A Sequential Phase 2/3, Single-Arm, Open-Label Study in Adults Followed by a Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of APL2 in Adults and Adolescents With Focal Segmental Glomerulosclerosis

This is a sequential phase 2/3 study to evaluate the efficacy and safety of twice-weekly subcutaneous (SC) infusions of APL2 in patients diagnosed with FSGS. The initial phase 2 portion is a single-arm, open-label study in adults diagnosed with FSGS. Phase 2 will commence prior to randomizing for phase 3. The phase 3 portion of the study is a randomized, placebo-controlled, double-blinded, multicenter study in adults and adolescents diagnosed with FSGS.

开始日期2026-12-01

申办/合作机构

Apellis Pharmaceuticals, Inc.

NCT07495722

/ Not yet recruiting临床1期IIT

Safely Quenching Complement in Stroke Subjects: A Phase 1 Safety Trial

This study will include adults (ages 18-80) who have had a stroke caused by a large blood clot blocking blood flow in the brain. All patients in the study must have already had a treatment called a thrombectomy, where doctors remove the clot to help blood flow return to the brain.
The goal of this study is to test the safety of a drug called EMPAVELI (pegcetacoplan). This drug is meant to lower swelling and inflammation that can happen after blood flow returns. The hope is that it may help protect the brain from more damage and improve recovery.
People in the study will get three doses of EMPAVELI through an EMPAVELI-designed pump 0-3 hours post thrombectomy surgery and 24 and 48 hours after the initial dose. Doctors will check them with exams, blood tests, brain scans, and other tests while they are there. Patients will also have follow-up visits at 30 and 90 days to see how they are doing, per the usual standard of care.
This research is important because, even with current stroke treatments, many patients still have problems like disability. If this drug is found to be safe, it could lead to better treatments to protect the brain and help people recover more fully after a stroke.

开始日期2026-10-01

申办/合作机构

Columbia University

JPRN-jRCT2031260416

/ RecruitingN/A

Specified Drug Use-Results Survey of Empaveli (Long-term Use, All-Case Surveillance in Patients with C3 Glomerulopathy or Primary Immune Complex Membranoproliferative Glomerulonephritis)

开始日期2026-08-24

申办/合作机构-

100 项与 Pegcetacoplan 相关的临床结果

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100 项与 Pegcetacoplan 相关的转化医学

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100 项与 Pegcetacoplan 相关的专利（医药）

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232

项与 Pegcetacoplan 相关的文献（医药）

2026-12-31·Hematology

Real-world clinical outcomes and treatment response in complement inhibitor experienced and naïve PNH patients prescribed pegcetacoplan in Europe and Canada

Article

作者: Panse, Jens ; Kerr, Brianne ; Hatchell, Niall ; Williamson, Sam ; Czech, Barbara ; Wilson, Koo ; Patriquin, Christopher J. ; Taylor, Yasmin ; Llamas, Juan Carlos Vallejo ; Hakimi, Zalmai

OBJECTIVES:

This study investigated outcomes and response to pegcetacoplan in complement inhibitor naïve (CI_naïve) and experienced (CI_exp) PNH patients.

METHODS:

Data were drawn from the Adelphi PNH Disease Specific Programme™, a cross-sectional survey of physicians and their patients in Canada, France, Germany, Italy, Spain, and the UK between December 2023 and April 2024. Physicians reported patient characteristics and clinical outcomes, which were used to define pegcetacoplan response. Results were stratified by prior CI prescription. Analyses were descriptive.

RESULTS:

Forty-eight physicians reported on 63 patients (CI_naïve:11; CI_exp:52). Median (IQR) age was 45.0 (33.0-55.0) years, 60.3% were male. At treatment initiation versus at survey for CI_naïve and CI_exp, respectively, median (IQR) haemoglobin levels (g/dL) were 8.0 (5.0-9.0) versus 12.0 (11.2-12.3), and 9.0 (8.0-9.2) versus 11.0 (10.2-12.0); lactate dehydrogenase levels (U/L) were 500 (350-1625) versus 250 (175-525), and 470 (290-588) versus 265 (190-379); absolute reticulocyte counts (x10⁹ /L) were 220 (151-250) versus 110 (95-140), and 212 (134-281) versus 120 (105-228). At pegcetacoplan initiation, 4.4% of patients met criteria of good-to-complete response versus 79.5% at survey.

CONCLUSIONS:

Pegcetacoplan proved effective for CI_naïve and CI_exp patients in a real-world setting, with numerically improved clinical outcomes and high response rate.

2026-12-31·Hematology

Real-world pegcetacoplan treatment of paroxysmal nocturnal hemoglobinuria patients with an unsatisfactory response to prior therapies

Article

作者: Vara, Míriam ; González, Ataúlfo ; Benet, Carmen ; Díaz, Bianca ; Vallejo, Carlos ; Martí, Jaime ; Tormo, Mar ; Morado, Marta ; de la Iglesia, Silvia ; González-Rodríguez, Ana Pilar ; Bonanad, Santiago ; Melero, Virginia ; Torres, Williana ; Lavilla, Esperanza ; Benéitez, David ; Fernández, Ana ; Carnicero, Fernando ; on behalf of PETHEMA (Spain) ; Vidán, Julia ; González, Carmen ; Gaya, Anna ; Salido, Eduardo ; Sánchez, Piva ; Hernández, Inés

OBJECTIVES:

Terminal complement inhibitors can control intravascular hemolysis in Paroxysmal Nocturnal Hemoglobinuria (PNH) patients, although the hematological response achieved may not persist, and it may become unsatisfactory. The proximal (C3) complement inhibitor Pegcetacoplan (PEG) improves this situation in clinical trials, yet real-world data on its efficacy and safety are scarce.

METHODS:

This non-interventional, retrospective, multicenter study presents clinical and hematological data from the first PNH patients in Spain treated with PEG (n = 32, median 13 months, range 4-61).

