Santen and RemeGen Announce Biologic License Application (BLA) Acceptance for RC28-E Intravitreal Injection in Diabetic Macular Edema in China

September 30, 2025, - Osaka, Japan - Santen Pharmaceutical Co., Ltd. (hereinafter Santen), and RemeGen Co., Ltd. (hereinafter RemeGen) jointly announced that the Biologic License Application (BLA) for RC28-E intravitreal injection, a bi-specific fusion protein drug targeting vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF), has been officially accepted by China’s Center for Drug Evaluation (CDE) for the treatment of patients with diabetic macular edema (DME).

The BLA is based on a multicenter, randomized, double-blind, active-controlled Phase III clinical study, which was led by Peking Union Medical College Hospital (PUMCH) of the Chinese Academy of Medical Sciences. The eligible subjects were randomized in a 1:1 ratio to receive either RC28-E 2.0 mg or aflibercept 2.0 mg. The primary endpoint was the mean change from baseline in Best Corrected Visual Acuity (BCVA) in the study eye at Week 52. RC28-E was administered as a single 2.0 mg dose via intravitreal injection every 4 weeks from Week 0 to Week 16 (for a total of 5 consecutive doses), followed by dosing every 8 weeks up to Week 48. The study enrolled 316 subjects, and the results demonstrated that RC28-E met the pre-specified primary endpoint, confirming its non-inferiority compared to the active control aflibercept, with a favorable safety and tolerability profile.

The DME is a common and serious ocular complication in patients with diabetes, and one of the leading causes of vision loss and blindness among the working-age population.¹ Its core pathological feature includes edema of the macula, which is responsible for central vision, resulting in symptoms such as decreased visual acuity and distorted vision.² There are 5.7 million patients with clinically significant DME in China.³ The number of diabetic patients in China was estimated to exceed 140 million in 2021.⁴

In August 2025, Santen obtained the rights to develop, manufacture, and commercialize RC28-E, under a license agreement with RemeGen. As a VEGF/FGF bi-specific fusion protein, RC28-E simultaneously inhibits the binding of both VEGF and FGF to their receptors. RC28-E is being clinically developed for the treatment of retinal diseases — DME, wet age-related macular degeneration (wAMD), and diabetic retinopathy (DR). RemeGen expects to submit a BLA in China for the wAMD indication in mid-2026.

References

1. International Council of Ophthalmology. ICD-10 Coding for Diabetic Macular Edema and Diabetic Retinopathy. 2017, p.1.
2. Sivaprasad S, et al. Ophthalmology, 2015, 122(7): 1375-1394.
3. Yingyi LU, et al. Chin J Exp Ophthalmol, 2018, 36(6): 401-403.
4. Sun H, et al. Diabetes Res Clin Pract, 2022, 183:109-119.

About Santen
As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of “Happiness with Vision” by providing products and services to patients, consumers, and medical professionals around the world. Since its establishment, and guided by its CORE PRINCIPLE, “Tenki ni sanyo suru,” Santen has been committed to helping people maintain and improve their eye health for more than 130 years. Santen is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people in more than 60 countries and regions worldwide. Santen’s mission is to provide essential and significant value to patients and society in the prevention, diagnosis, and treatment of eye diseases through products and services created from its expertise in the ophthalmology field and from the patient's perspective. To create a future in which as many patients as possible can lead happy and fulfilling lives, Santen is committed to doing its utmost to realize a society in which people around the world can experience “Happiness with Vision.”
For more information, please visit Santen’s website https://www.santen.com/en.

About RemeGen
RemeGen Co., Ltd. is a leading innovative biopharmaceutical company in China，headquartered in Yantai Economic & Technological Development Zone, China, with R&D centers and subsidiaries in Beijing, Shanghai, and California, USA. The company achieved dual listings on Main Board of The Stock Exchange of Hong Kong Limited (2020) and Shanghai Stock Exchange STAR Market (2022), becoming a dual-listed "A+H" company.
The company focuses on discovering, developing, manufacturing, and commercializing novel biologic drugs with independent intellectual property rights. Focusing on critical therapeutic areas including autoimmune diseases, oncology, and ophthalmology, the company has successfully developed multiple biologic drugs with significant clinical value.

Contact
Corporate Communications
Santen Pharmaceutical Co., Ltd.
E-mail: communication@santen.com   

This press release has been published in Japanese, Simplified Chinese and English languages and in the event of any inconsistency, the English version shall prevail.