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更新于：2025-11-06

Povetacicept

更新于：2025-11-06

概要

概要

基本信息

药物类型

Fc融合蛋白

别名

povetacicept、ALPN-303、ALPN303

靶点

APRIL x BAFF

作用方式

抑制剂

作用机制

APRIL抑制剂(肿瘤坏死因子配体超家族成员13抑制剂)、BAFF抑制剂(B细胞活化因子/B淋巴细胞刺激因子抑制剂)

治疗领域

免疫系统疾病心血管疾病血液及淋巴系统疾病+ [5]

在研适应症

免疫球蛋白a肾病特发性膜性肾病自身免疫性血细胞减少症+ [9]

非在研适应症-

原研机构

Alpine Immune Sciences, Inc.

在研机构

Alpine Immune Sciences, Inc.

Ajinomoto Bio-Pharma Services

再鼎医药（上海）有限公司

+ [2]

非在研机构-

权益机构

Zai Lab Ltd.

Ono Pharmaceutical Co., Ltd.

Evotec SE

+ [2]

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评突破性疗法 (美国)、快速通道 (美国)、孤儿药 (欧盟)

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结构/序列

Sequence Code 631430029

来源: *****

关联

项与 Povetacicept 相关的临床试验

NCT07204275

/ Recruiting临床2/3期

A Phase 2b/3 Adaptive, Randomized, Active-controlled Study Evaluating the Efficacy, Safety, and Tolerability of Povetacicept Versus Calcineurin Inhibitor in the Treatment of Primary Membranous Nephropathy

The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).

开始日期2025-09-30

申办/合作机构

Vertex Pharmaceuticals, Inc.

NCT07010406

/ Completed临床1期

A Phase 1, Open-label, Randomized, 2-part Study to Evaluate the Relative Bioavailability of Povetacicept Formulations and Bioequivalence of Povetacicept Presentations in Healthy Subjects

The purpose of this study is to evaluate the relative bioavailability of Povetacicept formulations, bioequivalence of Povetacicept presentations, and safety and tolerability of Povetacicept.

开始日期2025-06-06

申办/合作机构

Vertex Pharmaceuticals, Inc.

CTR20244331

/ Recruiting临床3期

在免疫球蛋白 A 肾病成人患者中评价 POVETACICEPT 的随机、双盲、安慰剂对照 III 期研究（RAINIER）

主要目的（主队列）评价 Povetacicept 与安慰剂相比在减少蛋白尿方面的疗效评价 Povetacicept 与安慰剂相比在保护肾功能方面的疗效次要目的（主队列）评价 Povetacicept 与安慰剂相比在减缓肾衰竭方面的疗效评价 Povetacicept 与安慰剂相比在改善疲劳方面的疗效安全性目的（主队列）评价 Povetacicept 与安慰剂相比的安全性和耐受性特征

开始日期2024-12-16

申办/合作机构

乔治（北京）临床医学研究有限公司

[+3]

100 项与 Povetacicept 相关的临床结果

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100 项与 Povetacicept 相关的转化医学

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100 项与 Povetacicept 相关的专利（医药）

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项与 Povetacicept 相关的文献（医药）

2024-11-01·CTS-Clinical and Translational Science

A first‐in‐human, randomized study of the safety, pharmacokinetics and pharmacodynamics of povetacicept, an enhanced dual BAFF/APRIL antagonist, in healthy adults

Article

作者: Smith, Alina ; Davies, Rupert ; Blair, Tiffany ; Dillon, Stacey R. ; Peng, Stanford L. ; Thomas, Heather M. ; McLendon, Kristi ; Wang, NingXin ; Chunyk, Allison G. ; Blanchfield, Lori ; Enstrom, Amanda ; Lickliter, Jason

Abstract:

