China-based RemeGen has filed a new drug application (NDA) with China's Centre for Drug Evaluation (CDE) for VEGF/FGF dual-target fusion protein RC28 in diabetic macular oedema following Phase II data showing visual acuity improvements comparable to conbercept, with potential for extended dosing intervals. The first-in-class biologic simultaneously blocks VEGF and FGF pathways addressing compensatory angiogenesis mechanisms, with structural design incorporating an immunoglobulin G1 fragment for prolonged serum half-life enabling eight-week administration frequency. RemeGen licensed Greater China and Southeast Asian rights to Japan's Santen Pharmaceutical for RMB 1.295 billion (USD 182 million) in August 2025.

Phase II results demonstrated best corrected visual acuity gains of 5.5 to 11.0 letters across dosing regimens at 52 weeks, with central subfield thickness reductions of 136.9 to 163.2 micrometres matching conbercept's 160.7 micrometre improvement. The ongoing Phase III trial compares RC28 against aflibercept in diabetic macular oedema and wet age-related macular degeneration (wAMD), with potential differentiation through dual-action and reduced injection frequency burden for chronic retinal conditions requiring long-term management.

According to PharmCube's NextBiopharm® database, RC28 is also being developed for non-proliferative diabetic retinopathy (NPDR), with all three of the candidate's indications currently in the review stage. Click here to request a free trial for NextBiopharm®.