Drugs / SYSA1801
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05009966 | Sep 2021 → Dec 2023 | gastric cancer, gastroesophageal junction adenocarcinoma, malignant pancreatic neoplasm | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2021-07-16 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - ANTIBODY-DRUG CONJUGATE "SYSA1801" OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S. irasia.com ↗
SYSA1801” (the “Product”), an antibody-drug conjugate developed by the Group, has obtained approval of its Investigational New Drug Application (IND) from the U.S. Food and Drug Administration (FDA) to conduct clinical trials for advanced pancreatic cancer with positive Claudin 18.2 expression. |
| 2021-06-16 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - ANTIBODY-DRUG CONJUGATE "SYSA1801" OBTAINS CLINICAL TRIAL APPROVAL IN CHINA irasia.com ↗ |
| 2021-05-07 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - INVESTIGATIONAL FIRST-IN-CLASS PRODUCT SYSA1801 GRANTED ORPHAN-DRUG DESIGNATION BY THE U.S. FDA irasia.com ↗ |
| 2020-11-24 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - INVESTIGATIONAL FIRST-IN-CLASS PRODUCT SYSA1801 GRANTED ORPHAN-DRUG DESIGNATION BY THE U.S. FDA irasia.com ↗ |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-07-28 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - EXCLUSIVE LICENSE AGREEMENT FOR SYSA1801 WITH ELEVATION ONCOLOGY, INC. irasia.com ↗ |
| 2021-07-16 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - ANTIBODY-DRUG CONJUGATE "SYSA1801" OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S. irasia.com ↗ |
| 2021-06-16 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - ANTIBODY-DRUG CONJUGATE "SYSA1801" OBTAINS CLINICAL TRIAL APPROVAL IN CHINA irasia.com ↗ |
| 2021-05-07 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - INVESTIGATIONAL FIRST-IN-CLASS PRODUCT SYSA1801 GRANTED ORPHAN-DRUG DESIGNATION BY THE U.S. FDA irasia.com ↗ |
| 2020-11-24 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - INVESTIGATIONAL FIRST-IN-CLASS PRODUCT SYSA1801 GRANTED ORPHAN-DRUG DESIGNATION BY THE U.S. FDA irasia.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 | SYSA1801 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05009966 ↗ |
| Route | Intravenous | “SYSA1801 will be administered intravenously (IV)” NCT05009966 ↗ |