阿柏西普生物类似药(Viatris)(AFLIBERCEPT-JBVF) - 药物靶点：PGF x VEGF-A_在研适应症：视力低下，糖尿病性视网膜病变，糖尿病性黄斑水肿_专利_临床

概要

基本信息

药物类型

Fc融合蛋白、生物类似药

别名

Aflibercept Biosimilar (Viatris, Inc.)、阿柏西普生物类似药（Viatris, Inc.）、MYL-1701P

+ [1]

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

神经系统疾病心血管疾病遗传病与畸形+ [3]

在研适应症

视力低下糖尿病性视网膜病变糖尿病性黄斑水肿+ [3]

非在研适应症-

原研机构

Viatris, Inc.

在研机构

Biocon Biologics Ireland Ltd.Biocon Biologics, Inc.

Biocon Biologics Ltd. (India)

非在研机构

Momenta Pharmaceuticals, Inc.Mylan Pharmaceuticals, Inc.

权益机构

Biocon Ltd.

Mylan NV

Momenta Pharmaceuticals, Inc.

最高研发阶段批准上市

首次获批日期

欧盟 (2023-09-15),

糖尿病性黄斑水肿近视脉络膜新生血管视网膜静脉阻塞相关黄斑水肿+ [1]

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 4715606

当前序列信息引自: *****

关联

3

项与阿柏西普生物类似药(Viatris) 相关的临床试验

NCT04674800

/ Completed临床3期

A Multi Center, Extension Study to Evaluate the Safety and Efficacy of MYL-1701P in Subjects With Diabetic Macular Edema Completed MYL-1701P-3001 Study.

This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 study.

开始日期2020-11-23

申办/合作机构

Mylan Pharmaceuticals, Inc.

[+1]

CTRI/2020/11/028961

/ Completed临床3期

A Multi center, Extension Study to Evaluate the Safety and Efficacy of MYL-1701P in Subjects with Diabetic Macular Edema Completed MYL-1701P-3001 Study.

开始日期2020-11-03

申办/合作机构

Mylan, Inc.

[+1]

NCT03610646

/ Completed临床3期

A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)

Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®.
The primary endpoint is mean change from baseline in Best Corrected Visual Acuity (BCVA) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Pharmacokinetics (PK) and immunogenicity to be evaluated in the subjects participating in the study.

开始日期2018-08-23

申办/合作机构

Mylan Pharmaceuticals, Inc.

[+1]

100 项与阿柏西普生物类似药(Viatris) 相关的临床结果

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100 项与阿柏西普生物类似药(Viatris) 相关的转化医学

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100 项与阿柏西普生物类似药(Viatris) 相关的专利（医药）

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3

项与阿柏西普生物类似药(Viatris) 相关的文献（医药）

2024-10-01·JAMA Ophthalmology

Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema

Article

Importance:

Biosimilars may be lower-cost alternatives to originator biologic products, potentially offering expanded access or reduced economic burden, but have not been evaluated with aflibercept in diabetic macular edema (DME).

Objective:

To compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME.

Design, Setting, and Participants:

This was a double-masked, randomized clinical trial that included participants at 77 centers across the US, Europe, Japan, and India. Included in the analysis were individuals 18 years and older with type 1 or type 2 diabetes with central DME and best-corrected visual acuity (BCVA) letter score of 73 to 38 in the study eye using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Study data were analyzed from October to December 2021.

Interventions:

Formulations of MYL-1701P (0.5-mg vial) or reference aflibercept every 4 weeks for 5 consecutive intravitreal injections, followed by every 8 weeks through week 52.

Main Outcomes and Measures:

The primary outcome was the adjusted difference in least squares mean (SE) change from baseline BCVA letter score at week 8 with an equivalence margin of −3 to +3 letters. Secondary outcomes included change in central subfield thickness (CST), BCVA, number of injections over 52 weeks, incidence of adverse events (AEs), and antidrug antibodies (ADAs).

