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（苏州）有限公司

信达生物制药

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

NCT05403749

/ Completed临床2期

A Multi-center, Randomized, Double-masked, Active-controlled Study to Evaluate the Longer Interval of Intravitreal (IVT) Injection of IBI302 in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

The study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.

开始日期2022-06-29

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 ; Wu, Zhifeng ; Sun, Junran ; 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 ; Feng, Liqi ; Jia, Huixun ; 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 ; Zhai, Yuanqi ; Li, Yiming ; Wan, Xiaoling ; Qian, Lei ; Li, Xiaomeng ; Lu, Shujie ; Luo, Xueting ; Liu, Junjian ; Li, Min ; Yang, Shiqi ; Sun, Xiaodong ; Yu, Dechao ; Gao, Min ; Yang, Xiaotong ; Huang, Zhen

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）

2025-05-10

·CPHI制药在线

荣昌生物HER2-ADC针对乳腺癌肝转移的新适应症获批；长效镇痛新药美洛昔康注射液获批上市 | 制药在线一周药闻复盘

点击蓝字关注我们本周，热点很多。首先看审评审批方面，多个药获批新适应症，值得关注的是，荣昌生物HER2-ADC针对乳腺癌肝转移的新适应症获批以及国内长效镇痛新药获批上市；其次是研发方面，多个药取得重要进展，有好消息有坏消息，好消息比如，第一三共/阿斯利康德曲妥珠单抗治疗早期乳腺癌Ⅲ期成功，坏消息是诺和诺德终止开发每周1次司美格鲁肽口服片剂；最后是交易及投融资方面，多个交易正在进行，其中金额较大的是，齐鲁制药以13.45亿元与明慧医药达成B7-H3 ADC授权合作。本期盘点包括审评审批、研发以及交易及投融资三大板块，统计时间为2025.5.5-5.9，包含34条信息。点个审评审批NMPA上市批准1、5月7日，NMPA官网显示，云顶新耀的布地奈德肠溶胶囊（商品名：耐赋康）正式由附条件批准转为完全批准，取消了对蛋白尿水平的限制，用于治疗具有疾病进展风险的原发性免疫球蛋白A肾病（IgAN）成人患者，以减少肾功能损失。该药成为国内首个且唯一获完全批准的IgA肾病对因治疗药物。该药是靶向肠道的黏膜免疫调节剂。2、5月7日，NMPA官网显示，罗氏的格菲妥单抗注射液（glofitamab，商品名：Columvi）新适应症获批，联合吉西他滨与奥沙利铂（GemOx）用于治疗不适合自体造血干细胞移植（ASCT）的复发或难治性弥漫大B细胞淋巴瘤非特指型（DLBCLNOS）成人患者（2L+DLBCL）。格菲妥单抗是一款靶向CD20和CD3的双特异性T细胞衔接蛋白。3、5月8日，NMPA官网显示，辉瑞的新型抗菌药物注射用头孢他啶阿维巴坦钠（商品名：思福妥）获批新适应症，用于治疗全年龄段儿童（包括新生儿）人群因革兰阴性菌引起的复杂性腹腔内感染（cIAI）、医院获得性肺炎和呼吸机相关性肺炎（HAP/VAP）、治疗方案选择有限的感染。