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

/ Unknown status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: Song, Zongming ; Zhang, Ming ; 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 ; Ha, Shaoping ; Chen, He ; Li, Zhuo ; Wu, Chan ; Dai, Hong ; 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.

2015-01-01·International journal of medicinal mushrooms4区 · 生物学

Antiviral Activity of a Cloned Peptide RC28 Isolated from the Higher Basidiomycetes Mushroom Rozites caperata in a Mouse Model of HSV-1 Keratitis

4区 · 生物学

Article

作者: Haotian Xiang ; Jun Chen ; Naihong Yan ; Yun Wang ; Xuyang Liu ; Frank F. Piraino ; Fen He

An Escherichia coli-expressed peptide with a molecular weight of 28.26, derived from the complementary DNA of antiviral protein RC28 isolated from the mushroom Rozites caperata (=Cortinarius caperatus), demonstrated potent antiviral activity against herpes simplex virus-1 in Vero cells and in a herpes simplex virus-1 mouse keratitis model. Plaque assays in Vero cells showed that the peptide reduced viral yields by at least 1.2 logs; in the animal model the cloned peptide delayed the occurrence of stromal keratitis and alleviated the severity of the disease. We believe this is the first report of a cloned mushroom peptide with antiviral activity for the prevention and treatment of a viral disease.

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项与伊立芙普α 相关的新闻（医药）

2026-08-03

·药通社

刚刚，两款1类新药，上市失败！

刚刚，NMPA通知件显示，两款1类新药收到通知件，分别是——步长制药的注射用艾帕依泊汀α和荣昌生物的伊立芙普α眼内注射液。注射用艾帕依泊汀α，是步长制药开发的一款促红细胞生成素-Fc（EPO-Fc）融合蛋白，属于长效 EPO 药物，用于慢性肾病贫血。 2024年9月，步长制药提交了上市申请，历经六百多天审评，发补资料都审评完了，结果居然被下了通知件，有点意外。图源：摩熵医药艾帕依泊汀α最初是由山东丹红制药有限公司委托旭华（上海）生物研发中心有限公司和上海美烨生物科技有限公司研发的，步长生物后续推进临床开发与产业化落地，这也被视为步长制药切入生物药赛道的核心布局品种，可惜收到了通知件。另一款，伊立芙普α眼内注射液，2025年9月30日荣昌生物1类上市申请获受理，历经两百多天审评，未发补，收到通知件原因未知。图源：摩熵医药伊立芙普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（血管内皮生长因子）和FGF（成纤维细胞生长因子）家族的血管生成因子，从而更有效地抑制血管异常生长。 2025年8月，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。本次申报的适应症为：用于治疗糖尿病性黄斑水肿（DME）。据荣昌生物新闻稿称，该产品治疗湿性年龄相关性黄斑变性（wAMD）适应症也预计2026年年中递交中国上市申请。 ↓⭐关注药通社，洞见行业趋势↓

2026-08-01

·寻找那棵摇钱树

白话药企 | 荣昌生物（9995.HK）：家里两棵“摇钱树”正旺，手里还攥着两张能换美元的“王牌”

