By Fineline Cube 
China‑based RemeGen Co., Ltd. (SHA: 688331, HKG: 9995) and Japan’s Santen Pharmaceutical Co., Ltd. confirmed that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for RC28‑E, RemeGen’s proprietary VEGF/FGF dual‑target fusion protein intended to treat patients with diabetic macular edema (DME).
What is RC28‑E?
RC28‑E is a next‑generation ocular therapy engineered to simultaneously inhibit vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF) binding to their receptors. By blocking both pathways, the drug is expected to deliver synergistic benefits across anti‑inflammatory, anti‑fibrotic, and anti‑neovascularization mechanisms—key drivers of DME progression.
Licensing Milestone
In August 2025, RemeGen granted Santen exclusive rights to RC28‑E throughout Greater China and Asia for USD 1.3 billion. This partnership positions Santen, a leading ophthalmology player, to accelerate development, regulatory review, and commercialization of the dual‑target therapy in the region.
Regulatory and Commercial Implications
- CDE Acceptance removes a critical regulatory hurdle, paving the way for phase‑III clinical trials and eventual market approval in China.
- The dual‑target mechanism may differentiate RC28‑E from existing single‑pathway agents, potentially improving patient outcomes and expanding the treatment landscape for DME.
- If successful, the drug could command a premium pricing tier, benefiting both RemeGen and Santen through increased market share and revenue streams.
Next Steps
- RemeGen and Santen will coordinate clinical trial design, manufacturing scale‑up, and post‑marketing surveillance.
- A joint effort will seek NMPA approval in the near term, followed by international regulatory submissions (e.g., EMA, FDA) to broaden global access.-Fineline Info & Tech