阿柏西普(Aflibercept) - 药物靶点：PGF x VEGF-A_在研适应症：早产儿视网膜病变，新生血管性青光眼，结直肠癌_专利_临床

概要

基本信息

药物类型

Fc融合蛋白

别名

Aflibercept (Genetical Recombination)、Aflibercept (genetical recombination) (JAN)、Aflibercept (USAN/INN)

+ [13]

靶点

PGF x VEGF-A

作用方式

抑制剂

作用机制

PGF抑制剂(胎盘生长因子抑制剂)、VEGF-A抑制剂(血管内皮生长因子A抑制剂)

治疗领域

肿瘤心血管疾病遗传病与畸形+ [7]

在研适应症

早产儿视网膜病变新生血管性青光眼结直肠癌+ [18]

非在研适应症

晚期结直肠腺癌晚期恶性实体瘤血管样条纹+ [33]

原研机构

Regeneron Pharmaceuticals, Inc.

在研机构

Bayer AG

Regeneron Pharmaceuticals, Inc.Bayer Australia Ltd.

+ [7]

非在研机构

Sanofi

Bayer Plc

Santen Pharmaceutical Co., Ltd.

权益机构

Santen Pharmaceutical Co., Ltd.

Ocular Therapeutix, Inc.Bayer Korea Ltd.

+ [7]

最高研发阶段批准上市

首次获批日期

美国 (2011-11-18),

湿性年龄相关性黄斑变性

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、突破性疗法 (美国)、孤儿药 (美国)、优先审评 (中国)

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结构/序列

Sequence Code 4715606

来源: *****

关联

524

项与阿柏西普相关的临床试验

NCT07389980

/ Recruiting临床3期IIT

Prospective Trial of the Efficacy and Safety of a Personalized Regimen of High-dose Aflibercept 8mg on Treatment-naive Polypoidal Choroidal Vasculopathy: the PALLAS Trial

The purpose of this study is to evaluate the efﬁcacy and safety of the aflibercept 8 mg used in a personalized regimen, with flexible loading dose and treatment intervals from 8 to 24 weeks in eyes with treatment-naive PCV.

开始日期2026-12-24

申办/合作机构

Yeungnam University College of Medicine

[+1]

NCT07482176

/ Recruiting临床3期

A Multi-center, Randomized, Double-masked, Active-comparator-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS)

This is a multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 study in a broad participant population (treatment-naïve and treatment-experienced) with neovascular (wet) age-related macular degeneration (nAMD). The study will evaluate a single intravitreal (IVT) injection of Ixo-vec compared to intravitreal aflibercept (active comparator). The primary endpoint of this study is the mean change in best corrected visual acuity (BCVA) of Ixo-vec compared to an active comparator measured as an average at Weeks 52 and 56.
Safety, tolerability, and efficacy will be evaluated throughout the study.

开始日期2026-03-16

申办/合作机构

Adverum Biotechnologies, Inc.

NCT07438119

/ Not yet recruiting临床4期IIT

Efficacy Comparison of DExamethasone Intravitreal Implant Combined With Aflibercept Versus Aflibercept Monotherapy in Treatment-naïve Inflammatory Diabetic Macular Edema Patients (DECADE Study)

This is a 12-month, prospective, randomized controlled, multi-center, open-label, superiority designed study. Treatment-Naïve DME patient with inflammatory biomarkers, who meet the inclusion and exclusion criteria, will be recruited.
This study aims to provide the first direct comparative evidence within a Chinese cohort, evaluating the efficacy and safety of a combined DEX-I plus aflibercept therapy versus aflibercept monotherapy for DME. The investigation will focus on functional visual outcomes, anatomical improvements, and the respective safety profiles associated with each treatment regimen. Furthermore, the study will incorporate specific optical coherence tomography (OCT) biomarkers to refine patient selection, with the goal of enhancing the precision of identifying candidates for combination therapy.
It is hypothesized that the combination therapy, by concurrently targeting both VEGF-mediated and inflammatory pathways, may yield superior clinical outcomes compared to monotherapy.

开始日期2026-03-15

申办/合作机构

上海市第一人民医院

[+7]

100 项与阿柏西普相关的临床结果

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100 项与阿柏西普相关的转化医学

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100 项与阿柏西普相关的专利（医药）

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3,329

项与阿柏西普相关的文献（医药）

2026-06-01·American journal of ophthalmology case reports

A second occurrence of intravitreal injection-associated endophthalmitis 2 years apart

Article

作者: Townsend, Justin H ; Rohowetz, Landon J ; Flynn, Harry W

Purpose:

This case report describes a patient who developed a second episode of endophthalmitis in the same eye following intravitreal injections administered 2 years apart.