RESULTS:

PEG rapidly increases the patient's hemoglobin (median increase of 2.65 g/dL in 4 weeks, > 2 g/dL increase in 56.3% of patients), reaching > 8, 10 and 12 g/dL in 93.7%, 87.5% and 46.9% of patients, respectively. Packed red blood cell transfusion requirements dropped from 62.5% to 15.6% of patients treated with PEG, and there was a fall in breakthrough hemolysis from 34.4% to 9.4% after 6 months of treatment. No thrombosis and only mild adverse events (n = 11 patients) were described with PEG therapy. Finally, physicians perceived important enhancements in patients' health-related quality of life.

DISCUSSION:

This real-world clinical data confirms that PEG produces significant and rapid improvements in hemoglobin and hemolytic parameters, with a favorable safety profile. The data extends that of earlier clinical trials and small real-world studies by offering a longitudinal (as opposed to cross-sectional) assessment of the patient responses across a large number of centers, following a variety of clinical practices..

CONCLUSION:

PEG treatment of patients with PNH produces significant and rapid improvements in hemoglobin and hemolytic parameters, with a favorable safety profile.

2026-12-31·Hematology

Switching patients with PNH from pegcetacoplan to iptacopan: a case series

Article

作者: Dingli, David ; Gurnari, Carmelo ; Maciejewski, Jaroslaw ; Sanikommu, Srinivasa ; Orland, Mark

OBJECTIVES:

Limited published data exist on switching therapy from pegcetacoplan to iptacopan in patients with paroxysmal nocturnal hemoglobinuria (PNH).

METHODS:

Three patient cases were collected from the Mayo Clinic, Cleveland Clinic, and Levine Cancer Institute.

RESULTS:

Patient 1 is a 57-year-old woman with PNH. She experienced extravascular hemolysis (EVH) while on C5 inhibitors and breakthrough hemolysis (BTH) after switching to pegcetacoplan. Patient 2 is a 37-year-old woman seeking care for PNH, who was initiated on C5 inhibitor therapy and switched to pegcetacoplan. EVH and BTH were observed while she was on C5 inhibitor therapy, and transfusions were required with both C5 inhibitor and pegcetacoplan therapy. Patient 3 is a 58-year-old man with aplastic anemia and PNH who was initiated on C5 inhibitor therapy, then switched to pegcetacoplan. He experienced both EVH and BTH.

DISCUSSION:

All three patients switched from pegcetacoplan to iptacopan, and none experienced EVH or BTH while on iptacopan. After switching to iptacopan, all three patients improved hemoglobin levels and abating transfusion requirements.

CONCLUSION:

In this case series, three patients with PNH were successfully transitioned from pegcetacoplan to iptacopan monotherapy. No patients exhibited laboratory evidence of BTH, EVH, or intravascular hemolysis after switching to iptacopan.

707

项与 Pegcetacoplan 相关的新闻（医药）

2026-09-01

·allsci.com

Ocugen launches Phase III trial of one-time gene therapy for geographic atrophy

Ocugen (Nasdaq: OCGN) has dosed the first patient in ArMaDa3, a global Phase III registrational trial of OCU410, an AAV5-based modifier gene therapy for geographic atrophy (GA) secondary to dry age-related macular degeneration. The company describes ArMaDa3 as the first pivotal gene therapy trial in GA, marking a notable development in a field where approved treatments require repeated intravitreal injections and have not consistently demonstrated corresponding functional vision benefits. OCU410 delivers the retinoid-related orphan receptor alpha (RORA) gene through an AAV5 vector with the aim of modulating complement activation, neuroinflammation, oxidative stress, and lipid dysregulation. The approach differs from the two approved US GA drugs, Apellis Pharmaceuticals' Syfovre (pegcetacoplan), a C3 inhibitor, and Astellas Pharma's Izervay (avacincaptad pegol), a C5 inhibitor. Izervay is also approved in Australia and Macau and conditionally approved in Japan, while Syfovre failed to secure EU approval following a negative EMA review. ArMaDa3 will enroll 237 patients with GA secondary to dry AMD and randomize them 2:1 to a single 200 µL subretinal injection of OCU410 or an untreated control. The primary endpoint is the rate of change in square root-transformed GA lesion area by fundus autofluorescence at 12 months. Secondary measures include sustained loss of at least 15 ETDRS letters in low-luminance visual acuity and change in ellipsoid zone area by optical coherence tomography. The study design followed a July 2026 Type B End-of-Phase 2 meeting with the US FDA's Center for Biologics Evaluation and Research, where Ocugen said it reached alignment on the dose, endpoints, and use of a single adequate and well-controlled Phase III study to support a potential Biologics License Application. The company is targeting a BLA filing in 2028 and is also engaging the EMA on whether the same dataset could support a European filing. The program received FDA Regenerative Medicine Advanced Therapy designation in July 2026 based on Phase II data. RMAT provides benefits available under Breakthrough Therapy designation, including intensive FDA interaction and potential rolling review, while accelerated approval or priority review would remain subject to the relevant regulatory criteria. The Phase III study is supported by 12-month Phase II ArMaDa data from 51 patients. Ocugen reported a statistically significant 31% reduction in GA lesion growth at the selected medium dose versus untreated control, alongside a 27% reduction in ellipsoid zone loss. Seventy-five percent of treated patients showed more than 30% reduction in lesion growth, and no OCU410-related serious adverse events or adverse events of special interest were reported. Ocugen has said the 31% lesion-growth reduction compares favorably with effects reported for Syfovre and Izervay, although cross-trial comparisons are limited by the small Phase II sample and differences in study design, including ArMaDa's untreated control versus the sham-controlled pivotal trials used for the approved complement inhibitors. OCU410 also has Advanced Therapy Medicinal Product classification from the EMA. If a single administration can produce durable benefit, the approach could reduce the treatment burden associated with chronic complement inhibition. The central Phase III questions will be whether the Phase II anatomical benefit is reproduced in a larger registrational population and whether it translates into sustained functional benefit. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article

