On September 3, Qilu Pharmaceutical’s new Class 4 generic drug, afatinib maleate tablets, was approved for marketing by the National Medical Products Administration (NMPA), making Qilu the second company in China to receive approval for this product, following Hansoh Pharmaceutical.
Afatinib, a second-generation EGFR-TKI developed by Boehringer Ingelheim, differs from first-generation reversible EGFR TKIs by binding irreversibly to EGFR, thereby blocking cancer cell signaling pathways and inhibiting tumor growth. Afatinib received FDA approval in July 2013 and entered the Chinese market in February 2017 for the first- and second-line treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC). In September 2018, afatinib was included in Category B of the National Reimbursement Drug List through price negotiations.
EGFR gene mutations are the most common type of genetic mutation in Chinese patients with non-small cell lung cancer (NSCLC), accounting for approximately 50% of cases. Currently, there are eight EGFR-TKIs approved for marketing worldwide. Among them, gefitinib has been included in China’s volume-based procurement program, with Qilu Pharmaceutical successfully winning the bid.
Hansoh Pharmaceutical’s afatinib was first approved for marketing in China in June 2020. According to the NextPharma database by PharmCube, there are currently six other manufacturers that have submitted new drug applications (Class 4) for afatinib in China, including CSPC Pharmaceutical Group, Yangtze River Pharmaceutical Group, Chia Tai Tianqing Pharmaceutical Group, and Kelun Pharmaceutical.