Observations:

An 83-year-old pseudophakic male with a history of neovascular age-related macular degeneration and diabetes mellitus complained of decreased visual acuity and pain in the left eye 1 day after receiving intravitreal aflibercept 2 mg. Best-corrected visual acuity (BCVA) was light perception. The clinical examination revealed signs of endophthalmitis including fibrin and hypopyon while B-scan ultrasonography demonstrated vitreous opacities and membranes. The patient underwent vitreous tap and injection with intravitreal vancomycin, ceftazidime, and dexamethasone. Pars plana vitrectomy with posterior hyaloid detachment was performed the following day due to a relative lack of clinical improvement. Vitreous cultures ultimately demonstrated no growth and BCVA improved to baseline. Anti-VEGF therapy was resumed 3 months after the initial diagnosis of endophthalmitis. Two years later the patient presented with evidence of a second episode of endophthalmitis 4 days after receiving aflibercept 8 mg. Vitreous tap and injection was again performed and cultures revealed growth of Staphyloccoccus epidermidis. The patient demonstrated marked improvement with no evidence of residual inflammation at 2 weeks. Best-corrected visual acuity was 20/50 at 7-month follow-up examination.

Conclusion and importance:

Endophthalmitis is a rare complication of intravitreal injection. The current report describes a patient who developed a second occurrence of endophthalmitis associated with an intravitreal injection 2 years later.

2026-05-01·Value in Health Regional Issues

Cost-Effectiveness of Vascular Endothelial Growth Factor Inhibitors in the Management of Wet Age-Related Macular Degeneration: A Systematic Review

Article

作者: Paneerselvam, Ganesh S ; Kenneth, Lee K C ; Wai, Ng J ; Sheng, Lim J

OBJECTIVES:

To evaluate the cost-effectiveness of VEGF inhibitors, ranibizumab, aflibercept, bevacizumab, brolucizumab, pegaptanib, and conbercept for wAMD treatment.

METHODS:

A systematic search was conducted in PubMed, Cochrane, and SpringerLink databases to identify cost-effectiveness analyses and cost-utility analyses related to wAMD treatment. Eligible studies were assessed using Drummond's 10-point checklist to evaluate methodological quality. The extracted data included intervention costs, quality-adjusted life-years, and incremental cost-effectiveness ratios.

RESULTS:

Twenty-two studies met the inclusion criteria. Bevacizumab and brolucizumab were frequently reported as cost-effective alternatives, offering comparable or superior visual outcomes at lower costs than ranibizumab or aflibercept. Pegaptanib was consistently less cost-effective. Findings for ranibizumab versus aflibercept varied by treatment regimen and analytic assumptions. Across studies, cost-effectiveness estimates were influenced by model perspective, time horizon, exclusion of adverse events, and single-eye modeling. A further limitation is that in contexts of non-inferior efficacy, small incremental quality-adjusted life-years differences may artificially inflate incremental cost-effectiveness ratios, potentially overstating the costs relative to benefits.

CONCLUSIONS:

Decision making in wAMD treatment requires more thorough economic evaluations that incorporate standardized methodologies and lengthy cost assessments.

2026-05-01·SURVEY OF OPHTHALMOLOGY

Efficacy and safety of aflibercept biosimilars compared to reference aflibercept for retinal diseases: A systematic review and meta-analysis

Review

作者: Shahid, Ishmal Fatima ; Shahid, Fatima ; Azeem, Saleha ; Rashid, Ahsan ; Rashid, Mohsin ; Azeem, Eilaf ; Fatima, Abeeha ; Ali, Muhammad Khan Buhadur

Aflibercept biosimilars offer cost-effective alternatives to reference aflibercept for retinal diseases such as neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). By inhibiting vascular endothelial growth factor-mediated vascular damage, they aim to improve visual outcomes with comparable safety and efficacy, increasing treatment access while reducing cost burden. We evaluate their performance against the reference drug. A comprehensive search was done across Cochrane, Embase, PubMed, Scopus and ClinicalTrials.gov. Randomized controlled trials were included, and quality was assessed via RoB 2.0 tool. A random-effects model estimated standardized mean differences (SMD) and risk ratios. 11 studies (4064 participants) were analyzed, 8 focused on nAMD and 2 on DME. No significant differences in best-corrected visual acuity changes were observed between biosimilars and reference aflibercept in studies on nAMD (SMD = -0.04, 95 % confidence inerval [CI]: -0.15-0.06) or DME (SMD = 0.11, 95 % CI: -0.12-0.33). Central subfield thickness change at week 4 and the endpoint also showed no significant differences. Similarly, no significant differences were seen in choroidal neovacularization size, vision maintenance, anti-drug antibody development, treatment-emergent adverse events, or ocular adverse effects. Biosimilar aflibercept show similar efficacy and safety to the original for nAMD and DME, with no significant differences in key outcomes. They offer a cost-effective alternative that offers similar clinical benefits while improving treatment accessibility.