Therapeutic agents targeting the tumor necrosis factor (TNF) superfamily cytokines B‐cell activating factor (BAFF, BLyS) and/or A PRoliferation Inducing Ligand (APRIL) have demonstrated clinical effectiveness in multiple autoimmune diseases, such as systemic lupus erythematosus, lupus nephritis, and immunoglobulin A nephropathy (IgAN). However, their clinical utility can often be limited by incomplete and/or prolonged times to clinical response and inconvenient dosing regimens, which may be improved by more potent dual inhibition of both cytokines. Povetacicept (ALPN‐303; TACI vTD‐Fc) is a crystallizable fragment (Fc) fusion protein of an engineered transmembrane activator and CAML interactor (TACI) domain which mediates more potent inhibitory activity than wild‐type TACI‐Fc or BAFF‐ or APRIL‐specific antibodies and demonstrates superior pharmacokinetic and pharmacodynamic activity in multiple preclinical disease models. In this first‐in‐human study in healthy adults, povetacicept was well‐tolerated as single ascending doses of up to 960 mg administered intravenously or subcutaneously. Dose‐dependent pharmacokinetics were observed. Coverage of BAFF and APRIL was observed for 2–3 weeks and ≥4 weeks after doses of 80 mg and ≥240 mg, respectively. Maximal pharmacodynamic effects were observed at dose levels ≥80 mg for a single dose, associated with on‐target reductions in antibody‐secreting cells as well as in all circulating immunoglobulin isotypes, including the IgAN disease‐related biomarker galactose‐deficient‐immunoglobulin A1 (Gd‐IgA1), and were superior to results reported for wild‐type TACI‐Fc. These data strongly support further development of povetacicept for the treatment of B‐cell‐mediated automimmune diseases.

2023-12-02·Expert opinion on biological therapy

Antibody based therapeutics for autoimmune hemolytic anemia

Review

作者: Fattizzo, Bruno ; Cavallaro, Francesca ; Barcellini, Wilma

INTRODUCTION:

Autoimmune hemolytic anemia (AIHA) treatment has been revolutionized by the introduction of target therapies, mainly monoclonal antibodies (MoAbs).

AREAS COVERED:

The anti-CD20 rituximab, which targets Ab production by B-cells, induces 80% of response in warm-type AIHA (wAIHA) and 50-60% in cold agglutinin disease (CAD). Other B-cell targeting MoAbs including ianalumab, povetacicept, and obexelimab are under active study. The anti-CD38 MoAb daratumumab has been used in several reports to target long-lived plasma-cells responsible for AIHA relapse, being effective even in multi-refractory cases. Anti-complement MoAbs will soon change the treatment paradigm in CAD; the anti-C1s sutimlimab rapidly increased Hb in more than 80% of the cases. Finally, MoAbs inhibiting the neonatal Fc receptor (FcRn), such as nipocalimab, can reduce the half-life of the pathogenic autoAbs, representing a promising treatment for wAIHA.

EXPERT OPINION:

MoAbs offer the potential to improve efficacy by reducing toxicity. However, there is a huge need for clinical trials exploring response duration rather than short-term efficacy. Complement inhibitors and anti-FcRns do not abrogate autoAb production and are being developed as long-term therapies. Thus, the combination of B-cell/plasma cell targeting drugs deserves to be explored. On the other hand, their rapid efficacy should be exploited for the acute AIHA phase.

2023-07-01·Arthritis & rheumatology (Hoboken, N.J.)

Povetacicept, an Enhanced Dual APRIL/BAFF Antagonist That Modulates B Lymphocytes and Pathogenic Autoantibodies for the Treatment of Lupus and Other B Cell–Related Autoimmune Diseases

Article

作者: Evans, Lawrence S. ; Mudri, Sherri ; Bhandari, Janhavi G. ; Maria, Zahra ; Kuijper, Joseph L. ; Rixon, Mark W. ; Dillon, Stacey R. ; Wang, NingXin ; Griffin, Luana L. ; Lewis, Katherine E. ; DeMonte, Daniel ; Wolfson, Martin F. ; Hong, Youji ; Messenheimer, David J. ; Holland, Pamela M. ; Garrett, Logan B. ; Peng, Stanford L. ; Yang, Jing ; Hebb, LuAnne ; Seaberg, Michelle ; Kleist, Kayla ; Debrot, Susan ; Ardourel, Daniel ; Sanderson, Russell J. ; Chunyk, Allison G.

Objective:

Dysregulated APRIL/BAFF signaling is implicated in the pathogenesis of multiple autoimmune diseases, including systemic lupus erythematosus and lupus nephritis. We undertook this study to develop and evaluate a high‐affinity APRIL/BAFF antagonist to overcome the clinical limitations of existing B cell inhibitors.