Results:

A total of 355 participants (mean [SD] age, 62.2 [9.2] years; 216 male [60.8%]) were randomized to MYL-1701P (179 participants [50.4%]) and aflibercept (176 participants [49.6%]). At week 8, mean (SE) change in BCVA was 6.60 (0.55) letters vs 6.56 (0.55) letters in the MYL-1701P vs aflibercept groups. The adjusted mean difference of 0.04 letters (90% CI, −1.16 to 1.24 letters) met the primary outcome. At week 8, mean (SE) change in CST was −112 (7) μm vs −124 (7) μm in the MYL-1701P vs aflibercept groups (adjusted mean difference, 12 μm; 90% CI, −3 to 26 μm). The incidence of treatment-emergent AEs in the MYL-1701P and aflibercept arms were ocular (30.9% [55 of 178] vs 29.5% [52 of 176]), serious ocular (0.6% [1 of 178] vs 1.1% [2 of 176]), nonocular (65.2% [116 of 178] vs 65.3% [115 of 176]), and serious nonocular (16.9% [30 of 178] vs 11.9% [21 of 176]). The mean (SD) total number of injections was 8.4 (2.1) vs 8.7 (1.8) in the MYL-1701P vs aflibercept groups. The incidence of treatment-induced or treatment-boosted ADAs was 2.8% (5 of 177) vs 5.7% (10 of 176) in the MYL-1701P vs aflibercept arms.

Conclusions and Relevance:

MYL-1701P demonstrated clinical equivalence in regard to efficacy, with comparable safety and immunogenicity, to reference aflibercept. These findings support use of MLY-1701P as an alternative to reference aflibercept.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03610646

1989-02-01·Scandinavian journal of immunology4区 · 医学

Reduced Erythrocyte CR1 (CD 35) Receptor Function and Complement Opsonization in Factor I‐Deficient Patients is Restored by Plasma Infusion

4区 · 医学

Article

作者: J M Rasmussen ; H H Jepsen ; B Teisner ; S E Svehag

Erythrocytes (E) from three factor I‐deficient patients were investigated for surface‐bound complement factors and CR1 (CD 35) expression and function. The E were coated with C4b,C3b, and factor H. Following plasma infusion of in vitro incubation of the patients’ E with normal human serum (NHS) or purified factor I, cell‐bound C4b and C3b could no longer be detected. The E now expressed C3d, and factor H was unaffected, indicating that factor H was hound to the C3d part of the C3b molecules, providing the co‐factor for effective cleavage of E‐bound C3b when purified factor 1 was added. The binding of monoclonal anti‐CR1 antibodies (M710) to the patients’ E was markedly reduced compared with control E, and was not normalized by treatment with NHS, probably because covalently bound C3d/factor H interfered with the binding of M710. By contrast, the reduced ability of the patients’ E‐CR1 to bind complement‐opsonized immune complexes (IC) was normalized after plasma infusion. This shows that the impaired CR1 function was acquired and emphasizes the importance of performing functional CR1 assays. Complement opsonization of IC for binding to normal E was severely compromised in the patients’ sera due to consumption of factor B and C3. After plasma infusion the opsonization capacity of the patients’ sera was restored. Thus, two mechanisms of importance for normal clearance of IC were compromised in factor I‐deficient patients: (1) the opsonization of IC for binding to E‐CRI, and (2) the capacity of E‐CRI to bind opsonized complexes. Both dysfunctions were temporarily corrected by plasma infusion.

1986-01-01·Journal of immunopharmacology

Complement Receptors (CR) and Cytotoxic Responses: Monoclonal Antibodies Directed Against CR1 AMD CR3 Inhibit the Generation of Human Allospecific and Virus Specific Cytotoxic Cells in Vitro

Article

作者: Giorgio Inghirami ; George C. Tsokos ; John D. Lambris

A variety of cellular immune responses involve complement factors which bind to specific receptors, and modulate or effect a specific reaction. Monoclonal antibodies (MAb) have been generated against complement receptors (CR) 1 and 3, which were utilized to investigate human allogeneic and Epstein-Barr virus specific cytotoxic cells in vitro. MAb OKM1, which binds to the C3bi CR (CR3), and MAb M710, which binds to the C3b/4b CR (CR1), inhibited the generation of both allogeneic and virus specific cytotoxic responses in vitro in a dose-dependent way; doses of 1 microgram/ml (or greater) completely abrogated the cytotoxic responses. Inhibition of these responses was observed when the MAb was added to the cultures at any time point except the last two days. In addition, treatment of the responder (but not the stimulator cells) with either MAb resulted in complete inhibition of cytotoxic responses. These experiment indicate that complement receptors participate in the generation of human cytotoxic responses in vitro.

