Drugs / SIM0500
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06375044 | May 2024 → Jun 2026 overdue | refractory plasma cell neoplasm | Jiangsu Simcere Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-04-11 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory SIM0500, Simcere Zaiming’s Tri-specific Antibody Candidate for Multiple Myeloma Received FDA Fast Track Designation simcere.com ↗ |
| 2024-03-12 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory SIM0500, Simcere Zaiming’s Tri-specific Antibody Candidate for Multiple Myeloma Achieved Concurrent Approval for Clinical Trials in both the United States and China simcere.com ↗
Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group Ltd., announced that it has received approval both from the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA) for the investigational new drug candidate SIM0500, to carry out clinical trials in patients with relapsed or refractory multiple myeloma (MM). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-06-19 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Simcere Zaiming Announces First Patient Dosed in the US in a Phase 1 Trial of Trispecific Antibody SIM0500 in Patients with Relapsed/Refractory Multiple Myeloma simcere.com ↗ |
| 2024-05-25 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Simcere Zaiming Announces Enrollment of First Patient in GPRC5D-BCMA-CD3 Tri-Specific Antibody SIM0500 Clinical Trial simcere.com ↗ |
| 2024-04-11 | Jiangsu Simcere Pharmaceutical Co., Ltd. | SIM0500, Simcere Zaiming’s Tri-specific Antibody Candidate for Multiple Myeloma Received FDA Fast Track Designation simcere.com ↗ |
| 2024-03-12 | Jiangsu Simcere Pharmaceutical Co., Ltd. | SIM0500, Simcere Zaiming’s Tri-specific Antibody Candidate for Multiple Myeloma Achieved Concurrent Approval for Clinical Trials in both the United States and China simcere.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SIM0500 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06375044 ↗ |
| Modality | Monoclonal antibody | “A Humanized GPRC5D-BCMA-CD3 Tri-specific Antibody” NCT06375044 ↗ |
| Target | GPRC5D | “A Humanized GPRC5D-BCMA-CD3 Tri-specific Antibody” NCT06375044 ↗ |