Drugs / SYS6010
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07692048 | Jun 2026 → Dec 2027 expected | non-small cell lung carcinoma | Sichuan University | Not yet recruiting | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07472647 | Feb 2026 → Feb 2029 expected | non-small cell lung carcinoma, small cell lung carcinoma | Shanghai JMT-Bio Inc. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07241936 | Nov 2025 → Oct 2027 expected | cancer | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06775236 | Mar 2025 → Jun 2027 expected | breast cancer | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07254585 | Dec 2025 → Jun 2026 overdue | head and neck squamous cell carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07256509 | Nov 2025 → Nov 2026 expected | non-small cell lung carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07251062 | Dec 2025 → Dec 2029 expected | esophageal squamous cell carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07672223 | Jun 2026 → Sep 2029 expected | non-small cell lung carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07633873 | Jun 2026 → Sep 2027 expected | non-small cell lung carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07376382 | Jun → Dec 2026 expected | non-small cell lung carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07406542 | Apr 2026 → Apr 2029 expected | Her2-receptor negative breast cancer | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07417735 | Mar 2026 → Dec 2028 expected | esophageal squamous cell carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07442565 | Mar 2026 → Dec 2027 expected | non-small cell lung carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06927986 | Mar 2025 → Jul 2026 overdue | — | CSPC Megalith Biopharmaceutical Co.,Ltd. | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07104877 | Apr → Nov 2024 overdue | colorectal cancer, gastric cancer | Fujian Cancer Hospital | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-09-15 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - SYS6010 GRANTED BREAKTHROUGH THERAPY DESIGNATION BY NMPA IN CHINA FOR THE TREATMENT OF PATIENTS WITH ACTIONABLE GENOMIC ALTERATION-NEGATIVE NON-SQUAMOUS NON-SMALL CELL LUNG CANCER irasia.com ↗ |
| 2026-09-14 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Results VOLUNTARY ANNOUNCEMENT - PHASE I/II CLINICAL TRIAL DATA OF SYS6010 IN COMBINATION WITH ENLONSTOBART FOR THE TREATMENT OF SYSTEMIC TREATMENT-NAIVE, ACTIONABLE GENOMIC ALTERATION-NEGATIVE ADVANCED NSCLC ORALLY PRESENTED AT THE 2026 WORLD CONFERENCE ON LUNG CANCER (WCLC) irasia.com ↗ |
| 2026-09-01 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - SYS6010 GRANTED ANOTHER BREAKTHROUGH THERAPY DESIGNATION BY THE NMPA IN CHINA FOR THE TREATMENT OF PATIENTS WITH RECURRENT OR METASTATIC HEAD AND NECK SQUAMOUS CELL CARCINOMA irasia.com ↗ |
| 2026-08-26 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Results VOLUNTARY ANNOUNCEMENT - PHASE III CLINICAL STUDY OF SYS6010 FOR EGFR-MUTATED LOCALLY ADVANCED OR METASTATIC NSCLC FOLLOWING FAILURE OF EGFR TKI THERAPY MEETS PRE-SPECIFIED PRIMARY ENDPOINT irasia.com ↗ |
| 2026-05-11 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - SYS6010 GRANTED ANOTHER BREAKTHROUGH THERAPY DESIGNATION IN CHINA FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ESOPHAGEAL SQUAMOUS CELL CARCINOMA irasia.com ↗
SYS6010 GRANTED ANOTHER BREAKTHROUGH THERAPY DESIGNATION IN CHINA FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ESOPHAGEAL SQUAMOUS CELL CARCINOMA |
| 2025-05-19 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - CPO301 GRANTED THE THIRD FAST TRACK DESIGNATION BY U.S. FDA FOR THE TREATMENT OF ADULT PATIENTS WITH NSCLC irasia.com ↗ |
| 2025-01-02 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - SYS6010 WAS GRANTED BREAKTHROUGH THERAPY DESIGNATION IN CHINA irasia.com ↗
SYS6010 WAS GRANTED BREAKTHROUGH THERAPY DESIGNATION IN CH INA |
| 2024-10-08 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - CPO301 RECEIVES FAST TRACK DESIGNATION FROM THE US FDA irasia.com ↗ |
| 2023-06-12 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - CPO301 WAS GRANTED FAST TRACK DESIGNATION BY THE U.S. FDA irasia.com ↗
CPO301 WAS GRANTED FAST TRACK DESIGNATION BY THE U.S. FDA |
| 2023-06-08 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - CPO301 OBTAINS CLINICAL TRIAL APPROVAL IN CANADA irasia.com ↗ |
| 2023-04-20 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - ANTIBODY-DRUG CONJUGATE SYS6010 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 SYS6010 (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. |
| 2023-04-02 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - ANTIBODY-DRUG CONJUGATE CPO301 OBTAINS CLINIAL 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 CPO301 developed by the Group has obtained approval of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to conduct clinical trial in the U.S.. |
All press releases naming this drug 14 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SYS6010 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07472647 ↗ |
| Action | Inhibit | “anti-EGFR” NCT07251062 ↗ |
| Modality | Monoclonal antibody | “anti-EGFR monoclonal antibody” NCT06775236 ↗ |
| Route | Intravenous | “intravenous drip” NCT06775236 ↗ |
| Target | EGFR | “anti-EGFR monoclonal antibody” NCT06775236 ↗ |