48

项与阿柏西普生物类似药(Viatris) 相关的新闻（医药）

2025-08-21

·BioSpace

Two FDA Decisions for Regeneron’s Eylea HD Delayed Into Q4

iStock, Natalya Kosarevich The delays, first revealed in Regeneron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants. The FDA has pushed back its target decision date for two of Regeneron’s supplemental applications for a high-dose formulation of Eylea. After initially setting a decision date for Aug. 19 , the agency now expects to deliver verdicts in the fourth quarter. The delay applies to Regeneron’s application to use Eylea HD for patients with macular edema after retinal vein occlusion, as well as the proposal to expand its dosing schedule to include a monthly regimen across approved indications. There do not appear to be problems with the safety or efficacy of Eylea HD in the affected applications. Instead, the review extension is linked to findings at a Catalent manufacturing site. Novo Nordisk, which acquired the CDMO giant in February last year, has already responded to the FDA’s observations, but the regulator considered the submission a major amendment to the affected applications. “It is our understanding that the FDA will be able to act expeditiously on these applications once the manufacturing issues have been resolved,” Regeneron wrote on Wednesday. Meanwhile, Eylea HD vials will remain available in the U.S. for the already approved indications and dosing schedules. Regeneron alluded to the delay earlier this month during second-quarter earnings on Aug. 1, revealing that the FDA would need to extend its review for the two Eylea HD applications. At the time, Novo hadn’t yet addressed the FDA’s concerns at the production facility, and Regeneron wasn’t able to provide an updated timeline for the decisions. “Based on our discussions, we believe that there’s nothing significant left to be done,” CEO Leonard Schleifer said during an investor call at the time. “We are expecting, once the resolution of the filling issues has occurred, to receive favorable action, we hope, from the FDA.” Despite an expected approval, the delays still represent a setback for Regeneron’s Eylea franchise, which once dominated the retinal disease market but has since steadily lost market share to Roche’s Vabysmo. Soon, Eylea will also have to contend with biosimilars after the FDA signed off on two interchangeable copycats in May 2024. One of these, Biocon Biologics’ Yesafili, is expected to hit U.S. shelves late next year . The U.S. launch for the other biosimilar, branded Opuviz and marketed by Samsung Bioepis and Biogen, is still uncertain. Still, the updated FDA timeline likely puts the launch of the new Eylea versions ahead of investor expectations, BMO Capital Markets analysts noted on Wednesday. “Given recent biosimilar competition and subsequent market erosion for Eylea, we appreciate a shorter path to regulatory approval as Regeneron attempts to regain market share for the franchise,” the firm wrote. In the second quarter, the Eylea franchise suffered a 25% year-on-year sales dip, though its $1.15 billion in revenue still came 9% ahead of consensus forecasts.

