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The Phase 3 Registration STAR Study of Efdamrofusp Alfa (IBI302) Met its Primary Endpoint, Making it the First Self-developed Extended-interval Treatment for nAMD in China
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announces that the Phase 3 clinical study (STAR) of efdamrofusp alfa injection (recombinant human vascular endothelial growth factor receptor [VEGFR]/human complement receptor 1 [CR1] fusion protein, R&D code: IBI302) in the Chinese patients with neovascular a
About this update from Innovent Biologics, Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"73% of participants achieved Q16W dosing interval; Furthermore, nearly 60% of the participants held the potential to extend the dosing interval to Q20W.","length":152,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":152,"olType":false},{"type":"text","content":"SAN FRANCISCO and SUZHOU, China, March 23, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announces that the Phase 3 clinical study (STAR) of efdamrofusp alfa injection (recombinant human vascular endothelial growth factor receptor [VEGFR]/human complement receptor 1 [CR1] fusion protein, R&D code: IBI302) in the Chinese patients with neovascular age-related macular degeneration (nAMD) has met the 52-week primary endpoint. Efdamrofusp alfa demonstrated non-inferiority to aflibercept in vision improvement, while also showing the clinical advantage of extended 16-week dosing intervals and the potential to reduce the risk of macular atrophy (MA).","length":879,"tagName":"p"},{"type":"text","content":"STAR (NCT05972473) is a Phase 3 clinical study evaluating the efficacy and safety of IB302 8 mg in Chinese participants with nAMD. A total of 600 participants were randomized in a 1:1 ratio to the IBI302 8 mg group and the aflibercept 2 mg group. Both groups received 3 loading doses administered every 4 weeks. After the completion of the loading doses, participants in the IBI302 8 mg group were administered at Q16W, Q12W, or Q8W intervals based on the disease activity assessment at Weeks 16 and 20. Participants in the aflibercept 2 mg group completed the subsequent treatment at Q8W intervals. The study lasts for 100 weeks, and the primary endpoint is the change from baseline in the best corrected visual acuity (BCVA) of the study eye at Week 52. The randomization stratification factors in this study were: the presence or absence of Type 2 choroidal neovascularization (CNV) on optical coherence tomography (OCT) in the study eye, and whether the study eye had previously received anti-VEGF treatment.","length":1012,"tagName":"p"},{"type":"text","content":"The study enrolled 600 participants (including 65% treatmen...