ZhiXiang GeneTech's BCMA/CD3 Bispecific Antibody GR1803 Nominated for Priority Review in China

▎Armstrong

On December 29, 2025, GENRIX BIO's BCMA/CD3 bispecific antibody is proposed for priority review for the treatment of patients with relapsed or refractory multiple myeloma who have previously received at least three lines of therapy (including a proteasome inhibitor, an immunomodulatory agent, and a CD38 antibody).

GR1803 is the core pipeline of GENRIX BIO in the oncology field.

GR1803 was included in the breakthrough therapy category in August 2024, and this time it is proposed to be included in the priority review. In September this year, GENRIX BIO's GR1803 IND for the treatment of systemic lupus erythematosus was approved, expanding into the autoimmune field. Additionally, in June 2025,Cullinan Therapeutics Announces Global Rights Outside Greater China for GR1803 in Treating Autoimmune DiseasesCullinan Therapeutics paid $20 million upfront, $390 million in R&D and regulatory milestones, $400 million in sales milestones, along with mid-single-digit to mid-double-digit sales royalties.

In June 2024, the phase I clinical data of GR1803 for the treatment of multiple myeloma was presented at the EHA conference. The ORR in 40 evaluable patients was 85%. Among them, 23 patients in the 180ug/kg dose group were evaluable for efficacy, with an ORR of 96%, VGPR and above at 43%, and CR and above at 13%.

Summary

Johnson & Johnson's Tecvayli is the world's first BCMA/CD3 bispecific antibody, with sales of $494 million in the first three quarters of 2025, and the full-year forecast is expected to approach $700 million, still in a rapid growth phase.