# Icotinib

Source: https://onco.cc/drugs/icotinib/  
OnCo record `icotinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Icotinib, approved in 2011, was the first cancer drug invented and developed in China, and it showed that a domestic lung cancer pill could match a Western one head to head.

## Summary

Betta Pharmaceuticals' icotinib was approved by the then SFDA in June 2011 for advanced NSCLC after chemotherapy, on the ICOGEN trial that showed non-inferiority to gefitinib (Lancet Oncology 2013). First-line EGFR-mutant approval followed in 2014, and the EVIDENCE trial (Lancet Respiratory Medicine 2021) supported adjuvant use after resection of stage II to IIIA EGFR-mutant disease. It was the first drug in the 2016 pilot of national price negotiation, taking a large cut to enter reimbursement, the template for the later NRDL rounds.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: china
- Brand: Conmana
- Code: BPI-2009H
- Modality: Small-molecule first-generation EGFR TKI
- Mechanism: Reversible ATP-competitive inhibitor of EGFR tyrosine kinase, structurally related to erlotinib.
- Approvals: China 2011: Advanced NSCLC after failure of at least one chemotherapy regimen (ICOGEN); China 2014: First-line EGFR-mutant NSCLC; China 2021: Adjuvant treatment of resected stage II to IIIA EGFR-mutant NSCLC (EVIDENCE)

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Icotinib
- Betta Pharmaceuticals: https://www.bettapharma.com/
- ICOGEN (Lancet Oncol 2013): https://doi.org/10.1016/S1470-2045(13)70355-3
- NMPA (National Medical Products Administration): https://www.nmpa.gov.cn

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- companies: [Betta Pharmaceuticals](https://onco.cc/companies/betta/)
- pathways: [RAS / RAF / MEK / ERK (MAPK)](https://onco.cc/pathways/ras-mapk/)
- trials: [Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations](https://onco.cc/trials/nct06041776/), [Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations](https://onco.cc/trials/nct06955325/)
- key papers: [Icotinib versus gefitinib in previously treated advanced non-small-cell lung cancer (ICOGEN): a randomised, double-blind phase 3 non-inferiority trial](https://onco.cc/key-papers/paper-shi-lancet-oncol/)

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