Santen Announces New Licensing Agreement with RemeGen for RC28-E Intravitreal Injection, an Anti-VEGF/FGF Dual-Target Fusion Protein

August 19, 2025, - Osaka, Japan - Santen Pharmaceutical Co., Ltd. (hereinafter Santen), a global pharmaceutical company committed to eye health announced that it has entered into a license agreement through its local subsidiary Santen Pharmaceutical (China) Co. Ltd., with RemeGen Co., Ltd. (hereinafter RemeGen), a Chinese biopharmaceutical company dedicated to R&D and commercialization of innovative drugs. Under the agreement, RemeGen has granted Santen a paid license for its proprietary RC28-E intravitreal injection. Santen has obtained exclusive rights to develop, manufacture, and commercialize RC28-E within the following business territories: Mainland China, Taiwan, Hong Kong, Macau, South Korea, Thailand, Vietnam, Singapore, the Philippines, Indonesia, and Malaysia.

RC28-E intravitreal injection is a bi-specific fusion protein drug targeting vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF). It is being clinically developed for the treatment of retinal diseases — wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR). This collaboration between Santen and RemeGen is expected to significantly accelerate patient access of this new innovative molecule.

There are 5.7 million patients with clinically significant DME¹, and 3.81 million patients with wAMD² in China. Moreover, the number of diabetic patients in China was estimated to exceed 140 million in 2021³.

On May 7, 2025, results from a Phase II clinical trial of RC28-E for the treatment of DME were presented as an oral report at the 2025 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO 2025). The study demonstrated that RC28-E significantly improved best-corrected visual acuity (BCVA) and reduced central subfield thickness (CST), and was also well tolerated in patients with DME.

In 2023, RemeGen initiated Phase III clinical trials of RC28-E for the treatment of wAMD and DME. RemeGen expects to submit a Biologic License Application (BLA) in China for the DME indication in the second half of 2025, followed by an BLA for the wAMD indication in mid-2026.

Takeshi Ito, President & CEO of Santen, commented: “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. Looking ahead, Santen are committed to strengthening cooperation and collaboration with all partners, by global-to-local synergy, to help advancing the high-quality development in ophthalmology, uncovering and addressing unmet patient needs, and aiming to realize ‘Happiness with Vision’ for all.”

Dr. Fang Jianmin, CEO of RemeGen, 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 Category 1* innovative drug, RC28-E is approaching the critical stage of BLA submission. We are confident that the full integration of the strengths of RemeGen and Santen will maximize the potential of RC28-E to deliver innovative and highly effective solutions for retinal disease treatment. This agreement not only lays a solid foundation for the future commercialization of RC28-E but also fully demonstrates the high recognition from an internationally-renowned ophthalmic company of RemeGen’s capabilities in ophthalmic drug R&D. We look forward to jointly advancing this breakthrough with Santen to open a new chapter in eye care.”

Under the terms of the agreement, RemeGen will receive upfront payment of RMB 250 million, development and regulatory milestone payments of up to RMB 520 million, and sales milestone payments of up to RMB 525 million, along with additional royalties based on net sales in the licensed territories.

References

1. Yingyi LU et al. Chinese Journal of Experimental Ophthalmology, 2018; 36(6): 401-403.
2. Song P et al. J Glob Health. 2017 Dec;7(2):020703.
3. Sun H et al. Diabetes Res Clin Pract. 2022; 183:109119.

• Category 1 refers to innovative biologic products, meaning therapeutic biologic products that have not been marketed either in China or overseas, according to the Requirements for Registration Classification and Application Dossiers of Biologic Products issued by China’s National Medical Products Administration.

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.