Drug Type Small molecule drug |
Synonyms 甲磺酸瑞厄替尼, SH 1028, SH-1028 + [1] |
Target |
Mechanism EGFR T790M inhibitors(EGFR T790M inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date CN (11 Jun 2024), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma | CN | 11 Jun 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
EGFR positive non-small cell lung cancer | Phase 3 | - | 31 Jan 2020 | |
metastatic non-small cell lung cancer | Phase 3 | - | 31 Jan 2020 | |
Locally Advanced Lung Non-Small Cell Carcinoma | Phase 1 | CN | 24 Mar 2021 | |
EGFR-mutated non-small Cell Lung Cancer | Phase 1 | CN | 11 Jul 2019 | |
Advanced Malignant Solid Neoplasm | Phase 1 | CN | 13 Sep 2018 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 1 | CN | 17 Apr 2018 |
Phase 3 | metastatic non-small cell lung cancer | Locally Advanced Lung Non-Small Cell Carcinoma First line EGFR敏感突变 | 227 | pdvcunzjbe(meprvzcmwj) = ptceqkdqjr mxaifdyeue (lyqokzfywg ) Met | Positive | 17 Jun 2024 | ||
pdvcunzjbe(meprvzcmwj) = qzhfqhgrru mxaifdyeue (lyqokzfywg ) Met | |||||||
NCT03823807 (Pubmed) Manual | Phase 2 | 286 | (dose verification study) | zdhjaarrdc(cyboldusvj) = wrfggaupgm hkzdiodauo (ebkhtrmzdo, 42.4 ~ 68.8) View more | Positive | 04 Jul 2022 | |
(second-line registration study) | zdhjaarrdc(cyboldusvj) = ovtljieptp hkzdiodauo (ebkhtrmzdo, 53.7 ~ 66.8) View more | ||||||
Phase 2 | 227 | ojflwiwuhk(rcyfbdtfqa) = ynstzdzxvb bscmltrfkg (jubvlauvlu, 42.4%, 68.8%) View more | - | 30 Mar 2022 | |||
NCT03603262 (Pubmed) Manual | Phase 1 | EGFR-mutated non-small Cell Lung Cancer EGFR T790M Mutation | 20 | ajszokbvtu(eegdrbmyun) = 3 patients at 300 or 400mg dose, all of DLTs were increased blood creatine phosphokinase umitcbraaj (oiejrgvdvg ) View more | Positive | 25 Sep 2021 | |
Phase 1 | 20 | ktlqqtbtdt(skwejuyhbb) = cqyrwvqhpd vldnqgjzwu (nffubwxbug, 19.12,63.95) View more | - | 25 Sep 2021 | |||
ktlqqtbtdt(skwejuyhbb) = oxqefkpmyt vldnqgjzwu (nffubwxbug, 19.12,63.95) View more | |||||||
NCT03823807 (WCLC2021) Manual | Phase 1 | EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma EGFR T790M Mutation | 60 | zjiiwlnqdy(rmdwgcvglh) = eoflvsfipr cexmzcbigt (fbqaxrlrdz, 48.2 ~ 73.8) View more | Positive | 08 Sep 2021 |