Drugs / SYS6023
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07110883 | Aug 2024 → Oct 2026 expected | neoplasm | CSPC Megalith Biopharmaceutical Co.,Ltd. | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07597629 | May 2026 → Nov 2027 expected | breast cancer | CSPC Megalith Biopharmaceutical Co.,Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-07-08 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - ANTIBODY-DRUG CONJUGATE SYS6023 OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S. irasia.com ↗
The board of directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that the antibody-drug conjugate SYS6023 (the ‘‘Product ’’) developed by CSPC Megalith Biopharmaceutical Co., Ltd.* ( 石藥集團巨石生物製藥有限公司), a subsidiary of the Group, has obtained approval of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States (the ‘‘U.S. ’’). |
| 2024-03-20 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - ANTIBODY-DRUG CONJUGATE SYS6023 OBTAINS CLINICAL TRIAL APPROVAL irasia.com ↗
The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the antibody-drug conjugate SYS6023 (the “Product”) developed by the Group has obtained clinical trial approval granted by the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in China. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-07-08 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - ANTIBODY-DRUG CONJUGATE SYS6023 OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S. irasia.com ↗ |
| 2024-03-20 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - ANTIBODY-DRUG CONJUGATE SYS6023 OBTAINS CLINICAL TRIAL APPROVAL irasia.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SYS6023 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07110883 ↗ |
| Modality | Other / unclassified | “novel antibody-drug conjugate (ADC)” NCT07110883 ↗ |
| Route | Intravenous | “administered via intravenous infusion” NCT07110883 ↗ |
| Target | ERBB3 | “targeting HER3” NCT07597629 ↗ |