C3b抑制剂(补体C3b抑制剂)、C4B inhibitors(complement C4B (Chido blood group) inhibitors)、CR1 antagonists(complement C3b/C4b receptor 1 (Knops blood group) antagonists)

治疗领域

遗传病与畸形眼部疾病心血管疾病+ [1]

在研适应症

湿性年龄相关性黄斑变性糖尿病性黄斑水肿

非在研适应症

脉络膜新生血管

原研机构

信达生物制药（苏州）有限公司圆祥生技股份有限公司

在研机构

圆祥生技股份有限公司

信达生物制药

信达生物制药（苏州）有限公司

非在研机构-

权益机构

信达生物制药（苏州）有限公司圆祥生技股份有限公司

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-

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结构/序列

Sequence Code 25108715

来源: *****

关联

项与重组人血管内皮生长因子受体-抗体-人补体受体1融合蛋白(AP Biosciences/Innovent Biologics) 相关的临床试验

NCT06908876

/ Not yet recruiting临床2期

A Randomized, Double-maskedblind, Activity-controlled Phase II Clinical Study to Evaluateing the Efficacy and Safety of Intravitreal Injection of IBI302 in Patients With Diabetic Macular Edema（DME） Subjects

The study is designed for multi-center,randomized,double-masked,active-contralledstudy to evaluate effective and security of intravitrealinjection of IBI302 in subjects with Diabetic Macular Oedema.

开始日期2025-04-15

申办/合作机构

信达生物制药

NCT05972473

/ Active, not recruiting临床3期

A Phase 3, Randomized, Double-masked, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravitreal IBI302(Efdamrofusp Alfa) in Subjects with Neovascular Age-Related Macular Degeneration

The study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.

开始日期2023-09-21

申办/合作机构

信达生物制药（苏州）有限公司

CTR20232229

/ Active, not recruiting临床3期

一项评估在新生血管性年龄相关性黄斑变性受试者中玻璃体腔注射IBI302的疗效和安全性的随机、双盲、活性对照的III期临床研究

与2 mg阿柏西普每8周一次治疗相比，8 mg IBI302在新生血管性年龄相关性黄斑变性（nAMD）受试者中的最佳矫正视力（ BCVA）变化是否能达到非劣效性

开始日期2023-09-21

申办/合作机构

信达生物制药（苏州）有限公司

100 项与重组人血管内皮生长因子受体-抗体-人补体受体1融合蛋白(AP Biosciences/Innovent Biologics) 相关的临床结果

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100 项与重组人血管内皮生长因子受体-抗体-人补体受体1融合蛋白(AP Biosciences/Innovent Biologics) 相关的转化医学

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100 项与重组人血管内皮生长因子受体-抗体-人补体受体1融合蛋白(AP Biosciences/Innovent Biologics) 相关的专利（医药）

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项与重组人血管内皮生长因子受体-抗体-人补体受体1融合蛋白(AP Biosciences/Innovent Biologics) 相关的文献（医药）

2025-02-01·Ophthalmology Retina

Efficacy and Safety of Efdamrofusp Alfa versus Aflibercept in Participants with Neovascular Age-Related Macular Degeneration

Article

作者: Li, Jinying ; Wen, Ying ; Lu, Shujie ; Yu, Songping ; He, Tao ; Li, Haoyu ; Wang, Xian ; Xu, Yihua ; Wei, Wenbin ; Dai, Hong ; Tong, Jianping ; Zhang, Wenfang ; Jia, Huixun ; Wang, Wei ; Wu, Miaoqin ; Zhang, Jinglin ; Zheng, Qinxiang ; Pei, Cheng ; Li, Mingxin ; Liu, Qinghuai ; Deng, Junjie ; Mao, Junfeng ; Ye, Jian ; Cui, Ling ; Gong, Yuanyuan ; Hao, Jilong ; Guan, Huaijin ; Liu, Xiaoling ; Tao, Liming ; Yan, Ming ; Bi, Yanlong ; Qian, Lei ; Shu, Xiangwen ; Ding, Lin ; Sun, Xiaodong ; Peng, Hui ; Fan, Ke ; Li, Chaopeng ; Xu, Xiangzhong ; Song, Yanping ; Sun, Junran ; Wu, Zhifeng ; Zhao, MingWei ; Wang, Hong ; Zhu, Dan ; Liu, Wei ; Wang, Feng ; Lu, Peirong

PURPOSE:

To evaluate efficacy and safety of efdamrofusp alfa compared with aflibercept in neovascular age-related macular degeneration (nAMD).