上市批准

2025-07-20

·药事纵横

三抗的风，起了

三抗的风最近吹得有些猛。7月10号，艾伯维（AbbVie）与IGI Therapeutics SA共同宣布，双方就CD3/CD38/BCMA TCE新药ISB 2001达成独家许可协议。根据协议条款，艾伯维将获得在北美、欧洲、日本和大中华区开发、制造和商业化ISB 2001的独家权利。在获得监管部门批准后，IGI将有资格获得7亿美元的预付款，并有望获得高达12.25亿美元的开发、监管和商业里程碑付款，以及分层的两位数净销售额特许权使用费。高达7亿美金的首付款，表明艾伯维对于ISB2001未来前景的强烈看好。无独有偶，年初，艾伯维以10亿美金的价格将另一款三抗——来自先声药业的SIM0500（CD3/BCMA/GPRC5D）收入囊中。此外，葛兰素史克、默沙东、吉利德等MNC近年来亦在三抗领域频频出手，充分反映了巨头对三抗药物的兴致。如果说双抗接棒PD-1，有望成为免疫治疗的基石药物，未来，三抗药物能否继双抗药物，再次划破浩瀚苍穹，且拭目以待。（一）三抗药物三特异性抗体是在双特异性抗体的基础上进一步发展而来，与双抗相比，三抗增加了一个特异性抗原结合位点，因而有望产生特异性更强、更准确靶向肿瘤细胞并降低脱靶毒性的临床疗效。具体而言，三抗主要存在三大优势，包括：（1）三个结合位点可以结合肿瘤细胞或免疫细胞，重新定向免疫细胞，将免疫细胞募集至肿瘤细胞周围，增强对肿瘤的杀伤力。如先声药业的CD3/BCMA/GPRC5D，抗CD3臂募集T细胞，另外两个臂分别链接肿瘤细胞的BCMA和GPRC5D。（2）可以同时阻断三种不同的信号通路，从而增强细胞杀伤毒性；（3）与三种不同的细胞表面抗原结合后，相对而言可能潜在增加结合特异性，降低脱靶等引起的副作用。图：先声再明的技术平台数据来源：先声药业宣传资料（二）海外MNC三抗药物布局随着双抗市场的火热，MNC对于三抗产品的布局正在提速，艾伯维、默沙东、吉利德等MNC近年来相继在三抗市场扫货。表：MNC三抗药物布局数据来源：公开资料整理默沙东近年来多次出手三抗药物，涉及的领域包括眼科及小细胞肺癌等。2024年5月，默沙东将以13亿美元的前期付款和高达17亿美元的未来里程碑付款收购EyeBio公司，收购潜在总价值30亿美元。 EyeBio的先导候选药物Restoret (EYE103)是一种在研的、潜在的“first-in-class”的四价、三特异性Wnt抗体，旨在解决视网膜疾病患者未满足的医疗需求。Restoret通过玻璃体内注射给药，旨在通过激动Wnt途径消除视网膜血管疾病中的渗漏，恢复和维持血-视网膜屏障（BRB）。2024年2月，EyeBio披露了Restoret的首次人体 1b/2a期AMARONE试验的第12周数据。数据显示，DME患者接受Restoret单药治疗，经光学相干断层扫描 (OCT) 测量，最佳矫正视力平均改善+11.2 个字母，视网膜厚度平均减少-143微米；新生血管性年龄相关性黄斑变性 (NVAMD)患者 (n=5) 接受Restoret 与阿柏西普联合治疗，也观察到了类似的结果；每月多次服用 Restoret（无论是单药治疗还是与阿柏西普联合治疗）的耐受性良好。图：Restoret结构数据来源：EyeBio官网2024年1月，默沙东以约6.8亿美元收购Harpoon Therapeutics，后者的核心管线HPN328（MK-6070）为一款DLL3/CD3/Albumin三特异性抗体。7个月后，第一三共（Daiichi Sankyo）和默沙东宣布将共同开发及商业化MK-6070，默沙东仅保留了日本权益。第一三共这步棋意图明显，进一步探索MK-6070与DS-7300a（B7H3 ADC）在小细胞肺癌的协同作用。MK-6070用优异的数据证明了其临床价值。在2024WCLC上，49 名先前接受过2线治疗的SCLC患者接受≥1.215 mg（MK-6070的最低有效剂量）治疗，有脑转移的患者 ORR 为 37%，EC-ORR 为 52%，DCR 为 78%，均高于无脑转移患者（ORR 、EC-ORR均为 19% ， DCR 为 48%）。在 28 名（32%）有脑转移的患者中，有 9 名发生了 CNS 进展事件，而无脑转移患者未出现此类事件。整体来看，MK-6070 对 SCLC 患者（包括有脑转移的患者）显示出良好的疗效。图：DLL3在小细胞肺癌表面呈现高表达数据来源：HARPOON Therapeutics（2）除了默沙东、艾伯维外，吉利德于2024年携手Merus，共同开发靶向新型双重肿瘤相关抗原（TAA）的三特异性抗体。Merus作为中国企业的老朋友，先后与先声药业和贝达医药等均展开项目合作。根据协议条款，Merus将领导两个项目的早期研究活动，并可选择开展第三个项目。