Icotinib hydrochloride (ConmanaTM, chemical formula: C22H21N3O4·HCl), is an orally administered small-molecule, reversible tyrosine kinase inhibitor, which was independently researched and developed by Betta Pharmaceuticals (Hangzhou, China) with part support from the Chinese National Key Special Program for Innovative Drugs. Icotinib is considered as the first home-grown anticancer targeted drug in China and has been recognized as the first and best scientific innovation in Chinese pharmaceutical industry. Icotinib was approved by China’s State Food and Drug Administration (SFDA) in June, 2011, and its annual sales has already exceeded 120 million US$ in 2014. As The Lancet Oncology ‘ s comments said: “Scientifically, icotinib was the perfect test case for kick-starting the Chinese anticancer drug industry.”
A remarkable efficacy and favorable safety profile of icotinib monotherapy was seen in the phase I, II, and III clinical trials, and the phase IV study further confirmed the clinical outcome benefits of icotinib in a broader range of patients subtype. The EGFR mutations, which strongly drive the benefit of EGFR TKIs in non-small-cell lung cancer (NSCLC), are now known to be present in almost 60% of NSCLC patients in east Asia compared with only 10–20% in Caucasian patients. As its alternative agents, gefitinib and erlotinib, superior efficacy to chemotherapy was also seen in single icotinib as first-line treatment in treatment-naive NSCLC patients, based on which, icotinib was approved for treating NSCLC patients harboring positive EGFR mutation regardless of prior chemotherapies by SFDA in December, 2014, only three years after its marketing.
Icotinib has milder side effects, better tolerance, and significantly lower costs compared with gefitinib and erlotinib. Ever since its initial launch in August, 2011 in China, icotinib has been widely used, becoming one of the best treatment options for Chinese patients with advanced NSCLC. Icotinib has now been included in regional healthcare in some cities in China. A program is now ongoing to offer complimentary medicine for patients with disease control from icotinib treatment over 6 months to benefit more patients clinically and economically. Currently, more than 17,000 patients have received complimentary medicine, and 600,000 boxes of drugs have been distributed valuing over 1200 million RMB totally, which reduces the long-term economic burden for Chinese patients with advanced NSCLC.
Table I: The Awards of Icotinib