临床3期临床2期临床结果突破性疗法上市批准

2026-08-31

·青白视角

从“束手无策”到“主动干预”—地图样萎缩(GA)诊疗开启新篇章

前言地图样萎缩（GA）是晚期年龄相关性黄斑变性（AMD）的重要表现，以视网膜色素上皮（RPE）、光感受器和脉络膜毛细血管的进行性萎缩为特征，最终可导致中心视力不可逆丧失。长期以来，GA因其早期症状隐匿且无有效治疗方案，在临床上被忽视。如今，随着补体通路机制研究的突破和补体靶向药物的问世，GA正式迈入主动干预的新时代。近期，青白视角・眼畅家栏目特邀国际眼科科学院院士、希玛医疗集团创始人林顺潮教授，以及安斯泰来中国区总裁赵萍女士、安斯泰来中国区副总经理兼中国区医学事务部负责人李真博士，从临床痛点、产业布局到循证机制展开深度对话。本文旨在为国内GA诊疗体系的升级提供路径参考，搭建一座通向“早治疗、缓进展、保视力”的桥梁。医企对话：临床与创新的双向奔赴主持人两位这次坐在一起，最想跟对方说的是什么？林顺潮教授诊疗要有进步，不单是从临床医学方面，医生通过临床医学实践，知道病人的问题在哪里以及哪些问题最重要，把这些问题跟研发企业做交流、沟通，然后希望催生新的治疗概念，一步步从临床前到临床，最后能够上市，给患者使用。赵萍总裁林教授您说的这一席话，我深有感触，科学只有真正转化为患者的获益，才能体现它的社会价值。对我们企业而言，尤其是专注眼科研发与创新的企业，深入理解医生和患者的诉求、找准临床真正的未满足需求，再据此开发创新药物、服务患者，这是我们最核心的工作。展望未来，我特别希望企业能更早地与林教授这样顶尖的临床科研团队携手，从病因学、病理学的源头就介入，共同开发新的药物和技术，最终服务更多患者。 GA的临床全景与诊疗困境主持人林教授您好，从临床角度看，GA是一种怎样的疾病？它对患者日常生活会造成哪些影响？林顺潮教授首先我们来聊聊常说的黄斑变性。打个比方，眼底就相当于相机的传感器：光线经过晶状体聚焦，落到视网膜中央的黄斑区，再通过视神经把信号传到大脑，我们就能看清东西。黄斑一旦出问题，视力就会受影响。黄斑变性是老年人致盲的主要原因之一，大家看这张图，这片区域就是病变的黄斑。黄斑变性分为干性和湿性两类，我们今天的主题 —— 地图样萎缩，就属于干性黄斑变性。干性的病理机制是黄斑区萎缩、神经细胞坏死，所以患者的周边视野往往还保留着，比如活动时大致的空间感不受影响，但中央视力会出问题：看书、认人脸、看精细物体时，视物会变形、出现暗点，甚至完全看不清。视力若持续下降，最终可能导致失明。这里有一点很重要：如果只有一只眼发病，另一只眼代偿，日常生活可能感觉不到明显异常；但双眼都受累时，生活质量会受到极大影响。主持人目前国内GA诊疗面临哪些主要挑战？存在哪些未满足的临床需求？林顺潮教授黄斑变性分为干性和湿性两类。干性黄斑变性早期没有新生血管增生、也没有渗漏，几乎不影响视力。但它的发展有两条路径：一部分患者不经过湿性阶段，直接从早期干性进展为黄斑区萎缩，也就是我们说的继发于黄斑变性的地图样萎缩（GA）；另一部分患者先经历湿性黄斑变性，最终也会出现萎缩性改变。 GA 是黄斑变性中比较棘手的一种情况。湿性患者出现渗漏，可以用标准的抗 VEGF 药物治疗；但 GA 患者没有渗漏，缺乏湿性 AMD 那样典型的影像学表现，常规检查中容易被忽视 —— 而实际上，患者的神经细胞已经发生萎缩。目前诊断上的一大问题是，一看是干性黄斑变性，就误以为不用治或没法治，和湿性区别对待，因此没有得到足够重视。以往患者进展到 GA 这个阶段，临床上确实束手无策。当下的临床需求非常大：国内黄斑变性患者约 4000 万，其中 GA 占 0.5%–1%。随着人口老龄化加剧，加上临床对 GA 的关注度不断提升，我估计未来确诊GA的患者人数会不断增加。以未满足之需为航标的眼科布局主持人赵总您好，您提出“未被满足的临床需求是企业创新风向标”，安斯泰来是如何结合国内GA患者现状、临床端长期空白做出眼科赛道布局决策的？赵萍总裁安斯泰来是一家创新生物制药企业，始终坚持以患者为中心，填补治疗空白、满足患者需求是我们的使命。中国约有 200 万 GA 患者，但在现实中，实际诊断率不足 10%。GA 早期几乎没有感觉，患者不重视，就诊意识低，大部分的患者得到确诊的时候，已经发展为中晚期，错失了治疗的最佳时机，只能接受视力的损失，甚至失明。这是一个巨大的未被满足的医疗需求。创新药物的诞生只是治疗 GA 的第一步，我们将携手医院、医生和社会各界，提升 GA 认知和早筛，提高正确诊断率，尽早实现“早治疗、缓进展、保护患者的中心视力”，共同开启 GA 诊疗新篇章。主持人作为眼科赛道的“新入局者”，安斯泰来将如何构建自己的差异化优势和创新布局？赵萍总裁 “新入局者”的身份给了我们一个机会，用全新视角定义治疗范式，我们的策略可以概括为聚焦、突破、协同。首先是聚焦，GA 的临床需求非常迫切，科学基础扎实，患者诉求明确，是我们进入眼科领域的战略切入点，值得我们深耕。其次是突破，我们凭借细胞治疗、基因治疗等前沿技术，拥有业界领先的眼科管线，覆盖 GA、视网膜色素变性、青光眼等难治性疾病，其中ASP7317是一种更具变革性的细胞疗法，不仅延缓了 GA 的疾病进展，更可能改善视觉功能，目前已进入临床开发后期阶段。最后是协同，我们与眼科领域专家携手，提升临床医生对 GA 疾病的认知，建立规范化的诊断路径，搭建更完善的疾病管理体系，推动中国 GA 诊疗从“长期缺乏有效干预手段”迈向“早治疗、缓进展、保护中心视力”的新时代。从补体机制到循证数据的科学根基主持人李总您好，请您从医学视角分享下如何看待GA这一疾病在国内的临床诊疗现状？目前存在哪些亟待解决的难点？李真博士谈到 GA 在国内的诊疗现状，我想用一句话概括：疾病负担非常沉重，但认知体系相当薄弱。这两者之间的落差，恰恰需要我们用科学证据和体系化工作去填补。先看疾病负担。2020 年国内最新流调数据（2026年最新文献）显示，中国 GA 患者约 200 万例，整体患病率约 0.3%，其中两个趋势值得特别关注。一是 GA 本身：从 50 岁起，患病率随年龄快速上升，80 岁以上可达 1.6%。二是人口老龄化：我国老龄化正加速加深，联合国数据显示，目前 60 岁及以上人口约占总人口的 15%，预计到 2030 年将达到 30% 左右。在这样的老龄化背景下，GA 的疾病负担势必越来越重。再看对生活的影响。去年发表的一项大样本回顾性研究显示，GA 患者跌倒和骨折风险显著高于同龄老人，住院率和急诊就诊率也明显上升。可以说，GA 带来的不只是视力损失，更是对老年人独立生活能力的系统性侵蚀。但问题在于，我们现有的诊疗体系可能未准备好应对这一疾病，我把它归纳为三重短板。第一是认知短板：GA 早期症状不典型，患者极易误认为是老花或白内障，基层医生对干性与湿性 AMD 的鉴别意识也有待加强。第二是诊断能力短板：GA 确诊需要多模态影像联合判读，包括眼底彩照、自发荧光、OCT 等，但这些设备在基层普及率较低，判读能力也相对薄弱。第三是管理路径短板：GA 是终身进展性疾病，需要长期规律随访，但目前从筛查、确诊到定期监测的分级诊疗通路仍不健全。因此，改善 GA 诊疗格局需要从三个方面系统推进：提高早期识别率、建立标准化影像评估流程以提升诊断准确性、打通长期管理路径—— 这也是我们与国内专家持续合作的重点方向。主持人 GA的核心发病机制中，补体通路扮演了怎样的角色？目前靶向补体通路的干预策略有哪些？李真博士补体通路的异常过度激活，是目前公认驱动 GA 发生发展的核心机制。补体系统是人体一套古老而重要的固有免疫防御网络，负责清除病原体和受损细胞。但在 GA 患者眼中，该系统被持续异常激活，转而攻击自身的视网膜组织。图示补体系统通过三条通路激活：经典途径、旁路途径和凝集素途径。 2023 年，两款补体抑制剂在美国获批用于 GA 治疗，机制上分别作用于补体级联反应的不同环节。一款为 C3 抑制剂，作用于级联反应的中心环节，通过阻断 C3 及其下游反应，减少炎症介导的细胞损伤。另一款为 C5 抑制剂 ACP，通过抑制 C5 裂解，减少促炎介质 C5a 的生成，并抑制上述膜攻击复合物的形成，从而减轻下游补体介导的炎症与组织损伤。除这两款已获批疗法外，针对 GA 的其他机制疗法也在进一步开发中。主持人围绕补体疗法在GA治疗中的临床研究，有哪些关键数据值得关注？这些数据对国内临床实践意味着什么？