补体3肾小球病市场迎来转型：4种新兴疗法引领下一增长阶段 DelveInsight-动脉网

Complement 3 Glomerulopathy Market Set for Transformation: 4 Emerging Therapies Leading the Next Growth Phase

CISION 等信源发布 2026-07-16 22:31

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Emerging therapies targeting novel mechanisms such as dual complement inhibitors (C5 and Factor H (KP104), MASP-3 inhibitors (Zaltenibart), RNA interference (RNAi) therapeutics targeting complement C3 (ARO-C3), and others are showing promise as potential treatment options. The expected launch of these therapies shall further create a positive impact on the C3G market..

针对新机制的新兴疗法，如双重补体抑制剂（C5和H因子（KP104））、MASP-3抑制剂（Zaltenibart）、靶向补体C3的RNA干扰（RNAi）疗法（ARO-C3）等，正展现出作为潜在治疗选择的良好前景。这些疗法的预期上市将对C3G市场产生进一步的积极影响。

LAS VEGAS

拉斯维加斯

，

July 16, 2026

2026年7月16日

/PRNewswire/ -- The treatment landscape for C3G has historically depended on the off-label use of multiple prescription therapies, underscoring the substantial unmet need for disease-specific treatment options. Conventional management primarily involves immunosuppressive agents, corticosteroids, Renin-Angiotensin-Aldosterone System (RAAS) inhibitors, along with supportive therapies such as calcineurin inhibitors and monoclonal antibodies to help control disease progression and preserve kidney function..

/美通社/ -- C3G（C3肾小球病）的治疗格局历来依赖于多种处方药的超说明书使用，这凸显出针对该疾病的特异性治疗选项存在巨大的未满足需求。传统管理方案主要涉及免疫抑制剂、皮质类固醇、肾素-血管紧张素-醛固酮系统（RAAS）抑制剂，以及包括钙调神经磷酸酶抑制剂和单克隆抗体在内的支持性疗法，以帮助控制疾病进展并保护肾功能。

The therapeutic landscape has recently evolved with the approval of

随着批准，治疗格局最近发生了变化。

FABHALTA

法布哈塔

, the first drug specifically indicated for the treatment of C3G, followed by

，首款专门用于治疗C3G的药物，随后是

EMPAVELI/ASPAVELI

, developed by

，由...开发

Apellis Pharmaceuticals and Sobi

阿佩利斯制药和Sobi

. Despite these advances, safety concerns remain a key consideration. Both therapies carry a boxed warning for the risk of life-threatening infections caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type b, making vaccination at least two weeks before treatment initiation essential..

尽管取得了这些进展，安全性问题仍然是关键考量因素。这两种疗法均带有黑框警告，提示存在由荚膜细菌（包括脑膜炎奈瑟菌、肺炎链球菌和b型流感嗜血杆菌）引起的危及生命的感染风险，因此必须在治疗开始前至少两周进行疫苗接种。

Discover what is the future of the complement 3 glomerulopathy treatment market @

探索补体3肾小球病治疗市场的未来 @

https://www.delveinsight.com/report-store/complement-3-glomerulopathy-c3g-market

Aparna Thakur, Project Manager of Forecasting at DelveInsight, said that FABHALTA and EMPAVELI/ASPAVELI represent the currently available and clinically validated therapies for C3G, positioning them as established options with regulatory approval and real-world treatment experience.

DelveInsight 预测项目经理 Aparna Thakur 表示，FABHALTA 和 EMPAVELI/ASPAVELI 代表了目前可用且经临床验证的 C3G 疗法，使其成为拥有监管批准和真实世界治疗经验的成熟选择。

Beyond the currently approved therapies, the C3G pipeline continues to expand with several promising investigational candidates. Notable programs include

除目前获批的疗法外，C3G 研发管线持续扩展，拥有多个颇具前景的在研候选药物。值得关注的项目包括

KP104

(Kira Pharmaceuticals),

（基拉制药）

Zaltenibart (OMS906)

扎尔特尼巴特（OMS906）

(Omeros Corporation),

（奥美罗斯公司）

Ruxoprubart (NM8074)

鲁索普鲁巴特（NM8074）

(NovelMed Therapeutics),

（NovelMed Therapeutics），

ARO-C3

(Arrowhead Pharmaceuticals),

（Arrowhead Pharmaceuticals）

TAVNEOS (avacopan)

TAVNEOS（阿伐可潘）

(Amgen),

（安进）

CPV-104

(Eleva), and other emerging therapies that have the potential to further reshape the C3G treatment landscape.

