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SIM0500, Simcere Zaiming’s Tri-specific Antibody Candidate for Multiple Myeloma Received FDA Fast Track Designation

Release time:2024-04-11

April 10, 2024. Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group Ltd., announced that the US Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA) have granted Fast Track designation for SIM0500, a tri-specific antibody candidate for treatment of patients with multiple myeloma(MM), who are refractory to, or intolerant of, established therapies known to provide clinical benefit and have received ≥3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 monoclonal antibody.

Fast Track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug intended to facilitate the development and expedite the review of drugs to treat serious or life-threatening condition conditions and fill an unmet medical need.

Multiple Myeloma, ranking as the second most common blood cancer, has seen significant advancements in its prognosis due to the introduction of new therapies. However, a complete cure remains elusive for most patients, making them susceptible to relapses. The complexity of treating MM escalates with each recurrence. Hence, there is a persistent demand for treatments that are more efficacious, safer, and economically accessible for these patients.

SIM0500 is a humanized GPRC5D-BCMA-CD3 tri-specific antibody independently developed through Simcere Zaiming’s T-cell engager polyspecific antibody technology platform. By combining a low affinity/high target activating CD3 antibody, along with 2 tumor-related antibodies(GPRC5D, BCMA), this novel T cell-activating molecule specifically targets MM tumor cells and has an enhanced tumor suppression activity due to the synergistic effects of multiple targets.


Data from preclinical studies has demonstrated a favorable tumor-killing effect at low doses and a and good tolerance profile. In animal models, no tumor recurrence is observed after drug discontinuation. It is potentially a best-in-class candidate that may provide new therapeutic choices to overcome the drug resistance caused by existing treatments of MM.


SIM0500 is being developed both in the US and China. It has received approval both from the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA) to carry out clinical trials in patients with relapsed or refractory multiple myeloma (MM).