Drugs / SIM1811-03
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05569057 | Sep 2022 → Jun 2024 | primary cutaneous T-cell lymphoma | Jiangsu Simcere Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05781386 | Mar 2022 → Jun 2025 | primary cutaneous T-cell lymphoma | Jiangsu Simcere Biologics Co., Ltd | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2022-02-01 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory SIM0235, aTNFR2 monoclonal antibody independently developed by Simcere received IND approval by the U.S. FDA simcere.com ↗ |
| 2021-10-14 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory IND Application for Simcere’s Independently Developed Anti-TNFR2 Antibody Accepted by CDE simcere.com ↗
On October 8 th , Simcere Pharmaceutical Group (2096.HK), announced that the clinical trial application for its independently developed SIM0235 (SIM1811-03) antibody has been accepted by China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration ( NMPA ) . |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-02-01 | Jiangsu Simcere Pharmaceutical Co., Ltd. | SIM0235, aTNFR2 monoclonal antibody independently developed by Simcere received IND approval by the U.S. FDA simcere.com ↗ |
| 2021-10-14 | Jiangsu Simcere Pharmaceutical Co., Ltd. | IND Application for Simcere’s Independently Developed Anti-TNFR2 Antibody Accepted by CDE simcere.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SIM1811-03 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05781386 ↗ |
| Modality | Monoclonal antibody | “SIM1811-03 is a first-in-class IgG1-based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of malignant tumors.” NCT05569057 ↗ |
| Route | Intravenous | “Eligible subjects will receive intravenous infusion of SIM1811-03 on Days 1 and 15 of each 28-day cycle.” NCT05569057 ↗ |