4、5月9日，NMPA官网显示，翰森制药的甲磺酸阿美替尼片（商品名：阿美乐）获批第4项新适应症，用于具有表皮生长因素受体（EGFR）外显子19缺失或外显子21（L858R）置换突变阳性的非小细胞肺癌（NSCLC）成人患者肿瘤切除术后的辅助治疗。阿美替尼是国产首款三代EGFR-TKI，早在2020年3月就已经获批上市，同年通过谈判进入医保目录。5、5月9日，NMPA官网显示，荣昌生物的维迪西妥单抗获批一项新适应症，用于既往接受过曲妥珠单抗或其生物类似物和紫杉类药物治疗的HER2阳性（HER2IHC3+或FISH+）存在肝转移的晚期乳腺癌患者。维迪西妥单抗由荣昌生物研发，是首款获批上市的国产ADC药物。6、5月9日，NMPA官网显示，强生的古塞奇尤单抗注射液（静脉输注）（特诺雅达）和古塞奇尤单抗注射液（特诺雅）新适应症获批，用于治疗对传统治疗或生物制剂应答不充分、失应答或不耐受的中度至重度活动性溃疡性结肠炎成人患者。古塞奇尤单抗是首个获得批准的全人源、具有双重作用机制的白介素23抑制剂。7、5月9日，NMPA官网显示，丽珠医药全资附属公司丽珠微球申报的改良型新药注射用阿立哌唑微球获批上市。这是丽珠微球自主开发的一款阿立哌唑的长效缓释微球制剂，每月给药一次，适用于成人精神分裂症。 8、5月9日，NMPA官网显示，高德美（Galderma）的阿达帕林过氧苯甲酰凝胶获批上市，这是一款每日一次的处方药（商品名：Epiduo），已经获美国FDA批准用于治疗寻常性痤疮。本次在中国获批产品为阿达帕林过氧苯甲酰凝胶（0.3%/2.5%），它结合了两种有效的药物来治疗顽固的痤疮，并通过畅通毛孔和杀死细菌来防止痤疮的形成。9、5月9日，NMPA官网显示，南京清普生物的美洛昔康注射液（QP001）获批上市。这是国内长效镇痛新药，单次注射可实现24h持续强效镇痛。QP001注射液由清普自主知识产权的难溶药物增溶技术平台（SimSolTM）开发，是旗下非阿片类镇痛新药管线的首款产品。申请10、5月8日，CDE官网显示，赛诺菲的注射用卡普赛珠单抗申报上市，适应症为与血浆置换和免疫抑制疗法联合治疗获得性血栓性血小板减少性紫癜（aTTP）（也称为免疫介导的血栓性血小板减少性紫癜），适用群体范围为成人和12岁及以上体重至少40kg的青少年患者。此前该适应症曾被纳入优先审评。11、5月8日，CDE官网显示，恒瑞医药的达尔西利第3项适应症申报上市，联合内分泌治疗用于激素受体（HR）阳性，人表皮生长因子受体2（HER2）阴性的早期或局部晚期乳腺癌的辅助治疗。达尔西利（商品名：艾瑞康）是恒瑞医药自主研发的口服、选择性的小分子CDK4/6抑制剂，也是中国首个自主研发的新型高选择性CDK4/6抑制剂。此前，已获批两项适应症。临床批准 12、5月6日，CDE官网显示，宜联生物1类新药注射用YL217获批临床，用于经病理学确诊的晚期实体瘤，包括胃肠道、食管、胃食管结合部、胰腺或壶腹部腺癌和神经内分泌肿瘤等。这是该药首次在国内获批临床。YL217是一款基于宜联生物TMALIN平台构建的CDH17ADC，可在肿瘤细胞和肿瘤微环境中释放有效载荷。目前YL217正在美国开展临床I期研究。13、5月6日，CDE官网显示，百济神州1类新药BGB-45035片新适应症获批临床，拟开发治疗结节性痒疹。BGB-45035片是一款靶向IRAK4的蛋白降解剂（IRAK4CDAC），该产品此前于2024年8月首次在中国获批IND，用于治疗中重度特应性皮炎。14、5月8日，CDE官网显示，士泽生物的异体通用“现货型”iPSC衍生亚型神经前体细胞产品（XS228注射液）获批注册临床试验Ⅰ期及Ⅱ期，用于治疗渐冻症（即肌萎缩侧索硬化症/ALS/运动神经元症/渐冻人症）。此前于2025年2月，XS228注射液用于治疗“渐冻症”的IND申请已获美国FDA批准开展注册临床试验。15、5月8日，CDE官网显示，诺华1类新药PIT565获批临床，用于类风湿关节炎。PIT565是一种同类首创的CD3/CD19/CD2三抗，该药最早于24年11月在国内申请临床，25年1月首次获批临床，用于复发性和/或难治性B细胞恶性肿瘤。25年2月再次获批临床，用于系统性红斑狼疮，实现肿瘤到自免的跨界。优先审评16、5月8日，CDE官网显示，勃林格殷格翰的那米司特片（nerandomilast）拟纳入优先审评，适应症为进展性肺纤维化（PPF）。