李真博士 C3 抑制剂在美国的获批基于两项多中心 Ⅲ 期研究，结果显示持续补体 C3 抑制可减缓 GA 病灶扩大。C5 抑制剂 ACP 的关键临床证据则来自 GATHER-1 和 GATHER-2 两项研究：GATHER-1 的 12 个月结果显示，ACP 组 GA 面积增长较对照组相对降低 35.4%，这是随机对照研究首次证实 C5 抑制可显著延缓 GA 进展；GATHER-2 验证性研究同样达到主要终点。安全性方面，ACP 未报告严重眼部不良事件或眼内炎，无论每月还是隔月给药，耐受性均良好。这些数据对国内的启示在于：随着补体抑制疗法的发展，GA 治疗正从“无药可治”迈入“可延缓进展”的新阶段。以 ACP 为例，其延缓 GA 进展的证据已覆盖从关键性 Ⅲ 期临床研究到真实世界的多个层面。这不仅是治疗手段的突破，更代表认知上的根本转变 ——GA 不再是“束手无策”的疾病。这一转变，也将推动国内的影像随访标准化、病灶进展定量的评估和患者分层管理体系的加速建设。结语从“束手无策”到“可延缓进展”，地图样萎缩的治疗正在经历一次重要的范式转变。补体靶向疗法的突破，让临床首次拥有了主动干预疾病进程的工具，但药物只是起点。对于国内GA而言，真正需要补上的，是从疾病认知、早期识别、精准诊断到长期随访管理的完整链条。这既是医学的挑战，也是产业创新的机会。未来，随着更多循证证据和创新疗法进入临床，医、企及社会各方需要共同推动GA从“发现晚、诊断少、干预迟”，走向早识别、早干预、长期管理。当治疗手段与诊疗体系真正形成合力，GA才有望从长期被忽视的致盲性眼病，逐步走向可干预、可管理的慢性疾病。参考文献（上下滑动可查看） [1] Wu J, Shan S, Zhou J, Li Y, Ke Q, Zhu L, Rudan I, Song P; Global Health Epidemiology Research Group. National, regional, and provincial prevalence of age-related macular degeneration in China in 2020: an updated systematic review and modelling study. J Glob Health. 2026;16:04062 [2] Hu A, Teneralli RE, Rodriguez R, Abdul Sultan A, Garey C, Ackert J, Ong R. Falls and Fractures in Patients with Geographic Atrophy: A US Claims Data Analysis. Adv Ther. 2025 May;42(5):2234-2247. doi: 10.1007/s12325-025-03134-6. Epub 2025 Mar 13. PMID: 40080238; PMCID: PMC12006262. [3]Singh RP, Weng CY, Schwartz R, et al. Consideration of patient phenotypes in geographic atrophy due to age-related macular degeneration [J]. BMJ Open Ophthalmology, 2025, 10: e002105. [4]Goldberg RA, Boyer DS, Holz FG, et al. Pegcetacoplan for Geographic Atrophy Over 30 Months: Data From OAKS, DERBY, and the GALE Long-Term Extension Study. Ophthalmic Surgery, Lasers and Imaging Retina. 2025;56(7):398-406. doi:10.3928/23258160-20250217-01 [5]Astellas Pharma US, Inc. IZERVAY (avacincaptad pegol intravitreal solution) full prescribing information. Northbrook, IL: Astellas Pharma US; February 2025. FDA Access Data Reference ID 5530503. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217225s001lbl.pdf [6]Danzig CJ, Khanani AM, Kaiser PK, Chang MA, Kovach JL, Lally DR, Rachitskaya A, Sheth VS, Vajzovic L, Clark J, Tang J, Zhu L, Desai D, Chakravarthy U. Vision Loss Reduction with Avacincaptad Pegol for Geographic Atrophy: A 12-Month Post Hoc Analysis of the GATHER1 and GATHER2 Trials. Ophthalmol Retina. 2024 Nov;8(11):1052-1060. doi: 10.1016/j.oret.2024.04.023. Epub 2024 May 7. PMID: 38719191. [7]Jaffe GJ, Westby K, Csaky KG, Monés J, Pearlman JA, Patel SS, Joondeph BC, Randolph J, Masonson H, Rezaei KA. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021 Apr;128(4):576-586. doi: 10.1016/j.ophtha.2020.08.027. Epub 2020 Sep 1. PMID: 32882310. [8]Khanani AM, Patel SS, Staurenghi G, Tadayoni R, Danzig CJ, Eichenbaum DA, Hsu J, Wykoff CC, Heier JS, Lally DR, Monés J, Nielsen JS, Sheth VS, Kaiser PK, Clark J, Zhu L, Patel H, Tang J, Desai D, Jaffe GJ; GATHER2 trial investigators. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1449-1458. doi: 10.1016/S0140-6736(23)01583-0. Epub 2023 Sep 8. PMID: 37696275. [9]Khanani AM, Danzig CJ, Heier JS, et al. Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: two-year efficacy and safety results from the GATHER2 phase 3 trial. Ophthalmology. 2026;133(4):451-465. [10]Patel, P.N.; Patel, P.A.; Land, M.R.; Bakerkhatib-Taha, I.; Ahmed, H.; Sheth, V. Targeting the Complement Cascade for Treatment of Dry Age-Related Macular Degeneration. Biomedicines 2022, 10, 1884. https://doi.org/10.3390/biomedicines10081884 相关阅读：多模态成像在地图样萎缩中的作用青白视角全球眼健康创新技术产品开发及应用的专业交流合作平台