(Eleva)，以及其他有望进一步重塑C3G治疗格局的新兴疗法。

As per Thakur, the absence of oral route of administration therapies in the emerging pipeline presents a significant opportunity for development, addressing unmet patient preferences for more convenient and non-invasive treatment options.

根据塔库尔的说法，新兴研发管线中缺乏口服给药疗法，这为开发提供了重大机遇，能够满足患者对更便捷、非侵入性治疗方案的未满足偏好。

Reflecting the strong commercial and clinical momentum in this space, DelveInsight estimates that the C3G market across the 7MM, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately

鉴于该领域强劲的商业和临床发展势头，DelveInsight估计，包括美国、欧盟四国（德国、法国、意大利和西班牙）、英国和日本在内的七大主要市场（7MM）中，C3G市场的价值约为

USD 1 billion

10亿美元

in 2025, and it is expected to grow at a phenomenal

在2025年，预计将以惊人的速度增长

CAGR of 28%

28%的复合年增长率

by 2036.

到2036年。

Below, we highlight 4 emerging C3G therapies poised to reshape the future of C3G

以下，我们重点介绍4种有望重塑C3G未来的新兴C3G疗法

management.

管理。

Novo Nordisk/Omeros Corporation's Zaltenibart

诺和诺德/奥美罗斯公司的扎尔特尼巴

Phase III

第三阶段

Zaltenibart is an investigational human monoclonal antibody that selectively targets

Zaltenibart 是一种研究性的人源单克隆抗体，可选择性靶向

Mannan-binding lectin-associated serine protease-3 (MASP-3)

甘露糖结合凝集素相关丝氨酸蛋白酶-3（MASP-3）

, the primary upstream activator of the alternative complement pathway. By inhibiting MASP-3, the therapy is intended to suppress activation of the alternative pathway, offering a targeted approach for treating complement-mediated disorders. In December 2025, Omeros Corporation completed an asset sale and licensing agreement with Novo Nordisk for zaltenibart. .

，作为替代补体途径的主要上游激活因子。通过抑制MASP-3，该疗法旨在抑制替代途径的激活，为治疗补体介导的疾病提供一种靶向方法。2025年12月，Omeros公司完成了与诺和诺德关于zaltenibart的资产出售及许可协议。

As part of the transaction, Novo Nordisk obtained exclusive worldwide rights to develop and commercialize the therapy across all indications. Under the agreement, Omeros is entitled to receive

作为交易的一部分，诺和诺德获得了在全球范围内开发和商业化该疗法所有适应症的独家权利。根据协议，Omeros有权获得

USD 340 million

3.4亿美元

in upfront and near-term milestone payments, with the total deal value potentially reaching

以预付款和近期里程碑付款的形式，交易总价值有望达到

USD 2.1 billion

21亿美元

through additional development and commercial milestone payments, as well as tiered royalties on future net sales. In October 2024, Omeros Corporation announced that zaltenibart received

通过额外的开发和商业里程碑付款，以及基于未来净销售额的分级特许权使用费。2024年10月，Omeros Corporation宣布zaltenibart获得

RPDD

from the US FDA for the treatment of C3G.

来自美国食品药品监督管理局，用于C3G的治疗。

Kira Pharmaceuticals' KP104

凯拉制药的KP104

Phase II

第二阶段

KP104 is a novel, first-in-class bifunctional biologic engineered to simultaneously and selectively inhibit both the alternative and terminal complement pathways. This dual mechanism is designed to provide a synergistic therapeutic effect by targeting two well-established drivers of complement-mediated diseases..

KP104 是一种新型、首创新类的双功能生物制剂，旨在同时且选择性地抑制补体替代途径和终末途径。这种双重机制通过靶向补体介导疾病的两个公认驱动因素，旨在产生协同治疗效应。

The candidate is currently undergoing Phase II proof-of-concept clinical studies across several diseases with substantial unmet medical need, including IgA nephropathy (IgAN), Complement 3 Glomerulopathy (C3G), Systemic Lupus Erythematosus-associated Thrombotic Microangiopathy (SLE-TMA), and Paroxysmal Nocturnal Hemoglobinuria (PNH)..