那米司特是一款first-in-class小分子磷酸二酯酶4B（PDE4B）抑制剂。2月10日，勃林格殷格翰针对PPF患者的Ⅲ期FIBRONEER-ILD研究达到其主要终点，即与安慰剂相比，第52周时用力肺活量（FVC）相对于基线的绝对变化。17、5月8日，CDE官网显示，麓鹏制药的洛布替尼片（Rocbrutinib）拟纳入优先审评，适用于既往接受过布鲁顿氏酪氨酸激酶（BTK）抑制剂治疗的成人套细胞淋巴瘤（MCL）患者。洛布替尼是其自主研发的一款共价兼非共价BTK抑制剂，2024年8月，翰森制药就洛布替尼签署合作协议，获得LP-168非肿瘤适应症在中国的研发、注册、生产及商业化的权益。研发临床状态18、5月6日，ClinicalTrials.gov官网显示，Tagworks登记了一项评估TGW101对晚期实体瘤患者安全性、耐受性、药代动力学和初步疗效的I期临床研究（TGW101-101，NCT06959706）。TGW101是全球首个以Click-to-Release为核心机制开发的ADC药物，靶向非内化泛癌种靶点肿瘤相关糖蛋白72（TAG-72），有效载荷为MMAE。19、5月6日，药物临床试验登记与信息公示平台显示，翰森制药登记了一项在超重和肥胖受试者中评估每天一次口服HS-10501/HS-10501-2的有效性和安全性的多中心、随机、双盲、安慰剂对照的Ⅱ期临床研究。HS-10501是一款GLP-1R激动剂，剂型为普通片剂。HS-10501-2剂型为缓释片。临床数据20、5月5日，Immutep Limited宣布，TACTI-003（KEYNOTE-C34）Ⅱb期临床试验B队列患者取得了17.6个月的优异中位总生存期（OS）。TACTI-003是一项多中心、开放标签、随机、Ⅱ期临床试验，旨在研究可溶性LAG-3融合蛋白EftilagimodAlpha联合帕博利珠单抗（PD-1单抗）用于不可切除的复发性或转移性头颈部鳞状细胞癌(HNSCC)患者一线治疗的有效性和安全性。21、5月6日，锐正基因宣布，基于非病毒载体的体内基因编辑药物ART001在治疗转甲状腺素蛋白淀粉样变性（ATTR）的研究者发起的临床研究（IIT）中获得了优异的临床数据。截至目前，所有受试者均已完成72周随访。最新的临床数据显示，给药72周后，高剂量组受试者的外周TTR蛋白较基线平均下降且依旧维持稳定在90%以上，个体下降最高可达95%。在72周临床试验中，ART001展现出优异的有效性和安全性。22、5月6日，强生宣布，bota-vec治疗X连锁视网膜色素变性的Ⅲ期LUMEOS研究未能达到主要终点，主要终点评估的是患者在视觉引导下通过行动能力评估迷宫的能力变化。2023年，强生以6500万美元的预付款从MeiraGTx收购了bota-vec。bota-vec利用腺相关病毒（AAV）将视网膜色素变性GTP酶调节蛋白（RPGR）基因的功能性拷贝传递到视网膜，这种基因在X连锁色素性视网膜炎患者中发生突变。23、5月6日，远大医药宣布，全资拥有附属公司GrandMedicalPtyLtd.开发的STC3141在中国开展的用于治疗脓毒症的Ⅱ期临床研究成功达到临床终点。STC3141为远大医药自主开发的、拥有全球知识产权的、具有全新作用机制的小分子化合物，通过中和胞外游离组蛋白和中性粒细胞诱捕网来逆转机体过度免疫反应造成的器官损伤，可用于多种重症适应症。24、5月6日，信达生物宣布，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）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Ⅱ期研究结果，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。25、5月7日，阿斯利康宣布，其与第一三共联合开发的德曲妥珠单抗（Enhertu）在一项具有里程碑意义的Ⅲ期DESTINY-Breast11研究中取得积极结果，该研究针对高风险HER2阳性早期乳腺癌患者，在新辅助治疗时（手术前），Enhertu联合THP（紫杉醇、曲妥珠单抗和帕妥珠单抗）相较于标准化疗方案（剂量密集型多柔比星和环磷酰胺联合THP，即ddAC-THP），显著提升了病理完全缓解（pCR）率，且具有统计学意义和临床意义。