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.

Start Date14 Mar 2023

Sponsor / Collaborator

RemeGen Co., Ltd.

NCT04782128

/ Unknown statusPhase 2

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.

Start Date25 May 2021

Sponsor / Collaborator

RemeGen Co., Ltd.

100 Clinical Results associated with Eflimrufusp alfa

100 Translational Medicine associated with Eflimrufusp alfa

100 Patents (Medical) associated with Eflimrufusp alfa

Literatures (Medical) associated with Eflimrufusp alfa

01 Jul 2025·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

Author: Zhang, Ming ; Song, Zongming ; Chen, He ; Liu, Xinyu ; Gao, Lei ; Sun, Bin ; Fang, Jianmin ; Wang, Wenxiang ; Zhuang, Wenjuan ; Gu, Xingwang ; Zhang, Wenfei ; 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.

01 Sep 2024·Ophthalmology and Therapy

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

Article

Author: Jiang, Qin ; Ha, Shaoping ; Chen, He ; Li, Zhuo ; Dai, Hong ; Wu, Chan ; Lu, Yingyi ; Wang, Wenxiang ; Zhang, Han ; Bi, Yanlong ; Fang, Jianmin ; Chen, Youxin ; Liu, Xiaoling ; 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.

01 Jan 2020·Experimental eye researchQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: Huang, Min ; Kou, Xiangying ; Li, Hongzhen ; Jiang, Jing ; 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.

News (Medical) associated with Eflimrufusp alfa

22 Aug 2025

·www.fiercepharma.com

Fierce Pharma Asia—J&J's $2B Fujifilm deal; Drug recalls for 3 Indian firms; RemeGen, Santen's eye med pact

Johnson & Johnson's manufacturing pact with Fujifilm Biotechnologies, three Indian companies' drug recalls, and an eye disease deal between Santen Pharmaceutical and RemeGen made our news this week. Johnson & Johnson is spending part of its big U.S. investment at a Fujifilm Biotechnologies site. Three Indian drugmakers issued U.S. drug recalls in recent weeks due to impurities. Japan's Santen Pharma licensed a VEGF/FGF bispecific from RemeGen. And more.1. In US manufacturing push, J&J earmarks $2B for Fujifilm in 10-year deal in North CarolinaJohnson & Johnson has committed $2 billion over the next 10 years to secure a 160,000-plus-square-foot facility at Fujifilm Biotechnologies’ biomanufacturing campus in Holly Springs, North Carolina. The deal will create about 120 new jobs in the state, J&J said. The pact followed a $3 billion arrangement Fujifilm recently made with Regeneron.2. Alembic, Sun and Glenmark issue US drug recalls due to the presence of carcinogens or foreign matterThree Indian drugmakers—Alembic, Sun Pharma and Glenmark—have issued separate U.S. drug recalls in recent weeks. Alembic recalled 9,492 bottles of doxepin hydrochloride due to an impurity of the potential human carcinogen nitrosamine. In addition, Sun recalled 11,328 bottles of spironolactone due to the presence of aluminum, and Glenmark issued three recalls, including two covering carvedilols because of the presence of a nitrosamine.3. China's RemeGen sells Asia rights to VEGF/FGF eye drug in $180M dealJapanese eye disease specialist Santen Pharmaceutical is paying 250 million Chinese yuan ($34.8 million) for certain Asia rights to a VEGF/FGF fusion protein by China’s RemeGen. The drug, coded RC28-E, is already in phase 3 development in diabetic macular edema and wet age-related macular degeneration. The deal could eventually be worth about $180 million.4. GC’s Made Scientific opens cell therapy facility in New Jersey (release)Made Scientific, a U.S.-based cell therapy CDMO subsidiary of Korea’s GC Holdings, has opened its 60,000-square-foot facility and headquarters in Princeton, New Jersey. The opening marked the completion of a $12 million initial investment in the site. The company plans to add 12,000 square feet in additional clean room space to support late-stage and commercial programs.