2026-08-31

·百度百家

从“束手无策”到“主动干预”—地图样萎缩(GA)诊疗开启新篇章

前言地图样萎缩（GA）是晚期年龄相关性黄斑变性（AMD）的重要表现，以视网膜色素上皮（RPE）、光感受器和脉络膜毛细血管的进行性萎缩为特征，最终可导致中心视力不可逆丧失。长期以来，GA因其早期症状隐匿且无有效治疗方案，在临床上被忽视。如今，随着补体通路机制研究的突破和补体靶向药物的问世，GA正式迈入主动干预的新时代。近期，青白视角・眼畅家栏目特邀国际眼科科学院院士、希玛医疗集团创始人林顺潮教授，以及安斯泰来中国区总裁赵萍女士、安斯泰来中国区副总经理兼中国区医学事务部负责人李真博士，从临床痛点、产业布局到循证机制展开深度对话。本文旨在为国内GA诊疗体系的升级提供路径参考，搭建一座通向“早治疗、缓进展、保视力”的桥梁。医企对话：临床与创新的双向奔赴主持人两位这次坐在一起，最想跟对方说的是什么？林顺潮教授诊疗要有进步，不单是从临床医学方面，医生通过临床医学实践，知道病人的问题在哪里以及哪些问题最重要，把这些问题跟研发企业做交流、沟通，然后希望催生新的治疗概念，一步步从临床前到临床，最后能够上市，给患者使用。赵萍总裁林教授您说的这一席话，我深有感触，科学只有真正转化为患者的获益，才能体现它的社会价值。对我们企业而言，尤其是专注眼科研发与创新的企业，深入理解医生和患者的诉求、找准临床真正的未满足需求，再据此开发创新药物、服务患者，这是我们最核心的工作。展望未来，我特别希望企业能更早地与林教授这样顶尖的临床科研团队携手，从病因学、病理学的源头就介入，共同开发新的药物和技术，最终服务更多患者。GA的临床全景与诊疗困境主持人林教授您好，从临床角度看，GA是一种怎样的疾病？它对患者日常生活会造成哪些影响？林顺潮教授首先我们来聊聊常说的黄斑变性。打个比方，眼底就相当于相机的传感器：光线经过晶状体聚焦，落到视网膜中央的黄斑区，再通过视神经把信号传到大脑，我们就能看清东西。黄斑一旦出问题，视力就会受影响。黄斑变性是老年人致盲的主要原因之一，大家看这张图，这片区域就是病变的黄斑。黄斑变性分为干性和湿性两类，我们今天的主题 —— 地图样萎缩，就属于干性黄斑变性。干性的病理机制是黄斑区萎缩、神经细胞坏死，所以患者的周边视野往往还保留着，比如活动时大致的空间感不受影响，但中央视力会出问题：看书、认人脸、看精细物体时，视物会变形、出现暗点，甚至完全看不清。视力若持续下降，最终可能导致失明。这里有一点很重要：如果只有一只眼发病，另一只眼代偿，日常生活可能感觉不到明显异常；但双眼都受累时，生活质量会受到极大影响。主持人目前国内GA诊疗面临哪些主要挑战？存在哪些未满足的临床需求？林顺潮教授黄斑变性分为干性和湿性两类。干性黄斑变性早期没有新生血管增生、也没有渗漏，几乎不影响视力。但它的发展有两条路径：一部分患者不经过湿性阶段，直接从早期干性进展为黄斑区萎缩，也就是我们说的继发于黄斑变性的地图样萎缩（GA）；另一部分患者先经历湿性黄斑变性，最终也会出现萎缩性改变。GA 是黄斑变性中比较棘手的一种情况。湿性患者出现渗漏，可以用标准的抗 VEGF 药物治疗；但 GA 患者没有渗漏，缺乏湿性 AMD 那样典型的影像学表现，常规检查中容易被忽视 —— 而实际上，患者的神经细胞已经发生萎缩。目前诊断上的一大问题是，一看是干性黄斑变性，就误以为不用治或没法治，和湿性区别对待，因此没有得到足够重视。以往患者进展到 GA 这个阶段，临床上确实束手无策。当下的临床需求非常大：国内黄斑变性患者约 4000 万，其中 GA 占 0.5%–1%。随着人口老龄化加剧，加上临床对 GA 的关注度不断提升，我估计未来确诊GA的患者人数会不断增加。以未满足之需为航标的眼科布局主持人赵总您好，您提出“未被满足的临床需求是企业创新风向标”，安斯泰来是如何结合国内GA患者现状、临床端长期空白做出眼科赛道布局决策的？赵萍总裁安斯泰来是一家创新生物制药企业，始终坚持以患者为中心，填补治疗空白、满足患者需求是我们的使命。中国约有 200 万 GA 患者，但在现实中，实际诊断率不足 10%。GA 早期几乎没有感觉，患者不重视，就诊意识低，大部分的患者得到确诊的时候，已经发展为中晚期，错失了治疗的最佳时机，只能接受视力的损失，甚至失明。这是一个巨大的未被满足的医疗需求。创新药物的诞生只是治疗 GA 的第一步，我们将携手医院、医生和社会各界，提升 GA 认知和早筛，提高正确诊断率，尽早实现“早治疗、缓进展、保护患者的中心视力”，共同开启 GA 诊疗新篇章。主持人作为眼科赛道的“新入局者”，安斯泰来将如何构建自己的差异化优势和创新布局？赵萍总裁“新入局者”的身份给了我们一个机会，用全新视角定义治疗范式，我们的策略可以概括为聚焦、突破、协同。首先是聚焦，GA 的临床需求非常迫切，科学基础扎实，患者诉求明确，是我们进入眼科领域的战略切入点，值得我们深耕。其次是突破，我们凭借细胞治疗、基因治疗等前沿技术，拥有业界领先的眼科管线，覆盖 GA、视网膜色素变性、青光眼等难治性疾病，其中ASP7317是一种更具变革性的细胞疗法，不仅延缓了 GA 的疾病进展，更可能改善视觉功能，目前已进入临床开发后期阶段。最后是协同，我们与眼科领域专家携手，提升临床医生对 GA 疾病的认知，建立规范化的诊断路径，搭建更完善的疾病管理体系，推动中国 GA 诊疗从“长期缺乏有效干预手段”迈向“早治疗、缓进展、保护中心视力”的新时代。从补体机制到循证数据的科学根基主持人李总您好，请您从医学视角分享下如何看待GA这一疾病在国内的临床诊疗现状？目前存在哪些亟待解决的难点？李真博士谈到 GA 在国内的诊疗现状，我想用一句话概括：疾病负担非常沉重，但认知体系相当薄弱。这两者之间的落差，恰恰需要我们用科学证据和体系化工作去填补。先看疾病负担。2020 年国内最新流调数据（2026年最新文献）显示，中国 GA 患者约 200 万例，整体患病率约 0.3%，其中两个趋势值得特别关注。一是 GA 本身：从 50 岁起，患病率随年龄快速上升，80 岁以上可达 1.6%。二是人口老龄化：我国老龄化正加速加深，联合国数据显示，目前 60 岁及以上人口约占总人口的 15%，预计到 2030 年将达到 30% 左右。在这样的老龄化背景下，GA 的疾病负担势必越来越重。再看对生活的影响。去年发表的一项大样本回顾性研究显示，GA 患者跌倒和骨折风险显著高于同龄老人，住院率和急诊就诊率也明显上升。可以说，GA 带来的不只是视力损失，更是对老年人独立生活能力的系统性侵蚀。但问题在于，我们现有的诊疗体系可能未准备好应对这一疾病，我把它归纳为三重短板。第一是认知短板：GA 早期症状不典型，患者极易误认为是老花或白内障，基层医生对干性与湿性 AMD 的鉴别意识也有待加强。第二是诊断能力短板：GA 确诊需要多模态影像联合判读，包括眼底彩照、自发荧光、OCT 等，但这些设备在基层普及率较低，判读能力也相对薄弱。第三是管理路径短板：GA 是终身进展性疾病，需要长期规律随访，但目前从筛查、确诊到定期监测的分级诊疗通路仍不健全。因此，改善 GA 诊疗格局需要从三个方面系统推进：提高早期识别率、建立标准化影像评估流程以提升诊断准确性、打通长期管理路径—— 这也是我们与国内专家持续合作的重点方向。主持人GA的核心发病机制中，补体通路扮演了怎样的角色？目前靶向补体通路的干预策略有哪些？李真博士补体通路的异常过度激活，是目前公认驱动 GA 发生发展的核心机制。补体系统是人体一套古老而重要的固有免疫防御网络，负责清除病原体和受损细胞。但在 GA 患者眼中，该系统被持续异常激活，转而攻击自身的视网膜组织。图示补体系统通过三条通路激活：经典途径、旁路途径和凝集素途径。2023 年，两款补体抑制剂在美国获批用于 GA 治疗，机制上分别作用于补体级联反应的不同环节。一款为 C3 抑制剂，作用于级联反应的中心环节，通过阻断 C3 及其下游反应，减少炎症介导的细胞损伤。另一款为 C5 抑制剂 ACP，通过抑制 C5 裂解，减少促炎介质 C5a 的生成，并抑制上述膜攻击复合物的形成，从而减轻下游补体介导的炎症与组织损伤。除这两款已获批疗法外，针对 GA 的其他机制疗法也在进一步开发中。主持人围绕补体疗法在GA治疗中的临床研究，有哪些关键数据值得关注？这些数据对国内临床实践意味着什么？