荣昌生物（9995.HK）这家公司，用大白话讲就是：左边在自身免疫病（自免）里靠一款“双靶点神药”泰它西普持续拓展适应症放量收钱；右边在肿瘤赛道依托国产首款ADC维迪西妥单抗销售+联合治疗双线发力； 2026年又通过PD-1/VEGF双抗RC148对外授权，一次性入账6.5亿美元首付款，彻底从持续烧钱的研发企业，转变为自有药品持续回款、海外大额BD兑现、成长逻辑清晰的双赛道创新药龙头。一、自免线：泰它西普接连拿下五大适应症，医保放量是公司基本盘泰它西普（RC18）是荣昌自主研发的全球首创BLyS/APRIL双靶点融合蛋白，简单理解就是药物能同时阻断两条致病通路，从源头抑制异常活化的自体B细胞。 2021年率先获批系统性红斑狼疮（SLE），后续持续拓展适应症，2024年拿下类风湿关节炎、2025年获批全身型重症肌无力（gMG），2026年6月同步获批干燥综合征、IgA肾病。国内目前合计五大上市适应症；眼肌型重症肌无力、膜性肾病等多个新适应症也在推进III期临床。• 系统性红斑狼疮：虽未开展头对头对照试验，但52周SRI-4临床应答率达82.6%，大幅甩开GSK单靶点竞品贝利尤单抗（53.8%），疗效优势突出；• IgA肾病：III期TELIGAN试验显示，39周患者尿蛋白较基线下降58.9%，经安慰剂校正降幅达55%，同时能稳定保护肾功能（eGFR），严重不良反应发生率显著更低；• 干燥综合征：全球首款针对该病症获批的生物制剂，是唯一能同步改善患者全身疾病活动度（ESSDAI）与主观干燥症状（ESSPRI）的药物，填补临床空白。销售端，2025年泰它西普国内销售额13.87亿元，同比增长41.94%。2026年一季度，泰它西普、维迪西妥两款核心商业化产品合计实现收入6.56亿元，公司单季度归母净利润3.28亿元，内生业务正式稳定盈利。海外开发交由Vor Bio全权负责，全身型重症肌无力（gMG）全球III期临床预计2027上半年读出关键顶线数据，实现国内自主销售、海外伙伴分担研发成本、共享商业化收益的模式。二、肿瘤线：维迪西妥是国产ADC标杆，单药、联用、海外分成三线开花维迪西妥单抗（RC48）是国内首款原创HER2 ADC药物，精准靶向HER2阳性肿瘤细胞。当前已获批三大适应症：三线晚期胃癌、二线晚期尿路上皮癌、HER2阳性伴肝转移乳腺癌；一线尿路上皮癌联合特瑞普利单抗方案已于2025年7月递交国内上市申请，一线胃癌多项III期临床试验同步开展。产品核心优势是联用方案疗效亮眼，不局限单药治疗：• 胃癌联合方案：搭配PD-1+曲妥珠单抗治疗HER2阳性胃癌，客观缓解率（ORR）82.4%；联合PD-1+化疗用于HER2阴性胃癌，ORR可达72%；• 一线尿路上皮癌III期数据：维迪西妥+特瑞普利单抗对比标准化疗，ORR 76% vs 50%，中位无进展生存期13.1个月 vs 6.5个月，中位总生存期31.5个月 vs 16.9个月；疗效对标辉瑞Padcev联合K药方案，且三级及以上不良反应发生率更低，患者耐受性更好。海外布局方面，2021年荣昌将维迪西妥除亚太外全球权益授权给Seagen（现已被辉瑞收购）；二线尿路上皮癌全球II期临床完成，一线尿路上皮癌全球III期在2026年年中抵达主要终点，未来将持续获得海外销售分成。除此之外，眼科管线RC28（VEGF/FGF双靶点融合蛋白）已授权参天制药，合作总额13.95亿元，黄斑病变两大适应症将在2026年陆续申报上市，肿瘤+眼科形成多元增长梯队，不靠单一药物支撑业绩。三、出海王炸：RC148交易对价最高56亿美元，双抗+ADC联用卡位下一代肿瘤疗法2026年1月，荣昌与艾伯维签署RC148独家海外授权协议，首付款6.5亿美元，后续最高可兑现49.5亿美元开发、商业化里程碑，首付款+里程碑合计最高56亿美元（不含海外销售分级特许权使用费），6.5亿美金首付款已于2026年4月全额到账。这笔大额一次性收入直接推高机构业绩预测：民银国际预计2026年公司总营收76.49亿元，同比大增135.97%，归母净利润37.36亿元，现金流彻底由紧转充裕。 RC148自身临床数据扎实：单药治疗一线PD-L1阳性非小细胞肺癌ORR 61.9%；用于免疫治疗耐药的二线肺癌，联合化疗ORR达66.7%。更具差异化的是荣昌提前布局“PD-1/VEGF双抗+ADC”联合疗法赛道，走在全球行业前列：自研RC148搭配CLDN18.2 ADC（RC118）用于二线胃癌，ITT人群ORR 57.1%，显著优于传统PD-1单抗联合RC118的33.3%；中位无进展生存期7.9个月对比4.3个月，疗效大幅提升且安全性无恶化；后续还可与艾伯维自有c-Met ADC ABBV-400开展全球联合临床。整体成长梯队清晰：泰它西普负责当下稳定现金流，维迪西妥支撑中期国内、海外销售增长，RC148双抗+ADC联合疗法锁定5-10年长期行业红利。