该候选药物目前正在针对多种存在重大未满足医疗需求的疾病开展II期概念验证临床研究，包括IgA肾病（IgAN）、C3肾小球病（C3G）、系统性红斑狼疮相关血栓性微血管病（SLE-TMA）以及阵发性睡眠性血红蛋白尿症（PNH）。

Discover more about which pipeline drugs could transform complement 3 glomerulopathy treatment @

了解更多关于哪些在研药物可能改变补体3肾小球病的治疗 @

Best Medication for

最佳药物

Complement 3 Glomerulopathy

补体3肾小球病

Arrowhead Pharmaceuticals' ARO-C3

Arrowhead Pharmaceuticals 的 ARO-C3

Phase I/II

I/II期

ARO-C3 is an investigational RNA interference (RNAi) therapy developed to suppress hepatic production of

ARO-C3 是一种研究性 RNA 干扰 (RNAi) 疗法，旨在抑制肝脏中

complement component 3 (C3)

补体成分3（C3）

, to treat a range of complement-mediated kidney diseases. The therapy is currently being evaluated in the Phase I/IIa first-in-human dose-escalation study (NCT05083364/AROC3-1001), which is assessing its safety, tolerability, pharmacokinetic profile, and pharmacodynamic effects in both healthy adult volunteers and patients with complement-mediated renal disorders..

，用于治疗多种补体介导的肾脏疾病。该疗法目前正处于首次人体剂量递增的I/IIa期临床试验（NCT05083364/AROC3-1001）评估阶段，旨在评估其在健康成年志愿者和补体介导性肾病患者中的安全性、耐受性、药代动力学特征及药效学效应。

In March 2025, Arrowhead Pharmaceuticals reported positive topline results from Part 2 of the ongoing Phase I/II clinical trial of ARO-C3. The investigational RNAi therapy is designed to reduce liver-derived C3 production and is being developed as a potential treatment for multiple complement-mediated diseases..

2025年3月，Arrowhead Pharmaceuticals公布了在研药物ARO-C3正在进行的I/II期临床试验第二部分积极的顶线结果。这款在研RNAi疗法旨在降低肝脏来源的C3蛋白生成，目前正被开发作为多种补体介导疾病的潜在治疗手段。

Eleva's CPV-104

Eleva 的 CPV-104

Phase I

第一阶段

Eleva is advancing

Eleva 正在推进

Factor H (CPV-104)

H因子（CPV-104）

, a recombinant human complement Factor H therapy, with C3 glomerulopathy (C3G) as its lead clinical indication. In addition to C3G, the therapy has demonstrated potential across several complement-mediated disorders, including atypical hemolytic uremic syndrome (aHUS) and dry age-related macular degeneration (dry AMD)..

，一种重组人补体因子H疗法，其首要临床适应症为C3肾小球病（C3G）。除C3G外，该疗法在多种补体介导的疾病中也展现出潜力，包括非典型溶血性尿毒症综合征（aHUS）和干性年龄相关性黄斑变性（干性AMD）。

Preclinical studies have generated encouraging results for Factor H (CPV-104), including positive in vivo findings in a well-established animal model of C3G. Treatment with CPV-104 restored serum C3 levels to normal within 24 hours of administration and promoted the rapid clearance of C3 deposits from the kidneys, supporting its potential to address the underlying disease pathology..

临床前研究为H因子（CPV-104）带来了令人鼓舞的结果，包括在成熟的C3G动物模型中获得的阳性体内发现。CPV-104治疗在给药后24小时内使血清C3水平恢复正常，并促进了肾脏中C3沉积物的快速清除，这支持了其针对潜在疾病病理机制的治疗潜力。

Building on these findings, Eleva initiated its first clinical study evaluating Factor H (CPV-104) in patients with C3G in July 2025. Following the successful completion of the single ascending dose (SAD) phase in healthy volunteers, with no significant safety concerns observed, the trial progressed to dosing C3G patients in October 2025..