DESIGN:

Randomized, double-masked, multicenter, active-controlled, noninferiority phase II study.

PARTICIPANTS:

A total of 231 treatment-naive and previously treated participants with active choroidal neovascularization secondary to nAMD were enrolled.

METHODS:

Eligible participants were randomized (1:1:1) to 2 mg efdamrofusp alfa, 4 mg efdamrofusp alfa, or 2 mg aflibercept groups. Participants in all groups received 3 initial monthly loading doses, followed by treatment every 8 weeks, with assessment every 4 weeks up to week 52.

MAIN OUTCOME MEASURES:

The primary end point was the mean best-corrected visual acuity (BCVA) change from baseline to week 36. The prespecified noninferiority margin was set as -5 letters (80% confidence interval [CI]).

RESULTS:

Each treatment group included 77 participants. The mean BCVA changes from baseline to week 36 for 2 mg efdamrofusp alfa, 4 mg efdamrofusp alfa and aflibercept groups were +10.6, +11.4, and +12.0 letters, respectively; least squares mean difference were -1.4 (80% CI: -3.5 to 0.7) between 2 mg efdamrofusp alfa and aflibercept, and -0.6 (80% CI: -2.7 to 1.6) between 4 mg efdamrofusp alfa and aflibercept. Mean central retinal thickness changes were consistent across groups. Adverse event rate was comparable among the groups.

CONCLUSIONS:

Efdamrofusp alfa demonstrated noninferiority to aflibercept in BCVA improvement, accompanied by a similar safety profile.

FINANCIAL DISCLOSURE(S):

The author(s) have no proprietary or commercial interest in any materials discussed in this article.

2023-04-01·American journal of ophthalmology

A Novel Bispecific Fusion Protein Targeting C3b/C4b and VEGF in Patients With nAMD: A Randomized, Open-Label, Phase 1b Study

Article

作者: Gong, Yuanyuan ; Li, Tong ; Lu, Shujie ; Wang, Fenghua ; Jia, Huixun ; Feng, Liqi ; Liu, Haiyun ; Qian, Lei ; Liu, Wenjia ; Sun, Xiaodong ; Wan, Qiuchen ; Chen, Jieqiong ; Sun, Junran ; Wang, Hong ; Liu, Xiaoling

PURPOSE:

To evaluate the safety, tolerability, and efficacy of efdamrofusp alfa in patients with neovascular age-related macular degeneration (nAMD).

DESIGN:

Prospective randomized, open-label, multiple ascending-dose, phase 1b study.

METHODS:

Patients aged 50 years or older with active choroid neovascularization (CNV) secondary to nAMD were screened from 2 hospitals in 2 provinces in China. The first 9 patients were randomized 2:1 to intravitreally receive efdamrofusp alfa 2 mg at weeks 0, 4, and 8 or aflibercept 2 mg at weeks 0, 4, 8, and 16. After the dose-limiting toxicity assessment, 9 additional patients were randomized 2:1 to intravitreally receive efdamrofusp alfa 4 mg at weeks 0, 4, and 8 or aflibercept 2 mg at weeks 0, 4, 8, and 16. All patients were followed until week 20. Primary outcomes were safety and tolerability of efdamrofusp alfa. Secondary outcomes included changes from baseline in best-corrected visual acuity (BCVA), central subfield thickness (CST) as measured by spectral domain optical coherence tomography (SD-OCT), and CNV area as measured by fluorescein angiography (FA).

RESULTS:

A total of 18 patients were enrolled. Six each of them received efdamrofusp alfa 2 mg, efdamrofusp alfa 4 mg, or aflibercept 2 mg, respectively. No dose-limiting toxicity was reported, and all patients completed the study. No ocular serious adverse events were reported. All ocular treatment-emergent adverse events were intravitreal injection related and were mild or moderate in severity. At week 20, mean changes from baseline in BCVA were 5.64 ± 3.56, 8.93 ± 3.59, and 7.92 ± 3.55 letters for patients receiving efdamrofusp alfa 2 mg, efdamrofusp alfa 4 mg and aflibercept 2 mg, respectively. Meanwhile, CST and CNV area reductions indicative of anatomic improvement were observed in the majority of the patients receiving both doses of efdamrofusp alfa and aflibercept.

CONCLUSIONS:

Intravitreal efdamrofusp alfa dosed up to 4 mg every 4 weeks was well tolerated in nAMD patients with similar vision acuity and anatomic improvements.