Methods:

A variant of TACI‐Fc generated by directed evolution showed enhanced binding for both APRIL and BAFF and was designated povetacicept (ALPN‐303). Povetacicept was compared to wild‐type (WT) TACI‐Fc and related molecules in vitro and in vivo.

Results:

Povetacicept inhibited APRIL and BAFF more effectively than all evaluated forms of WT TACI‐Fc and selective APRIL and BAFF inhibitors in cell‐based reporter assays and primary human B cell assays, mediating potent suppression of B cell proliferation, differentiation, and immunoglobulin (Ig) secretion. In mouse immunization models, povetacicept significantly reduced serum immunoglobulin titers and antibody‐secreting cells more effectively than anti‐CD20 monoclonal antibodies, WT TACI‐Fc, or APRIL and BAFF inhibitors. In the NZB × NZW mouse lupus nephritis model, povetacicept significantly enhanced survival and suppressed proteinuria, anti–double‐stranded DNA antibody titers, blood urea nitrogen, glomerulonephritis, and renal immunoglobulin deposition. In the bm12 mouse lupus model, povetacicept significantly reduced splenic plasmablasts, follicular helper T cells, and germinal center B cells. In non‐human primates, povetacicept was well tolerated, exhibited high serum exposure, and significantly decreased serum IgM, IgA, and IgG levels after a single dose.

Conclusion:

Enhanced APRIL and BAFF inhibition by povetacicept led to greater inhibition of B cell populations critical for autoantibody production compared to WT TACI‐Fc and CD20‐, APRIL‐, or BAFF‐selective inhibitors. Potent, dual inhibition by povetacicept has the potential to significantly improve clinical outcomes in autoantibody‐related autoimmune diseases.image

