RemeGen and Santen Strike $1.3 Billion Licensing Deal for Dual-Target Ophthalmic Drug RC28-E
核心洞察
RemeGen has entered into an exclusive licensing agreement with Santen Pharmaceutical for RC28-E, a VEGF (搜索)/FGF (搜索) dual-target fusion protein drug for ocular neovascular diseases (搜索), with potential payments totaling up to RMB 1.295 billion ($180 million USD).
RC28-E demonstrated significant improvements in visual acuity and reduced central subfield thickness in Phase II trials for diabetic macular edema (搜索), with Phase III trials currently underway for both DME and wet age-related macular degeneration (搜索).
The agreement grants Santen exclusive rights to develop and commercialize RC28-E in Greater China and eight Asian countries, while RemeGen retains global rights outside these territories.
Chinese biopharmaceutical company RemeGen Co., Ltd. has secured a major licensing partnership with Santen Pharmaceutical for its innovative ophthalmic drug RC28-E, with the deal potentially worth up to RMB 1.295 billion (approximately $180 million USD) in total payments. The agreement positions RC28-E, a dual-target fusion protein drug for ocular neovascular diseases (搜索), for broad commercialization across Asia's largest markets.
Strategic Partnership Details
Under the exclusive licensing agreement announced in August 2025, Santen China has obtained 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.
The financial structure includes an 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. Additionally, RemeGen will receive tiered royalties based on net sales of the product in the licensed territories.
Dual-Target Mechanism Shows Promise
RC28-E is a VEGF (搜索)/FGF (搜索) dual-target fusion protein drug independently developed by RemeGen for ocular neovascular diseases (搜索). The drug's differentiated approach simultaneously targets angiogenesis and fibrosis, potentially providing a new therapeutic option for fundus diseases.
Phase II clinical trial results for diabetic macular edema (搜索) (DME) were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting on May 7, 2025. The study demonstrated that RC28-E significantly improved best-corrected visual acuity (BCVA) and reduced central subfield thickness (CST), while showing good tolerability in patients with DME.
Advanced Clinical Development Timeline
RemeGen initiated Phase III clinical trials for RC28-E in both wet age-related macular degeneration (搜索) (wAMD) and DME in 2023. The company has outlined an aggressive regulatory timeline, planning 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.
Leadership Perspectives
Dr. Jianmin Fang, CEO of RemeGen, emphasized the strategic value of the partnership: "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."
Takeshi Ito, President & CEO of Santen, highlighted the drug's potential: "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."
Company Backgrounds
RemeGen is a leading innovative biopharmaceutical company 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 the Hong Kong Stock Exchange (2020) and Shanghai Stock Exchange STAR Market (2022). In 2021, RemeGen received marketing approval for two first-in-class drugs: Telitacicept for autoimmune diseases and Disitamab Vedotin for various cancers, with a total of six approved indications.
Santen Pharmaceutical, established over 130 years ago, specializes in eye health and supports approximately 50 million people in more than 60 countries and regions worldwide. The company is engaged in global research and development, manufacturing, and sales of pharmaceutical products in the field of eye care.