Sanofi's First-in-Class Anti-Tumor New Drug SAR446523 Receives First Clinical Approval in China for Relapsed/Refractory Multiple Myeloma

On October 22, the CDE website showed that Sanofi's injectable SAR446523 was approved for clinical trials in China for the first time, with the indication for treating relapsed/refractory multiple myeloma.（R/R MM）Patient. SAR446523 isThe world's first GPRC5D monoclonal antibody to enter clinical stage。

Screenshot source: CDE official website

SAR446523 is an investigational monoclonal antibody based on IgG1 developed by Sanofi, targeting GPRC5D.(G protein-coupled receptor family C group 5 member D),And includes an engineered crystallizable fragment domain to enhance antibody-dependent cell-mediated cytotoxicity. (ADCC)。

In July this year, the US FDA granted SAR446523 orphan drug designation for the treatment of multiple myeloma. Overseas, Sanofi is conducting a Phase I clinical trial.（NCT06630806）To evaluate the safety, anti-tumor activity, pharmacokinetics, and pharmacodynamics of subcutaneous injection of SAR446523 in patients with relapsed/refractory multiple myeloma.

GPRC5D is highly expressed in plasma cells of multiple myeloma patients, while its expression is low in healthy tissues, making it a potential therapeutic target for MM.

Insight database shows that nationwideNo GPRC5D-targeted drug has been approved globally, with a total of 37 GPRC5D pipelines currently under research.(Active status only), including categories such as CAR-T, bispecific antibodies, trispecific antibodies, and monoclonal antibodies. Among these, in the GPRC5D monoclonal antibody field, there are three pipelines under research, with Sanofi's SAR446523 being the first and currently the only GPRC5D monoclonal antibody to enter the clinical stage.