Innovent Biologics announced that IBI302, a first-in-class dual-target fusion protein drug licensed from AP Biosciences, has completed the first dose administration for a Phase II clinical trial in the treatment of diabetic macular edema (DME), marking a significant milestone in the development of this innovative therapy for retinal diseases.
DME is a leading cause of vision loss in patients with diabetes, with an incidence rate of approximately 35% among diabetic individuals. It is estimated that over 21 million patients globally require treatment. IBI302 is the world’s first bispecific fusion protein that targets both VEGF and the complement pathway. It simultaneously inhibits VEGF-mediated angiogenesis and vascular leakage, as well as inflammation triggered by complement activation. In previous clinical studies for neovascular age-related macular degeneration (nAMD), high-dose IBI302 (8 mg) demonstrated significant improvements in visual acuity and retinal edema, with the added advantage of a potentially extended dosing interval of up to 12–16 weeks, while maintaining a favorable safety and tolerability profile.
IBI302 is currently undergoing a global Phase III trial for nAMD, known as the STAR study. This registrational study, which compares IBI302 with standard-of-care treatments, is expected to pave the way for its global market entry. Professor Sun Xiaodong, Vice President of Shanghai General Hospital affiliated with Shanghai Jiao Tong University School of Medicine and Director of the National Clinical Research Center for Eye Diseases, presented the Phase II results of IBI302 at the ARVO 2025 Annual Meeting this week. He noted that although current anti-VEGF therapies are the first-line standard, their frequent dosing schedule can hinder patient compliance. IBI302, as the world’s first VEGF × complement dual-function molecule, showed notable improvements in visual acuity—by approximately 10 letters—in the high-dose group, with over 80% of patients achieving dosing intervals of at least 12 weeks. Preliminary data also suggest the potential to delay macular atrophy. Further studies are expected to offer longer-lasting and more accessible treatment options for patients with nAMD.
Licensed globally by AP Biosciences to Innovent Biologics for commercial development, IBI302 represents a landmark in international collaboration in ophthalmic innovation. This partnership will provide critical momentum for advancing clinical development, global market deployment, and future out-licensing opportunities. Upon successful commercialization, IBI302 is expected to generate a stable stream of revenue for AP Biosciences.
Resource: 圓祥授權信達雙靶點融合蛋白IBI302，開啟糖尿病黃斑部病變治療新篇章
