Icotinib

For the targeted therapy of EGFR mutation-positive non-small cell lung cancer, tyrosine kinase inhibitor (TKI) drugs are the first-line clinical preferred option. Icotinib, as the first-generation EGFR-TKI independently developed in China, competitively binds to the ATP binding site of the functional domain of EGFR tyrosine kinase, blocks the transmission of downstream signaling pathways such as RAS/MAPK and PI3K/AKT, thereby inhibiting the proliferation of tumor cells and inducing apoptosis. This drug is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer harboring sensitive EGFR gene mutations, and can also be used for the treatment of locally advanced or metastatic non-small cell lung cancer that has failed after prior treatment with at least one chemotherapy regimen. With better safety and supported by localized clinical data, it has become one of the core drugs for domestic targeted therapy of lung cancer.

The market size of targeted drugs for non-small cell lung cancer in China continues to expand. In 2023, the overall market size has exceeded 35 billion yuan, among which the first-generation EGFR-TKI drugs account for approximately 18%. As the only domestic first-generation EGFR-TKI, icotinib has remarkable competitive advantages in the primary care market and medical insurance coverage scenarios. The annual sales at the terminal of public medical institutions are stable at around 2 billion yuan, with a market share exceeding 60% of the overall market of first-generation EGFR-TKI. At present, more than 10 pharmaceutical companies have deployed the research and development of generic icotinib. With the gradual approval of generics after patent expiration, market competition will further promote the improvement of drug accessibility.

The original research enterprise of icotinib is Betta Pharmaceuticals Co., Ltd., with the brand name "Conmana". Its core compound patent expires in June 2023, and the formulation patent expires in November 2024. The currently approved main dosage form is tablet, with two specifications including 125mg and 0.125g, which has been included in the Reference Listed Drug Catalog of China Listed Medicines. In terms of API registration, as of the retrieval time point, the public information of CDE shows that the icotinib API of the original research enterprise Betta Pharmaceuticals has been registered with A status, and the API registrations of another 3 enterprises are under approval. In the domestic formulation market, only the original research drug Conmana has been approved for marketing at present, and no generic formulation has been approved yet. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for icotinib API, most of which are available in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products fully meet the regulatory compliance requirements of the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard requirements of pharmaceutical enterprises in the whole process of R&D, quality research and registration application.