2022-06-01·Science translational medicine1区 · 医学

Targeting C3b/C4b and VEGF with a bispecific fusion protein optimized for neovascular age-related macular degeneration therapy

1区 · 医学

Article

作者: Li, Tong ; Song, Yanping ; Jia, Huixun ; Wang, Tao ; Gu, Qing ; Liang, Jian ; Wang, Fenghua ; Li, Yiming ; Zhai, Yuanqi ; Wan, Xiaoling ; Qian, Lei ; Li, Xiaomeng ; Lu, Shujie ; Luo, Xueting ; Liu, Junjian ; Li, Min ; Yang, Shiqi ; Sun, Xiaodong ; Yu, Dechao ; Gao, Min ; Huang, Zhen ; Yang, Xiaotong

Antiangiogenesis therapies targeting vascular endothelial growth factor (VEGF) have revolutionized the treatment of neovascular ocular diseases, including neovascular age-related macular degeneration (nAMD). Compelling evidence has implicated the vital role of complement system dysregulation in AMD pathogenesis, implying it as a potential therapeutic strategy for geographic atrophy in dry AMD and to enhance the efficacy of anti-VEGF monotherapies in nAMD. This study reports the preclinical assessment and phase 1 clinical outcomes of a bispecific fusion protein, efdamrofusp alfa (code: IBI302), which is capable of neutralizing both VEGF isoforms and C3b/C4b. Efdamrofusp alfa showed superior efficacy over anti-VEGF monotherapy in a mouse laser-induced choroidal neovascularization (CNV) model after intravitreal delivery. Dual inhibition of VEGF and the complement activation was found to further inhibit macrophage infiltration and M2 macrophage polarization. Intravitreal efdamrofusp alfa demonstrated favorable safety profiles and exhibited antiangiogenetic efficacy in a nonhuman primate laser-induced CNV model. A phase 1 dose-escalating clinical trial (NCT03814291) was thus conducted on the basis of the preclinical data. Preliminary results showed that efdamrofusp alfa was well tolerated in patients with nAMD. These data suggest that efdamrofusp alfa might be effective for treating nAMD and possibly other complement-related ocular conditions.

