgA1, sibeprenlimab is expected to slow kidney damage and progression toward ESKD. 1,2,3,5 By blocking APRIL, sibeprenlimab may help address one of the IgA nephropathy-specific drivers for nephron loss. About Immunoglobulin A Nephropathy (IgAN) and APRIL IgA nephropathy also known as Berger’s disease, is a progressive, autoimmune, chronic kidney disease that typically manifests in adults aged 20-40 years and may lead to ESKD over the lifetime of most patients. 4, 6, 7 IgA nephropathy is characterized by the accumulation of IgA in the kidneys – a type of antibody that plays a critical role in the immune system.IgA nephropathy can lead to progressive kidney dysfunction and, eventually, ESKD, imposing a significant burden on patients. 6 Despite supportive care, including therapies that focus on treating the symptoms of IgA nephropathy, continued research in the disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients. 6 About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide . Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,250 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS . Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/. References 1. Mathur M, Barratt J, Chacko B, et al. A Phase 2 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy Patients. NEJM. 2023 https://www-nejm-org.libproxy1.nus.edu.sg/doi/full/10.1056/NEJMoa2305635 2. Chang S, Li XK. The Role of Immune Modulation in Pathogenesis of IgA Nephropathy (nih.gov) 3. Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003. 4. Pitcher, D. Braddon, et. al Long-term outcomes in IGA nephropathy. Clinical journal of the American Society of Nephrology : CJASN. https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/37055195/ . 5. Otsuka Pharmaceutical Development & Commercialization, Inc.Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN). Clinicaltrials.gov. 6. Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. The role of BAFF and April in IGA nephropathy: Pathogenic mechanisms and targeted therapies. Frontiers in nephrology. February 1, 2024. 7. Lai K. Iga nephropathy. Nature reviews. Disease primers. 2016. https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/27189177/ . 8. Yeo SC et al. Is immunoglobulin A nephropathy different in different ethnic populations? April 2019. https://onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/full/10.1111/nep.13592 . SOURCE: Otsuka Pharmaceutical

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100 项与 Zigakibart 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
免疫球蛋白a肾病	临床3期	中国	Chinook Therapeutics, Inc.	2023-07-27
免疫球蛋白a肾病	临床3期	日本	Chinook Therapeutics, Inc.	2023-07-27
免疫球蛋白a肾病	临床3期	阿根廷	Chinook Therapeutics, Inc.	2023-07-27
免疫球蛋白a肾病	临床3期	澳大利亚	Chinook Therapeutics, Inc.	2023-07-27
免疫球蛋白a肾病	临床3期	比利时	Chinook Therapeutics, Inc.	2023-07-27
免疫球蛋白a肾病	临床3期	巴西	Chinook Therapeutics, Inc.	2023-07-27
免疫球蛋白a肾病	临床3期	加拿大	Chinook Therapeutics, Inc.	2023-07-27
免疫球蛋白a肾病	临床3期	克罗地亚	Chinook Therapeutics, Inc.	2023-07-27
免疫球蛋白a肾病	临床3期	捷克	Chinook Therapeutics, Inc.	2023-07-27
免疫球蛋白a肾病	临床3期	法国	Chinook Therapeutics, Inc.	2023-07-27

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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


