Simcere and its subsidiary Xianxiang have initiated the phase 1 study ( NCT06375044 ) of SIM0500, an anti-GPRC5D×BCMA×CD3 tri-specific antibody in China. The first-in-human trial is estimated to enroll 130 patients to evaluate the safety, tolerability, efficacy, and pharmacokinetics of SIM0500. SIM0500 The US FDA has recently approved several anti- GPRC5D ×CD3 and anti-BCMA×CD3 bispecific antibodies for patients with multiple myeloma (MM). Up to now, no tri-specific antibody has been approved for MM. Previously, we reported the submission of the IND application for the phase 1 trial of SIM0500. The preclinical study showed the binding and efficacy data compared to teclistamab ( 特立妥单抗, JNJ 7957) and talquetamab (塔奎妥单抗, JNJ 7564). Preclinical results of SIM0500 The phase 1 study for SIM0500 is focused on patients with refractory or relapsed multiple myeloma (rrMM) who have not responded to conventional standard-of-care treatments. Since no anti- GPRC5D ×CD3 and anti-BCMA×CD3 bispe
China Biotech XYZ Shares Updates Related to New Drug Development in China