项与重组人血管内皮生长因子受体-抗体-人补体受体1融合蛋白(AP Biosciences/Innovent Biologics) 相关的新闻（医药）

2025-05-07

·信达生物

双靶头对头：全球首创抗VEGF-补体双靶融合蛋白依莫芙普（IBI302）治疗糖尿病黄斑水肿II期临床研究完成首例受试者给药

2025年5月7日，美国旧金山和中国苏州——信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售肿瘤、自身免疫、代谢及心血管、眼科等重大疾病领域创新药物的生物制药公司，宣布其研发的重组人血管内皮生长因子受体（VEGFR）和人补体受体1（CR1）融合蛋白依莫芙普注射液（研发代号：IBI302）的一项II期临床研究完成首例受试者给药。本研究是一项在糖尿病黄斑水肿（DME）受试者中进行的随机、双盲、多中心、活性对照的II期临床研究（NCT06908876），旨在评估玻璃体腔注射IBI302在DME受试者中的疗效和安全性。本试验计划入组150例受试者，按1:1:1比例随机分配至IBI302 4 mg组、IBI302 8 mg组和法瑞西单抗（抗VEGF/ANG-2双抗）6 mg组。主要终点为第16周时研究眼最佳矫正视力字母数 (BCVA) 较基线的改变。DME已成为中国糖尿病人群中出现视力损害的最主要原因：据统计，中国糖尿病患者数量超过1.4亿，其中约三分之一患者合并糖尿病视网膜病变（DR）1；DR患者中，DME患病率为7%~14%，预计中国DME患者约在400~500万。DME发病机制复杂，血管内皮细胞生长因子（VEGF）和炎症介质表达上调介导的微血管损害是DME发生和疾病进展的主要原因2。此外，补体活化也参与了DME的发生发展，主要通过细胞溶解、调理作用和介导促炎微环境等破坏神经血管单元，造成视网膜微血管病变、神经变性及黄斑水肿等3。目前，玻璃体腔注射抗VEGF药物或者糖皮质激素是DME治疗的重要手段，可有效改善视网膜水肿，提高视力，但是频繁玻璃体腔注射（每4~8周一次）存在患者依从性较差的问题，同时会引起白内障、眼压升高等并发症的风险，长期治疗视力获益亦难以达到预期4,5。近年来新型药物如以法瑞西单抗为代表的双特异性抗体进入市场后，极大的提升了治疗标准，并显著的拉长了治疗间隔，法瑞西单抗代表了全球目前DME最高的治疗标准。依莫芙普作为全球首个靶向VEGF和补体的双特异性融合蛋白，可以同时抑制VEGF介导的血管新生、血管渗漏和补体不同途径活化介导的炎症反应。目前，依莫芙普已在新生血管性年龄相关性黄斑变性（nAMD）、DME患者中开展多项临床研究，其中高剂量（8 mg）依莫芙普展现出改善视力和视网膜水肿的显著疗效，同时长给药间隔潜力凸显（最长可达12~16周），并具有良好的安全性和耐受性。该研究的主要研究者、上海交通大学医学院附属第一人民医院副院长、眼科中心主任孙晓东教授表示：“DME是中国常见的眼底疾病之一，影响人口可达400~500万；随着我国老龄化加重和糖尿病患病率的持续走高，DME已经成为严重危害我国人民群众的疾病之一，给国家、社会和个人都带来了沉重的负担。目前DME一线治疗药物是抗VEGF药物，但仍存在巨大的未满足的临床需求：其治疗过程存在频繁注射、长期疗效衰减、部分患者疗效欠佳等问题，给广大患者带来诸多不便和经济负担。作为全球首创的抗VEGF-补体双靶点药物，依莫芙普在DME患者中已完成的临床I期研究中安全性良好，明显改善视力和黄斑水肿，并具有长间隔给药的潜力，这给研究者带来了很大的信心。依莫芙普在DME患者中的II期临床研究将进一步探索其疗效和安全性，期待该研究取得成功，为广大DME患者提供全新的治疗方案。”信达生物制药集团临床开发高级副总裁钱镭博士表示：“依莫芙普是信达生物拥有全球自主知识产权的抗VEGF-补体双靶点分子。本研究中，依莫芙普将挑战本领域全球当前最高的治疗标准，本研究也是全球第一个双靶点创新药物之间的对决，以法瑞西单抗为阳性对照的随机双盲对照临床研究。我期待并非常有信心本研究能取得成功，为III期研究提供支持，争取早日为医生提供更多的临床治疗方案选择，造福更多患者。”关于糖尿病黄斑水肿- 滑动查看更多介绍 -糖尿病视网膜病变（DR）是糖尿病导致的视网膜微血管损害所引起的一系列病变，是糖尿病的主要微血管并发症。糖尿病黄斑水肿（DME）则是由于黄斑区毛细血管渗漏所致的视网膜水肿增厚、渗出，是血视网膜屏障（BRB）破坏的结果，主要影响中心视力，可发生在DR的任何阶段。目前DR已成为全球工作年龄人群首位的致盲眼病，而DME已成为糖尿病人群中出现视力损害的最主要原因6。