A Randomized, Double-Masked, Multicenter, Two-Arm Study Comparing the Efficacy and Safety of RC28-E 2mg Versus Aflibercept in Subjects With Wet Age-Related Macular Degeneration

This is a randomized, double-masked, multicenter study comparing the the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) versus aflibercept in patients with wet age-related macular degeneration.

开始日期2023-03-14

申办/合作机构

荣昌生物制药（烟台）股份有限公司

NCT04782128

/ Active, not recruiting临床2期

A Randomized, Open-label, Multicenter Study of the Efficacy and Safety of RC28-E Injection in Subjects With Moderately Severe to Severe Nonproliferative Diabetic Retinopathy

This is a randomized, open-label, multicenter study of the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in the treatment of patients with moderately severe to severe nonproliferative diabetic retinopathy.

开始日期2021-05-25

申办/合作机构

荣昌生物制药（烟台）股份有限公司

100 项与伊立芙普α 相关的临床结果

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100 项与伊立芙普α 相关的转化医学

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100 项与伊立芙普α 相关的专利（医药）

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项与伊立芙普α 相关的文献（医药）

2025-07-01·BRITISH JOURNAL OF OPHTHALMOLOGY

Simultaneous inhibition of fibroblast growth factor-2 and vascular endothelial growth factor-a with RC28-E in diabetic macular edema: a phase 2 randomised trial

Article

作者: Zhang, Ming ; Song, Zongming ; Chen, He ; Liu, Xinyu ; Gao, Lei ; Sun, Bin ; Fang, Jianmin ; Wang, Wenxiang ; Zhuang, Wenjuan ; Zhang, Wenfei ; Gu, Xingwang ; Sun, Xuguang ; Dai, Hong ; Chen, Youxin ; Li, Lin ; Cheng, Shiyu

Objective:

To compare different doses and dosing regimens of RC28-E, a novel bispecific antibody that simultaneously binds vascular endothelial growth factor-A (VEGF-A) and fibroblast growth factor-2 (FGF-2), with conbercept in patients with diabetic macular edema (DME).

Design:

Prospective, randomised, active comparator-controlled, open-label, multicentre, phase 2 clinical trial.cente

Participants:

The trial enrolled patients aged 18 years or older with centre-involving DME, best-corrected visual acuity (BCVA) of 73 to 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, and central subfield thickness (CST) of 300 µm or more.

Methods:

Patients were assigned randomly to one of five treatment regimens: 1.0 mg RC28-E for three initial monthly doses and then every 8 weeks (1.0mgQ8); 1.0 mg RC28-E for five initial monthly doses and then on a pro re nata (PRN) basis (1.0mgPRN); 2.0 mg RC28-E for three initial monthly doses and then every 8 weeks (2.0mgQ8); 2.0 mg RC28-E for five initial monthly doses and then on a PRN basis (2.0mgPRN); or 0.5 mg conbercept for three initial monthly doses and then on a PRN basis. Assessments were made at baseline and every 4 weeks thereafter.

Main outcome measures:

The primary endpoint was the change in BCVA compared with baseline at 24 and 52 weeks. Secondary endpoints included the change in CST from baseline at 52 weeks; the proportion of patients who gained/lost ≥15 letters, ≥10 letters and >0 letter in BCVA; and the number of injections and safety outcomes.

Results:

The trial enrolled 156 patients. Mean improvements in BCVA in the RC28-E groups at week 24 were 7.1, 11.0, 7.4 and 10.5 letters for 1.0mgQ8, 1.0mgPRN, 2.0mgQ8 and 2.0mgPRN regimens, respectively, versus 9.7 letters for the conbercept group (p=0.146). By week 52, the RC28-E groups exhibited respective mean BCVA enhancements of 5.5, 9.5, 9.2 and 9.7 letters, compared with 8.4 letters of the conbercept group (p=0.469). Mean reductions in CST in the RC28-E groups at week 52 were −163.2 µm, −136.9 µm, −142.5 µm and −153.6 µm, versus −160.7 µm for the conbercept group (p=0.948). The Per Protocol Set analysis indicated that at 24 weeks, the BCVA improvement in the 2.0mgPRN group was significantly greater than that in the conbercept group (14.0 vs 9.8, p=0.019). In patients with poor baseline glycaemic control (HbA1c ≥7.5%), the 2.0mgPRN group showed greater BCVA improvement than the conbercept group (14.4 vs 4.2, p=0.039) at week 52. During the maintenance phase, the 2.0mgPRN group had fewer injections (2.8, 95% CI 1.8 to 3.7) compared with the conbercept group (4.4, 95% CI 3.5 to 5.2). RC28-E was generally well tolerated. The incidence of ocular adverse events in study eyes was comparable between RC28-E groups (22.6% in 1.0mgQ8 group, 26.7% in 1.0mgPRN group, 34.4% in 2.0mgQ8 group, 25.0% in 2.0 mg PRN group) and conbercept group (32.3%). The number of ocular serious adverse events was 1 (1.0mgQ8), 0 (1.0mgPRN), 1 (2.0mgQ8), 2 (2.0mgPRN) and 0 (conbercept).

