RemeGen Strikes $180M Deal with Santen for Novel Eye Disease Drug

RemeGen, a Chinese biopharmaceutical company, has entered into a significant licensing agreement with Japan's Santen Pharmaceutical for its innovative eye disease drug, RC28-E. The deal, valued at up to $180 million, marks a major milestone in the development and commercialization of this dual-target fusion protein designed to treat ocular neovascular diseases.

Deal Structure and Financial Terms

The agreement grants Santen's China subsidiary the rights to develop and commercialize RC28-E in greater China, South Korea, and several Southeast Asian countries. The financial terms of the deal include:

• An upfront payment of 250 million Chinese yuan ($34.8 million)
• Potential development and regulatory milestones totaling 520 million yuan ($72.4 million)
• Sales milestones of up to 525 million yuan ($73 million)
• Tiered royalties on sales in the licensed territories

This structured deal not only provides immediate capital for RemeGen but also aligns both companies' interests in the successful development and commercialization of RC28-E.

RC28-E: A Novel Approach to Eye Disease Treatment

RC28-E represents a potentially groundbreaking approach to treating ocular neovascular diseases. Unlike current market leaders that primarily target vascular endothelial growth factor (VEGF), such as Roche's Lucentis and Vabysmo or Regeneron and Bayer's Eylea, RC28-E is designed to work on both VEGF and fibroblast growth factors (FGFs).

The drug has shown promising results in clinical trials:

• Currently in phase 3 studies for diabetic macular edema (DME) and wet age-related macular degeneration (wAMD)
• Phase 2 study in DME demonstrated improved vision and reduced retinal thickness

Santen CEO Takeshi Ito highlighted the drug's potential, stating 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."

Regulatory Timeline and Market Implications

RemeGen has outlined an ambitious regulatory timeline for RC28-E:

• Submission of a China approval application for DME indication later in 2025
• Planned submission for wAMD indication around mid-2026

This partnership with Santen, a well-established player in vision care, is expected to accelerate the commercialization process in key Asian markets. RemeGen CEO Jianmin Fang, Ph.D., emphasized that the deal "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."

As the global market for eye disease treatments continues to grow, this collaboration between RemeGen and Santen could potentially reshape the competitive landscape, offering patients a new option that addresses multiple pathways involved in ocular neovascular diseases.