26、5月7日，诺和诺德宣布，基于投资组合考虑，终止每周一次口服司美格鲁肽的开发。司美格鲁肽是诺和诺德开发的一款GLP-1R激动剂，其中注射剂型已经获批2型糖尿病、肥胖、心血管事件二级预防、糖尿病肾病等适应症，MASH适应症也已提交上市申请；每日口服一次剂型已获批2型糖尿病适应症，肥胖适应症已递交上市申请。27、5月8日，星汉德生物宣布，HBV特异性TCR-T细胞疗法SCG101公布临床数据。数据显示，SCG101在治疗晚期HBV相关肝细胞癌（HCC）患者中展现出抗病毒和抗肿瘤双效果。17名患者在接受单次SCG101输注治疗后，全部获得血清乙型肝炎表面抗原（HBsAg）快速“断崖式”下降，其中高达94%的患者在28天内降幅达到1.0–4.6log10。28、5月8日，GSK宣布，Ⅲ期临床试验GLISTEN取得了积极结果，Linerixibat可显著改善原发性胆汁性胆管炎(PBC)中的胆汁淤积性瘙痒（持续性瘙痒）。GLISTEN是一项双盲、随机、安慰剂对照的Ⅲ期临床试验（NCT04950127），旨在评估回肠胆汁酸转运蛋白（IBAT）靶向抑制剂Linerixibat治疗PBC患者胆汁淤积性瘙痒的疗效和安全性。主要终点是使用数值评定量表(NRS)计算24周内每月瘙痒评分相对于基线的变化。29、5月9日，阿斯利康宣布，Imfinzi（度伐利尤单抗）方案在Ⅲ期临床试验POTOMAC中显示出对高风险非肌层浸润性膀胱癌（NMIBC）患者无病生存期（DFS）具有统计学显著和临床意义的改善。度伐利尤单抗是一种人源化的PD-L1单克隆抗体。交易及投融资30、5月6日，Alchemab Therapeutics宣布，与礼来就ATLX-1282达成许可协议，这是Alchemab针对肌萎缩侧索硬化症（ALS）和其他神经退行性疾病开发的创新候选药物。此次交易总价值高达4.15亿美元，包括未披露的预付款、潜在的发现、开发和商业化里程碑付款以及特许权使用费。根据协议条款，Alchemab将负责该项目的早期I期临床试验，之后礼来将主导所有进一步的开发和商业化工作。31、5月7日，Nuevocor宣布，成功完成4500万美元B轮融资。该公司致力于开发针对力学生物学异常所致心肌病的潜在疗法。本轮融资由KurmaPartners、AngeliniVentures及弘晖基金（HLC）联合投资，勃林格殷格翰风险基金（BIVF）、EDBI、ClavystBio等老股东继续投资。Nuevocor是一家处于IND阶段的生物技术公司，正在开发由异常力学生物学驱动的遗传性心肌病的新疗法。32、5月7日，Imbria Pharmaceuticals宣布，完成5750万美元B轮融资。本轮融资由DeepTrackCapital领投，ANVentures、CatalioCapitalManagement和Cytokinetics等机构纷纷下注，现有股东RACapitalManagement和SVHealthInvestors则持续追加投资。Imbria主打一款核心管线产品Ninerafaxstat。这是一种新型心脏线粒体调节剂和部分脂肪酸氧化（pFOX）抑制剂。33、5月8日，罗氏制药中国宣布，投资20.4亿人民币，并举行了该投资项目的启动仪式。这笔投资将用于在沪新建生物制药生产基地，旨在加强罗氏在中国的供应链和本地化生产布局。此次加码投资，旨在通过加强罗氏在中国的供应链和本地化生产布局，全面强化端到端的完整医药价值产业链，彰显了罗氏持续深耕中国、造福中国老百姓的长期承诺。34、5月9日，明慧医药宣布，已与齐鲁制药达成一项独家许可与合作协议，旨在大中华区（包括中国大陆、中国香港、中国澳门和中国台湾）开发、生产和商业化其B7-H3 ADC（MHB088C）。根据协议，齐鲁制药将获得MHB088C在上述区域的独家权利，明慧医药则有望获得总额高达13.45亿元人民币的付款，其中包括2.8亿元的首付款和近期里程碑付款，以及10.65亿元人民币的开发、监管和销售里程碑付款，以及高达两位数的净产品销售分成。END【企业推荐】领取CPHI & PMEC China 2025展会门票来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

