Innovent Biologics, Inc. , a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, announced that its anti-GPRC5D/BCMA/CD3 tri-specific antibody IBI3003 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). This designation applies to the treatment of relapsed or refractory multiple myeloma, (R/R MM) in patients who have received four or more lines of previous anti-myeloma therapies, that include at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody.

IBI3003 was discovered and developed using Innovent's proprietary Sanbody® platform and its development is being advanced globally. IBI3003 is currently undergoing a Phase 1/2 clinical trial in patients with relapsed or refractory multiple myeloma in China and Australia, and there are plans to initiate a Phase 1/2 clinical trial in the United States imminently.

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 (TEAEs) related to GPRC5D targeting, including those affecting the oral cavity, skin, and nails, were Grade 1–2, with two patients experiencing Grade 3 rash.

Dr. Hui Zhou, Chief R&D Officer of Oncology in Innovent, stated, "IBI3003 monotherapy has demonstrated encouraging efficacy and a favorable safety profile in R/R MM patients who had received three or more prior lines of therapy. Notably, meaningful clinical activity was observed even in high-risk patients with EMD or those previously treated with anti-BCMA and/or GPRC5D-targeted therapies, highlighting IBI3003's potential to address key unmet needs. Its overall manageable safety profile further supports continued investigation and the potential for durable survival benefit. The Fast Track Designation granted by the U.S. FDA represents an important milestone in the global development of IBI3003, and we look forward to further evaluating its potential to benefit patients worldwide."

Fast Track Designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs. Programs granted FTD benefit from more frequent interactions with the FDA, which may accelerate clinical development and regulatory review.