RemeGen, a leading Chinese biopharmaceutical company, has entered into an exclusive licensing agreement for the ophthalmic innovative drug RC28-E with Santen China, a wholly-owned subsidiary of Santen Pharmaceutical.   

Under the agreement, Santen China has obtained exclusive rights to develop, manufacture, and commercialise 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 (around USD 35.0 million), development and regulatory milestone payments of up to RMB 520 million (around USD 72.8 million), and sales milestone payments of up to RMB 525 million (around USD 73.5 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. In a Phase II clinical trial, RC28-E significantly improved best-corrected visual acuity (BCVA) and reduced central subfield thickness (CST), and was also well tolerated in patients with diabetic macular edema (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, "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 commercialisation of RC28-E but also reflects international recognition of RemeGen's capabilities in ophthalmic drug development."  

Takeshi Ito, President and CEO of Santen, highlighted that 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 is committed to strengthening cooperation and collaboration with all partners, by global-to-local synergy, to help advance the high-quality development in ophthalmology, uncovering and addressing unmet patient needs, and aiming to realize 'Happiness with Vision 'for all,” he added.