Flonoltinib Maleate — Competitive Intelligence Brief

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

phase 2 tyrosine kinase inhibitor BCR-ABL1 Oncology Small molecule

Target snapshot

Flonoltinib Maleate (Flonoltinib Maleate) — Chengdu Zenitar Biomedical Technology Co., Ltd. Flonoltinib maleate is a tyrosine kinase inhibitor that targets the BCR-ABL1 protein.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Flonoltinib Maleate TARGET	Flonoltinib Maleate	Chengdu Zenitar Biomedical Technology Co., Ltd	phase 2	tyrosine kinase inhibitor	BCR-ABL1
Ponatinib + Blinatumomab	Ponatinib + Blinatumomab	Gruppo Italiano Malattie EMatologiche dell'Adulto	phase 3	Tyrosine kinase inhibitor, Bispecific monoclonal antibody	BCR-ABL1, CD19, CD3
Inlyta	Axitinib	Pfizer	marketed	Receptor tyrosine kinase inhibitor	Vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, VEGFR-3	2012-01-01
Sequential Icotinib Plus Chemotherapy	Sequential Icotinib Plus Chemotherapy	Betta Pharmaceuticals Co., Ltd.	marketed	EGFR tyrosine kinase inhibitor	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)
lorlatinib plus chemotherapy	lorlatinib plus chemotherapy	The First Affiliated Hospital of Guangzhou Medical University	marketed	ALK tyrosine kinase inhibitor (combination therapy)	ALK (anaplastic lymphoma kinase), ROS1
pazopanib or guideline conform chemotherapy	pazopanib or guideline conform chemotherapy	GWT-TUD GmbH	marketed	Multi-targeted tyrosine kinase inhibitor	VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-α, PDGFR-β, c-Kit

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 (tyrosine kinase inhibitor class)

1. Centre Leon Berard · 2 drugs in this class
2. Akeso · 1 drug in this class
3. Astex Pharmaceuticals, Inc. · 1 drug in this class
4. Chengdu Zenitar Biomedical Technology Co., Ltd · 1 drug in this class
5. Jiangsu HengRui Medicine Co., Ltd. · 1 drug in this class
6. Jiangsu ShengDiYa Medicine Co., Ltd. · 1 drug in this class
7. Nanjing Leads Biolabs Co.,Ltd · 1 drug in this class
8. Ocular Therapeutix, Inc. · 1 drug in this class
9. Peking University Cancer Hospital & Institute · 1 drug in this class
10. Pfizer · 1 drug in this class