基于这些发现，Eleva 于 2025 年 7 月启动了其首个评估因子 H（CPV-104）在 C3G 患者中疗效的临床试验。在健康志愿者中顺利完成单次递增剂量（SAD）阶段且未观察到重大安全性问题后，该试验于 2025 年 10 月进入对 C3G 患者给药的阶段。

Download the report to understand the top emerging therapies in C3G @

下载报告以了解C3G领域最顶尖的新兴疗法

Complement 3 Glomerulopathy Clinical Trials

补体3肾小球病临床试验

Source:

来源：

Complement 3 Glomerulopathy Market Report

补体3肾小球病市场报告

Complement 3 Glomerulopathy Market Insights, Epidemiology, and Market Forecast – 2036

补体3肾小球病市场洞察、流行病学及市场预测——2036年

report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key C3G companies, including

本报告深入解析了该疾病、历史及预测流行病学，以及市场趋势、市场驱动因素、市场壁垒和关键的C3G企业，包括

Novartis, Apellis Pharmaceuticals, Sobi, Kira Pharmaceuticals, Novo Nordisk, Omeros Corporation, Arrowhead Pharmaceuticals

诺华、Apellis Pharmaceuticals、Sobi、Kira Pharmaceuticals、诺和诺德、Omeros Corporation、Arrowhead Pharmaceuticals

, and others.

，以及其他。

Related Reports

相关报告

Complement 3 Glomerulopathy Clinical Trial Analysis

补体3肾小球病临床试验分析

Complement 3 Glomerulopathy Pipeline Insight

补体3肾小球病研发管线洞察

–

2026

report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key C3G companies, including

报告提供了关于管线格局、管线药物概况（包括临床和非临床阶段产品）以及关键C3G公司的全面洞察，包括

ChemoCentryx, Novartis Pharmaceuticals, Omeros Corporation, Apellis Pharmaceuticals,

ChemoCentryx、诺华制药、Omeros 公司、Apellis 制药，

and others.

以及其他。

Complement Inhibitors Market

补体抑制剂市场

Complement Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast

补体抑制剂市场规模、目标人群、竞争格局及市场预测

–

2036

report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key complement inhibitors companies, including

本报告提供对疾病的深入理解、历史及预测的流行病学数据，以及市场趋势、市场驱动因素、市场障碍和关键补体抑制剂公司，包括

Genentech, Ionis, Roche, AKARI Therapeutics, CARE Pharma, NovelMed Therapeutics, Omeros Corporation

基因泰克、Ionis、罗氏、AKARI Therapeutics、CARE Pharma、NovelMed Therapeutics、Omeros Corporation

, and others.

，以及其他。

Immune Complex Membranoproliferative Glomerulonephritis Market

免疫复合物性膜增生性肾小球肾炎市场

Immune Complex Membranoproliferative Glomerulonephritis Market Insights, Epidemiology, and Market Forecast

免疫复合物性膜增生性肾小球肾炎市场洞察、流行病学及市场预测

–

2036

report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key IC-MPGN companies, including

报告提供对疾病的深入理解、历史和预测的流行病学，以及市场趋势、市场驱动因素、市场障碍和关键的IC-MPGN公司，包括

Novartis Pharmaceuticals, Apellis Pharmaceuticals

诺华制药，Apellis 制药

, and others.

，以及其他。

IgA Nephropathy Market

IgA肾病市场

IgA Nephropathy

IgA肾病

Market Insight, Epidemiology, and Market Forecast

市场洞察、流行病学及市场预测

–

2036

report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key IgAN companies, including

报告深入剖析了市场趋势、市场驱动因素、市场壁垒以及IgAN领域的主要企业，包括

Novartis, F. Hoffmann-La Roche, Ionis Pharmaceuticals, AstraZeneca (Alexion Pharmaceuticals), Vertex Pharmaceuticals, Otsuka Pharmaceutical, Biogen, Arrowhead Pharmaceuticals, NovelMed, Q32 Bio, Walden Biosciences, Takeda Pharmaceutical, Vera Therapeutics

诺华、罗氏（F. Hoffmann-La Roche）、Ionis Pharmaceuticals、阿斯利康（Alexion Pharmaceuticals）、Vertex Pharmaceuticals、大冢制药、渤健（Biogen）、Arrowhead Pharmaceuticals、NovelMed、Q32 Bio、Walden Biosciences、武田制药、Vera Therapeutics

, and others.

，以及其他。

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SOURCE DelveInsight Business Research, LLP

来源：DelveInsight Business Research, LLP

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