DR和DME的病理机制复杂，主要与高血糖相关代谢异常、氧化应激及炎症反应有关，引起VEGF等血管活性因子表达上调，进而破坏血视网膜屏障；持续的炎症状态会增加血管通透性，临床表现为视网膜水肿、渗出，累及黄斑区时即发展为DME2。此外，补体系统活化也参与到DR和DME的发生发展过程中，主要通过细胞溶解、调理作用和介导促炎微环境等破坏神经血管单元，造成视网膜微血管病变、神经变性、黄斑水肿以及视网膜新生血管等3。关于依莫芙普（IBI302）- 滑动查看更多介绍 -依莫芙普是信达生物拥有全球知识产权的一种双特异性重组全人源融合蛋白,研发代号：IBI302。N端为VEGF结合域，能够与VEGF家族结合阻断VEGF介导的信号通路，抑制血管内皮细胞的生存、增殖，从而抑制血管新生，降低血管渗透性，减少血管渗漏；C端为补体结合域，能够通过特异性结合C3b和C4b，抑制补体经典途径和旁路途经的激活，减轻补体活化介导的炎症反应。IBI302通过同时抑制VEGF介导的新生血管生成和补体活化通路，发挥治疗作用。关于信达生物- 滑动查看更多介绍 -“始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有15个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®），雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®），氟泽雷塞片（达伯特®），匹妥布替尼片(捷帕力®)，己二酸他雷替尼胶囊（达伯乐®），利厄替尼片（奥壹新®）和替妥尤单抗N01注射液（信必敏®）。目前，同时还有3个品种在NMPA审评中，4个新药分子进入III期或关键性临床研究，另外还有15个新药品种已进入临床研究。公司已与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及20余万普通患者，药物捐赠总价值36亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问公司网站：www.innoventbio.com或公司领英账号：Innovent Biologics。声明：1.信达不推荐任何未获批的药品/适应症使用。2.雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®）和匹妥布替尼片（捷帕力®）由礼来公司研发。参考文献1.中华医学会眼科学分会眼底病学组, 中国医师协会眼科医师分会眼底病学组. 我国糖尿病视网膜病变临床诊疗指南（2022年）. 中华眼底病杂志. 2023;39(02):99-124.2.Kusuhara S, Fukushima Y, Ogura S, Inoue N, Uemura A. Pathophysiology of Diabetic Retinopathy: The Old and the New. Diabetes Metab J. 2018;42(5):364-376.3.Jiang F, Lei C, Chen Y, Zhou N, Zhang M. The complement system and diabetic retinopathy. Surv Ophthalmol. 2024;69(4):575-584.4.Ehlken C, Ziemssen F, Eter N, et al. Systematic review: non-adherence and non-persistence in intravitreal treatment. Graefes Arch Clin Exp Ophthalmol. 2020;258(10):2077-2090.5.Ciulla TA, Bracha P, Pollack J, Williams DF. Real-world Outcomes of Anti-Vascular Endothelial Growth Factor Therapy in Diabetic Macular Edema in the United States. Ophthalmol Retina. 2018;2(12):1179-1187.6.Tan GS, Cheung N, Simó R, et al. Diabetic macular oedema. Lancet Diabetes Endocrinol, 2017, 5(2): 143-155.前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

