First Patient Dosed with SIM0500 in US Trial for Multiple Myeloma Combat

First Patient Dosed with SIM0500 in the US



On June 18, 2025, Simcere Zaiming, a promising subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that the first patient has begun treatment in a Phase 1 clinical trial for SIM0500 in the United States. This trial, identified as SIM0500-101 and registered under NCT06375044, is taking place at The Tisch Cancer Institute, part of the Icahn School of Medicine at Mount Sinai. The primary objective of this trial is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of SIM0500 in patients suffering from relapsed or refractory multiple myeloma (RRMM).

What is SIM0500?


SIM0500, previously known as SCR-8572, is an innovative humanized trispecific antibody designed to target GPRC5D, BCMA, and CD3. Its development leverages Simcere Zaiming's exclusive T-cell engager polyspecific antibody platform. Recent advancements in therapies targeting BCMA and GPRC5D have shown significant potential in the treatment of RRMM, sparking anticipation that SIM0500 could represent the next pivotal progression in myeloma treatment.

Dr. Joshua Richter, an Associate Professor of Medicine at the Icahn School of Medicine, and the Principal Investigator for the study, emphasized, "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." He believes that SIM0500 is a logical evolution of these therapy targets, striving to enhance clinical outcomes for RRMM patients.

Supporting this claim, Dr. Shaji Kumar remarked, "SIM0500 is designed to bind to two tumor antigens, GPRC5D and BCMA. It has shown strong T-cell cytotoxicity against multiple myeloma cells in preclinical studies. I look forward to participating in the Phase 1 study of SIM0500 to evaluate the safety and efficacy of this potentially transformative therapy in patients with RRMM."

Progress in Clinical Trials


Simcere Zaiming has expressed satisfaction with the safety and preliminary efficacy results generated during the ongoing dose escalation studies. The expansion of the SIM0500 Phase 1 trial into the U.S. marks a significant milestone in the company's commitment to advancing oncology treatments for RRMM. “This marks an important step forward in Simcere Zaiming's continued commitment to advance new oncology treatments and elevate the standard of care for patients with RRMM,” said Dr. Yongyu Wang, Chief Medical Officer of Simcere Zaiming.

This novel therapy is being developed in collaboration with AbbVie, further underscoring the seriousness of this initiative in the pharmaceutical landscape.

The Significance of SIM0500


SIM0500 is making headlines as a potentially best-in-class candidate due to its prospects of addressing drug resistance challenges found in existing multiple myeloma treatments. The FDA has awarded this investigational agent a Fast Track designation, which signifies the agency's recognition of the urgency and promise of this therapeutic approach. Furthermore, an agreement was made between Simcere Zaiming and AbbVie in January 2025, allowing AbbVie the option to license SIM0500, highlighting its importance in the oncology pipeline.

It is crucial to note that SIM0500 remains an investigational agent, and it hasn't received approval from the FDA or any other regulatory authorities yet. Current Phase 1 studies are being conducted concurrently in the U.S. and China, where preliminary data has indicated a favorable safety profile and encouraging efficacy results related to SIM0500.

Conclusion


Simcere Zaiming holds a robust and innovative R&D pipeline tailored to meet the unmet clinical needs of cancer patients worldwide. Founded in 2023, the company has succeeded in launching various groundbreaking cancer therapies, such as COSELA®, Enweida®, Endostar®, and Enlituo®. With a commitment to provide potentially transformative treatment options, Simcere Zaiming illustrates the dynamic nature of biopharmaceutical innovation in the oncology sector. The ongoing developments surrounding SIM0500 could be a game-changer for those battling RRMM, and the industry at large is keen to observe where this journey leads.

Contact Information


For more details on SIM0500 and the ongoing trial, stakeholders can reach out to Simcere Zaiming's communications office or check the press release distribution on major news platforms.

Topics Health)

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