李真博士C3 抑制剂在美国的获批基于两项多中心 Ⅲ 期研究，结果显示持续补体 C3 抑制可减缓 GA 病灶扩大。C5 抑制剂 ACP 的关键临床证据则来自 GATHER-1 和 GATHER-2 两项研究：GATHER-1 的 12 个月结果显示，ACP 组 GA 面积增长较对照组相对降低 35.4%，这是随机对照研究首次证实 C5 抑制可显著延缓 GA 进展；GATHER-2 验证性研究同样达到主要终点。安全性方面，ACP 未报告严重眼部不良事件或眼内炎，无论每月还是隔月给药，耐受性均良好。这些数据对国内的启示在于：随着补体抑制疗法的发展，GA 治疗正从“无药可治”迈入“可延缓进展”的新阶段。以 ACP 为例，其延缓 GA 进展的证据已覆盖从关键性 Ⅲ 期临床研究到真实世界的多个层面。这不仅是治疗手段的突破，更代表认知上的根本转变 ——GA 不再是“束手无策”的疾病。这一转变，也将推动国内的影像随访标准化、病灶进展定量的评估和患者分层管理体系的加速建设。结语从“束手无策”到“可延缓进展”，地图样萎缩的治疗正在经历一次重要的范式转变。补体靶向疗法的突破，让临床首次拥有了主动干预疾病进程的工具，但药物只是起点。对于国内GA而言，真正需要补上的，是从疾病认知、早期识别、精准诊断到长期随访管理的完整链条。这既是医学的挑战，也是产业创新的机会。未来，随着更多循证证据和创新疗法进入临床，医、企及社会各方需要共同推动GA从“发现晚、诊断少、干预迟”，走向早识别、早干预、长期管理。当治疗手段与诊疗体系真正形成合力，GA才有望从长期被忽视的致盲性眼病，逐步走向可干预、可管理的慢性疾病。参考文献（上下滑动可查看）[1] Wu J, Shan S, Zhou J, Li Y, Ke Q, Zhu L, Rudan I, Song P; Global Health Epidemiology Research Group. National, regional, and provincial prevalence of age-related macular degeneration in China in 2020: an updated systematic review and modelling study. J Glob Health. 2026;16:04062[2] Hu A, Teneralli RE, Rodriguez R, Abdul Sultan A, Garey C, Ackert J, Ong R. Falls and Fractures in Patients with Geographic Atrophy: A US Claims Data Analysis. Adv Ther. 2025 May;42(5):2234-2247. doi: 10.1007/s12325-025-03134-6. Epub 2025 Mar 13. PMID: 40080238; PMCID: PMC12006262.[3]Singh RP, Weng CY, Schwartz R, et al. Consideration of patient phenotypes in geographic atrophy due to age-related macular degeneration [J]. BMJ Open Ophthalmology, 2025, 10: e002105.[4]Goldberg RA, Boyer DS, Holz FG, et al. Pegcetacoplan for Geographic Atrophy Over 30 Months: Data From OAKS, DERBY, and the GALE Long-Term Extension Study. Ophthalmic Surgery, Lasers and Imaging Retina. 2025;56(7):398-406. doi:10.3928/23258160-20250217-01[5]Astellas Pharma US, Inc. IZERVAY (avacincaptad pegol intravitreal solution) full prescribing information. Northbrook, IL: Astellas Pharma US; February 2025. FDA Access Data Reference ID 5530503. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217225s001lbl.pdf[6]Danzig CJ, Khanani AM, Kaiser PK, Chang MA, Kovach JL, Lally DR, Rachitskaya A, Sheth VS, Vajzovic L, Clark J, Tang J, Zhu L, Desai D, Chakravarthy U. Vision Loss Reduction with Avacincaptad Pegol for Geographic Atrophy: A 12-Month Post Hoc Analysis of the GATHER1 and GATHER2 Trials. Ophthalmol Retina. 2024 Nov;8(11):1052-1060. doi: 10.1016/j.oret.2024.04.023. Epub 2024 May 7. PMID: 38719191.[7]Jaffe GJ, Westby K, Csaky KG, Monés J, Pearlman JA, Patel SS, Joondeph BC, Randolph J, Masonson H, Rezaei KA. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021 Apr;128(4):576-586. doi: 10.1016/j.ophtha.2020.08.027. Epub 2020 Sep 1. PMID: 32882310.[8]Khanani AM, Patel SS, Staurenghi G, Tadayoni R, Danzig CJ, Eichenbaum DA, Hsu J, Wykoff CC, Heier JS, Lally DR, Monés J, Nielsen JS, Sheth VS, Kaiser PK, Clark J, Zhu L, Patel H, Tang J, Desai D, Jaffe GJ; GATHER2 trial investigators. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1449-1458. doi: 10.1016/S0140-6736(23)01583-0. Epub 2023 Sep 8. PMID: 37696275.[9]Khanani AM, Danzig CJ, Heier JS, et al. Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: two-year efficacy and safety results from the GATHER2 phase 3 trial. Ophthalmology. 2026;133(4):451-465.[10]Patel, P.N.; Patel, P.A.; Land, M.R.; Bakerkhatib-Taha, I.; Ahmed, H.; Sheth, V. Targeting the Complement Cascade for Treatment of Dry Age-Related Macular Degeneration. Biomedicines 2022, 10, 1884. https://doi.org/10.3390/biomedicines10081884相关阅读：多模态成像在地图样萎缩中的作用青白视角全球眼健康创新技术产品开发及应用的专业交流合作平台

