Gefitinib

For the treatment of non-small cell lung cancer (NSCLC) with sensitive mutations of epidermal growth factor receptor (EGFR), gefitinib is the first-generation EGFR tyrosine kinase inhibitor launched globally. It competitively binds to the ATP binding site of the intracellular segment of EGFR, blocks the transduction of the downstream RAS/RAF/MAPK signaling pathway, thereby inhibiting the proliferation of tumor cells and inducing cell apoptosis. Compared with traditional chemotherapy, gefitinib can significantly prolong the progression-free survival of NSCLC patients with positive EGFR mutations, with a lower incidence of adverse reactions. It is one of the core options for first-line targeted therapy of advanced non-small cell lung cancer, and the applicable population covers patients with locally advanced or metastatic non-small cell lung cancer who have exon 19 deletion or exon 21 L858R mutation.

The global gefitinib market size was approximately USD 870 million in 2023. Driven by the increasing penetration rate of targeted therapy for lung cancer in emerging markets, the compound annual growth rate is expected to remain at 3.2% from 2024 to 2029. China is the largest single consumer market for gefitinib, accounting for about 38% of the total global demand. At present, the domestic market has formed a pattern of full competition between original research drugs and generic drugs. Since it was included in the national centralized procurement in 2018, the price of preparations has dropped by more than 90%, and the accessibility at the grassroots level has been greatly improved, driving the continuous and steady growth of demand for API. At present, the annual domestic demand has exceeded 200 tons.

The original research enterprise of gefitinib is AstraZeneca, and the original trade name is Iressa. The expiration dates of its core compound patents in major global markets are: 2021 in the United States and 2016 in China. The main dosage form approved by the original research is tablet, with a specification of 250mg. This variety has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also included in the FDA Reference Preparations Catalogue. In terms of domestic API registration, 12 enterprises including the original research company have completed the CDE evaluation and registration of gefitinib API (status A) up to now, and there are more than 30 product specifications of gefitinib preparations approved for marketing in China. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of gefitinib impurity reference standards, covering all types of impurities such as process impurities, degradation impurities and enantiomers. All products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA. Most products are in stock all the year round, and orders placed before 16:00 can be delivered on the same day, which can fully meet the reference standard supply needs of pharmaceutical enterprises in the whole process of R&D, quality research and consistency evaluation.