Osimertinib tablet — Competitive Intelligence Brief

Osimertinib tablet (Osimertinib tablet) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: EGFR tyrosine kinase inhibitor (third-generation). Area: Oncology.

phase 3 EGFR tyrosine kinase inhibitor (third-generation) EGFR (Epidermal Growth Factor Receptor) Oncology Small molecule

Target snapshot

Osimertinib tablet (Osimertinib tablet) — Shanghai JMT-Bio Inc.. Osimertinib is a third-generation EGFR tyrosine kinase inhibitor that irreversibly binds to and inhibits mutant EGFR, including T790M resistance mutations, blocking downstream signaling in cancer cells.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Osimertinib tablet TARGET	Osimertinib tablet	Shanghai JMT-Bio Inc.	phase 3	EGFR tyrosine kinase inhibitor (third-generation)	EGFR (Epidermal Growth Factor Receptor)
Osimertinib (Osi)	Osimertinib (Osi)	AbbVie	marketed	EGFR tyrosine kinase inhibitor (third-generation)	EGFR (Epidermal Growth Factor Receptor)
Aumolertinib Oral Tablet	Aumolertinib Oral Tablet	Shanghai Cancer Hospital, China	phase 3	EGFR tyrosine kinase inhibitor (third-generation)	EGFR (Epidermal Growth Factor Receptor)
Cross-over to Osimertinib	Cross-over to Osimertinib	AstraZeneca	phase 3	EGFR tyrosine kinase inhibitor (third-generation)	EGFR (Epidermal Growth Factor Receptor)
HS-10241+ Almonertinib	HS-10241+ Almonertinib	Jiangsu Hansoh Pharmaceutical Co., Ltd.	phase 3	EGFR tyrosine kinase inhibitor (third-generation)	EGFR (Epidermal Growth Factor Receptor)
Osimertinib Mesylate Tablets	Osimertinib Mesylate Tablets	Sun Yat-sen University	phase 3	EGFR tyrosine kinase inhibitor (third-generation)	EGFR (epidermal growth factor receptor), particularly mutant forms including T790M
AZD9291 Dosing	AZD9291 Dosing	AstraZeneca	phase 3	EGFR tyrosine kinase inhibitor (third-generation)	EGFR (Epidermal Growth Factor Receptor)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (EGFR tyrosine kinase inhibitor (third-generation) class)

1. AstraZeneca · 2 drugs in this class
2. AbbVie · 1 drug in this class
3. Jiangsu Hansoh Pharmaceutical Co., Ltd. · 1 drug in this class
4. Shanghai Cancer Hospital, China · 1 drug in this class
5. Shanghai JMT-Bio Inc. · 1 drug in this class
6. Sun Yat-sen University · 1 drug in this class