Conclusions:

Intravitreous RC28-E improved BCVA and CST in eyes with centre-involved DME. Compared with conbercept, the 2.0mgPRN regimen of RC28-E was recommended due to its superior efficacy in improving vision particularly for patients with poor glycaemic control, fewer treatment injections during the maintenance phase and comparable safety profile.

Trial registration number:

NCT04782115.

2024-09-01·Ophthalmology and Therapy

Safety and Efficacy of Multiple Escalating Doses of RC28-E for Neovascular Age-Related Macular Degeneration: A Phase 1b Trial

Article

作者: Jiang, Qin ; Chen, He ; Ha, Shaoping ; Li, Zhuo ; Dai, Hong ; Wu, Chan ; Lu, Yingyi ; Wang, Wenxiang ; Bi, Yanlong ; Liu, Xiaoling ; Fang, Jianmin ; Chen, Youxin ; Zhang, Han ; Zhang, Yifan ; Yu, Xiaobing ; Zhu, Dan ; Li, Lin

INTRODUCTION:

To assess the safety and efficacy of repeated intravitreal injections of RC28-E, a novel bispecific antibody that simultaneously binds vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in patients with neovascular age-related macular degeneration (AMD). This was a prospective, multicenter, open-label clinical trial; 37 patients with choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) letter scores between 73 and 34 were enrolled.

METHODS:

Treatment regimens consisted of a 3-month loading phase and a pro re nata (PRN) maintenance phase. This study included three treatment groups: the 0.5, 1.0, and 2.0 mg RC28-E groups, with escalating doses ranging from 0.5 to 2.0 mg. Patients were evaluated monthly for 48 weeks. Safety was assessed based on ocular and systemic adverse events (AEs), pharmacokinetic characteristics, and the presence of anti-RC28-E antibodies. Efficacy was assessed using the mean change in BCVA and central subfield thickness (CST) from baseline to week 48.

RESULTS:

Most AEs were mild or moderate. The most common AE was a minor injection-related subconjunctival hemorrhage (16.2%). The AEs did not increase with dose or repeated injections. At week 48, mean improvements in BCVA from baseline in the 0.5, 1.0, and 2.0 mg groups were 6.1 ± 8.3, 9.9 ± 10.7, and 7.6 ± 9.38 letters, respectively; mean reductions in CST in the three groups were 112.1 ± 160.5, 175.1 ± 212.4, and 128.7 ± 145.8 μm, respectively. The serum RC28-E concentrations in 95% of the patients were below the quantification limit of the assay. No significant change from baseline was observed in the mean plasma concentrations of VEGF or FGF over the 48 weeks of treatment. Pre-treatment antibodies to RC28-E were detected in 1 of the 37 patients. Antibodies to RC28-E were detected in two patients after dosing with RC28-E for 48 weeks.

CONCLUSION:

RC28-E was well tolerated and exhibited an overall favorable safety profile with evidence of improvements in BCVA and anatomical parameters.

2020-01-01·Experimental eye research3区 · 医学

In vivo characterization of RC28-E, a fusion protein targeting VEGF and bFGF: Pharmacokinetics and ocular distribution in primates

3区 · 医学

Article

作者: Huang, Min ; Kou, Xiangying ; Jiang, Jing ; Li, Hongzhen ; Liu, Zhihao ; Wu, Chuandong ; Wang, Ling

Administration of RC28-E, a VEGF/bFGF dual decoy receptor (IgG1 Fc-fusion protein), have shown relative therapeutic value in ocular in vivo models, including laser-induced choroidal neovascularization (CNV) in monkeys and streptozotocin (STZ)-induced diabetic retinopathy (DR) in rats. In the present study, we have elucidated the pharmacokinetics profiles of RC28-E at the systemic, vitreous and aqueous humor after administration in a primate model (Macaca fascicularis). Moreover, here we tease out the ocular tissue distribution of RC28-E after intravitreal administration, and we also determine the systemic bioavailability after both intravitreal and intravenous administration. Our results show that RC28-E is rapidly and well-distributed into ocular tissues after intravitreal administration. Drug exposure in choroid and retina was approximately one-quarter and one-twelfth of that in vitreous humor, while its half-life in vitreous and aqueous humor were well-sustained (3.3 and 3.0 days). Remarkably, RC28-E could cross the blood-ocular barrier, and the systemic bioavailability of RC28-E was ~25%. No drug accumulation after multiple administration was noticed, but low titers of antibody produce against RC28-E were detected. Overall, RC28-E exhibited high clinical value due to adequate pharmacokinetic profiling, safety and efficacy.