150

项与 Povetacicept 相关的新闻（医药）

2025-11-04

·QQ浏览器

ASN 2025肾脏周即将开幕：4场主旨报告领航未来，32项最新临床试验燃亮休斯敦，4项中国研究入围LBCT！

编者按：美国肾脏病学会（ASN）年度盛会——Kidney Week 2025（美国肾脏周）将于2025年11月5日至9日在美国得克萨斯州休斯敦隆重举行。作为全球肾脏领域规模最大、学术影响力最强的国际会议，ASN 2025将再度汇聚来自世界各地的近12 000名肾脏病学专家、科研人员及产业界代表，共同展望肾脏医学的未来趋势与科研前沿。一会议亮点四场全体会议主旨报告领航未来今年的主旨报告（Plenaries）将延续ASN历年的高水准阵容，每日呈现不同主题的前沿思考：开幕式主旨11月6日ASN主席致辞后，Vlado Perkovic教授将带来题为“Yes We Can … Cure Kidney Diseases”的前沿讲座，探讨肾脏疾病“可治愈时代”的到来；并将重磅揭晓两项高影响力临床试验结果。专家讨论环节将由Julie R. Ingelfinger和Alan S. Kliger主持。系统生物学专题11月7日Julio Saez-Rodriguez教授的“Systems Biology of Kidney Diseases”将展示AI与组学时代下的肾脏疾病系统生物学图谱，Laura Barisoni、Matthias Kretzler与 Navdeep Tangri等共同参与讨论。前沿专题讲座11月8日Vertex Pharmaceuticals首席执行官Reshma Kewalramani教授将发表“On Kidney Medicine, Drug Development, and Coming Home”，回顾肾病药物研发之路；紧随其后，心理学家Michael Ungar博士以“Resilience at Work and at Home”探讨科研与临床中的心理韧性建设。压轴主题：异种移植11月9日伴随器官短缺危机，异种移植（Xenotransplantation）成为本届大会最受关注的议题。David K. C. Cooper、Paul E. Klotman、Robert A. Montgomery 及 Leonardo V. Riella等专家将围绕手术技术、伦理、转化科学及支付机制展开全景讨论。值得一提的是，两位肾脏病学领域的杰出代表——Reshma Kewalramani博士和Robert A. Montgomery博士——成功入选2025年《TIME》杂志全球最具影响力人物100强。他们的当选彰显了肾脏病学在全球健康领域日益提升的重要性。二前沿研究Late-Breaking Clinical Trials全面升级ASN 2025将继续强化“Late-Breaking Clinical Trials（LBCTs）”板块，聚焦AKI、CKD、糖尿病肾病、透析、遗传病、肾小球疾病、移植等方向。学术联动：与JASN、JAMA、Lancet、NEJM等顶级期刊同步合作，促进研究成果即时传播。亮点机制：两项高影响力临床试验将登上开幕式主旨舞台；【TH-OR082】Finerenone in CKD and Type 1 Diabetes非奈利酮在1型糖尿病合并慢性肾病患者中的疗效研究报告人：Hiddo J.L. Heerspink【TH-OR083】ORIGIN 3: A Phase 3 Trial of Atacicept in IgANORIGIN 3：Atacicept治疗IgA肾病的Ⅲ期临床试验报告人：Richard A. Lafayette此外设有多场LBCT口头报告与海报展示：两场高影响力临床试验（High-Impact Clinical Trials）专场：分别于11月7日和11月8日的10:30-12:30在Hall A举行，共公布12项研究结果；三场最新研究口头报告（Late-Breaking Research Orals）专场：分别于11月6、7、8日的16:30-18:00在Grand Ballroom C举行，共公布18项研究结果。包括11月6日开幕式上公布的两项精选高影响力临床试验，累计有32项最新临床试验进展与参会者分享。44项最新研究壁报（Late-Breaking Research Posters）将于11月6日10:00-12:00在Exhibit Hall供与会者浏览。12项高影响力临床试验　【FR-OR082】透析患者每日补充鱼油预防严重心血管事件发生的研究（PISCES）——讲者：Charmaine E. Lok　【FR-OR083】摆脱急性透析研究（LIBERATE-D）——讲者：Chi-yuan Hsu　【FR-OR084】急性肾损伤预警的个体化治疗效应建模：一项随机试验——讲者：Laura Aponte Becerra　【FR-OR085】老年肾移植受者中比较依维莫司联合低剂量他克莫司与霉酚酸酯联合他克莫司免疫抑制方案的随机临床试验：OPTIMIZE 研究——讲者：Stefan P. Berger　【FR-OR086】SGLT2 抑制剂按糖尿病状态和蛋白尿分层的净效应——讲者：Natalie Staplin　【FR-OR087】在合并心血管疾病及极高肾脏风险的2型糖尿病患者中，替尔泊肽较度拉鲁肽可显著降低主要肾脏事件风险——讲者：Sophia Zoungas　【SA-OR082】Setanaxib治疗Alport综合征患者的Ⅱa期随机、双盲、安慰剂对照试验：安全性与初步疗效结果——讲者：Daniel P. Gale　【SA-OR083】泰它西普治疗IgA肾病患者的疗效与安全性：Ⅲ期临床研究A阶段结果——讲者：吕继成　