Abivertinib Maleate Capsules — Competitive Intelligence Brief

Abivertinib Maleate Capsules (Abivertinib Maleate Capsules) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: EGFR tyrosine kinase inhibitor. Area: Oncology.

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

Target snapshot

Abivertinib Maleate Capsules (Abivertinib Maleate Capsules) — Hangzhou ACEA Pharmaceutical Research Co., Ltd.. Abivertinib is a tyrosine kinase inhibitor that targets mutant EGFR and other kinases involved in cancer cell proliferation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Abivertinib Maleate Capsules TARGET	Abivertinib Maleate Capsules	Hangzhou ACEA Pharmaceutical Research Co., Ltd.	phase 3	EGFR tyrosine kinase inhibitor	EGFR (Epidermal Growth Factor Receptor)
Maintenance icotinib	Maintenance icotinib	Betta Pharmaceuticals Co., Ltd.	marketed	EGFR tyrosine kinase inhibitor (TKI)	EGFR (epidermal growth factor receptor)
Icotinib plus WBRT	Icotinib plus WBRT	Betta Pharmaceuticals Co., Ltd.	marketed	EGFR tyrosine kinase inhibitor	EGFR (epidermal growth factor receptor)
Sequential and maintenance icotinib	Sequential and maintenance icotinib	Betta Pharmaceuticals Co., Ltd.	marketed	EGFR tyrosine kinase inhibitor	EGFR
Erlotinib, Pemetrexed	Erlotinib, Pemetrexed	Hunan Province Tumor Hospital	marketed	EGFR tyrosine kinase inhibitor + antifolate antimetabolite	EGFR; thymidylate synthase and folate-dependent enzymes
Osimertinib (Osi)	Osimertinib (Osi)	AbbVie	marketed	EGFR tyrosine kinase inhibitor (third-generation)	EGFR (Epidermal Growth Factor Receptor)
Sequential Icotinib Plus Chemotherapy	Sequential Icotinib Plus Chemotherapy	Betta Pharmaceuticals Co., Ltd.	marketed	EGFR tyrosine kinase inhibitor	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 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