Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Aumseqa | — | 2026-02-12 | europa.eu ↗ |
Trials 62 · started per year
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05223595 Background | Apr 2021 → Sep 2023 | non-small cell lung carcinoma | Changchun GeneScience Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06474455 Background | Jul 2024 → Jun 2029 expected | cancer | Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06452433 Background | Jun 2024 → Dec 2027 expected | non-small cell lung carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04755738 Background | Jan 2022 → Mar 2023 | non-small cell lung carcinoma | Qianfoshan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04519983 Background | Jan 2022 → Dec 2023 | lung carcinoma | Shanghai Cancer Hospital, China | Unknown | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07183189 Comparator | Oct 2025 → Nov 2032 expected | non-small cell lung carcinoma | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05768490 Background | Mar 2023 → Dec 2028 expected | metastatic malignant neoplasm in the brain | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT04500717 Comparator | Oct 2020 → Oct 2022 | non-small cell lung carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 3 | NCT04500704 Comparator | Oct 2020 → Dec 2021 | non-small cell lung carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04401059 Comparator | Nov 2020 → Sep 2025 | adenocarcinoma, non-small cell lung carcinoma | Tian Xie | Unknown | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 74 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | almonertinib | “Almonertinib (HS-10296) is a novel, third-generation EGFR tyrosine kinase inhibitor (EGFR TKI) that targets both EGFR-sensitizing and T790M resistance mutations.” PMID 32916310 ↗ Sep 202052“Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation epidermal growth factor receptor tyrosine kinase inhibitor approved in China.” PMID 35580297 ↗ May 2022 “Gentuximab: 8mg/kg or 12mg/kg intravenous (IV) infusion administered on Day 1 and 15 of each cycle; Almonertinib: 110 mg orally once daily.” NCT05223595 ↗ “Gefitinib(Iressa,YiRuiKe), Erlotinib(Tarceva), Icotinib(Kaimeina), Osimertinib(Tagrisso), Almonertinib, Furmonertinib, etc.” NCT04401059 ↗ “Dose escalation: HS-10241 and Almonertinib will be administered in combination.” NCT05430386 ↗ “Intervention: Oral almonertinib (110 mg/day) for three months” NCT06924398 ↗ “2. Almonertinib: 110mg, orally once a day” NCT04978753 ↗ “almonertinib 220mg once daily” NCT07398599 ↗ |
| Known as | Almonertinib Mesilate | “Almonertinib Mesilate Tablets.” NCT06474455 ↗ |
| Known as | aumolertinib | “Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation epidermal growth factor receptor tyrosine kinase inhibitor approved in China.” PMID 35580297 ↗ May 202219“All patients receive first-line oral therapy with standard-dose third-generation EGFR-TKIs (osimertinib, aumolertinib, or furmonertinib).” NCT07637448 ↗ “INTERVENTIONS: Patients received aumolertinib, 165 mg, orally once daily until disease progression or unacceptable toxic effects.” PMID 40569623 ↗ Aug 2025 |
| Known as | aumolertinib mesylate | “Aumolertinib mesylate tablets are administered 110 mg orally once a day” NCT06102928 ↗ |
| Known as | HS-10296 | “This is a phase II, single-arm, open-label study to evaluate the efficacy and safety of the third generation tyrosine kinase inhibitors (TKIs) Almonertinib (HS-10296) as...” NCT04685070 ↗3“Almonertinib (HS-10296) is a novel, third-generation EGFR tyrosine kinase inhibitor (EGFR TKI) that targets both EGFR-sensitizing and T790M resistance mutations.” PMID 32916310 ↗ Sep 2020 “Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation epidermal growth factor receptor tyrosine kinase inhibitor approved in China.” PMID 35580297 ↗ May 2022 |
| Action | Inhibit | “tyrosine kinase inhibitor (EGFR TKI)” PMID 32916310 ↗ Sep 2020 |
| Modality | Small molecule | “novel, third-generation EGFR tyrosine kinase inhibitor (EGFR TKI)” PMID 32916310 ↗ Sep 2020 |
| Route | Oral | “Eligible patients were enrolled and randomly assigned in a 1:1 ratio to orally receive either aumolertinib or gefitinib in a double-blinded fashion.” PMID 39016053 ↗ Jul 2024 |
| Target | EGFR | “targets both EGFR-sensitizing and T790M resistance mutations” PMID 32916310 ↗ Sep 2020 |