在选定的研究活动完成后，吉利德将有权获得合作开发项目的许可权。如果吉利德行使其选择权，将负责项目的额外研究、开发和商业化活动。Merus则有权获得5600万美元预付款和吉利德2500万美元股权投资。在所有潜在项目中，Merus还有资格获得高达15亿美元付款，包括额外近期和期权付款、潜在开发和商业化里程碑付款，以及销售版税。对于第三个潜在项目，Merus可能会选择与吉利德50/50分成，以代替未来的里程碑和版税支付。图：Merus产品管线数据来源：Merus官网（三）中国企业三抗布局中国创新药企业作为研发的弄潮儿，在三抗领域的布局十分广泛，涉及肿瘤、自免等多个适应症，先声药业、维立志博、恩沐生物等企业是这一领域的佼佼者，相关三抗产品已成功出海。表：成功出海的国产三抗药物数据来源：公开资料整理（1）先声药业的SIM0500是一种靶向GPRC5D/BCMA/CD3的人源化三特异性抗体。2025年1月，先声药业与艾伯维（AbbVie）宣布就SIM0500达成许可选择协议，根据该协议条款，先声再明将从艾伯维收取首付款，以及最高10.55亿美金的选择性权益付款和里程碑付款。BCMA和GPRC5D在多发性骨髓瘤的效果不言而喻，强生在今年ASCO上披露了旗下三款JNJ-5322（GPRC5D/BCMA/CD3）的Ⅰ期临床研究，126例既往接受过4线治疗的患者的ORR为73%，VGPR=66%，其中36例RP2D剂量组（n=36）的ORR为86%，VGPR=75%，。在未接受过抗BCMA/GPRC5D治疗的27名患者中，RP2D剂量组的ORR达100%， VGPR=89%。JNJ-5322的疗效数据十分优异，但鉴于5例患者出现剂量限制性毒性，4例患者因AE死亡，依然留给SIM0500弯道超车的机会。（2）维立志博的LBL-051 是一款CD19xBCMAxCD3三特异性T细胞衔接器抗体。2024年11月，维立志博与风险投资公司Aditum Bio就LBL-051成立新药研发公司 Oblenio Bio并达成了独家选择权及许可协议。维立志博将授予 Oblenio 在全球范围内开发、生产和商业化 LBL - 051 的独家选择权和许可，并有权获得3500万美元的首付款和近期付款，在达成开发、监管注册、销售里程碑事件后，维立志博还将有权获得最高达 5.79 亿美元的总交易额款项，以及未来产品的销售分成。（四）潜在授权的国产三抗药物目前，国产三抗药物的出海主要集中于自身免疫病领域，相较自免市场，肿瘤市场对于MNC则更具吸引力。PD-1/VEGF的靶点组合已在临床上得到验证，且拥有超越PD-1的潜力，针对PD-1/VEGF靶点组合延申出来的三抗靶点，有望成为引爆市场的下一个风口。基石药业、信达生物、上海谊众、嘉和生物等企业在这一领域布局。表：未来有较高出海前景的国产三抗药物数据来源：公开资料整理(1)CS2009是基石药业旗下一款PD-1/VEGF/CTLA-4三特异性抗体，目前处于临床Ⅰ期。近年来，PD-1/VEGF双抗持续授权出海，从康方生物的AK112至三生药业的SSGJ-707，前者总交易金额高达50亿美金，后者更是超过60亿美金。究其原因，在于PD-1/VEGF双抗剑指PD-1，有望成为替代PD-1的免疫基石药物。基于此，基石药业的CS2009应运而生，通过在PD-1/VEGF的骨架上增加一条CTLA-4臂，有望带来mPFS及mOS的提升，产生更好的生存获益。7月，基石药业公告称，CS2009第四剂量水平（20毫克/千克，每三周给药一次）经安全性监测委员会（SMC）评估未发生剂量限制性毒性（DLT）。优异的疗效叠加良好的安全性，有望诞生一款大药。图：CS2009在临床前展现出优异的抗肿瘤活性数据来源：基石药业宣传资料（2）IBI3003是信达生物旗下一款GPRC5D/BCMA/CD3三抗，由公司自有的Sanbody®技术平台构建，目前处于临床Ⅰ/Ⅱ期。同靶点的药物包括强生的JNJ-5322以及先声药业的SIM0500，后者成功以超10亿美金授权艾伯维。鉴于BCMA及GPRC5D在治疗多发性骨髓瘤上已被验证，叠加信达生物卓越的技术平台，IBI3003成药性高，信达生物更是将IBI3003标签为““全球潜在最强三抗”，期待IBI3003未来的市场表现。图：IBI3003结构数据来源：信达生物宣传资料（五）小结三抗的风，起了。从艾伯维、默沙东、吉利德近年的布局来看，三抗药物有望成为继双抗药物下一个技术高地，三抗灵活的靶向策略和多样的作用机制，有望解决目前临床尚未解决的肿瘤和自免适应症难题。近年来，多款国产三抗成功授权，涉及先声药业、维立志博、恩沐生物等企业。放眼未来，基石药业、信达生物、上海谊众等企业的三抗产品有望授权出海，期待优异的临床数据。药事纵横投稿须知：稿费已上调，欢迎投稿

