Sequential and maintenance icotinib — Competitive Intelligence Brief

Sequential and maintenance icotinib (Sequential and maintenance icotinib) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: EGFR tyrosine kinase inhibitor. Area: Oncology.

marketed EGFR tyrosine kinase inhibitor EGFR Oncology Small molecule

Target snapshot

Sequential and maintenance icotinib (Sequential and maintenance icotinib) — Betta Pharmaceuticals Co., Ltd.. Icotinib is a small-molecule tyrosine kinase inhibitor that selectively blocks epidermal growth factor receptor (EGFR) signaling to inhibit tumor cell proliferation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Sequential and maintenance icotinib TARGET	Sequential and maintenance icotinib	Betta Pharmaceuticals Co., Ltd.	marketed	EGFR tyrosine kinase inhibitor	EGFR
Rybrevant	AMIVANTAMAB	Johnson & Johnson	marketed		EGFR, MET	2021-01-01
NERATINIB	NERATINIB		marketed		EGFR, HER2, HER4	2017-01-01
Inlyta	Axitinib	Pfizer	marketed	Receptor tyrosine kinase inhibitor	Vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, VEGFR-3	2012-01-01
PONATINIB HYDROCHLORIDE	PONATINIB HYDROCHLORIDE		marketed		ABL, T315I mutant ABL, VEGFR, PDGFR, FGFR, EPH receptors, SRC family, KIT, RET, TIE2, FLT3	2012-01-01
REGORAFENIB	REGORAFENIB		marketed		RET, VEGFR1, VEGFR2, VEGFR3, KIT, PDGFR-alpha, PDGFR-beta, FGFR1, FGFR2, TIE2, DDR2, TrkA, Eph2A, RAF-1, BRAF, BRAF V600E, SAPK2, PTK5, Abl, CSF1R	2012-01-01
PAZOPANIB HYDROCHLORIDE	PAZOPANIB HYDROCHLORIDE		marketed		VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-α, PDGFR-β, FGFR-1, FGFR-3, Kit, Itk, Lck, c-Fms	2009-01-01

Recent regulatory actions (last 90 days)

• 2026-02-13 — Rybrevant · FDA · approved · US · Johnson & Johnson

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 class)

1. Betta Pharmaceuticals Co., Ltd. · 4 drugs in this class
2. Hangzhou ACEA Pharmaceutical Research Co., Ltd. · 2 drugs in this class
3. Genentech, Inc. · 2 drugs in this class
4. AstraZeneca · 2 drugs in this class
5. Millennium Pharmaceuticals, Inc. · 1 drug in this class
6. Pfizer · 1 drug in this class
7. Sichuan Cancer Hospital and Research Institute · 1 drug in this class
8. Sun Yat-sen University · 1 drug in this class
9. University of Chicago · 1 drug in this class
10. Xinqiao Hospital of Chongqing · 1 drug in this class