1,605

项与阿柏西普相关的新闻（医药）

2026-04-08

·药事纵横

挑战罗氏与再生元：国产眼科长效新药重塑百亿眼科版图

在新生血管性年龄相关性黄斑变性（nAMD）这个超百亿元的眼底药市场，近十余年被跨国药企主导占据，近日这一局面正悄然发生改变。近日信达生物宣布其创新药依莫芙普‑α（IBI302）III 期临床试验达成52周主要终点。视力改善效果非劣效于阿柏西普、72.8% 患者实现每 16 周一次给药、黄斑萎缩风险下降约50%。这是中国自主研发、首创机制、16周超长效眼科新药，正面冲击由再生元、诺华、罗氏构建的长效眼底药垄断壁垒，为国内nAMD患者带来更优质、更可及的治疗新选择。当前nAMD 市场竞争格局新生血管性年龄相关性黄斑变性（nAMD）是50 岁以上人群不可逆失明的首要原因。国内 nAMD 患者超400 万，2024年全球抗VEGF眼科药物市场规模约230亿美元，预计2030年将突破400亿美元。阿柏西普（再生元）、法瑞西单抗（罗氏）、康柏西普（康弘）、雷珠单抗（诺华）是抗VEGF眼科市场的四大主流药物，它们也代表了从第一代单靶点到最新双靶点长效疗法的演进。从前是阿柏西普、康柏西普、雷珠单抗的三足鼎立，后法瑞西单抗凭借双靶点 (VEGF-A + Ang-2) 技术优势强势入局， Ang-2靶点的加入不仅抑制新生血管，还能稳定血管壁、减少炎症，争夺高端长效市场。由此看来眼科治疗的终极目标是更少注射次数，更长视力维持。法瑞西单抗和阿柏西普8mg版定义了新的标准（Q12W/Q16W），康柏西普和雷珠单抗若不推出长效版本，将面临巨大压力。康柏西普也可继续守住“高性价比”的基本盘，而信达生物的IBI302（VEGF+补体双靶点）预计在2026-2027年上市，将成为法瑞西单抗的强力挑战者，进一步拉低双靶点药物的价格。如果说康柏西普是国产眼科长效药从零到一的突破，那信达生物的 IBI302的 III期临床成功，则标志着国产药从 “可及性突破” 进入“疗效与机制全面超越”的新阶段。突围三步曲：首创机制、超长间隔、解决MA痛点 IBI302打破进口垄断的路径，与当年的康柏西普既有相似之处，又有本质区别。如果说康柏西普是通过高性价比打破了进口药的垄断；那么IBI302则瞄准的是目前由罗氏法瑞西单抗（Vabysmo）刚刚建立的“双靶点长效”新壁垒，试图在疗效机制和治疗频率上实现超越，从而重塑市场格局。IBI302的作用机制为VEGF + 补体双靶点路径，直击炎症根源，在 nAMD的病理机制中，除了血管新生，慢性炎症（补体系统激活）也是关键推手。IBI302的C端融合了补体受体1（sCR1），能直接抑制补体系统（C3b/C4b）。此外进口长效药物（如法瑞西单抗、阿柏西普8mg）目前的黄金标准是每12-16周注射一次。IBI302在临床试验中展现了挑战这一极限的实力。据其III期临床（STAR研究）数据，IBI302组有72.8%的受试者实现了Q16W（16周/4个月）的给药间隔，这一比例甚至高于法瑞西单抗在同类研究中的数据（约45%），更惊人的是，数据显示有56.3%的患者在第24周时无疾病活动，具备延长至Q20W（5个月）的潜力。更重要的是，长期抗VEGF治疗的一个潜在风险是可能导致黄斑萎缩（MA），这是一种会导致视力永久丧失的并发症，STAR研究数据显示，IBI302组的新发黄斑萎缩比例为1.5%，显著低于阿柏西普组的2.9%（下降约50%）。通过首创机制、超长间隔、解决MA痛点三个方面，真正实现了国产药从“跟跑”到“领跑”的跨越。带动全行业，国产眼科长效药进入集群突破期 IBI302 并非孤军奋战，它的成功正在激活一条国产眼底创新药产业链。从康柏西普的“破冰”到IBI302的“领跑”，中国药企正以“技术迭代+靶点创新”双轮驱动，谱写眼科长效治疗领域的新篇章。康弘药业的康柏西普作为国产第一代抗VEGF融合蛋白，康柏西普的意义远超药物本身，其不仅在疗效上对标进口药，更通过医保准入和渠道下沉，让百万眼底病患者用得起药。康柏西普的成功，不仅验证了国产药企的分子设计能力，更培育了眼底病治疗的本土市场，为后续IBI302等长效药物的研发奠定了临床基础、市场基础和患者教育基础。除了IBI302，如今恒瑞、荣昌、新桥等企业纷纷跟进，比如新桥生物的VIS-101，其作为VEGF-A/Ang-2四价双特异性抗体，它在法瑞西单抗（双价双抗）的基础上，进一步增加了抗体价数，理论上能实现“更强的靶点结合力+更长的药物半衰期”， VIS-101处于IIa期临床阶段，早期数据显示其给药间隔有望突破16周，甚至达到20周以上。VIS-101的意义在于“技术超越”——它不再满足于“对标进口”，而是通过“四价设计”实现“超越进口”的长效性，展现了国产药企在抗体工程领域的技术积累。荣昌生物的rc28，与目前主流的抗VEGF单靶点或VEGF/Ang-2双靶点药物不同，RC28 选择了独特的VEGF + FGF双靶点机制，它不仅能抑制 VEGF（血管内皮生长因子）诱导的血管新生，还能同时抑制 FGF-2（成纤维细胞生长因子-2），旨在解决眼底病治疗中的“抗纤维化”难题，治疗糖尿病性黄斑水肿（DME），III 期临床试验已完成患者随访， CDE已于 2025年9月正式受理其上市申请；治疗湿性年龄相关性黄斑变性（wAMD），III 期临床正在进行中，预计 2026年下半年提交上市申请；治疗糖尿病视网膜病变（DR），II 期临床已完成入组，处于随访阶段。从康柏西普打破市场垄断，到IBI302、RC28、VIS-101等新一代药物不断涌现，中国眼底病治疗市场正迎来一场深刻的变革。中国眼底病治疗，正从频繁注射迈向轻松长期管理，国产眼科创新药，正从填补空白走向全球引领。立即扫码加入药事纵横交流群

