On March 5, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), the marketing application for Hansoh Pharma's Osimertinib Mesylate Tablets was accepted. Based on the acceptance time and the company’s R&D pipeline, this submission is likely an application for the approval of a new indication for the product.Source of the image: CDE official websiteAlmonertinib Mesylate Tablets (brand name: Amelo®), the first domestically developed third-generation EGFR-TKI in China, have been approved for five indications in China since its initial approval in March 2020. Last month, this product successfully received approval for marketing in the EU.Almonertinib Mesylate covers the treatment of EGFR-mutated non-small cell lung cancer (NSCLC) patients in full-course scenarios, including postoperative adjuvant therapy, consolidation therapy for unresectable stage III patients, and first-line and second-line treatments for advanced patients, making it the most comprehensively indicated domestically produced third-generation EGFR-TKI in China.▲ Approved Indications for Aumetinib MesylateSource of the image: YAOZHI Data Global Drug Analysis SystemFrom a commercial perspective, the more indications, the broader the patient population covered, and the higher the market ceiling for the product. According to data from Pharma Intelligence, domestic sales of this drug in 2024 are approaching 4.8 billion RMB, making it Hansoh Pharma's well-deserved "cash cow" product.Source of the image: YAOZHI Data - Drug Full Terminal Sales Analysis SystemIn terms of medical insurance access, several indications for Aumetinib have been included in the national medical insurance catalog, which will help improve the accessibility of the drug and benefit a wider population of lung cancer patients.This new indication submission is expected to further enrich clinical treatment options and provide more treatment possibilities for EGFR-mutated NSCLC patients at different stages and treatment phases.Statement:This article is for informational purposes only and does not represent the views of this platform. This article is not a recommendation for treatment plans. If you need guidance on treatment options, please visit a正规 hospital. If there are any issues regarding the content, copyright, or other aspects of this article, please leave a message on this platform, and we will verify and address it promptly.
Editorial Responsibility| Xiao Er
Typesetting Design | Xiao Bai
Reprint Permission| Teacher Chen 17308362010 (same WeChat)
