翰森制药的肺癌靶向药首入海外市场

Core Viewpoint - Hansoh Pharmaceutical's innovative drug, Amivantamab (Aumseqa®), has been approved for marketing in the UK, marking it as the first innovative drug from the company to enter the overseas market and the first Chinese-origin EGFR-TKI to be launched internationally [1][2]. Group 1: Drug Approval and Market Entry - Amivantamab is approved for use as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activated EGFR mutations, as well as for patients with T790M mutation-positive NSCLC [1]. - The drug has already been approved for four indications in China, making it the most approved indication for a Chinese-origin third-generation EGFR-TKI [2]. Group 2: Market Context and Competitors - As of March 2025, there are seven third-generation EGFR-TKI products available in China, including Amivantamab and others like Osimertinib and Furmonertinib [3]. - The market for NSCLC treatments is significant, with lung cancer accounting for 18.7% of global cancer deaths in 2022, and NSCLC being the most common type, representing approximately 85% of all lung cancer cases [4]. Group 3: Historical Context and Future Prospects - The first-generation EGFR-TKI, Gefitinib, was launched in the early 2000s, followed by second-generation drugs that also faced resistance issues, leading to the development of third-generation EGFR-TKIs like Osimertinib [5]. - Current research is focused on addressing resistance issues associated with third-generation EGFR-TKIs, with innovations such as EGFR/C-MET dual antibodies and ADC drugs being explored [6].