Overview
No overview information available.
Indication
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(NSCLC)成人患者的治疗。
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/03/07 | Phase 2 | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2025/01/01 | Phase 2 | Recruiting | Peng Zhang | ||
2024/08/20 | Phase 4 | Recruiting | |||
2024/07/24 | Phase 2 | Recruiting | Sun Yat-sen University | ||
2023/09/18 | Phase 3 | Recruiting | |||
2021/08/17 | Phase 2 | Active, not recruiting |
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 |
---|---|---|---|---|---|
Befotertinib Mesylate Capsules | 国药准字H20230012 | 化学药品 | 胶囊剂 | 9/28/2023 | |
Befotertinib Mesylate Capsules | 国药准字H20230011 | 化学药品 | 胶囊剂 | 9/28/2023 |
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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