Policy & Regulation
Simcere Zaiming reports first patient dosed in SIM0500 US Phase 1 trial in patients with relapsed/refractory multiple myeloma
19 June 2025 -

Simcere Zaiming, China-based Simcere Pharmaceutical Group's (2096.HK) oncology-focused subsidiary, announced on Wednesday that the first US patient has started treatment in the ongoing Phase 1 trial at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, evaluating safety, tolerability, pharmacokinetics and preliminary efficacy of SIM0500 in patients with relapsed/refractory multiple myeloma (RRMM).

SIM0500 (formerly SCR-8572) is a humanised trispecific antibody targeting GPRC5D, BCMA and CD3, developed using Simcere Zaiming's proprietary T-cell engager polyspecific antibody platform.

"In the last few years, BCMA and GPRC5D-targeted therapies have demonstrated significant promise in treating RRMM and have been anticipated as the cornerstones of the next chapter in the pursuit of curing myeloma. SIM0500 is the natural evolution of combining these targets with the aim to optimise outcomes in the RRMM," said Dr. Joshua Richter, M.D., associate professor of Medicine at the Icahn School of Medicine at Mount Sinai, director of Multiple Myeloma at the Blavatnik Family Chelsea Medical Center at Mount Sinai, and principal investigator.

SIM0500 is being developed in partnership with AbbVie (NYSE:ABBV).

The company says that SIM0500 stands as a potentially best-in-class candidate, poised to offer novel therapeutic options for solving drug resistance encountered in existing multiple myeloma treatments. The FDA awarded SIM0500 Fast Track designation in April 2024. In January 2025, Simcere Zaiming entered into an agreement with AbbVie granting AbbVie an option to license SIM0500.

SIM0500 is currently being investigated in a Phase 1 clinical trial both in US and in China. The company says that preliminary data suggested a good safety profile, desired pharmacokinetic profile of SIM0500 with encouraging efficacy.

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