Roche's GPRC5D×CD3 Bispecific Antibody Forimtamig Granted IND Approval in China for Relapsed/Refractory Multiple Myeloma

Recently, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Roche (RHHBY.US) has obtained clinical trial tacit approval for its Class 1 new drug Forimtamig, intended for the development of treatment for multiple myeloma. Public information shows that Forimtamig (RG6234) is a bispecific antibody that can simultaneously target GPRC5D and CD3, and is currently undergoing Phase 1 clinical trials overseas for the treatment of multiple myeloma.

Previously, forimtamig has demonstrated favorable efficacy and manageable safety in a Phase 1 clinical trial for heavily pretreated patients with relapsed/refractory multiple myeloma. The overall response rate (ORR) of this product as monotherapy reached 71.4%, with 52.4% of patients achieving very good partial response. The study data were presented at the 2022 European Hematology Association (EHA) Congress.

Editor: Guo Mingyu