2026-07-31

·北京药研汇

1类创新药上市遇阻，荣昌生物回应来了

1类新药，历经两百多天审评，最终收到通知件，荣昌生物回应来了 2026年7月28日，据NMPA官网最新公示的“药品通知件送达信息”中，共有7款药品，涉及多家知名药企。值得一提的是，荣昌生物制药（烟台）股份有限公司申报的伊立芙普α眼内注射液，也出现在通知件里。对此，荣昌生物回应称，根据国家药监局最新审评建议，经审慎研究，公司决定主动撤回本次药品注册申请，并将根据国家药监局的有关安全性样本量的要求，进一步补充临床病例数研究后再次提交注册申请；此外，关于RC28-E的对外授权合作正常推进。公开资料显示，伊立芙普α是荣昌生物自主研发的全球首创药物，其特征为VEGF/FGF双靶标融合蛋白。这种创新设计能同时抑制VEGF和FGF两大血管生成因子，从而更有效地遏制异常血管的生长。该药物通过独特的结构优势克服了传统单靶VEGF抑制剂的局限性。具体来说，伊立芙普α由VEGFR1、VEGFR2和FGFR1的胞外结构域与人IgG1融合生成，其中IgG1部分有助于延长药物在血清中的半衰期，因此可以降低给药频率。这一特性在需要直接眼内注射的药物应用中，能有效减轻患者的用药负担和不适感。 ‌2023年1月‌：启动治疗湿性年龄相关性黄斑变性（wAMD）的Ⅲ期临床试验。 ‌2025 年8月‌：荣昌生物与参天制药签署协议，授权后者在大中华区及东南亚多国独家开发商业化该药，首付款及总交易额达 12.95 亿元。 ‌2025年9月30日‌：针对糖尿病性黄斑水肿（DME）适应症的‌新药上市申请（NDA）正式提交‌至国家药监局药审中心（CDE），受理号 CXSS2500103。 ‌2025年10月上旬‌：CDE 正式‌受理‌该上市申请，基于一项多中心、随机、双盲、阳性对照的Ⅲ期临床研究数据。 ‌2026年7月28日‌：国家药监局公示药品通知件送达信息，显示该申请‌未获批准‌；荣昌生物回应系‌主动撤回‌，原因是拟上市剂量下安全性病例数不足，计划补充病例后重新递交。根据之前CDE网站审评任务公示，RC28-E均已完成了“药理毒理”“临床”“药学”“统计”“临床药理”“合规”等六大专业审评，对应审评灯全部熄灭，这也就意味着六大核心技术板块全部完成分项审评，无核心技术缺陷，综合六大维度均未发现足以直接驳回的重大问题。换句话说，如果存在疗效不足、严重安全风险、工艺不可控、数据造假、统计无效等问题，会在中途直接终止审评，根本走不到全灭灯。既然RC28-E的各专业未发现影响品种整体获益风险评价的重大技术缺陷，结合荣昌生物的回应，一条清晰的链路已经形成，此次RC28-E的审评结果不是基于监管部门的“纠错”，更不是该品种存在重大疗效及安全性问题，而是荣昌生物出于与监管部门充分沟通结果考虑，主动撤回上市申请，并补充相应的临床病例数研究。根据CDE《药品注册申请审评期间变更工作程序（试行）》，药品上市许可申请审评期间，申请人可撤回原注册申请，补充研究后重新申报。换言之，“主动撤回—补研究—再申报”是监管明确允许的标准路径，并非简单理解成“被否”。近年来，这一操作在创新药企中并不鲜见：恒瑞医药、复宏汉霖、信达生物、乐普生物等多家企业均有NDA阶段主动撤回后再申报并最终获批上市的记录。目前，行业共识是在审评标准趋严的背景下，主动撤回申请补充数据，优于硬推后被拒。此次撤回会推迟产品上市，也给其他长效和多靶点眼科药物留下更多时间。等RC28-E重新申报时，仅仅强调“全球领先的VEGF/FGF双靶点”可能已经不够，还需要拿出更完整的安全性数据，以及更能体现临床差异的结果。

100 项与伊立芙普α 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
糖尿病性黄斑水肿	申请上市	中国	荣昌生物制药（烟台）股份有限公司	2025-09-30
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	繭窪鏇鏇鹹製觸鑰廠壓(夢構選齋鬱簾蓋製齋鬱) = 鹽憲廠淵餘築蓋構鹹壓範齋膚鹹構鏇鬱艱鑰艱 (鏇願觸淵範網淵鏇襯鑰 ) 更多	积极	2025-07-01
				RC28-E 1.0mgPRN	繭窪鏇鏇鹹製觸鑰廠壓(夢構選齋鬱簾蓋製齋鬱) = 蓋積範醖簾膚繭顧遞淵範齋膚鹹構鏇鬱艱鑰艱 (鏇願觸淵範網淵鏇襯鑰 ) 更多
NCT04782115 (ARVO2025)	临床2期	糖尿病性黄斑水肿	156	RC28-E 1.0mgQ8	網願簾鏇繭鹹膚鬱積繭(糧齋膚醖蓋淵積淵願廠) = 鏇鑰願網窪簾製構選壓鑰廠襯選艱製構廠鑰齋 (餘衊淵襯夢遞觸蓋構壓 ) 更多	积极	2025-05-04
				RC28-E 1.0mgPRN	網願簾鏇繭鹹膚鬱積繭(糧齋膚醖蓋淵積淵願廠) = 廠積衊艱壓廠網選簾廠鑰廠襯選艱製構廠鑰齋 (餘衊淵襯夢遞觸蓋構壓 ) 更多
NCT04270669 \| CTR20192638 (NEWS) 人工标引	临床1期	湿性年龄相关性黄斑变性	-	RC28-E	醖網構醖築選獵觸廠艱(鹽淵齋壓鬱積選壓獵餘) = 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). 顧淵衊顧膚襯窪簾遞憲 (糧醖製壓積構淵齋憲簾 )	积极	2022-09-15