Overview
Pucotenlimab is a recombinant humanized anti-PD-1 monoclonal antibody. It received its first global approval in China in July 2022 for the treatment of solid tumours. It is being investigated in other cancers.
Indication
用于治疗微卫星高度不稳定╱错配修复缺陷(MSI-H/dMMR)实体瘤的患者，包括既往经过氟尿嘧啶类、奥沙利铂和伊立替康治疗后出现疾病进展的晚期结直肠癌患者；既往至少一线治疗后出现疾病进展且无满意替代治疗方案的其他晚期实体瘤患者。
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/08 | Not Applicable | Not yet recruiting | Jiyan Liu | ||
2025/05/06 | Phase 2 | Not yet recruiting | Groupe Oncologie Radiotherapie Tete et Cou | ||
2025/03/26 | Phase 2 | Not yet recruiting | |||
2025/03/12 | Phase 2 | Not yet recruiting | |||
2025/01/13 | Phase 2 | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2024/08/20 | Phase 2 | Not yet recruiting | |||
2024/06/13 | Phase 1 | Recruiting | Sun Yat-sen University | ||
2023/11/13 | Phase 2 | Not yet recruiting | Sun Yat-sen University | ||
2022/12/15 | Phase 3 | Not yet recruiting | Taizhou Hanzhong biomedical co. LTD | ||
2021/04/01 | Phase 1 | UNKNOWN | Taizhou Hanzhong biomedical co. LTD |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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