Aumolertinib

Aumolertinib
Clinical data
Trade names	Ameile, others
Other names	Almonertinib; HS-10296
Routes of; administration	By mouth
ATC code	L01EB11 (WHO) ;
Legal status
Legal status	EU: Rx-only; CN: Rx-only;
Identifiers
	IUPAC name N-[5-[[4-(1-Cyclopropylindol-3-yl)pyrimidin-2-yl]amino]-2-[2-(dimethylamino)ethyl-methylamino]-4-methoxyphenyl]prop-2-enamide;
CAS Number	1899921-05-1;
PubChem CID	121280087;
IUPHAR/BPS	11136;
DrugBank	DB16640;
ChemSpider	75535991;
UNII	T4RS462G19;
ChEMBL	ChEMBL4761468;
Chemical and physical data
Formula	C30H35N7O2
Molar mass	525.657 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES CN(C)CCN(C)C1=CC(=C(C=C1NC(=O)C=C)NC2=NC=CC(=N2)C3=CN(C4=CC=CC=C43)C5CC5)OC;
	InChI InChI=1S/C30H35N7O2/c1-6-29(38)32-24-17-25(28(39-5)18-27(24)36(4)16-15-35(2)3)34-30-31-14-13-23(33-30)22-19-37(20-11-12-20)26-10-8-7-9-21(22)26/h6-10,13-14,17-20H,1,11-12,15-16H2,2-5H3,(H,32,38)(H,31,33,34); Key:DOEOECWDNSEFDN-UHFFFAOYSA-N;

Aumolertinib, sold under the brand name Ameile among others, is an anti-cancer medication used for the treatment of lung cancer.^[3] It is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.^[4]

Medical uses

In China, aumolertinib is approved for the treatment of people with EGFR T790M mutation—positive non-small-cell lung cancer who have progressed on or after other EGFR tyrosine kinase inhibitor therapy.^[5]^[6]

In the European Union, aumolertinib, as monotherapy, is indicated for the first-line treatment of adults with advanced non-small-cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations;^[1] and for the treatment of adults with advanced EGFR T790M mutation positive NSCLC.^[1]

Society and culture

Legal status

In December 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Aumseqa, intended for the treatment of non-small cell lung cancer (NSCLC).^[1] The applicant for this medicinal product is SFL Pharmaceuticals Deutschland GmbH.^[1] Aumolertinib was authorized for medical use in the European Union in February 2026.^[1]^[2]

Names

Aumolertinib is the international nonproprietary name.^[7]

Aumolertinib is sold under the brand names Ameile and Aumseqa.

References

1 2 3 4 5 6 "Aumseqa EPAR". European Medicines Agency (EMA). 12 December 2025. Retrieved 22 December 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
1 2 "Aumseqa PI". Union Register of medicinal products. 13 February 2026. Retrieved 8 June 2026.
↑ Shirley M, Keam SJ (April 2022). "Aumolertinib: A Review in Non-Small Cell Lung Cancer". Drugs. 82 (5): 577–584. doi:10.1007/s40265-022-01695-2. PMID 35305259.
↑ Johnson ML, Miller VA, Patel S, Zhao Y, Cheng L, Ali SM, et al. (2023). "Aumolertinib with chemotherapy or alone compared with osimertinib in patients with EGFR-mutant non–small-cell lung cancer (TREBLE)". Journal of Clinical Oncology. 41 (16) TPS9153. doi:10.1200/JCO.2023.41.16_suppl.TPS9153.
↑ "Almonertinib Approved in China for EGFR T79M+ NSCLC". onclive.com. 19 March 2020.
↑ Lu S, Wang Q, Zhang G, Dong X, Yang CT, Song Y, et al. (March 2022). "Efficacy of Aumolertinib (HS-10296) in Patients With Advanced EGFR T790M+ NSCLC: Updated Post-National Medical Products Administration Approval Results From the APOLLO Registrational Trial". Journal of Thoracic Oncology. 17 (3): 411–422. doi:10.1016/j.jtho.2021.10.024. PMID 34801749.
↑ World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 86". WHO Drug Information. 35 (3). hdl:10665/346562.

Portal:

Medicine

[Aumseqa_EPAR-1] 1 2 3 4 5 6 "Aumseqa EPAR". European Medicines Agency (EMA). 12 December 2025. Retrieved 22 December 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

[Aumseqa_PI-2] 1 2 "Aumseqa PI". Union Register of medicinal products. 13 February 2026. Retrieved 8 June 2026.

[3] Shirley M, Keam SJ (April 2022). "Aumolertinib: A Review in Non-Small Cell Lung Cancer". Drugs. 82 (5): 577–584. doi:10.1007/s40265-022-01695-2. PMID 35305259.

[4] Johnson ML, Miller VA, Patel S, Zhao Y, Cheng L, Ali SM, et al. (2023). "Aumolertinib with chemotherapy or alone compared with osimertinib in patients with EGFR-mutant non–small-cell lung cancer (TREBLE)". Journal of Clinical Oncology. 41 (16) TPS9153. doi:10.1200/JCO.2023.41.16_suppl.TPS9153.

[5] "Almonertinib Approved in China for EGFR T79M+ NSCLC". onclive.com. 19 March 2020.

[6] Lu S, Wang Q, Zhang G, Dong X, Yang CT, Song Y, et al. (March 2022). "Efficacy of Aumolertinib (HS-10296) in Patients With Advanced EGFR T790M+ NSCLC: Updated Post-National Medical Products Administration Approval Results From the APOLLO Registrational Trial". Journal of Thoracic Oncology. 17 (3): 411–422. doi:10.1016/j.jtho.2021.10.024. PMID 34801749.

[7] World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 86". WHO Drug Information. 35 (3). hdl:10665/346562.

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