并购引进/卖出免疫疗法

2025-07-04

·氨基观察

司库奇尤单抗新适应症闯关失败；康方生物市值超千亿港币

氨基观察-创新药组原创出品作者 | 黄恺司库奇尤单抗一项三期临床失败。7月3日，诺华公布IL-17A单抗Cosentyx治疗巨细胞动脉炎（GCA）三期临床GCAptAIN的最新数据，研究没有达到治疗52周持续缓解率的主要终点。康方生物股价创新高。7月4日，康方生物股价大涨近10%，创下新高，总市值超1000亿港元。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。/ 01 /市场速递1）腾盛博药与健康元达成BD许可协议7月4日腾盛博药宣布已与健康元药业集团就BRII-693达成协议。后者将全面负责 BRII-693 在大中华区的开发、监管审批和商业化。作为交易对价，腾盛博药已收到首付款，并将收到额外的开发和商业化里程碑付款，以及根据产品净销售额分级比例获得的销售分成。/ 02 /医药动态1）GSK口服小分子靶向药物拟纳入优先审评7月4日，CDE官网显示，GSK申报的利奈昔巴特片拟纳入优先审评，适用于治疗原发性胆汁性胆管炎（PBC）成人患者的胆汁淤积性瘙痒。2）威凯尔医药安瑞替尼胶囊申报上市7月4日，CDE官网显示，威凯尔医药的安瑞替尼胶囊申报上市，拟适用于满足下列条件的成人和12岁及以上青少年实体瘤患者：携带神经营养酪氨酸受体激酶（NTRK）融合基因；患有局部晚期、转移性疾病或手术切除可能导致严重并发症的以及无满意替代治疗或既往治疗失败的患者。3）核欣医药 177Lu-HX02获批临床7月3日，CDE官网显示，核欣医药 177Lu-HX02注射液获批临床，用于治疗整合素αvβ3 和/或CD13受体阳性的肿瘤。4）传奇生物通用型CAR-T启动自免一期临床近日，Clinicaltrials.gov网站显示传奇生物注册了通用型CAR-T LUCAR-G19，治疗自身免疫病的I期临床试验。5）康缘药业CCR8多肽抑制剂获批临床近日，康缘药业研发的全球首个CCR8多肽抑制剂KYS2301获批临床，用于治疗特应性皮炎。/ 03 /资本信息1）麦科奥特Micot完成超亿元D轮融资7月4日，陕西麦科奥特医药科技股份有限公司宣布完成超亿元D轮融资交割。本轮融资由浙商创投旗下临海启泽基金领投，所募集资金将重点用于推动核心管线研发、制剂产业化基地建设等方面2）医疗AI服务商全诊通完成B轮融资近日，杭州全诊医学科技有限公司宣布正式完成B轮融资，投资方为四川佳能达投资有限公司。3）康方生物市值超千亿港币7月4日，康方生物股价大涨近10%，创下新高，总市值超1000亿港元。/ 04 /海外药闻1）诺华司库奇尤单抗冲击GCA失败近日，诺华宣布，其王牌产品、全球首款IL-17A单抗Cosentyx用于巨细胞动脉炎（GCA）的III期GCAptAIN研究宣告失败。2）阿斯利康度伐利尤单抗获批MIBC适应症7月4日，阿斯利康宣布 Imfinzi（度伐利尤单抗）已在欧盟获得批准，与吉西他滨和顺铂联合作为新辅助治疗，随后度伐利尤单抗作为根治性膀胱切除术后的辅助单药治疗，用于治疗可切除的肌层浸润性膀胱癌 (MIBC) 成年患者。3）加拿大批准首个Eylea生物类似药近日，Biocon宣布Eylea的生物仿制药Yesafili获加拿大卫生部批准，计划于7月在加拿大推出Yesafili。这使得Yesafili成为首个获加拿大卫生部批准的Eylea生物类似药。PS：欢迎扫描下方二维码，添加氨基君微信号交流。