抗体药物偶联物临床3期生物类似药上市批准优先审批

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

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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) 相关的药物交易

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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 (Company_Website) 人工标引	临床2期	湿性年龄相关性黄斑变性	132	IBI302 6.4 mg	鹹艱願衊鏇衊顧網艱憲(夢淵衊壓壓簾艱積鏇願) = 窪齋築襯膚鏇鬱憲糧觸簾鏇餘願鏇鹽鏇艱鹹鏇 (鑰膚遞蓋廠積壓窪膚簾, 9.6) 更多	积极	2025-05-06
				IBI302 8.0 mg	鹹艱願衊鏇衊顧網艱憲(夢淵衊壓壓簾艱積鏇願) = 網構淵衊鏇繭製製願窪簾鏇餘願鏇鹽鏇艱鹹鏇 (鑰膚遞蓋廠積壓窪膚簾, 11.4) 更多
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	襯夢網糧範顧膚鬱醖願(鬱築網顧膚觸膚構獵廠) = 遞積鬱糧廠壓窪齋衊繭憲鏇網觸廠壓艱鬱構鑰 (衊簾醖簾選構鏇遞壓繭, 9.6) 达到更多	积极	2024-03-19
				IBI302 8.0 mg	襯夢網糧範顧膚鬱醖願(鬱築網顧膚觸膚構獵廠) = 觸願憲獵壓願廠範獵鹽憲鏇網觸廠壓艱鬱構鑰 (衊簾醖簾選構鏇遞壓繭, 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	顧顧繭襯鑰網艱壓壓艱(積鏇鏇廠膚顧衊壓積顧) = 觸壓糧壓鹹蓋齋遞觸夢獵鹽築鑰簾觸鏇窪憲製 (齋繭衊網蓋鹹膚遞襯艱 ) 更多	非劣	2023-11-05
				IBI302 4 mg	顧顧繭襯鑰網艱壓壓艱(積鏇鏇廠膚顧衊壓積顧) = 夢簾鬱鏇艱選蓋餘簾選獵鹽築鑰簾觸鏇窪憲製 (齋繭衊網蓋鹹膚遞襯艱 ) 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	淵顧鬱鹽鏇觸簾壓糧膚(網築繭齋艱簾蓋廠遞選) = 憲糧鑰選構鹽鏇願鹹鹹鏇艱鹹醖衊憲願蓋齋餘 (製積製鹹淵鏇醖鹹鏇願 ) 更多	积极	2022-11-21
				efdamrofusp alfa 4 mg	淵顧鬱鹽鏇觸簾壓糧膚(網築繭齋艱簾蓋廠遞選) = 鬱範願製範鏇鑰膚製淵鏇艱鹹醖衊憲願蓋齋餘 (製積製鹹淵鏇醖鹹鏇願 ) 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	選積衊衊繭艱衊齋窪衊(鹽襯淵淵鑰積鹽選製壓) = improved by a mean of 6.4 letters from baseline 鑰築簾築製壓廠餘蓋顧 (網壓憲窪夢鏇築繭簾廠 ) 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	構觸網餘鹽鏇願蓋艱壓(淵積蓋網積顧膚窪艱窪) = 鏇製積齋顧壓憲築積築壓憲窪製積繭積觸鬱餘 (廠顧鹹齋餘淵製積淵鹽 )	-	2021-11-13
				4-mg IBI302	構觸網餘鹽鏇願蓋艱壓(淵積蓋網積顧膚窪艱窪) = 選繭廠製壓壓繭廠築繭壓憲窪製積繭積觸鬱餘 (廠顧鹹齋餘淵製積淵鹽 )
NCT03814291 (PRNewswire) 人工标引	临床1期	湿性年龄相关性黄斑变性	31	IBI302	憲願獵範糧餘鬱願齋淵(憲艱構繭獵顧膚淵醖顧) = no serious adverse event 構鏇窪壓夢壓願簾膚製 (醖廠蓋廠選壓廠艱廠製 ) 更多	积极	2020-11-15