临床2期临床1期

2025-05-07

·PRNewswire

Bispecific vs. Bispecific: Innovent Announces First Patient Dosed in the Phase 2 Clinical Study of Efdamrofusp Alfa (IBI302), a First-in-class Anti-VEGF and Anti-Complement Bispecific Fusion Protein for the Treatment of Diabetic Macular Edema

SAN FRANCISCO and SUZHOU, China, May 6, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces the completion of first patient dosing in the Phase 2 clinical study of efdamrofusp alfa (R&D code: IBI302), a recombinant human vascular endothelial growth factor receptor (VEGFR)-antibody human complement receptor 1 (CR1) fusion protein, for the treatment of diabetic macular edema (DME). This randomized, double-masked, multi-center, active-controlled Phase 2 clinical study (NCT06908876) aims to evaluate the efficacy and safety of intravitreal injections of efdamrofusp alfa in DME patients. A total of 150 participants will be enrolled and randomized in a 1:1:1 ratio to the IBI302 4 mg group, the IBI302 8 mg group, and the Faricimab (anti-VEGF/ANG-2 bispecific antibody) 6 mg group. The primary endpoint is the change in best corrected visual acuity (BCVA) from baseline in the study eye at week 16. DME has become the leading cause of vision impairment among the diabetic population in China: According to statistics, China has over 140 million diabetic patients, with approximately one-third of them developing diabetic retinopathy (DR). Among patients with DR, the prevalence rate of DME ranges from 7% to 14%, indicating an estimated 4 to 5 million DME patients in China1. DME development is primarily driven by microvascular damage mediated by VEGF upregulation and inflammatory factors2. Complement activation is also involved in the development of DME by damaging the neurovascular units through cytolysis, opsonization, and promotion of proinflammatory microenvironment, leading to retinal microvascular lesions, neurodegeneration, and macular edema3. At present, intravitreal injections of anti-VEGF agents or glucocorticoids are key treatment strategies, effectively improving visual acuity and retinal edema. However, frequent intravitreal injections (every 4 to 8 weeks) can result in poor patient compliance and increased risk of complications such as cataract and elevated intraocular pressure, making it challenging to achieve sustained visual acuity benefits with long-term treatment4,5. In recent years, bispecific antibodies represented by Faricimab have demonstrated significant efficacy and extended dosing intervals in patients with DME; Faricimab currently represents the highest global treatment standard for DME. Efdamrofusp alfa, the first-in-class bispecific fusion protein targeting VEGF and complement, can simultaneously inhibit angiogenesis and vascular leakage mediated by VEGF, and inflammatory responses mediated by complement activation. To date, multiple clinical studies of efdamrofusp alfa have been conducted in patients with neovascular age-related macular degeneration (nAMD) and DME, among which high-dose (8 mg) efdamrofusp alfa has shown significant efficacy in improving visual acuity and retinal edema. Meanwhile, efdamrofusp alfa has demonstrated the potential for extended dosing intervals (up to 12-16 weeks), with favorable safety and tolerability. Professor Xiaodong Sun, the leading Principal Investigator of this Study, Deputy Director of Shanghai General Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, and Director of the Ophthalmology Center, stated, " DME is one of the most common ocular fundus diseases in China, affecting up to 4- to 5 million patients. With increasingly the aging of the population and the continuous rise in diabetes prevalence in China, DME has become one of the diseases that seriously endangers public health, imposing heavy burdens to the society and individuals. Anti-VEGF drugs are currently the first-line treatment for DME, but huge unmet medical needs remain, such as frequent injections, long-term efficacy attenuation, and suboptimal response in a subset of patients . As a global first-in-class anti-VEGF-complement bispecific drug, efdamrofusp alfa has shown favorable safety profile, substantial improvement in visual acuity and macular edema, and the potential of extended dosing interval in the completed Phase 1 clinical study in DME patients, which has brought great confidence to our investigator team. efdamrofusp alfa. We look forward to the success of this Phase 2 study, hoping to provide of a new treatment option for a large number of DME patients." Dr. Lei Qian, Senior Vice President of Clinical Development of Innovent, stated, "Efdamrofusp alfa is an anti-VEGF-complement bispecific fusion protein self-developed by Innovent with global proprietary rights. This clinical study will be globally the first study comparing two dual-target agents, using Faricimab, the global standard of care in DME. We look forward to the success of this study, which could provide support for a Phase 3 clinical trial and a new treatment option for patients. Innovent's general biomedicine pipeline covers cardiovascular, endocrine and metabolic, ophthalmology, and autoimmune disease areas. We will continue to develop new therapies, providing physicians with more clinical treatment options and benefiting more patients." About diabetic macular edema Diabetic retinopathy (DR) is a series of lesions caused by retinal microvascular damage resulting from diabetes and is the main microvascular complication of diabetes. Diabetic macular edema (DME), featuring retinal edema, thickening and exudation, is caused by capillary leakage in the macular area. It is the result of the blood-retinal barrier (BRB) destruction and mainly affects central vision. At present, DR has become the leading cause of blindness among the working-age population worldwide, while DME has become the main cause of visual impairment among the diabetic population6. The pathological mechanisms of DR and DME are multifactorial, involving metabolic abnormalities related to hyperglycemia, oxidative stress, and inflammation. These processes lead to the upregulation of vasoactive factors such as VEGF, which subsequently disrupt the BRB and increase vascular permeability, manifesting clinically as retinal edema and exudation. When the macular area is involved, it develops into DME2. Additionally, complement system activation contributes to disease progression by damaging the neurovascular units through cytolysis, opsonization, and promotion of proinflammatory microenvironment, causing retinal microvascular lesions, neurodegeneration, macular edema, and retinal neovascularization3. About Effamrofusp Alfa (IBI302) Efdamrofusp alfa is a recombinant, fully human bispecific fusion protein developed by Innovent Biologics with global intellectual property rights. The N-terminal is the VEGF-binding domain, which can bind to the VEGF family to block the VEGF-mediated signaling pathway, inhibiting the survival and proliferation of vascular endothelial cells, thereby inhibiting angiogenesis, reducing vascular permeability, and reducing vascular leakage. The C-terminal is the complement binding domain, which can inhibit complement activation through the classical pathway and the bypass pathway by specifically binding to C3b and C4b, and thereby alleviate the inflammatory response mediated by complement activation. Through this dual mechanism, efdamrofusp alfa exerts its therapeutic effects by inhibiting both VEGF-mediated angiogenesis and complement activation pathways. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drugs/indications. Forward-Looking Statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References 1. 中华医学会眼科学分会眼底病学组, 中国医师协会眼科医师分会眼底病学组. 我国糖尿病视网膜病变临床诊疗指南（2022年）. 中华眼底病杂志. 2023;39(02):99-124. 2. Kusuhara S, Fukushima Y, Ogura S, Inoue N, Uemura A. Pathophysiology of Diabetic Retinopathy: The Old and the New. Diabetes Metab J. 2018;42(5):364-376. 3. Jiang F, Lei C, Chen Y, Zhou N, Zhang M. The complement system and diabetic retinopathy. Surv Ophthalmol. 2024;69(4):575-584. 4. Ehlken C, Ziemssen F, Eter N, et al. Systematic review: non-adherence and non-persistence in intravitreal treatment. Graefes Arch Clin Exp Ophthalmol. 2020;258(10):2077-2090. 5. Ciulla TA, Bracha P, Pollack J, Williams DF. Real-world Outcomes of Anti-Vascular Endothelial Growth Factor Therapy in Diabetic Macular Edema in the United States. Ophthalmol Retina. 2018;2(12):1179-1187. 6. Tan GS, Cheung N, Simó R, et al. Diabetic macular oedema. Lancet Diabetes Endocrinol, 2017, 5(2): 143-155. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床2期临床结果

