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

Title	Posted	Study ID	Phase	Status	Sponsor
Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations	2025/05/02	NCT06955325	Phase 3	Not yet recruiting	The First Affiliated Hospital of Guangzhou Medical University
Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations	2024/07/24	NCT06517953	Phase 2	Recruiting	Sun Yat-sen University
Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations	2023/09/18	NCT06041776	Phase 3	Recruiting	Betta Pharmaceuticals Co., Ltd.
A Multicenter Prospective Study to Assess the Effects of Adjuvant Icotinib in EGFRm Stage I NSCLC With High-risk of Disease Recurrence After Complete Resection	2022/08/24	NCT05514314	Phase 2	Not yet recruiting	Wu Nan
Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma	2021/11/24	NCT05132985	Phase 2	Not yet recruiting	Liaoning Tumor Hospital & Institute
A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer	2021/11/03	NCT05104788	Phase 2	Recruiting	Peking University Cancer Hospital & Institute
Befotertinib and Icotinib in Treatment-naive Patients With Advanced EGFR-Mutant Lung Cancer	2021/08/17	NCT05007938	Phase 2	Active, not recruiting	Betta Pharmaceuticals Co., Ltd.
Study of Anlotinib Combined With Icotinib as the First-line Treatment in Patients With EGFR Concomitant Mutation NSCLC	2021/03/15	NCT04797806	Phase 3	UNKNOWN	Tianjin Medical University Cancer Institute and Hospital
Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study	2020/10/05	NCT04575415	N/A	UNKNOWN	Guangdong Association of Clinical Trials
D-0316 Versus Icotinib in Patients With Locally Advanced or Metastatic EGFR Sensitising Mutation Positive NSCLC	2019/12/20	NCT04206072	Phase 2	Completed	Betta Pharmaceuticals Co., Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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