Drugs / SIM0508
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06686745 | Dec 2024 → Jun 2027 expected | cancer | Jiangsu Simcere Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-08-20 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Simcere Zaiming’s Polθ Inhibitor SIM0508 Obtains New IND Approval for Combination Use with Olaparib simcere.com ↗
SIM0508, an anticancer candidate targeting DNA polymerase theta (Polθ), has received a new IND approval from the National Medical Products Administration (NMPA) for the combination use with olaparib in patients with advanced solid tumors in clinical trials. |
| 2024-09-04 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Simcere Zaiming’s Pol θ inhibitor obtained IND approval from US FDA simcere.com ↗
On August 29, 2024, Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that the investigational new drug (IND) application of SIM0508, a DNA polymerase θ (Pol θ) small molecule inhibitor, has been approved by the Food and Drug Administration (FDA). |
| 2024-08-12 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Simcere Zaiming’s novel molecule targeting the synthetic lethal pathway Pol θ has obtained approval for clinical trials in China simcere.com ↗
On August 22, 2024, Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that SIM0508, a DNA polymerase θ (Pol θ) small molecule inhibitor developed independently by the company, has received Clinical Trial Approval from the National Medical Products Administration of China. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-08-20 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Simcere Zaiming’s Polθ Inhibitor SIM0508 Obtains New IND Approval for Combination Use with Olaparib simcere.com ↗ |
| 2024-09-04 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Simcere Zaiming’s Pol θ inhibitor obtained IND approval from US FDA simcere.com ↗ |
| 2024-08-12 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Simcere Zaiming’s novel molecule targeting the synthetic lethal pathway Pol θ has obtained approval for clinical trials in China simcere.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SIM0508 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06686745 ↗ |