【SA-OR084】REGENCY研究中临床应答之外：奥滨尤妥珠单抗对活动性狼疮性肾炎患者组织学缓解的影响——讲者：Brad Rovin　【SA-OR085】糖基化改造Ⅱ型抗CD20单抗MIL62治疗原发性膜性肾病的疗效与安全性：Ⅲ期随机对照试验——讲者：崔昭　【SA-OR086】斯贝利单抗治疗IgA肾病：VISIONARY Ⅲ期研究中期及预设亚组分析结果——讲者：Vlado Perkovic　【SA-OR087】Balcinrenone联合达格列净治疗对CKD患者蛋白尿的影响：疗效与安全性分析——讲者：Hiddo J.L. Heerspink18项最新研究口头报告　【TH-OR084】POINTER：RMC-035在心脏手术后高肾损伤风险参与者中的Ⅱb期、随机、安慰剂对照、双盲剂量探索临床试验——讲者：Jay L. Koyner　【TH-OR085】蛋白尿变化作为肾衰竭替代终点：随机对照试验的更新荟萃分析——讲者：Hiddo J.L. Heerspink　【TH-OR086】提高CKD患者血管紧张素转换酶抑制剂（ACEI）/ 血管紧张素受体阻滞剂（ARB）使用率的临床决策支持工具——讲者：Sankar D. Navaneethan　【TH-OR087】提高SGLT2抑制剂使用率的学习型健康系统干预措施——讲者：Areef Ishani　【TH-OR088】中心延长夜间透析与常规日间透析的对比：NightLife试验——讲者：James Burton　【TH-OR089】Tegoprubart 预防肾移植排斥反应的有效性和安全性：Ⅱ期BESTOW试验结果——讲者：Andrew B. Adams　【FR-OR088】口服小分子GLP-1受体激动剂HRS-7535在糖尿病肾病患者中的有效性和安全性——讲者：杜晓英　【FR-OR089】司美格鲁肽对2型糖尿病肾病的作用机制：REMODEL试验——讲者：Katherine R. Tuttle　【FR-OR090】血清钾、高钾血症，以及高钾血症对恩格列净、非奈利酮单独或联合治疗疗效的影响：CONFIDENCE试验报告——讲者：Rajiv Agarwal　【FR-OR091】新型醛固酮合酶抑制剂（ASI）Lorundrostat在未控制高血压、CKD及蛋白尿患者中的应用：Explore-CKD研究结果——讲者：Matthew R. Weir　【FR-OR092】肾小球滤过率和蛋白尿对SGLT2抑制剂肾脏结局影响的作用——讲者：Brendon Lange Neuen　【FR-OR093】成人CKD的全球、区域及国家疾病负担：全球疾病负担研究的最新系统分析——讲者：Patrick B. Mark　【FR-OR094】社区卫生工作者对拉丁裔透析患者的支持：Navigate-Kidney随机临床试验——讲者：Lilia Cervantes　【SA-OR088】抗CD19/B细胞成熟抗原（BCMA）嵌合抗原受体自然杀伤细胞（CAR-NK）疗法在难治性系统性红斑狼疮（SLE）儿童患者中的安全性和有效性：一项初步临床研究——讲者：Hanyan Meng　【SA-OR089】Farabursen增加ADPKD患者尿多囊蛋白1和多囊蛋白2平并降低身高校正总肾体积增长——讲者：Alan S. Yu　【SA-OR090】评估以全面肾脏替代治疗（KRT）为导向的终末期肾病前期（Pre-ESKD）教育（CoPE）对退伍军人家庭透析影响的试验（TEACH-VET）：评估 KRT 决策状态（KDS）结局——讲者：Ashutosh M. Shukla　【SA-OR091】Povetacicept治疗IgAN和原发性膜性肾病（pMN）患者48周的有效性和安全性：RUBY-3 研究——讲者：James A. Tumlin　【SA-OR092】口服甲泼尼龙对IgAN患者肾脏结局的长期影响：试验后观察性研究TESTING-ON的结果——讲者：Muh Geot Wong三前导课程从AI到精准治疗11月5日的“Early Programs”将率先揭开序幕，共设7个全天专题课程，形式为现场小班研讨：生成式人工智能在肾脏病研究与管理中的应用（Generative AI in Kidney Disease）；肾移植候选者与受者管理；糖尿病与肾脏照护中的新技术与新药物；床旁超声在肾脏病学中的应用（限80人）；临床遗传学；肾小球疾病：2025更新；居家透析：扩展可及性与未来展望；每一项课程均提供继续教育学分，参会者可任选其一。四学术与社交共聚休斯敦所有主要活动将于George R. Brown Convention Center 举行。Welcome Reception：11月6日18:00–19:00，于展览大厅举行，提供交流与社交平台。五致敬卓越ASN 2025年度奖项会议期间还将颁发多项学术荣誉，包括：Barbara T. Murphy奖、Homer W. Smith奖、Donald W. Seldin青年研究者奖、总统奖章等终身成就奖或青年奖项；以及杰出临床服务奖、杰出教育家奖、杰出领导者奖、杰出导师奖、杰出研究者奖等中期职业生涯奖项。结语无论是突破性的临床试验、系统生物学与AI的跨界融合，还是异种移植的伦理与技术新边界，ASN Kidney Week 2025都预示着肾脏医学正迈入一个更加开放、智能与协作的新时代。休斯敦的11月，将再次成为全球肾脏科学的焦点。ASN Kidney Week 2025更多报道请关注肾医线微信公众号（Nephrology on-line）（来源：《肾医线》编辑部）声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