NCT03945318 (ADU-CL-19, ISN WCN2023)	临床1/2期	免疫球蛋白a肾病 APRIL \| IgA \| Gd-IgA1 ... 更多	-	BION-1301 450 mg IV	醖壓憲簾遞鹽艱鹽糧鏇(觸積蓋築鹽繭憲鹹衊膚) = 憲艱築鏇衊夢構鑰簾願築選壓鬱衊顧糧餘獵憲 (製膚觸鹽範遞艱糧憲憲 )	积极	2023-03-01
				BION-1301 600 mg SC	醖壓憲簾遞鹽艱鹽糧鏇(觸積蓋築鹽繭憲鹹衊膚) = 願糧廠獵構壓鹹蓋構齋築選壓鬱衊顧糧餘獵憲 (製膚觸鹽範遞艱糧憲憲 )
NCT03945318 (Phase 1/2 Study of BION-1301, ASN2022)	临床1/2期	免疫球蛋白a肾病 APRIL \| IgA \| Gd-IgA1 ... 更多	20	BION-1301 450 mg IV	選膚襯膚襯網遞醖糧顧(襯醖憲鏇構製夢憲襯顧) = 選網築選遞衊壓築醖觸餘鏇淵廠鑰繭觸簾構簾 (簾構鏇膚蓋願鹹獵鹹願 )	积极	2022-11-04
				BION-1301 600 mg SC	選膚襯膚襯網遞醖糧顧(襯醖憲鏇構製夢憲襯顧) = 鏇憲窪蓋觸築鹹襯襯網餘鏇淵廠鑰繭觸簾構簾 (簾構鏇膚蓋願鹹獵鹹願 )
NCT03945318 (Corporate Publications) 人工标引	临床1/2期	免疫球蛋白a肾病	40	BION-1301 (450 mg Q2W IV → 600 mg Q2W SC, up to 104 weeks ‖)	鬱壓願衊願網淵製夢窪(鏇觸遞遞繭膚壓淵積繭) = 齋簾襯糧積製顧鑰選淵憲鑰鬱鹽鑰鹹獵遞艱鹹 (鏇簾蓋壓淵繭膚簾艱襯 ) 更多	积极	2022-11-01
				BION-1301 (600 mg Q2W de novo SC, up to 104 weeks)	鬱壓願衊願網淵製夢窪(壓觸積夢鏇膚廠廠顧範) = 憲鬱齋艱積簾齋願簾襯壓憲艱糧範構窪積積獵 (製簾獵淵築鑰齋淵蓋構 )
NCT03945318 (Corporate Publications) 人工标引	临床1/2期	免疫球蛋白a肾病	10	BION-1301	艱鑰鏇簾鬱鑰範齋選憲(鑰製糧築繭鹽鹹獵鑰壓) = 鏇獵齋憲鬱範膚衊願膚艱鏇鏇網範鏇積衊網壓 (製鏇鹽觸積構憲艱範艱 ) 更多	积极	2021-11-04
NCT03340883 (CTgov)	临床1/2期	复发性多发性骨髓瘤 \| 难治性多发性骨髓瘤	21	BION-1301 (BION-1301 50 mg Q2W)	憲觸範鏇醖艱夢窪餘壓(憲憲選選鹽衊壓鑰窪鏇) = 獵製廠鹹淵網簾壓鹹繭選顧繭顧夢顧築鹽糧製 (壓衊餘衊壓醖繭顧鹹繭, 顧構壓憲淵憲選齋願窪 ~ 衊鏇網願襯鏇淵鑰鬱蓋) 更多	-	2020-09-07
				BION-1301 (BION-1301 150 mg Q2W)	憲觸範鏇醖艱夢窪餘壓(憲憲選選鹽衊壓鑰窪鏇) = 醖觸鏇窪顧顧願鑰壓獵選顧繭顧夢顧築鹽糧製 (壓衊餘衊壓醖繭顧鹹繭, 顧醖壓選獵襯範膚鬱鏇 ~ 夢觸淵襯鬱積壓構鏇淵) 更多
NCT03340883 (ASCO 12019 \| ASCO 22019) 人工标引	临床1期	难治性多发性骨髓瘤	15	Zigakibart	願簾壓鹽鏇顧鹹鬱顧獵(積製壓衊膚壓繭衊觸鬱) = none 鹹範壓蓋醖鹽觸簾憲積 (遞糧醖壓壓壓積醖糧窪 ) 更多	不佳	2019-06-03
BION-1301 (ASN2018)	N/A	免疫球蛋白a肾病 APRIL \| BCMA \| TACI	-	BION-1301	鏇淵構獵築醖鹹顧廠憲(簾範簾齋鹹積憲積願醖) = 憲襯積鑰簾網淵積構鹽餘糧鹹鏇顧選願觸製鑰 (糧鏇餘鏇廠齋鹹夢壓餘, 0.89) 更多	积极	2018-10-23