100 项与 Pegcetacoplan 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11613	Pegcetacoplan	B03XA	-

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
C3肾小球病	美国	Apellis Pharmaceuticals, Inc.	2024-10-07
膜增生性肾小球肾炎	美国	Apellis Pharmaceuticals, Inc.	2024-10-07
地图样萎缩	美国	Apellis Pharmaceuticals, Inc.	2023-02-17
阵发性睡眠性血红蛋白尿症	美国	Apellis Pharmaceuticals, Inc.	2021-05-14

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
局灶性节段性肾小球硬化症	临床3期	美国	Apellis Pharmaceuticals, Inc.	2026-12-01
移植物功能延迟恢复	临床3期	巴西	Apellis Pharmaceuticals, Inc.	2026-05-18
终末期肾脏病	临床3期	巴西	Apellis Pharmaceuticals, Inc.	2026-05-18
冷凝集素病	临床3期	美国	Swedish Orphan Biovitrum AB	2022-10-20
冷凝集素病	临床3期	日本	Swedish Orphan Biovitrum AB	2022-10-20
冷凝集素病	临床3期	奥地利	Swedish Orphan Biovitrum AB	2022-10-20
冷凝集素病	临床3期	比利时	Swedish Orphan Biovitrum AB	2022-10-20
冷凝集素病	临床3期	加拿大	Swedish Orphan Biovitrum AB	2022-10-20
冷凝集素病	临床3期	芬兰	Swedish Orphan Biovitrum AB	2022-10-20
冷凝集素病	临床3期	德国	Swedish Orphan Biovitrum AB	2022-10-20