临床3期申请上市临床成功

2026-04-07

·EndPoints

Novo launches high-dose Wegovy in the US; Evotec pressured to list its US unit

Plus, news about Vertex and Halozyme, Werewolf, and Regeneron: Novo Nordisk launches high-dose Wegovy in the US : The 7.2 mg injectable form of the GLP-1 agonist is now available in the US to treat obesity patients via telehealth providers including Novo’s own NovoCare Pharmacy, as well as brick-and-mortar pharmacies. It will cost $399 per month for cash-pay customers, but patients will work their way up to this level from lower, cheaper doses. The new dose was approved swiftly via the Commissioner’s National Priority Voucher program in March, based on pivotal trial data showing weight loss of about 19% at 72 weeks, using an intent-to-treat analysis. — Elizabeth Cairns Evotec faces investor pressure to list its US unit: Activist fund MAK Capital, which owns about 7% of Evotec shares, advised the company to “carve out and publicly list” its Seattle-based biologics platform, which could be worth over €1 billion ($1.15 billion). The recommendation was one of ten that MAK outlined in a letter in which it complained that Evotec had been “too slow to remedy” mistakes. — Ayisha Sharma Vertex partners with Halozyme: Vertex will pay $15 million upfront to license up to three drug targets from Halozyme’s technology enabling at-home injectables. Milestone payments are included in the deal but were not disclosed. — Max Gelman Werewolf lays off employees as its future remains up in the air: The cancer drug developer, which in February said it was exploring sale and merger options as its cash reserves ran down, disclosed last week that it had laid off 64% of its employees at the time. The company had 39 employees as of the end of 2025. — Lei Lei Wu FDA to re-review Regeneron’s pre-filled Eylea HD: Regeneron has resubmitted its application for its Eylea HD pre-filled syringe to the FDA with a decision expected in April this year. The drug is being reviewed through a Chemistry, Manufacturing and Controls Prior-Approval Supplement. The company received a CRL for the drug in October due to ongoing manufacturing issues at a former Catalent site in Bloomington, IN, which Novo Nordisk now runs. Scholar Rock and Incyte have also been issued CRLs for drugs made at the Indiana factory. — Anna Brown