2025-05-06

·医药观澜

可每12周一次！信达生物双靶点新药2期临床完整数据公布

5月6日，信达生物宣布，在2025年视觉和眼科研究协会（ARVO）年会上以口头报告的形式公布了其研发的重组人血管内皮生长因子受体（VEGFR）和人补体受体1（CR1）融合蛋白依莫芙普注射液（研发代号：IBI302）在新生血管性年龄相关性黄斑变性（nAMD）受试者中为期一年的临床2期研究结果。ARVO年会于5月4~8日在美国犹他州盐湖城举办，是全球最大的眼科与视觉研究盛会之一。依莫芙普是一种双特异性重组全人源融合蛋白。其N端为VEGF结合域，能够与VEGF家族结合阻断VEGF介导的信号通路，抑制血管内皮细胞的生存、增殖，从而抑制血管新生，降低血管渗透性，减少血管渗漏；C端为补体结合域，能够通过特异性结合C3b和C4b，抑制补体经典途径和旁路途经的激活，减轻补体活化介导的炎症反应。依莫芙普潜在通过同时抑制VEGF介导的新生血管生成和补体活化通路，发挥治疗作用。本次公布的摘要标题为：IBI302（抗VEGF-抗补体双靶点药物）在新生血管性年龄相关性黄斑变性（nAMD）受试者中长间隔给药的2期临床研究。本次研究数据来自IBI302的二期临床研究（试验登记号：NCT05403749），旨在评估IBI302治疗nAMD一年的疗效及安全性。132例受试者以1:1:1随机分配至IBI302 6.4 mg组、IBI302 8.0 mg组及阿柏西普2.0 mg组。IBI302组完成负荷治疗后根据第20周疾病活动性评估，继之以Q12W或Q8W的个性化间隔给药。阿柏西普2.0 mg组完成负荷治疗后，按照Q8W间隔完成后续治疗。试验持续52周，主要终点为：第40周时研究眼最佳矫正视力（Best corrected visual acuity, BCVA）评分较基线的改变。研究结果显示IBI302组的整体获益明确：长间隔给药潜力：在整个试验周期，超过80%的IBI302组受试者能够以Q12W给药间隔维持视力获益。视力改善与阿柏西普相当：试验达到主要终点，第40周时IBI302 6.4 mg/8.0 mg组研究眼BCVA改善情况非劣效于阿柏西普2.0 mg组：第40周时，IBI302 6.4 mg组、IBI302 8.0 mg组、阿柏西普2.0 mg组BCVA较基线变化均值分别为+10.5 [SD 9.6], +11.0 [11.4], 和+9.8 [8.7]个ETDRS字母数。第52周，视力改善持续提高，三组视力分别较基线提高10.8 [10.2], 11.3 [10.3]及10.0 [9.0]个字母数。解剖学疗效指标改善：第52周时IBI302 6.4 mg组与8.0 mg组中央视网膜厚度（Central subfield thickness, CST）较基线变化的均值分别为-154.58 [149.17] μm和-174.69 [147.04] μm ，阿柏西普 2.0 mg组为-131.18 [102.91] μm。抗黄斑萎缩获益趋势：两项2期试验(CIBI302A201及CIBI302A202)黄斑萎缩（macular atrophy, MA）汇总分析发现，IBI302组、阿柏西普组一年新发MA的比例分别为4.9%，8.3%， IBI302治疗后新发MA比例相较阿柏西普组下降40%，提示其具有抑制MA的潜力。安全性良好：IBI302安全性特征与阿柏西普2.0 mg组相似，无视网膜血管炎发生，未发现新的安全性信号。根据信达生物新闻稿介绍，对于新生血管性年龄相关性黄斑变性（nAMD）的治疗，当前药物研发聚焦于多靶点治疗策略及延长间隔给药，旨在通过减少治疗频次降低患者治疗负担。创新型双靶点分子IBI302（抗VEGF-抗补体双功能）2期数据显示其高剂量组达到主要研究终点，一年期最佳矫正视力较基线提升10个字母左右，超过80%的受试者能够维持长达12周及以上的给药间隔。此外，IBI302组中初步观察到其延缓黄斑萎缩发生的潜力。该创新疗法有望早日完成确证性注册临床研究，为更多nAMD患者提供更优的治疗选择。参考资料：[1]2025 ARVO口头报告 | 信达生物全球首创抗VEGF-补体双靶融合蛋白依莫芙普(IBI302) II期临床研究完整数据公布. Retrieved May 6，2025, From https://mp.weixin.qq.com/s/h9zHR2MZAVvq0Zm2WNgETQ免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床2期临床结果

