Technology

Age-Related Macular Degeneration (nAMD), Diabetic macular edema (DME)

IBI302 is a first-in-class therapeutic protein for the treatment of neovascular age-related macular degeneration (nAMD). This dual-function recombinant protein is designed to simultaneously target two key pathological mechanisms in nAMD. It effectively neutralizes VEGF activity, thereby blocking angiogenesis, and also inhibits complement activation by targeting C3b and C4b components. Through this combined action, IBI302 aims to reduce inflammatory responses and provide a comprehensive approach to controlling and treating nAMD, addressing both vascular and immune pathways in disease progression.

1. The global development rights for IBI302 have been licensed to Innovent Biologics INC (1801.HK). AP Biosciences retains the rights to future development milestones, third-party licensing fees, and royalties on product sales.
2. The Phase III clinical trial (STAR study) for wAMD successfully met its primary endpoint in March 2026. Separately, patient enrollment for a Phase II trial (800 subjects) evaluating supplementary efficacy and safety was announced in November 2025.A New Drug Application (NDA) submission in China is currently under preparation.
3. The Phase II clinical trial for DME achieved its first patient dosing in April 2025.

Complement activation-related chronic inflammatory responses are a key mechanism in the early pathogenesis of AMD. They play a central role in regulating the high expression of VEGF in retinal pigment epithelial cells (RPE), promoting epithelial-mesenchymal transition in RPE, and triggering photoreceptor cell death. The development of complement antagonists has become a focal point in the international field of drug development.

IBI302, which targets both VEGF and complement activation, is a fully human recombinant protein developed in the early stages by APBio. It has been exclusively licensed to Innovent Biologics INC for further development at the preclinical stage. IBI302 is currently the only clinical trial drug that simultaneously addresses VEGF inhibition and complement activation. It is expected to provide superior therapeutic efficacy, making it an innovative First-in-Class drug.

Age-related macular degeneration (AMD) is one of the leading causes of blindness in individuals over 50, with prevalence rising sharply with age. In many developed countries, the incidence in people over 80 can exceed 30%. Clinically, AMD is categorized into dry and wet forms. Although 80–90% of cases are dry AMD, wet AMD accounts for around 90% of severe central vision loss, making it a major focus of global drug development. According to GlobalData, the global AMD therapeutics market is expected to exceed US$18 billion by 2028, with a CAGR of 6.9%. Meanwhile, diabetic macular edema (DME), another major retinal disease has grown rapidly due to increasing diabetes prevalence. The global DME market was estimated at US$5–6 billion in 2023 and is projected to surpass US$9 billion by 2030, with a CAGR of 7–8%. Positioned within these two high-growth and unmet-need retinal markets, IBI302, through its innovative mechanism and differentiated design, holds strong potential to become a First-in-Class therapy and compete in these large global therapeutic segments.