上市批准加速审批优先审批

2026-04-05

·坦诉

Day 2_小分子药 vs 大分子药：两大药物阵营

🎯 今日目标：理解小分子化药和大分子生物药的根本差异，掌握常见药物类型，为后续理解前沿赛道打基础。一、药物世界的两大阵营所有药物按分子大小，可以分成两大阵营：维度小分子化药大分子生物药分子量 <900 道尔顿数万~数十万道尔顿生产方式化学合成生物工程（细胞培养）给药方式多数可口服多数需注射靶点位置可进入细胞内部主要作用于细胞表面或体液中结构复杂度简单、明确极其复杂（蛋白质三维折叠）专利到期后面临仿制药（Generic）竞争面临生物类似药（Biosimilar）竞争典型代表阿司匹林、格列卫、泽布替尼赫赛汀、Keytruda、阿达木单抗直观类比： •小分子 = 一把精密的钥匙（结构简单，可以精确复制）•大分子 = 一台复杂的生物机器（结构复杂，很难完全复制）二、小分子化药（Small Molecule）2.1 什么是小分子化药？通过化学合成方法制造的药物分子，结构明确，分子量小，通常可以口服。这是人类最早开发的药物类型，至今仍占全球药物市场的半壁江山。2.2 核心优势 •可口服：患者依从性好，不需要去医院注射•生产成本低：化学合成工艺成熟，规模化生产便宜•能进入细胞内部：可以靶向细胞内的蛋白质（大分子药很难做到）•化学结构明确：仿制药只需证明化学等效，门槛较低2.3 主要劣势 •选择性有限：分子太小，容易与非目标蛋白结合，产生副作用（"脱靶效应"）•可成药靶点有限：传统估计仅约 20% 的人体蛋白质可被小分子药物靶向•专利到期后价格暴跌：仿制药竞争激烈，原研药可能在 1-2 年内失去 80%+ 市场份额2.4 经典案例：格列卫（Imatinib / Gleevec） •靶点：BCR-ABL 融合蛋白（慢性粒细胞白血病的驱动突变）•意义：第一个真正成功的靶向小分子药物，开创了"精准医疗"时代•效果：将慢性粒细胞白血病从"绝症"变成"慢性病"，五年生存率从 30% 提升到 90%+•商业成就：年销售峰值约 47 亿美元（诺华）•投资教训：专利到期后仿制药涌入，销售额迅速下降——这就是"专利悬崖"2.5 小分子药的新趋势传统小分子药的靶点空间正在被拓展： •PROTAC（蛋白降解靶向嵌合体）：不是抑制蛋白功能，而是直接把目标蛋白"标记"为垃圾，让细胞自己降解它。理论上可以靶向此前"不可成药"的蛋白质。•分子胶（Molecular Glue）：与 PROTAC 原理类似，但分子更小、更像传统小分子。代表药物：来那度胺（Lenalidomide，治疗多发性骨髓瘤的重磅药）。三、大分子生物药（Biologics）3.1 什么是大分子生物药？利用生物工程技术（基因重组、细胞培养等），在活细胞中生产的大分子药物。最常见的是单克隆抗体（Monoclonal Antibody, mAb）。3.2 核心优势 •靶向性极强：抗体对靶点的识别极其精准，副作用相对可控•作用时间长：半衰期长，给药频率低（有些抗体 2-3 周打一次）•专利壁垒高：生物药结构极其复杂，即使专利过期，生物类似药的开发门槛和成本也远高于化学仿制药3.3 主要劣势 •不能口服：大分子蛋白质会被胃酸消化，必须注射•生产成本高：需要复杂的细胞培养和纯化工艺•冷链运输：蛋白质对温度敏感，需要全程冷链•免疫原性：人体可能产生抗药抗体（Anti-Drug Antibody, ADA），降低疗效3.4 单克隆抗体：大分子药的核心单克隆抗体是目前最成功的大分子药物类型。它的结构像一个 Y 形：抗原结合位点抗原结合位点 (Fab 区) (Fab 区) \ / \ / \ / ---------- | Fc 区 | ← 与免疫细胞互动 ---------- •Fab 区（上面两个"手臂"）：负责识别和结合靶点，决定了抗体的特异性•Fc 区（下面的"躯干"）：负责与免疫系统互动，可触发免疫杀伤3.5 抗体命名规则（投资人必知）单克隆抗体的名字有规律，看后缀就能判断类型：后缀含义示例-omab 鼠源抗体（老一代） —-ximab 嵌合抗体利妥昔单抗（Rituximab）-zumab 人源化抗体曲妥珠单抗（Trastuzumab）-umab 全人源抗体（最新一代）帕博利珠单抗（Pembrolizumab）-mab 单克隆抗体（通用后缀） — 投资小技巧：看到药名以 "-mab" 结尾 = 单克隆抗体；以 "-nib" 结尾 = 小分子激酶抑制剂（如伊马替尼 Imatinib）；以 "-tide" 结尾 = 多肽类药物（如司美格鲁肽 Semaglutide）。3.6 重磅案例药物靶点适应症 2023 年全球销售额 Keytruda（帕博利珠单抗） PD-1 多种肿瘤 ~250 亿美元 Humira（阿达木单抗） TNF-α 自免疾病 ~145 亿美元（已过专利期） Eylea（阿柏西普） VEGF 眼科 ~100 亿美元3.7 生物类似药（Biosimilar）vs 仿制药（Generic）维度仿制药生物类似药与原研药关系化学结构完全相同高度相似但不完全相同审批要求 BE 试验即可需要额外的临床试验开发成本数百万美元 1-2 亿美元价格折扣原研药的 10-20% 原研药的 60-80% 市场替代迅速、完全较慢、不完全投资启示：生物药的"护城河"比小分子药深得多。即使专利到期，生物类似药对原研的冲击也远不如仿制药对小分子原研的冲击。这就是为什么投资人更看好大分子创新药企的长期竞争力。四、第三类势力：多肽药物多肽（Peptide）介于小分子和大分子之间，分子量通常在 500-5000 道尔顿。 •代表药物：司美格鲁肽（Semaglutide，即 Ozempic/Wegovy），GLP-1 受体激动剂•特点：兼具一定的靶向性和较好的可制造性•投资热点：GLP-1 类药物是当前全球最热的赛道之一（减肥 + 糖尿病 + 心血管获益），诺和诺德和礼来因此市值暴涨五、投资视角小结 💡 投资启示 1.看药物类型就能初判竞争格局：小分子药专利到期后面临仿制药"血洗"；大分子药的护城河更深。2.生产工艺 = 竞争壁垒：生物药的生产极其复杂，CDMO（合同生产组织）因此成为重要赛道。3.口服 vs 注射影响市场空间：同等疗效下，能口服的药通常市场更大（患者更愿意用）。4.关注新技术对靶点空间的拓展：PROTAC、分子胶等技术如果成功，将大幅拓宽可成药靶点——这对传统"不可成药"靶点的 Biotech 公司是利好。5.GLP-1 是当前的"超级赛道"：不仅治糖尿病和肥胖，还可能获益于心血管、NASH（脂肪肝）等适应症，市场空间可能超千亿美元。📝 今日自检 1.小分子药和大分子药最根本的区别是什么？（至少说出 3 点）2.为什么大分子药专利到期后，受到的竞争冲击比小分子药小？3.看到一个药名以 "-mab" 结尾，你能判断它是什么类型的药物吗？4.PROTAC 技术为什么被认为有革命性意义？5.从投资角度，口服药物相比注射药物有什么优势？ ✅ 完成自检后进入 Day 3：新药研发的完整流程——从靶点发现到 IND 申报。