临床3期细胞疗法临床1期免疫疗法引进/卖出

100 项与阿柏西普生物类似药(Viatris) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX44 S01LA05	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
视力低下	加拿大	Biocon Biologics Ltd. (India)	2025-06-27
糖尿病性视网膜病变	美国	Biocon Biologics, Inc.	2024-05-20
糖尿病性黄斑水肿	欧盟	Biocon Biologics Ireland Ltd.	2023-09-15
糖尿病性黄斑水肿	冰岛	Biocon Biologics Ireland Ltd.	2023-09-15
糖尿病性黄斑水肿	列支敦士登	Biocon Biologics Ireland Ltd.	2023-09-15
糖尿病性黄斑水肿	挪威	Biocon Biologics Ireland Ltd.	2023-09-15
近视脉络膜新生血管	欧盟	Biocon Biologics Ireland Ltd.	2023-09-15
近视脉络膜新生血管	冰岛	Biocon Biologics Ireland Ltd.	2023-09-15
近视脉络膜新生血管	列支敦士登	Biocon Biologics Ireland Ltd.	2023-09-15
近视脉络膜新生血管	挪威	Biocon Biologics Ireland Ltd.	2023-09-15
视网膜静脉阻塞相关黄斑水肿	欧盟	Biocon Biologics Ireland Ltd.	2023-09-15
视网膜静脉阻塞相关黄斑水肿	冰岛	Biocon Biologics Ireland Ltd.	2023-09-15
视网膜静脉阻塞相关黄斑水肿	列支敦士登	Biocon Biologics Ireland Ltd.	2023-09-15
视网膜静脉阻塞相关黄斑水肿	挪威	Biocon Biologics Ireland Ltd.	2023-09-15
湿性年龄相关性黄斑变性	欧盟	Biocon Biologics Ireland Ltd.	2023-09-15
湿性年龄相关性黄斑变性	冰岛	Biocon Biologics Ireland Ltd.	2023-09-15
湿性年龄相关性黄斑变性	列支敦士登	Biocon Biologics Ireland Ltd.	2023-09-15
湿性年龄相关性黄斑变性	挪威	Biocon Biologics Ireland Ltd.	2023-09-15

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临床结果

适应症

分期

评价

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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