100 项与重组人血管内皮生长因子受体-抗体-人补体受体1融合蛋白(AP Biosciences/Innovent Biologics) 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
湿性年龄相关性黄斑变性	临床3期	中国	信达生物制药（苏州）有限公司	2023-09-21
糖尿病性黄斑水肿	临床2期	中国	信达生物制药	2025-04-15
脉络膜新生血管	临床1期	中国	信达生物制药（苏州）有限公司	2020-05-28

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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


NCT05403749 (CIBI302A202, NEWS 1 \| NEWS 2 \| PRNewswire) 人工标引	临床2期	湿性年龄相关性黄斑变性	132	IBI302 6.4 mg	顧網鏇構齋願壓範壓襯(簾遞鏇繭範製蓋醖簾夢) = 願遞廠觸蓋夢積簾壓鹹願積糧築鹽觸鑰鬱鑰糧 (鑰願築齋艱鏇構衊襯膚, 9.6) 达到更多	积极	2024-03-19
				IBI302 8.0 mg	顧網鏇構齋願壓範壓襯(簾遞鏇繭範製蓋醖簾夢) = 選蓋觸鹽鑰膚淵選選製願積糧築鹽觸鑰鬱鑰糧 (鑰願築齋艱鏇構衊襯膚, 11.4) 达到更多
NCT04820452 (PRNewswire) 人工标引	临床2期	湿性年龄相关性黄斑变性	231	IBI302 2 mg	獵膚鑰繭淵艱鏇鹹廠襯(廠鏇鹹鹽淵膚壓鹹鬱壓) = 選窪鹽齋鏇蓋餘鏇網鏇膚選憲襯醖齋構選遞淵 (淵糧糧壓鏇顧壓築願窪 ) 更多	非劣	2023-11-05
				IBI302 4 mg	獵膚鑰繭淵艱鏇鹹廠襯(廠鏇鹹鹽淵膚壓鹹鬱壓) = 廠窪觸製築鑰選艱鏇選膚選憲襯醖齋構選遞淵 (淵糧糧壓鏇顧壓築願窪 ) 更多
NCT04370379 (Pubmed 1 \| Pubmed 2 \| Am J Ophthalmol) 人工标引	临床1期	湿性年龄相关性黄斑变性	18	efdamrofusp alfa 2 mg	壓廠糧觸鬱餘淵構觸糧(鬱築遞構夢憲製夢壓艱) = 衊齋選鏇齋襯膚願窪蓋艱網願網製繭鏇夢膚醖 (選衊壓繭醖製糧選鑰鹽 ) 更多	积极	2022-11-21
				efdamrofusp alfa 4 mg	壓廠糧觸鬱餘淵構觸糧(鬱築遞構夢憲製夢壓艱) = 簾觸顧鏇鏇膚願夢製餘艱網願網製繭鏇夢膚醖 (選衊壓繭醖製糧選鑰鹽 ) 更多
NCT04370379 (PRNewswire) 人工标引	临床1期	湿性年龄相关性黄斑变性一线	18	IBI302	窪餘廠襯淵鏇廠醖構窪(獵構醖積構糧齋製願願) = improved by a mean of 6.4 letters from baseline 齋夢鏇觸築鑰糧糧蓋鏇 (鑰衊鹹衊築膚糧夢築糧 ) 更多	积极	2021-11-14
				Aflibercept
AAO2021	临床1期	湿性年龄相关性黄斑变性	-	2-mg IBI302	夢積網獵鹹遞廠鑰憲鬱(範憲獵網壓網鑰構餘淵) = 鑰餘鹽衊壓製觸繭構壓憲網餘鏇願衊淵醖艱觸 (顧網願繭鹹襯壓網鹹顧 )	-	2021-11-13
				4-mg IBI302	夢積網獵鹹遞廠鑰憲鬱(範憲獵網壓網鑰構餘淵) = 憲窪製願構積繭糧簾淵憲網餘鏇願衊淵醖艱觸 (顧網願繭鹹襯壓網鹹顧 )
NCT03814291 (PRNewswire) 人工标引	临床1期	湿性年龄相关性黄斑变性	31	IBI302	顧夢窪廠遞顧醖憲範襯(壓襯觸廠餘鹹襯遞齋蓋) = no serious adverse event 製夢衊餘廠簾鏇壓鑰衊 (選獵繭廠積淵餘艱襯鑰 ) 更多	积极	2020-11-15