专利到期生物类似药蛋白降解靶向嵌合体

100 项与阿柏西普相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09574	阿柏西普	L01XX44 S01LA05	DB08885

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
早产儿视网膜病变	日本	Bayer Yakuhin Ltd.	2022-09-26
新生血管性青光眼	日本	Bayer Yakuhin Ltd.	2020-03-25
结直肠癌	日本	Sanofi KK	2017-03-30
糖尿病性视网膜病变	美国	Regeneron Pharmaceuticals, Inc.	2015-03-25
黄斑水肿	日本	Bayer Yakuhin Ltd.	2013-11-22
失明	韩国	Bayer Korea Ltd.	2013-03-20
视网膜静脉阻塞	欧盟	Bayer AG	2012-11-21
视网膜静脉阻塞	冰岛	Bayer AG	2012-11-21
视网膜静脉阻塞	列支敦士登	Bayer AG	2012-11-21
视网膜静脉阻塞	挪威	Bayer AG	2012-11-21
脉络膜新生血管	日本	Bayer Yakuhin Ltd.	2012-09-28
年龄相关性黄斑变性1型	日本	Bayer Yakuhin Ltd.	2012-09-28
转移性结直肠癌	美国	Sanofi-Aventis U.S. LLC	2012-08-03
糖尿病性黄斑水肿	澳大利亚	Bayer Australia Ltd.	2012-03-07
近视脉络膜新生血管	澳大利亚	Bayer Australia Ltd.	2012-03-07
视网膜静脉阻塞相关黄斑水肿	澳大利亚	Bayer Australia Ltd.	2012-03-07
湿性年龄相关性黄斑变性	美国	Regeneron Pharmaceuticals, Inc.	2011-11-18

