Drugs / SIM0348
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05718219 | Mar 2023 → Dec 2025 overdue | neoplasm | Jiangsu Simcere Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2022-12-30 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Simcere Received IND Approval for Two Immuno-oncology Bi-specific Antibodies from NMPA simcere.com ↗
Dec 29, 2022, Simcere Pharmaceutical Group (2096.HK) announced that the company has received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) for two immune-oncology bi-specific antibodies (SIM0348, SIM0237). |
| 2022-10-11 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Simcere filed 2 INDs for immune-oncology bispecific antibodies to NMPA simcere.com ↗
October 10, 2022, Simcere Pharmaceutical Group (2096.HK) announced that the company has recently submitted two new drug clinical trial (IND) applications to China National Medical Products Administration (NMPA) for two immune-oncology bi-specific antibodies (SIM0348, SIM0237). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-04-03 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Simcere Zaiming Doses First Patient in Phase 1 Trial of SIM0348, a TIGIT/PVRIG Bi-specific Antibody simcere.com ↗ |
| 2022-12-30 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Simcere Received IND Approval for Two Immuno-oncology Bi-specific Antibodies from NMPA simcere.com ↗ |
| 2022-10-11 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Simcere filed 2 INDs for immune-oncology bispecific antibodies to NMPA simcere.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SIM0348 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05718219 ↗ |
| Route | Intravenous | “SIM0348 will be given via IV infusion” NCT05718219 ↗ |