Simcere Pharmaceutical Group Limited announced that, on March 12, 2024, SIM0500 for injection, a humanized GPRC5D-BCMA-CD3 trispecific antibody, which is a new investigational anti-tumor drug independently developed by the Group, has obtained the Clinical Trial Approval issued by the National Medical Products Administration of China, which is intended to be investigated in a clinical trial for relapsed or refractory multiple myeloma. SIM0500 is a humanized GPRC5D-BCMA-CD3 trispecific antibody, which is a potential best-in-class (BIC) drug for the treatment of multiple myeloma based on the preclinical data. Through the research and development platform of multispecific antibody drugs with the Group's own T-cell engagers, SIM0500 is a tumor-targeted T-cell activating drug, composed with the Group's self-developed CD3 antibody with the feature activated by low affinity and high target activation and the antibody with anti-tumor associated antigen.

It has the advantages of excellent tumor-killing effect and good tolerance. SIM0500 can potentially overcome the drug resistance caused by the existing treatments, and show excellent anti-tumor activity in various animal pharmacodynamic models with different expression levels and has multiple advantages such as low effective dose and no recurrence of tumors after drug withdrawal. On March 9, 2024, the Investigational New Drug (IND) application of SIM0500 has been approved by the U.S. Food and Drug Administration (FDA).