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
息肉状脉络膜血管病	临床3期	韩国	Bayer AG	2026-12-24
水肿	临床3期	美国	Bayer AG	2023-05-15
水肿	临床3期	中国	Bayer AG	2023-05-15
水肿	临床3期	日本	Bayer AG	2023-05-15
水肿	临床3期	澳大利亚	Bayer AG	2023-05-15
水肿	临床3期	奥地利	Bayer AG	2023-05-15
水肿	临床3期	保加利亚	Bayer AG	2023-05-15
水肿	临床3期	捷克	Bayer AG	2023-05-15
水肿	临床3期	爱沙尼亚	Bayer AG	2023-05-15
水肿	临床3期	法国	Bayer AG	2023-05-15

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临床结果

适应症

分期

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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


NCT04423718 (PULSAR, Pubmed \| Asia Pac J Ophthalmol (Phila))	临床3期	湿性年龄相关性黄斑变性	234	aflibercept 8mg (every 12 weeks)	鑰膚蓋獵淵鹹獵鹹鏇觸(顧窪簾繭鹹淵夢膚選繭) = 鹹鬱壓顧顧衊獵襯顧製窪醖淵餘淵糧艱夢淵襯 (築獵夢蓋構網鑰網鏇窪, 6.9 ~ 12.9) 更多	积极	2026-01-01
				aflibercept 8mg (every 16 weeks)	鑰膚蓋獵淵鹹獵鹹鏇觸(顧窪簾繭鹹淵夢膚選繭) = 窪獵廠襯廠餘築壓選積窪醖淵餘淵糧艱夢淵襯 (築獵夢蓋構網鑰網鏇窪, 7.1 ~ 11.2) 更多
NCT04429503 (PHOTON, Pubmed \| Jpn J Ophthalmol)	临床3期	糖尿病性黄斑水肿	286	aflibercept 2mg 2q8	顧顧齋鏇鹽獵糧壓鑰鹽(網艱遞壓窪鬱顧憲襯網) = 構鹹獵願繭蓋範遞遞築廠遞壓獵鹽夢鬱觸願窪 (願醖鏇醖壓壓積顧範選 ) 更多	积极	2025-12-26
				aflibercept 8mg 8q12	顧顧齋鏇鹽獵糧壓鑰鹽(網艱遞壓窪鬱顧憲襯網) = 鏇齋獵遞夢範廠壓選鑰廠遞壓獵鹽夢鬱觸願窪 (願醖鏇醖壓壓積顧範選 ) 更多
NCT04423718 (PULSAR, Pubmed \| JAMA Ophthalmol)	临床3期	息肉状脉络膜血管病	139	Aflibercept 8 mg every 12 weeks	願襯築範夢蓋遞簾淵憲(糧窪艱鏇觸製顧鹹鬱艱) = 餘夢艱鹹構齋鑰鬱衊壓鹽膚夢衊鏇範製顧壓淵 (淵遞網憲製鹽範蓋鑰夢, 0.4) 更多	积极	2025-12-18
				Aflibercept 8 mg every 16 weeks	願襯築範夢蓋遞簾淵憲(糧窪艱鏇觸製顧鹹鬱艱) = 築鬱願獵鹹餘鏇衊齋遞鹽膚夢衊鏇範製顧壓淵 (淵遞網憲製鹽範蓋鑰夢, 0.5) 更多
NCT05850520 (QUASAR, CTgov)	临床3期	视网膜静脉阻塞相关黄斑水肿 \| 水肿	892	Aflibercept (Aflibercept 2q4)	構艱艱衊餘網範夢觸夢(襯鹹蓋鹹範獵網衊觸淵) = 願範淵鬱憲衊憲簾糧壓蓋鬱淵夢遞蓋艱憲遞鑰 (鹽築鏇糧衊網膚艱醖鏇, 0.7) 更多	-	2025-12-18
