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Icotinib

Generic Name
Icotinib
Drug Type
Small Molecule
Chemical Formula
C22H21N3O4
CAS Number
610798-31-7
Unique Ingredient Identifier
9G6U5L461Q

Overview

Icotinib is a potent and specific epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Icotinib was approved in China by the SFDA in June, 2011 and in January 2014, Beta Pharma, Inc. was given a “May Proceed” from the US FDA to conduct a Phase I study for the evaluation of icotinib as a treatment of EGFR+ Non-Small Cell Lung Cancer (NSCLC).

Indication

Icotinib hydrochloride is a novel epidermal growth factor receptor (EGFR)–tyrosine kinase inhibitor, exhibits encouraging efficacy and tolerability in patients with advanced non-small-cell lung cancer (NSCLC) who failed previous chemotherapy.

Associated Conditions

No associated conditions information available.

Research Report

Published: Aug 6, 2025

Icotinib (DB11737): A Comprehensive Monograph on a First-Generation EGFR Tyrosine Kinase Inhibitor

Introduction and Executive Synthesis

Overview and Strategic Context

Icotinib, marketed under the trade name Conmana, is an orally available, small-molecule inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.[1] It belongs to the first generation of EGFR tyrosine kinase inhibitors (TKIs), a class of targeted therapies that has revolutionized the treatment of specific subsets of non-small cell lung cancer (NSCLC). The development history of Icotinib is unique and central to understanding its market position and clinical validation pathway. First synthesized in 2002, Icotinib was identified, optimized, and developed by Beta Pharma, a Chinese pharmaceutical company.[3] This "homegrown" origin distinguishes it from its primary first-generation competitors, gefitinib and erlotinib, which were developed by global pharmaceutical corporations. This regional focus shaped its initial clinical development and commercial strategy, leading to its emergence as a major therapeutic option within China and a case study in strategic pharmaceutical innovation.[4]

Core Indication and Therapeutic Niche

Continue reading the full research report

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2013/10/31
Phase 2
Completed
Yuhong Li
2013/10/16
Phase 2
UNKNOWN
Anhui Medical University
2013/08/20
Phase 4
UNKNOWN
2013/05/17
Phase 2
Completed
2013/04/30
Phase 2
UNKNOWN
2012/12/07
Phase 2
UNKNOWN
2012/11/12
Phase 3
Completed
2012/11/02
Phase 4
Suspended
2012/11/01
Phase 3
Completed
2012/09/21
Phase 2
UNKNOWN

FDA Drug Approvals

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EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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Health Canada Drug Approvals

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CIMA AEMPS Drug Approvals

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Philippines FDA Drug Approvals

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Saudi SFDA Drug Approvals

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Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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