Erlotinib

For the treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations, the advent of targeted drugs has significantly prolonged the survival of patients. Erlotinib is a first-generation EGFR tyrosine kinase inhibitor. It competitively inhibits the phosphorylation process of tyrosine kinase in the intracellular segment of EGFR, and blocks the transduction of downstream signaling pathways such as RAS/MAPK and PI3K/AKT, thereby inhibiting the proliferation and invasion of tumor cells and inducing their apoptosis. Clinically, it is mainly used 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 subsequent treatment of locally advanced or metastatic non-small cell lung cancer in patients who have received at least one prior line of chemotherapy failure. The applicable population is mainly NSCLC patients carrying exon 19 deletion or exon 21 L858R mutation.

The peak size of the global erlotinib market once exceeded 1.8 billion US dollars before the expiration of the patent. With the successive launch of generic drugs, the market share of the original drug continues to decline, but there is still stable demand in primary treatment scenarios in emerging markets. In terms of the Chinese market, since erlotinib was included in the national centralized procurement catalogue in 2020, the price of winning generic drugs has dropped by more than 90%, the overall market size has stabilized, and clinical accessibility has been greatly improved. At present, there are more than 10 domestic manufacturers of erlotinib generic drugs, and the competitive landscape is relatively fragmented.

The original research enterprise of erlotinib is Roche, and the original brand name is Tarceva. The core compound patent of the original drug expired in China in March 2020. The main dosage form approved for the original drug is tablet, with two specifications of 100mg and 150mg. It has been included in the Catalogue of Listed Drugs in China as a reference listed drug, and is also included in the FDA Reference Listed Drug Directory. As of August 2025, more than 10 valid registration information of erlotinib active pharmaceutical ingredients can be queried on the platform of the Center for Drug Evaluation of China, among which more than 8 are A-status registration numbers. A number of domestic enterprises have obtained approval for the marketing of erlotinib generic preparations. (Data as of August 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of erlotinib impurity reference standards. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most impurities are available from stock. Stock orders submitted before 16:00 can be shipped on the same day, which can effectively meet the diverse scenario needs of pharmaceutical enterprises in drug R&D, quality research and daily quality control.