AHA会议临床3期

2025-11-04

·Firstwordpharma

After pain setback, Vertex spotlights renal portfolio in expectation-beating Q3

After disclosing a setback for its neuropathic pain aspirations during its second-quarter earnings report, Vertex Pharmaceuticals was eager to highlight some positive pipeline momentum Monday on its third-quarter call (see – Spotlight On: Despite setbacks, Vertex keeps its eyes on the chronic pain prize and Vital Signs: Winners and losers of the third quarter). But while management was bullish on its lead nephropathy candidate, povetacicept — and despite a consensus-beating financial print — the biotech's shares still fell about 4% during after-hours trading.Vertex reported total third-quarter revenues of $3.08 billion and adjusted earnings per share (EPS) of $4.80, ahead of analyst expectations of $3.05 billion and $4.56, respectively. The revenue figure also marked an 11% increase over the same period last year, when it recorded sales of $2.77 billion.Its cystic fibrosis franchise continues to bring in the bulk of its revenue, responsible for $2.9 billion in the third quarter, while its blood disease gene therapy Casgevy saw sales of $16.9 million and non-opioid pain drug Journavx had $19.6 million in sales. The drugmaker also slightly raised the bottom end of its full-year guidance. Vertex now expects revenues in the range of $11.9 billion to $12 billion, up from $11.85 billion to $12 billion. Analysts are projecting about $12 billion in revenues. Looking ahead to renalDuring Vertex's call with investors, CEO Reshma Kewalramani highlighted the best-in-class potential of povetacicept — which it gained last year in its $4.9-billion takeover of Alpine Immune Sciences — in a range of kidney diseases, as well as the company's efforts to bring it to market as fast as possible. Vertex will start a rolling FDA submission for accelerated approval in IgA nephropathy (IgAN) FDA by year-end, with the filling expected to be completed in the first half of 2026. Kewalramani confirmed that Vertex will use a priority review voucher to speed along the review of the dual BAFF/APRIL antagonist. A Phase III confirmatory trial in patients with IgAN is fully enrolled, she added, and a pivotal Phase II/III in patients with primary membranous nephropathy (PMN) is underway. Povetacicept has breakthrough therapy status in the former indication, and a fast track designation for the latter. "We expect that our renal franchise will become a significant growth driver and value generator for Vertex over the next several years," said Chief Commercial Officer Duncan McKechnie during the call. Povetacicept "is the only dual BAFF/APRIL inhibitor in pivotal trials for multiple serious kidney diseases, IgAN and PMN. We believe [povetacicept] has a superior mechanism of action, a superior clinical profile and will deliver a superior patient experience."