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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


NCT05067127 \| NCT05809531 (VALIANT, Pubmed \| Clin J Am Soc Nephrol)	临床3期	膜增生性肾小球肾炎 \| C3肾小球病	55	Pegcetacoplan	憲獵遞淵網蓋遞積鹽獵(窪餘鑰選鬱觸積夢齋鏇): P-Value = 0.002 更多	积极	2026-05-14
				Placebo
EHA2026	N/A	阵发性睡眠性血红蛋白尿症	10	EculizumabDanicopanRavulizumabPegcetacoplan + EculizumabDanicopanRavulizumabPegcetacoplan + EculizumabDanicopanRavulizumabPegcetacoplan + EculizumabDanicopanRavulizumabPegcetacoplan	鑰網襯襯艱膚蓋獵膚遞(齋糧觸鏇觸鹹製鬱憲構) = During a median follow-up of 49.5 months, 3/10 patients required therapy modification due to persistent anemia compatible with EVH. 構壓積顧遞觸選鹽糧艱 (醖構鏇製蓋憲鏇齋築襯 )	积极	2026-05-12
EHA2026	N/A	阵发性睡眠性血红蛋白尿症	38	Pegcetacoplan	繭顧願構範鹹範構製範(艱積願窪淵窪鬱鏇鹽艱) = 製鏇製選淵糧糧醖鬱遞簾膚襯糧蓋網壓齋製簾 (鑰顧簾夢遞積網鬱獵顧 ) 更多	积极	2026-05-12
ARVO2026	N/A	地图样萎缩	1,507	Avacincaptad Pegol	觸築壓壓憲繭糧觸網壓(觸積願顧簾網壓選範簾) = 膚鬱範廠製遞夢願淵艱鹹繭範廠鑰蓋齋鹽淵窪 (鑰鹹積顧構蓋簾網壓觸 ) 更多	积极	2026-05-03
				Pegcetacoplan	觸築壓壓憲繭糧觸網壓(觸積願顧簾網壓選範簾) = 觸鹹繭鹹齋醖衊願構選鹹繭範廠鑰蓋齋鹽淵窪 (鑰鹹積顧構蓋簾網壓觸 ) 更多
ARVO2026	N/A	地图样萎缩	21,914	Pegcetacoplan (PEG)	鬱繭衊淵簾蓋選壓積壓(憲選襯齋選觸製繭醖遞) = 齋顧網構遞醖鬱構築廠簾繭製壓廠範膚餘顧窪 (壓選衊鹹簾鹽獵壓鏇範, 7.85) 更多	积极	2026-05-03
GALE (ARVO2026)	临床3期	地图样萎缩	782	Pegcetacoplan every-month (PM) (Early Treatment)	鹹鬱鹹遞遞憲襯製鏇鬱(糧壓鏇艱製顧顧構壓獵) = 醖蓋遞醖製製網醖積網蓋構鏇艱積築窪選觸構 (構選廠鑰願鹽網鹽鑰網 ) 更多	积极	2026-05-03
				Pegcetacoplan every-other-month (PEOM) (Early Treatment)	鹹鬱鹹遞遞憲襯製鏇鬱(糧壓鏇艱製顧顧構壓獵) = 製衊積觸網範範願窪繭蓋構鏇艱積築窪選觸構 (構選廠鑰願鹽網鹽鑰網 ) 更多
ARVO2026	N/A	地图样萎缩	173	Pegcetacoplan	鹹鹽獵蓋遞積顧鹹憲廠(繭壓餘窪製襯觸網壓觸) = 蓋夢壓願壓夢襯鏇醖窪膚壓淵憲簾壓艱積網範 (窪齋糧鹽鹹艱範壓壓糧 ) 更多	不佳	2026-05-03
ARVO2026	N/A	地图样萎缩	1,214	Pegcetacoplanpegcetacoplan (Bilateral pegcetacoplan treatment)	膚鹹網積窪顧醖積襯網(醖簾鏇構鹹鹹淵醖選鬱) = 積艱鹽網繭網鏇艱遞憲糧襯繭構網選糧衊繭製 (膚構願糧衊糧繭觸遞選 ) 更多	积极	2026-05-03
				Pegcetacoplanpegcetacoplan (Unilateral pegcetacoplan treatment)	膚鹹網積窪顧醖積襯網(醖簾鏇構鹹鹹淵醖選鬱) = 範餘醖範獵餘淵糧獵蓋糧襯繭構網選糧衊繭製 (膚構願糧衊糧繭觸遞選 ) 更多
ARVO2026	N/A	地图样萎缩	582	Intravitreal Syfovre (IVS)	網鑰鑰網選醖艱鹽鹽醖(遞築夢襯膚廠選淵簾範) = 15.3% post AC therapy exudation, 0.17% severe, occlusive vasculitis, and no cases of endophthalmitis. 衊繭構鏇齋餘鏇範獵膚 (鏇壓積憲簾餘築襯窪鬱 ) 更多	积极	2026-05-03
				Intravitreal Izervay (IVI)
NCT05776472 (COMPLETE, ASH2025)	临床4期	阵发性睡眠性血红蛋白尿症	200	Pegcetacoplan (with a history of aplastic anemia)	衊範構鹹鬱繭繭齋鏇壓(製衊艱觸顧膚願鹹鏇餘) = 艱範獵網繭餘餘糧製製選觸齋窪蓋鹹夢獵憲網 (壓壓繭憲遞壓衊觸築窪, 62.0 ~ 118.7) 更多	积极	2025-12-06
				Pegcetacoplan (without a history of aplastic anemia)	衊範構鹹鬱繭繭齋鏇壓(製衊艱觸顧膚願鹹鏇餘) = 選選糧獵膚簾糧醖觸壓選觸齋窪蓋鹹夢獵憲網 (壓壓繭憲遞壓衊觸築窪, 81.8 ~ 136.6) 更多