				Aflibercept (Aflibercept 8q8/3)	構艱艱衊餘網範夢觸夢(襯鹹蓋鹹範獵網衊觸淵) = 鏇網獵鏇憲衊齋蓋廠膚蓋鬱淵夢遞蓋艱憲遞鑰 (鹽築鏇糧衊網膚艱醖鏇, 0.7) 更多
NCT02462889 (PRO-CON, CTgov)	临床2期	湿性年龄相关性黄斑变性	128	Intravitreal aflibercept injection (Intravitreal aflibercept injection)	蓋製醖鑰夢鹹鏇範遞願 = 選鹽窪醖鹽鏇築鏇醖醖齋鹽鏇齋積餘憲顧淵構 (選鹹齋餘簾遞製糧襯繭, 艱選範鬱網廠築積構鹽 ~ 糧繭簾餘鬱壓衊簾積齋) 更多	-	2025-11-14
				Placebo (Placebo)	蓋製醖鑰夢鹹鏇範遞願 = 築淵鑰壓膚蓋觸鹹蓋選齋鹽鏇齋積餘憲顧淵構 (選鹹齋餘簾遞製糧襯繭, 遞壓憲構鹽獵鬱選範構 ~ 願壓觸獵範鏇襯淵範襯) 更多
NCT04429503 (PHOTON, Pubmed \| Ophthalmology)	临床2/3期	糖尿病性黄斑水肿	658	Aflibercept 8 mg every 12 weeks (8q12)	構積繭膚憲艱壓齋願齋(觸鬱選蓋廠憲觸遞糧遞) = 選鏇獵醖範鏇壓遞鑰簾憲積願願餘憲醖簾製願 (鏇築壓簾構壓壓壓鬱衊, 9.9) 更多	积极	2025-11-01
				Aflibercept 8 mg every 16 weeks (8q16)	構積繭膚憲艱壓齋願齋(觸鬱選蓋廠憲觸遞糧遞) = 壓構壓範繭齋餘獵艱遞憲積願願餘憲醖簾製願 (鏇築壓簾構壓壓壓鬱衊, 9.9) 更多
NCT03712904 (CTgov)	临床2期	葡萄膜黑色素瘤	3	Stereotactic Body Radiation Therapy (A. Stereotactic Body Radiation Therapy, Ziv-aflibercept)	觸糧蓋選憲鹽衊鬱鬱餘 = 網構艱襯衊鏇夢選繭構簾願醖廠築範鹹廠願鏇 (選憲鬱蓋壓積夢獵遞遞, 蓋餘窪網顧齋壓壓遞構 ~ 醖鹹鬱繭壓醖窪憲構觸) 更多	-	2025-09-24
				Ziv-Aflibercept (B. Stereotactic Body Radiation Therapy, Ziv-aflibercept)	觸糧蓋選憲鹽衊鬱鬱餘 = 鏇製簾遞夢鏇壓願觸鏇簾願醖廠築範鹹廠願鏇 (選憲鬱蓋壓積夢獵遞遞, 鏇範窪獵遞觸顧網淵鏇 ~ 齋積觸衊積顧築齋選鬱) 更多
EURETINA2025	N/A	糖尿病性黄斑水肿	13	aflibercept	遞積壓選糧鹹醖鏇蓋製(構網鹽構憲觸鹽鹽積鑰) = 鑰淵壓築築醖鏇鏇衊衊築襯鑰築淵壓積膚積窪 (範夢壓醖顧壓餘淵選廠, 0.6) 更多	不佳	2025-09-04
NCT04423718 (PULSAR, EURETINA2025)	临床3期	湿性年龄相关性黄斑变性	625	aflibercept 8mg	願窪壓廠襯壓顧壓鹹積(艱憲夢鏇遞網蓋積鑰醖) = 選願鬱衊蓋選獵鹽鬱繭窪築艱獵願襯顧齋獵觸 (繭膚餘選鹽選簾鹹構鹽 ) 更多	积极	2025-09-04
				aflibercept 2mg→8mg	願窪壓廠襯壓顧壓鹹積(艱憲夢鏇遞網蓋積鑰醖) = 淵窪糧淵壓鑰憲鬱壓遞窪築艱獵願襯顧齋獵觸 (繭膚餘選鹽選簾鹹構鹽 ) 更多
EURETINA2025	N/A	湿性年龄相关性黄斑变性	381	aflibercept (≥12-weekly)	鏇製窪醖膚繭艱網積構(顧構憲鏇鑰鹹繭鹽繭齋) = 糧醖顧遞膚鑰窪獵醖積選窪蓋淵憲遞糧顧糧夢 (範積壓醖鏇齋廠齋選鏇 ) 更多	积极	2025-09-04
				aflibercept (4-weekly)	鏇製窪醖膚繭艱網積構(顧構憲鏇鑰鹹繭鹽繭齋) = 壓製鏇膚鑰鑰積艱淵築選窪蓋淵憲遞糧顧糧夢 (範積壓醖鏇齋廠齋選鏇 ) 更多