Overview
Almonertinib is a third-generation EGFR tyrosine kinase inhibitor targeting EGFR-sensitizing and T790M resistance mutations. It is being investigated against advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
Indication
1.用于既往经表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）治疗时或治疗后出现疾病进展，并且经检测确认存在EGFR T790M 突变阳性的局部晚期或转移性非小细胞肺癌成人患者的治疗。 2.用于表皮生长因子受体（EGFR）敏感突变阳性局部晚期或转移性非小细胞肺癌（NSCLC）患者一线治疗。
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/30 | Phase 2 | Not yet recruiting | Sichuan University | ||
2025/04/27 | Phase 1 | Recruiting | Sun Yat-sen University | ||
2024/06/25 | Phase 1 | Not yet recruiting | |||
2024/06/17 | Phase 2 | Not yet recruiting | Shanghai Pulmonary Hospital, Shanghai, China | ||
2024/03/08 | Phase 2 | Recruiting | |||
2023/11/01 | Phase 3 | Not yet recruiting | Jiangsu Hansoh Pharmaceutical Co., Ltd. | ||
2023/10/23 | Phase 1 | Not yet recruiting | |||
2023/09/21 | Phase 3 | Recruiting | Qianfoshan Hospital | ||
2023/08/16 | Phase 2 | Not yet recruiting | |||
2023/04/24 | Phase 1 | Recruiting | Guangzhou Institute of Respiratory Disease |
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 |
|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| Almonertinib Mesilate Tablets | 国药准字H20200004 | 化学药品 | 片剂 | 3/17/2020 |
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. | |||||
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