Drug · Small Molecule

Aumolertinib

CI-DRUG-00000085Explore in graph →NCIt C133691 CHEMBL4761468 CIViC Phase 3

Regulatory

Approvals (1)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	Lung Non-Small Cell Carcinoma	Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (forbiomarker-based patient selection, see section 4.2).- the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC (forbiomarker-based patient selection, see section 4.2)	approved	Feb 12, 2026	ema

Data updated 14 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	19	10	15	44	1	EU	Feb 12, 2026	May 8, 2017
Malignant Lung Neoplasm	Approved	Phase 3	13	5	13	36	1	EU	Feb 12, 2026	May 8, 2017
Malignant Central Nervous System Neoplasm	Phase Not Stated	N/A	0	0	0	1	0	—	—	2021-07

Computedclinicaltrials

Curated evidence

Clinical evidence (2)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–2 of 2 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
GNAT3 Fusion1
Aumolertinib	Lung Adenocarcinoma

Clinical trials

Trials with this intervention (44)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–44 of 44 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT07183189	A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC	active not recruiting	Phase 3	582	Suzhou Suncadia Biopharmaceuticals Co., Ltd.INDUSTRY	1	Sep 25, 2026	clinicaltrials
NCT07699952	First-line Therapy With Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor(EGFR-TKI) Combined With Trastuzumab Rezetecan for Advanced Non-small Cell Lung Cancer(NSCLC) Harboring EGFR Mutations Concomitant With Human Epidermal Growth Factor Receptor 2(HER2) Alterations

Molecule

Record

Kind: Small Molecule
Mechanism: Epidermal growth factor receptor erbB1 inhibitor
Targets: 1 gene
Aliases: Almonertinib, Ameile, Amerol, Aumolertinib, Aumseqa, Egfr t790m inhibitor hs-10296, EGFR Tyrosine Kinase Inhibitor HS-10296, EQ-143, EQ143, HS-10206, HS 10296, HS-10296, HS10296

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (2)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EB	Antineoplastic agents
EMA product	EMEA/H/C/006069	Aumseqa

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.