Overview
Sugemalimab is a fully human, full-length IgG4 monoclonal anti-PD-L1 antibody discovered by CStone Pharmaceuticals and being investigated against relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (R/R ENKTL) in adult patients and T-cell lymphoma. It has been granted the Breakthrough Therapy Designation by the FDA to treat R/R ENKTL and orphan drug designation to treat T-cell lymphoma. During studies, sugemalimab was well tolerated and has shown antitumor activity in multiple tumor types. Sugemalimab is under investigation in clinical trial NCT03802591 (A Study of CS1001 in Subjects With Gastric Adenocarcinoma or Gastro-esophageal Junction Adenocarcinoma).
Background
Sugemalimab is a fully human, full-length IgG4 monoclonal anti-PD-L1 antibody discovered by CStone Pharmaceuticals and being investigated against relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (R/R ENKTL) in adult patients and T-cell lymphoma. It has been granted the Breakthrough Therapy Designation by the FDA to treat R/R ENKTL and orphan drug designation to treat T-cell lymphoma. During studies, sugemalimab was well tolerated and has shown antitumor activity in multiple tumor types. Sugemalimab is under investigation in clinical trial NCT03802591 (A Study of CS1001 in Subjects With Gastric Adenocarcinoma or Gastro-esophageal Junction Adenocarcinoma).
Indication
用于联合培美曲塞和卡铂用于表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶（ALK）阴性的转移性非鳞状非小细胞肺癌患者的一线治疗，以及联合紫杉醇和卡铂用于转移性鳞状非小细胞肺癌患者的一线治疗。
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/27 | Phase 3 | Recruiting | |||
2024/01/22 | Phase 1 | Recruiting | Sichuan University | ||
2023/10/24 | Early Phase 1 | Recruiting | |||
2023/07/11 | Phase 2 | Recruiting | |||
2023/01/26 | Phase 3 | Not yet recruiting | |||
2022/11/21 | Phase 2 | Recruiting | Sun Yat-sen University | ||
2021/11/23 | N/A | NO_LONGER_AVAILABLE | |||
2020/07/16 | Phase 1 | Recruiting | |||
2020/06/09 | Phase 1 | Completed | |||
2019/12/16 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/24/2024 | ||
Authorised | 7/24/2024 |
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 |
|---|---|---|---|---|---|
| Sugemalimab Injection | 国药准字S20210053 | 生物制品 | 注射剂 | 12/20/2021 |
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. | |||||