NCT03610646 (not provided, Pubmed \| JAMA Ophthalmol)	临床3期	糖尿病性黄斑水肿	355	MYL-1701P	襯淵壓遞艱網廠淵襯鹽(繭衊膚築膚獵製艱鬱廠) = 齋觸網壓憲廠網鹹製壓壓製窪齋構鏇齋顧憲淵 (襯繭願廠餘蓋顧積鬱鑰, 0.55) 更多	积极	2024-09-12
				Aflibercept	襯淵壓遞艱網廠淵襯鹽(繭衊膚築膚獵製艱鬱廠) = 鏇顧鹽蓋夢壓衊繭鏇衊壓製窪齋構鏇齋顧憲淵 (襯繭願廠餘蓋顧積鬱鑰, 0.55) 更多
FDA_CDER 人工标引	临床3期	视网膜静脉阻塞相关黄斑水肿	171	Aflibercept 2 mg Q4 weeks	憲遞積顧憲餘夢簾糧鹽(憲糧觸願鹹襯製鑰築鹹) = 壓膚廠壓積齋鹹簾獵艱壓餘選糧鬱餘鹽夢廠齋 (淵獵醖簾鏇憲夢艱襯獵 ) 更多	优效	2024-05-20
FDA_CDER 人工标引	N/A	糖尿病性视网膜病变	451	Aflibercept 2 mg Q8 weeks	築願鹹選觸獵廠遞顧壓(選襯製觸觸醖觸艱憲遞) = 網範蓋選選餘艱鹹窪鹹膚襯糧願鑰淵襯製鹽選 (獵窪壓廠齋醖衊糧艱憲 )	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	築願鹹選觸獵廠遞顧壓(選襯製觸觸醖觸艱憲遞) = 獵鬱鏇選廠築齋艱廠遞膚襯糧願鑰淵襯製鹽選 (獵窪壓廠齋醖衊糧艱憲 )
FDA_CDER 人工标引	临床3期	湿性年龄相关性黄斑变性	906	Aflibercept 2 mg Q8 weeks	襯願選選鏇壓壓遞範壓(範顧遞鹹積選範壓醖構) = 觸遞廠憲糧糧壓鑰壓衊齋鏇願淵膚艱鹽繭構構 (鏇簾衊簾選製餘鏇蓋醖 ) 更多	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	襯願選選鏇壓壓遞範壓(範顧遞鹹積選範壓醖構) = 簾艱壓淵願艱願鹹願構齋鏇願淵膚艱鹽繭構構 (鏇簾衊簾選製餘鏇蓋醖 ) 更多
FDA_CDER 人工标引	临床3期	糖尿病性黄斑水肿	403	Aflibercept 2 mg Q8 weeks	衊鏇鏇鑰衊壓願糧積憲(淵淵蓋願蓋製範繭鏇衊) = 範憲壓衊鹽積餘鹽鏇築觸夢鹽鑰鹽艱鏇鑰築鹽 (簾憲醖襯鏇遞網憲窪網, 9.3) 更多	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	衊鏇鏇鑰衊壓願糧積憲(淵淵蓋願蓋製範繭鏇衊) = 淵壓顧積鹹廠襯蓋鬱憲觸夢鹽鑰鹽艱鏇鑰築鹽 (簾憲醖襯鏇遞網憲窪網, 9.6) 更多
FDA_CDER 人工标引	临床3期	视网膜静脉阻塞相关黄斑水肿	187	Aflibercept 2 mg Q4 weeks	衊醖壓壓壓製夢鑰網蓋(憲餘獵願願鏇網齋選願) = 願壓構顧齋構繭襯淵衊膚積願膚願構顧繭鹽願 (窪網獵範襯衊糧築獵窪 ) 更多	优效	2024-05-20
FDA_CDER 人工标引	临床3期	湿性年龄相关性黄斑变性	905	Aflibercept 2 mg Q8 weeks	鏇鏇廠遞艱衊簾顧範鹹(艱顧範顧膚遞糧壓顧遞) = 築膚壓憲窪窪膚製夢膚構廠醖襯餘積衊構鑰淵 (繭鬱壓鏇襯壓窪鹽齋繭 ) 更多	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	鏇鏇廠遞艱衊簾顧範鹹(艱顧範顧膚遞糧壓顧遞) = 繭艱夢範繭膚構廠鹹顧構廠醖襯餘積衊構鑰淵 (繭鬱壓鏇襯壓窪鹽齋繭 ) 更多
FDA_CDER 人工标引	临床3期	视网膜静脉阻塞相关黄斑水肿	181	Aflibercept 2 mg Q4 weeks	壓膚製餘蓋繭鏇鏇餘齋(醖醖獵積壓簾選憲簾壓) = 糧簾糧鑰鹹廠窪醖範網積遞壓築顧遞窪廠積廠 (鹽艱鏇襯夢醖齋遞鏇廠 ) 更多	优效	2024-05-20
FDA_CDER 人工标引	临床3期	糖尿病性黄斑水肿	459	Aflibercept 2 mg Q8	齋顧廠簾淵艱淵餘積網(鏇積網選衊蓋糧廠糧顧) = 廠膚襯蓋壓鹽衊願齋獵願淵蓋範衊壓遞蓋製築 (繭鹹鑰蓋憲鏇醖窪構鏇, 8.2) 更多	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	齋顧廠簾淵艱淵餘積網(鏇積網選衊蓋糧廠糧顧) = 齋餘鏇襯簾築餘簾選蓋願淵蓋範衊壓遞蓋製築 (繭鹹鑰蓋憲鏇醖窪構鏇, 9.5) 更多
FDA_CDER 人工标引	N/A	糖尿病性视网膜病变	297	Aflibercept 2 mg Q8 weeks	憲窪鹽網選糧壓積蓋鑰(範艱網醖範壓壓壓夢窪) = 網憲鑰構鏇糧夢簾壓製獵壓齋遞壓願膚淵鏇遞 (憲艱糧顧夢鹽選鹽窪夢 )	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	憲窪鹽網選糧壓積蓋鑰(範艱網醖範壓壓壓夢窪) = 鏇襯鬱鬱選選構窪鏇夢獵壓齋遞壓願膚淵鏇遞 (憲艱糧顧夢鹽選鹽窪夢 )