Post by HK Business Wire

Innovent Biologics Announces First Patient Dosed in a Phase 3 Clinical Trial of IBI3003(GPRC5D/BCMA/CD3 Tri-specific Antibody) for the Treatment of Multiple Myeloma SAN FRANCISCO and SUZHOU, China, June 22, 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 oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the first patient has been dosed in the Chinese pivotal Phase 3 clinical trial (TriadicMM-1) of its self-developed innovative anti-GPRC5D, BCMA and CD3 tri-specific antibody IBI3003 for the second to fifth-line treatment of patients with relapsed or refractory multiple myeloma (R/R MM). IBI3003 is China's first self-developed anti-GPRC5D/BCMA/CD3 tri-specific antibody to enter the pivotal registrational Phase III clinical trial, aiming to bring a promising next-generation immunotherapy option for Chinese R/R MM patients. TriadicMM-1 (NCT07623798) is a multicenter, randomized, controlled, open-label Phase 3 clinical trial designed to evaluate the efficacy and safety of IBI3003 versus investigator's choice of regimen (pomalidomide, bortezomib and dexamethasone [PVd] or daratumumab, pomalidomide and dexamethasone [DPd]). The primary endpoint of the study is progression-free survival (PFS) assessed by the Independent Review Committee (IRC). Clinical data presented at the American Society of Hematology (ASH) Annual Meeting on December 7, 2025 [Link], demonstrated a tolerable safety profile and promising efficacy signals for IBI3003 in patients who had failed ≥2 prior lines of myeloma therapy: Thirty-nine patients with R/R MM who had previously received at least a PI, an IMiD, and an anti-CD38 monoclonal antibody were treated with IBI3003 at dose levels ranging from 0.1 μg/kg to 800 μg/kg and underwent at least one tumor assessment after baseline. As of the data cutoff date of November 7, 2025, the median follow-up duration was 3.25 months (range: 0.4–7.4), and the median treatment duration was 12.14 weeks (range: 1.0–33.0). Among patients treated at doses ≥120 μg/kg (n=24), the overall response rate (ORR) was 83.3%, including 4 stringent complete responses (sCR), 7 very good partial responses (VGPR), and 9 partial responses (PR). In this cohort, the ORR was 80% among 10 patients with extramedullary disease (EMD) and 77.8% among 9 patients previously treated with BCMA- and/or GPRC5D-directed therapies. Among patients who achieved complete response or better, the minimal residual disease (MRD) negativity rate was 100% (n=4), as assessed by validated next-generation sequencing, with a threshold of 10-5, performed at a central laboratory. All cases of cytokine release syndrome (CRS) were Grade 1-2, with only 2 cases of Grade 1-2 immune effector cell-associated neurotoxicity syndrome (ICANS) reported. Most treatment-emergent adverse events (...