Outline:
Strategic Partnership Between RemeGen and Santen China
RemeGen Co., Ltd., a leading biopharmaceutical company in China, has entered into a significant agreement with Santen Pharmaceutical (China) Co., Ltd. This collaboration marks a major step forward for the development and commercialization of RC28-E, a groundbreaking drug for ocular neovascular diseases.
Under the terms of the agreement, Santen China has secured exclusive rights to develop, manufacture, and commercialize RC28-E across several key markets, including Greater China, South Korea, Thailand, Vietnam, Singapore, the Philippines, Indonesia, and Malaysia. Meanwhile, RemeGen will maintain global exclusive rights to RC28-E outside these regions. The financial structure of the deal includes an upfront payment of RMB 250 million, potential development and regulatory milestone payments up to RMB 520 million, and sales milestone payments reaching RMB 525 million. In addition, RemeGen will receive tiered royalties based on net sales within the licensed territories.
Advancements in Ocular Therapy
RC28-E is a VEGF/FGF dual-target fusion protein drug, developed independently by RemeGen. It is designed to address ocular neovascular diseases, which are a significant cause of vision loss. The Phase II clinical trial results for diabetic macular edema (DME) were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting on May 7, 2025. These results demonstrated that RC28-E significantly improved best-corrected visual acuity (BCVA) and reduced central subfield thickness (CST), while also showing good tolerability in patients with DME.
In 2023, RemeGen initiated Phase III clinical trials for RC28-E in both wet age-related macular degeneration (wAMD) and DME. The company plans to submit a Biologics License Application (BLA) for the DME indication in China during the second half of 2025, followed by a BLA for wAMD in mid-2026.
Expert Perspectives on the Collaboration
Dr. Jianmin Fang, CEO of RemeGen, emphasized the strategic value of this partnership. He highlighted Santen’s extensive experience in ophthalmology, spanning over 130 years, and its robust global sales network covering more than 60 countries. Dr. Fang noted that RC28-E is a Class 1 proprietary drug nearing the critical stage of BLA submission. He believes that this collaboration will combine the strengths of both companies to maximize the potential of RC28-E, offering innovative solutions for retinal diseases. This partnership not only lays the groundwork for future commercialization but also reflects international recognition of RemeGen’s capabilities in ophthalmic drug development.
Takeshi Ito, President & CEO of Santen, expressed confidence in RemeGen’s capabilities and innovation in novel drug development. He pointed out that RC28-E offers differentiated advantages by targeting both angiogenesis and fibrosis, potentially providing a new therapeutic approach for fundus diseases. Santen is committed to strengthening collaborations with partners globally, aiming to advance high-quality development in ophthalmology and address unmet patient needs, ultimately working towards achieving “Happiness with Vision” for all.
Looking Ahead
This partnership between RemeGen and Santen represents a significant milestone in the field of ophthalmology. With RC28-E poised for regulatory submissions, the collaboration is expected to drive innovation and improve treatment options for patients suffering from ocular neovascular diseases. As both companies move forward, their combined efforts could lead to transformative advancements in eye care, benefiting patients across multiple regions.