项与伊立芙普α 相关的新闻（医药）

2025-10-04

·药圈头条

新药BD授权；并递交上市申请 | 眼科大市场

近日，来自山东的荣昌生物制药（烟台）股份有限公司研发的针对眼部新生血管性疾病的VEGF/FGF双靶标融合蛋白药物RC28-E，用于治疗糖尿病性黄斑水肿（DME）患者的新药上市申请（NDA），正式获得中国国家药品监督管理局（NMPA）药品审评中心（CDE）受理。摩熵医药数据库，https://pharma.bcpmdata.com 药融圈数据显示：RC28-E（eflimrufusp alfa），一款针对眼部新生血管性疾病的VEGF/FGF双靶点融合蛋白类药物，可同时抑制VEGF/血管内皮生长因子和FGF/成纤维细胞生长因子两个因子与其受体结合。本次新药上市申请的三期临床试验中，阿柏西普2.0mg组为阳性对照。采用玻璃体腔内注射给药方式。本品相关专利有：WO2020114411A1。 https://pharma.bcpmdata.com；摩熵医药眼科领域疾病，糖尿病性黄斑水肿（DME）是糖尿病患者常见的严重眼部并发症，也是导致工作年龄人群视力下降和失明的主要原因之一，其核心病理因素为异常新生血管的形成及增殖性病变。眼内注射抗体的疗效，或许开发多靶点、长效给药已成为趋势。此前在今年的8月19日，荣昌生物与日本眼科巨头参天制药达成BD协议。前者将具有自主知识产权的RC28-E注射液有偿许可给后者，使其获得标的药物在大中华区及韩国、泰国、越南、新加坡、菲律宾、印度尼西亚及马来西亚的独家开发、生产和商业化权利。本次deal的细节：（1）荣昌生物从参天中国取得2.5亿元人民币的首付款；（2）最高可达5.2亿元人民币的开发及监管里程碑付款和最高可达5.25亿元人民币的销售里程碑付款；（3）根据授权地区的产品销售额收取高个位数至双位数百分比的梯度销售分成。此外，治疗wAMD/湿性年龄相关性黄斑变性适应症预计2026年年中递交中国上市申请；其他开发的适应症有糖尿病视网膜病变（DR）等。中国药企中，做眼科抗体新药的企业还有信达生物、恒瑞医药、复宏汉霖与亿胜生物、明慧医药、康弘药业、典晶生物、欧科健、百奥泰、正大天晴药业集团、普乐康；等等。参考： NMPA/CDE；摩熵医药数据库，https://pharma.bcpmdata.com； FDA/EMA/PMDA；相关公司公开披露（除标注外，正文图片均来自企业官网）；ARVO 2025；荣昌生物；https://www.remegen.cn/；http://www.santen-china.com.cn；https://www.santen-china.com.cn/node/172；Yingyi LU et al. Chinese Journal of Experimental Ophthalmology, 2018, 36(6): 401-403.；RC28；Zhang W, et al. Simultaneous inhibition of fibroblast growth factor-2 and vascular endothelial growth factor- a with RC28- E in diabetic macular edema: a phase 2 randomised trial. Br J Ophthalmol 2025;0:1–7. doi:10.1136/bjo-2024-326006；等等。备注后，立即扫码加入药融圈交流群植根上海、辐射全球,药融圈作为生物医药产业级战略平台,以"让智慧与人脉无界流动"为使命,构建覆盖药物研发、生产、流通、商业化的全产业链赋能体系。通过智能化云服务、精准资源链接、产业智库与生态社群四大核心引擎,打造中国医药价值流动的基础设施。在全球化与数字化双重浪潮下,药融圈正重新定义医药资源的流通范式--这里不仅是信息与人脉的枢纽站,更是催生产业变革的化学反应器。我们以中国为原点,编织全球医药智慧网络,让每一次精准链接都成为企业跨越式增长的催化剂。点点赞点分享点推荐

