Innovent Biologics has  announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to IBI3003, its investigational anti-GPRC5D/BCMA/CD3 tri-specific antibody, for the treatment of Relapsed or Refractory Multiple Myeloma (R/R MM).

The designation applies to patients who have received four or more prior lines of anti-myeloma therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Fast Track Designation is intended to accelerate the development and regulatory review of therapies addressing serious conditions with unmet medical needs.

IBI3003 was discovered using Innovent’s proprietary Sanbody platform and is being advanced through a global clinical development programme. The therapy is currently being evaluated in a Phase I/II clinical trial in China and Australia, with plans to initiate a Phase I/II study in the United States in the near term.

Clinical data presented at the American Society of Hematology (ASH) Annual Meeting in December 2025 demonstrated a favorable safety profile and encouraging efficacy signals. Among 39 evaluable patients with heavily pretreated R/R MM, doses ranging from 0.1 μg/kg to 800 μg/kg showed meaningful anti-tumor activity. In patients treated at doses of 120 μg/kg or higher, the overall response rate reached 83.3 percent, including stringent complete responses, very good partial responses and partial responses.

Notably, robust responses were observed in high-risk subgroups, including patients with extramedullary disease and those previously treated with BCMA- and/or GPRC5D-targeted therapies. Minimal residual disease negativity was achieved in all patients who reached complete response or better.

Safety data showed that cytokine release syndrome was limited to Grade 1–2 events, with only two cases of low-grade neurotoxicity reported. Most treatment-related adverse events were mild to moderate, supporting the continued clinical development of IBI3003.