ICP-488 Tablets — Competitive Intelligence Brief

ICP-488 Tablets (ICP-488 Tablets) 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

ICP-488 Tablets (ICP-488 Tablets) — Beijing InnoCare Pharma Tech Co., Ltd.. ICP-488 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
ICP-488 Tablets TARGET	ICP-488 Tablets	Beijing InnoCare Pharma Tech Co., Ltd.	phase 3	EGFR tyrosine kinase inhibitor	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)
Erlotinib, Pemetrexed	Erlotinib, Pemetrexed	Hunan Province Tumor Hospital	marketed	EGFR tyrosine kinase inhibitor + antifolate antimetabolite	EGFR; thymidylate synthase and folate-dependent enzymes
Icotinib plus WBRT	Icotinib plus WBRT	Betta Pharmaceuticals Co., Ltd.	marketed	EGFR tyrosine kinase inhibitor	EGFR (epidermal growth factor receptor)
placebo matching lapatinib	placebo matching lapatinib	GlaxoSmithKline	marketed	HER2/EGFR tyrosine kinase inhibitor	HER2, EGFR
Sequential and maintenance icotinib	Sequential and maintenance icotinib	Betta Pharmaceuticals Co., Ltd.	marketed	EGFR tyrosine kinase inhibitor	EGFR
Osimertinib (Osi)	Osimertinib (Osi)	AbbVie	marketed	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 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