临床3期并购财报突破性疗法快速通道

2025-11-04

·雪球

福泰制药（VRTX）2025年第三季度财报分析报告一、核心财务数据

福泰制药（VRTX）2025年第三季度财报分析报告一、核心财务数据：营收符合预期，盈利能力稳健2025年第三季度，福泰制药凭借核心产品的稳定增长与新获批药物的初期贡献，业绩基本符合市场预期，盈利端保持稳健态势。•营收：当季营收达30.59亿美元，与分析师一致预测的30.56-30.59亿美元区间持平，同比增长10.36%，增长动力主要来自囊性纤维化（CF）药物矩阵的持续渗透及新上市疗法的早期收入贡献。•利润：归属于普通股股东的净利润为10.33亿美元，同比大幅增长128.74%；基本每股收益（EPS）达4.02美元，接近分析师预测的4.105美元，同比增幅128.88%，盈利提升得益于规模效应释放与高毛利创新药收入占比上升。•费用结构：研发费用为9.78亿美元，同比微增1.22%，占营收比重约32%，投入重点集中在基因编辑、肾病及糖尿病等管线；销售和管理费用4.25亿美元，同比增长14.08%，主要用于新药物上市后的市场推广。•财务储备：截至季度末，公司市值约1045.54亿美元，市盈率（TTM）为29.95倍，处于生物制药行业合理估值区间，财务结构稳健为后续研发与商业化提供支撑。二、业务板块拆解：核心产品领跑，多领域管线突破1.囊性纤维化（CF）：产品矩阵持续主导市场CF治疗领域仍是公司营收核心支柱。第三季度，新获批药物Alyftrek（Vanzatriple）在欧美市场推进顺利，已在美国、英国、欧盟及加拿大获得批准，并在英格兰、德国等地区实现医保报销覆盖，逐步打开患者可及性。作为第五款CFTR调节剂，其针对6岁及以上特定基因突变患者，进一步完善了公司CF患者全生命周期治疗方案，预计2030年销售额将达83亿美元。同时，针对剩余5%未被现有药物覆盖的CF患者，与Moderna合作的mRNA疗法VX-522已恢复临床试验，第一/二期多剂量给药推进中，有望填补市场空白。2.基因编辑与细胞疗法：商业化与研发双线提速全球首个获批的基因编辑疗法CASGEVY（Exa-cel）在镰状细胞病（SCD）和β-地中海贫血（TDT）领域的全球商业化动能持续增强，第三季度在欧美市场的处方量稳步提升，成为第二增长曲线的核心抓手。在1型糖尿病领域，异体胰岛细胞疗法Zimislecel（VX-880）的关键性研究即将完成入组，12名随访超一年的患者中10人实现胰岛素脱离，计划2026年提交全球上市申请，瞄准6万名重症患者市场。3.疼痛管理：产品分化，聚焦慢性适应症非阿片类镇痛药Suzetrigine（JOURNAVX）在急性疼痛适应症获批后，上市前6个月获得积极的医生与患者反馈，但另一款钠离子通道抑制剂VX-993的急性疼痛II期试验未达主要终点，公司已终止其单药急性疼痛开发，转而推进其在糖尿病性外周神经病变（DPN）等慢性疼痛领域的研究。目前Suzetrigine已获DPN突破性疗法认定，第二项III期研究即将启动，目标2026年底前完成入组，力争将DPN打造为首个外周神经病变适应症。4.肾病领域：多条管线进入关键阶段针对APOL1介导的肾病（AMKD）的Inaxaplin已完成10-17岁青少年患者入组，关键试验中期分析队列招募推进中，若结果积极将申请加速批准；针对IgA肾病（IgAN）的Povetacicept已与FDA达成共识，即将启动二/三期适应性研究，同时皮下注射剂型研发同步开展。此外，首创ADPKD治疗药物VX-407于本季度启动概念验证试验，针对30万患者群体中10%的适用人群，有望填补病因治疗空白。三、盈利质量与财务健康：研发投入精准，规模效应凸显1.盈利效率持续优化本季度营业利润达11.54亿美元，同比大幅增长23.46%，扭转了去年同期的下滑趋势。高毛利创新药（CF药物及基因编辑疗法毛利率通常超80%）收入占比的提升，推动盈利端持续改善。尽管研发费用绝对值保持高位，但增速（1.22%）显著低于营收增速，投入产出比进一步优化。2.财务结构风险可控公司当前市盈率29.95倍，显著低于生物科技行业高增长企业的平均水平，估值与业绩增长匹配度较高。截至此前季度，公司无重大债务压力，流动资产储备充足，能够支撑多个III期项目推进及新药物商业化落地，财务抗风险能力强劲。四、未来指引与市场反应：全年目标明确，管线价值受关注1.业绩指引保持稳定公司重申2025年全年营收指导范围为118.5亿美元至120亿美元，以第三季度30.59亿美元营收计算，全年目标完成率已达76.5%，剩余季度有望凭借Alyftrek医保报销扩容及CASGEVY销售放量实现目标。2.市场与分析师反馈财报发布后，市场对其核心业务的稳定性及管线进展给予认可。分析师指出，福泰制药“五年内五款新药上市”（至2028年）的目标具备可行性，其中CASGEVY与Zimislecel有望成为年销售额超50亿美元的重磅炸弹，而肾病管线的推进将进一步打开长期增长空间，但VX-993等项目的临床挫折需持续关注。五、风险提示1.研发失败风险：疼痛领域VX-993急性适应症终止开发显示临床不确定性，后续肾病、神经疾病等管线若出现数据不及预期，将影响增长预期。2.医保谈判压力：Alyftrek等新药物在欧洲多国的医保报销谈判若进展缓慢，或导致市场渗透不及预期，挤压利润空间。3.市场竞争加剧：CF领域面临其他CFTR调节剂企业的份额争夺，基因编辑疗法领域亦有CRISPRTherapeutics等对手布局，竞争可能分流市场需求。4.新适应症拓展风险：Suzetrigine在DPN等慢性疼痛领域的临床推进若延迟，可能错失非阿片类镇痛药的市场窗口期。六、总结福泰制药2025年Q3财报呈现“核心业务稳增长、管线进展超预期”的特征：CF药物矩阵持续贡献营收基本盘，Alyftrek商业化提速；CASGEVY与Zimislecel等创新疗法成为增长新引擎，肾病等新领域布局打开长期空间。尽管部分临床项目遇挫，但整体研发管线推进有序，盈利端的规模效应持续释放。短期来看，全年业绩目标的确定性较强，新药物医保落地将驱动营收增长；长期则需关注基因编辑疗法的全球放量节奏、1型糖尿病与肾病管线的临床数据，以及新适应症拓展的成功率。当前估值处于合理区间，投资者可重点跟踪核心管线的商业化与研发里程碑进展。