引进/卖出临床3期

2025-10-03

·医药观澜

参天制药与荣昌生物宣布：眼科1类创新药在中国申报上市

近日，参天制药株式会社（简称"参天制药"）与荣昌生物共同宣布，针对眼部新生血管性疾病的VEGF/FGF双靶标融合蛋白RC28-E玻璃体腔注射液（伊立芙普α眼内注射液），用于治疗糖尿病性黄斑水肿（DME）的新药上市申请，正式获得中国国家药品监督管理局药品审评中心（CDE）受理。 DME是糖尿病患者常见的严重眼部并发症，也是导致工作年龄人群视力下降和失明的主要原因之一，其核心病理因素为异常新生血管的形成及增殖性病变。伊立芙普α眼内注射液为一款针对眼部新生血管性疾病的VEGF/FGF双靶标融合蛋白类药物，其可同时抑制VEGF和FGF两个因子与其受体结合，相比单独抑制其中一种因子，有望在抗炎、抗纤维化、抗新生血管等多方面发挥协同效果。此次上市申请是基于一项多中心、随机、双盲、阳性对照的3期临床研究。符合要求的受试者按1:1的比例随机分配至RC28-E 2.0mg组或对照组。研究主要终点为52周时研究眼最佳矫正视力（BCVA）相较于基线的变化均值。该研究中的RC28-E单次使用剂量为2.0mg，玻璃体内注射给药，在0~16周每4周注射一次，连续给药5次；此后至第48周，每8周给药一次。该研究纳入了316例受试者，结果显示，与阳性对照药相比，RC28-E达到了预设的主要终点，证实了其非劣效性，且安全耐受性良好。据荣昌生物和参天制药新闻稿介绍，RC28-E临床拟用于治疗糖尿病性黄斑水肿、湿性年龄相关性黄斑变性、糖尿病视网膜病变等眼部疾病。该产品治疗湿性年龄相关性黄斑变性（wAMD）适应症预计2026年年中递交中国上市申请。 8月19日，参天制药通过旗下全资子公司与荣昌生物正式签署合作协议。参天制药获得RC28-E在大中华区及韩国、泰国、越南、新加坡、菲律宾、印度尼西亚及马来西亚的独家开发、生产和商业化权利。参考资料：[1]参天制药与荣昌生物共同宣布RC28-E治疗糖尿病性黄斑水肿（DME）新药上市申请获受理. From https://www.prnasia.com/story/505610-1.shtml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3期申请上市

2025-09-30

·医药地理

眼科创新药伊立芙普α申报上市

9月30日，CDE官网显示，荣昌生物的眼科创新药伊立芙普α（RC28）申报上市，用于治疗糖尿病黄斑水肿（DME）。伊立芙普α是荣昌生物开发的一款全球首创VEGF/FGF双靶标融合蛋白药物，可同时阻断VEGF和FGF家族的血管生成因子，从而更有效地抑制血管异常生长。其独特的结构设计可以有效避免了单靶VEGF抑制剂的缺陷。此外，伊立芙普α由VEGFR1、VEGFR2和FGFR1的胞外结构域与人IgG1融合而成，其中IgG1片段可以帮助延长药物在血清中的半衰期，因此可以减少给药频率。对于直接注入患者眼内的药物，减少给药频率可以有效减轻患者不适。 2025年8月，荣昌生物与参天制药全资子公司参天中国达成协议，将伊立芙普α在大中华区及韩国、泰国、越南、新加坡、菲律宾、印度尼西亚及马来西亚的独家开发、生产和商业化权利授予后者，总交易金额为12.95亿元。 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

申请上市

100 项与伊立芙普α 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
糖尿病性黄斑水肿	临床3期	中国	荣昌生物制药（烟台）股份有限公司	2023-06-08
湿性年龄相关性黄斑变性	临床3期	中国	荣昌生物制药（烟台）股份有限公司	2023-03-14
非增殖性糖尿病视网膜病变	临床2期	中国	荣昌生物制药（烟台）股份有限公司	2021-05-25

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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


NCT04782115 (Pubmed \| Br J Ophthalmol \| NEWS) 人工标引	临床2期	糖尿病性黄斑水肿	156	RC28-E 1.0mgQ8	網遞壓淵糧淵築窪衊鹽(醖觸醖選醖遞衊鬱製遞) = 鏇願淵顧願觸築襯顧遞鬱鹹衊憲觸鏇憲衊製鏇 (顧製遞艱願觸壓蓋餘製 ) 更多	积极	2025-07-01
NCT04782115 (Pubmed \| Br J Ophthalmol \| NEWS) 人工标引	临床2期	糖尿病性黄斑水肿	156	RC28-E 1.0mgPRN	網遞壓淵糧淵築窪衊鹽(醖觸醖選醖遞衊鬱製遞) = 鹽蓋繭遞鬱鬱醖膚鏇艱鬱鹹衊憲觸鏇憲衊製鏇 (顧製遞艱願觸壓蓋餘製 ) 更多	积极	2025-07-01
NCT04270669 \| CTR20192638 (NEWS) 人工标引	临床1期	湿性年龄相关性黄斑变性	-	RC28-E	積窪積廠獵衊蓋艱糧蓋(壓襯襯網選築積製選構) = Patients using Rongchang BioRC28 demonstrated good tolerability and safety, with significant improvements in vision and disease, and were effective in patients who had previously received anti-VEGF therapy and PCV (fundus polypoid choroidal vasculopathy). 鹹範衊網廠淵艱膚窪醖 (夢鑰繭觸積醖鹹蓋獵齋 )	积极	2022-09-15