Innovent's IBI302 Hits Phase 3 Goal, Pioneering Extended nAMD Care in China

Innovent Biologics has announced that its Phase 3 registration study, STAR, for efdamrofusp alfa (IBI302) has successfully met its primary endpoint. This achievement is a landmark for the Chinese biotechnology sector, as IBI302 becomes the first self-developed, extended-interval therapy for neovascular age-related macular degeneration (nAMD) to reach this stage. The success of the STAR study validates a novel therapeutic approach that could significantly alter the treatment landscape for one of the leading causes of vision loss in the elderly, particularly within the rapidly aging Chinese demographic.

Unlike traditional anti-VEGF monotherapies such as aflibercept or ranibizumab, IBI302 is a first-in-class bispecific fusion protein. It simultaneously targets vascular endothelial growth factor (VEGF) and the complement system (C3b and C4b). This dual-action mechanism is designed not only to inhibit the abnormal blood vessel growth and leakage characteristic of nAMD but also to address the underlying inflammatory processes and complement activation that contribute to geographic atrophy and subretinal fibrosis—areas where current standards of care often fall short. By tackling two distinct pathways of retinal disease, IBI302 offers a more comprehensive biological intervention than existing single-target therapies.

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Innovent Biologics has announced that its Phase 3 registration study, STAR, for efdamrofusp alfa (IBI302) has successfully met its primary endpoint.

The "extended-interval" nature of IBI302 is its most significant commercial and clinical differentiator. Current treatments often require monthly or bimonthly intravitreal injections, which place a heavy burden on patients, caregivers, and healthcare systems. By extending the dosing interval, IBI302 aims to maintain visual acuity with fewer injections, potentially improving long-term adherence and real-world outcomes. In the STAR study, IBI302 demonstrated non-inferiority in visual acuity gains compared to the standard-of-care aflibercept, while offering a more flexible and less frequent dosing schedule that aligns with modern "treat-and-extend" protocols.