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Technology

IBI302

Indication

Neovascular Age-Related Macular Degeneration (nAMD)

Mechanism of Action

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.

Status

  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 product sales sharing.
  2. A Phase III clinical trial of IBI302 is currently underway in China.

Strength

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.

Market

AMD is a progressive disease that affects the central vision of the macula in eyes. It is one of the leading causes of blindness in adults over the age of 50, and its incidence increases with age. In developed countries or regions, the prevalence of AMD can exceed 30% in individuals over the age of 80. AMD can be clinically and pathologically categorized into two main types: dry AMD and wet AMD, with dry AMD accounting for approximately 80-90% of cases. Among patients with severe central vision impairment, wet AMD constitutes approximately 90%, making the development of drugs to slow down or treat wet AMD a major focus in this field.

According to a recent study by Grand View Research, Inc., the global age-related macular degeneration market is projected to reach $17.99 billion by 2030. It is expected to experience a compound annual growth rate (CAGR) of 6.9% from 2022 to 2030. With its innovative mechanism of action, IBI302 has the potential to become a First-in-Class innovative drug in this field and secure a prominent position in the competitive treatment market.

Development Progress

Conducted Phase III clinical trials in China by the authorized entity, Innovent Biologics.

  • Candidate
  • Target/Mechanism
  • Indication
  • Discovery
    Pre-Clinical
    Phase I
    Phase II
    Phase III
  • Partner
IBI302
Inhibit complement activation and angiogenesis
Elderly (wet) macular degeneration (nAMD) patients
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