财报基因疗法细胞疗法信使RNA上市批准

100 项与 Povetacicept 相关的药物交易

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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
特发性膜性肾病	临床3期	美国	Vertex Pharmaceuticals, Inc.	2025-09-30
免疫球蛋白a肾病	临床3期	美国	Alpine Immune Sciences, Inc.	2024-08-30
免疫球蛋白a肾病	临床3期	中国	Alpine Immune Sciences, Inc.	2024-08-30
免疫球蛋白a肾病	临床3期	中国	Zai Lab Ltd.	2024-08-30
免疫球蛋白a肾病	临床3期	日本	Alpine Immune Sciences, Inc.	2024-08-30
免疫球蛋白a肾病	临床3期	澳大利亚	Alpine Immune Sciences, Inc.	2024-08-30
免疫球蛋白a肾病	临床3期	奥地利	Alpine Immune Sciences, Inc.	2024-08-30
免疫球蛋白a肾病	临床3期	比利时	Alpine Immune Sciences, Inc.	2024-08-30
免疫球蛋白a肾病	临床3期	巴西	Alpine Immune Sciences, Inc.	2024-08-30
免疫球蛋白a肾病	临床3期	加拿大	Alpine Immune Sciences, Inc.	2024-08-30

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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


NCT05732402 (RUBY-3, ISN WCN2024) 人工标引	临床1/2期	免疫球蛋白a肾病 galactose-deficient IgA1 (Gd-IgA1)	12	Povetacicept 80 mg	觸鑰窪齋廠襯鑰膚齋遞(齋鬱鏇膚蓋鹽淵築簾製) = Povetacicept has been well tolerated, with the majority of treatment-emergent adverse events being of low grade and none leading to treatment discontinuation or dose reduction/interruption. 鬱構簾鹹齋顧築艱醖鏇 (淵積糧憲餘襯網願積鏇 )	积极	2024-04-01
NCT05732402 (RUBY-3, ASN2023) 人工标引	临床1/2期	肾小球肾炎	13	povetacicept 80 mg	鏇鑰壓構糧窪願膚範衊(夢夢衊鹹鹹蓋鏇鑰餘選) = 膚齋糧鹹網製選膚顧廠鑰窪蓋壓積憲廠觸醖選 (製鹽壓膚願夢鹽廠艱鑰 )	积极	2023-11-02
NCT05732402 (RUBY-3, BusinessWire) 人工标引	临床1/2期	免疫球蛋白a肾病	-	povetacicept	齋積築繭築醖顧蓋網艱(繭鹹鹽鏇窪鹽夢艱糧鏇) = in the first IgAN dose cohort (80 mg subcutaneously once every 4 weeks) has been safe and well-tolerated to date, with no serious or severe adverse events, no events of hypogammaglobulinemia (IgG < 3g/L), and no instances of hypersensitivity or administration-related reactions. 衊衊獵網築鏇選積鹹築 (糧夢鬱繭遞衊餘廠餘鏇 )	积极	2023-08-30