Phase 3Cell Therapy

19 Aug 2025

·www.fiercebiotech.com

China\'s RemeGen sells Asia rights to VEGF/FGF eye drug in $180M deal

Santen CEO Takeshi Ito said RC28-E \"offers differentiated advantages.\"\n China’s RemeGen has sold certain Asia rights to its phase 3-stage eye disease drug to Japan’s Santen Pharmaceutical for 250 million Chinese yuan ($34.8 million) upfront.The drug in question, dubbed RC28-E, is a VEGF/FGF dual-target fusion protein being aimed at ocular neovascular diseases. RemeGen has already taken RC28-E into phase 3 studies for diabetic macular edema (DME) and wet age-related macular degeneration (wAMD) off the back of a phase 2 study in DME the company said had demonstrated improved vision and reduced retinal thickness.RemeGen’s plan is to submit a China approval application for RC28-E in DME later this year, followed by an application in wAMD around mid-2026, according to an Aug. 18 release.This morning’s deal means that Santen’s China subsidiary now has the rights to develop and commercialize RC28-E in greater China as well as as South Korea, Thailand, Vietnam, Singapore, the Philippines, Indonesia and Malaysia.As well as the upfront fee, RemeGen could be in line for up to 520 million yuan ($72.4 million) in development and regulatory milestones, as well as 525 million yuan ($73 million) in sales milestones and then tiered royalties on sales in the licensed territories.RemeGen CEO Jianmin Fang, Ph.D., said the partnership with Japanese vision care company Santen “not only lays a solid foundation for the future commercialization of RC28-E but also reflects international recognition of RemeGen\'s capabilities in ophthalmic drug development.” While a number of approved eye disease drugs—such as Roche’s Lucentis and Vabysmo as well as Regeneron and Bayer’s Eylea—already target vascular endothelial growth factor (VEGF), RC28-E is also designed to work on fibroblast growth factors (FGFs), which play a significant role in eye development and disease.Santen CEO Takeshi Ito said RC28-E “offers differentiated advantages by simultaneously targeting angiogenesis and fibrosis, potentially providing a new therapeutic approach and innovative option for the treatment of fundus diseases.”

$China\'s RemeGen sells Asia rights to VEGF/FGF eye drug in $180M deal$

Phase 3Phase 2License out/in

19 Aug 2025

·www.pharmaceutical-technology.com

Santen and RemeGen sign licence deal for retinal disease injection

The RC28-E intravitreal injection is a dual-target fusion protein aimed at treating retinal diseases. Credit: Sai Thaw Kyar/Shutterstock.com. Santen Pharmaceutical has signed a licensing agreement with RemeGen for the RC28-E intravitreal injection, a dual-target fusion protein designed to treat retinal diseases. The agreement, facilitated through Santen’s subsidiary in China, grants the company exclusive rights to develop, manufacture and market RC28-E across Hong Kong, Macau, Mainland China, Indonesia, Malaysia, the Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam. RemeGen will receive an upfront payment of 250m yuan ($34.8m), milestone payments for development and regulatory achievements totalling up to 520m yuan ($72.3m), and up to 525m yuan ($73.09m) sales milestone payments. The company will also receive additional net sales-based royalties. RemeGen CEO Dr Fang Jianmin stated: “Santen brings over 130 years of ophthalmic expertise and a robust global commercial network spanning more than 60 countries and regions. “As RemeGen independently developed a Category 1 innovative drug, RC28-E is approaching the critical stage of BLA submission.” GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence RC28-E is a bi-specific fusion protein that targets vascular endothelial growth factor and fibroblast growth factor. It is currently under clinical development for conditions such as diabetic macular oedema, wet age-related macular degeneration and diabetic retinopathy. Recent findings from a Phase II clinical trial of RC28-E for diabetic macular oedema were presented at the 2025 Annual Meeting of the Association for Research in Vision and Ophthalmology. Results indicated that the treatment improved best-corrected visual acuity while reducing central subfield thickness, and was well-tolerated by patients. Santen president and CEO Takeshi Ito stated: “RemeGen has demonstrated outstanding capabilities and innovation in the field of novel drug development. “As RemeGen’s flagship pipeline in ophthalmology, RC28-E offers differentiated advantages by simultaneously targeting angiogenesis and fibrosis, potentially providing a new therapeutic approach and innovative option for the treatment of fundus diseases.” Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

Clinical ResultLicense out/inPhase 2Phase 1

100 Deals associated with Eflimrufusp alfa

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic macular oedema	NDA/BLA	China	RemeGen Co., Ltd.	30 Sep 2025
Wet age-related macular degeneration	Phase 3	China	RemeGen Co., Ltd.	14 Mar 2023
Nonproliferative diabetic retinopathy	Phase 2	China	RemeGen Co., Ltd.	25 May 2021

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04782115 (Pubmed \| Br J Ophthalmol \| NEWS) Manual	Phase 2	Diabetic macular oedema	156	RC28-E 1.0mgQ8	totcupguck(zoajdptttq) = nmvmnyyqtd fzysxupfxu (foyxgsriyy ) View more	Positive	01 Jul 2025
				RC28-E 1.0mgPRN	totcupguck(zoajdptttq) = vqesknqwol fzysxupfxu (foyxgsriyy ) View more
NCT04782115 (ARVO2025)	Phase 2	Diabetic macular oedema	156	RC28-E 1.0mgQ8	atbfzgehyf(bwjhwojlrc) = mbyxpcjbux mrihblkjpw (xmfkjaxoee ) View more	Positive	04 May 2025
				RC28-E 1.0mgPRN	atbfzgehyf(bwjhwojlrc) = juqwhbluib mrihblkjpw (xmfkjaxoee ) View more
NCT04270669 \| CTR20192638 (NEWS) Manual	Phase 1	Wet age-related macular degeneration	-	RC28-E	onhlnxrhhy(izuxaiyaxn) = 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). hykgtpcqgv (zinnxheejq )	Positive	15 Sep 2022

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