RemeGen Co., a leading Chinese biopharmaceutical company, announced that it has entered into an agreement with Santen Pharmaceutical (China) Co., Ltd. ("Santen China"), a wholly-owned subsidiary of Santen Pharmaceutical Co., Ltd. ("Santen"). Under the agreement, Santen China has obtained exclusive rights to develop, manufacture, and commercialize RC28-E in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan) as well as in South Korea, Thailand, Vietnam, Singapore, the Philippines, Indonesia, and Malaysia. RemeGen will retain global exclusive rights to RC28-E outside these regions. 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. In addition, RemeGen will be entitled to tiered royalties based on net sales of the product in the licensed territories.

RC28-E is a VEGF/FGF dual-target fusion protein drug for ocular neovascular diseases, independently developed by RemeGen. On May 7, 2025, the Phase II clinical trial results of RC28-E for diabetic macular edema (DME) were presented as an oral report at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting. 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 for RC28-E in wet age-related macular degeneration (wAMD) and DME. RemeGen plans to submit a Biologics License Application (BLA) for the DME indication in China in the second half of 2025, followed by a BLA for wAMD in mid 2026.

Dr. Jianmin Fang, CEO of RemeGen, stated: "Santen brings over 130 years of expertise in ophthalmology and a robust global sales network spanning 60+ countries and regions. RC28-E, a Class 1 proprietary drug developed by RemeGen, is approaching the critical stage of BLA submission. We believe this collaboration will fully leverage the strengths of both parties to maximize the potential of RC28-E, providing innovative and effective solutions for retinal diseases. This partnership 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. We look forward to jointly advancing this breakthrough therapy with Santen to open a new chapter in eye care."

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."