--- title: "The anti-tumor Class 1 new drug Liratinib tablets have been approved for market launch" type: "News" locale: "en" url: "https://longbridge.com/en/news/226829273.md" description: "The new anti-tumor drug Liratinib tablets (development code ASK120067) has been approved for marketing by the National Medical Products Administration, suitable for patients with locally advanced or metastatic non-small cell lung cancer with EGFR T790M mutation positive. The drug was jointly developed by the Chinese Academy of Sciences and Jiangsu Aosaikang Pharmaceutical, with clinical studies showing an objective response rate of 68.8% and a disease control rate of 92.4%. Liratinib is a third-generation EGFR TKI with significant anti-tumor activity" datetime: "2025-02-01T01:40:27.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/226829273.md) - [en](https://longbridge.com/en/news/226829273.md) - [zh-HK](https://longbridge.com/zh-HK/news/226829273.md) generator: "portal-rs" --- # The anti-tumor Class 1 new drug Liratinib tablets have been approved for market launch The chemical drug class 1 new drug EGFR third-generation inhibitor Aoyi Xin® (Leratinib tablets, research and development code ASK120067) has been approved for marketing by the National Medical Products Administration (NMPA) for the treatment of adult patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI). This drug was jointly developed by the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Guangzhou Institute of Biomedicine and Health, Chinese Academy of Sciences, and Jiangsu Aosaikang Pharmaceutical Co., Ltd. Lung cancer is one of the most prevalent and deadly malignant tumors globally, with NSCLC accounting for approximately 85% of all lung cancers. About 70% of NSCLC patients are diagnosed with locally advanced or metastatic disease that is not suitable for surgical resection. EGFR is the most common driver gene in NSCLC, with 30% to 50% of Asian NSCLC patients having EGFR gene mutations. EGFR-TKI is the first-line standard treatment recommended for this patient group, with third-generation EGFR-TKIs having a broad applicable population. Leratinib tablets are a new molecular entity with independent intellectual property rights, an orally active third-generation EGFR TKI that selectively inhibits the EGFR T790M mutation. Preclinical studies have shown that it can significantly inhibit the growth of lung cancer with EGFR mutations. In the pivotal phase IIB clinical study of Leratinib for EGFR T790M mutation-positive NSCLC, a total of 301 subjects with EGFR T790M mutation-positive or primary EGFR T790M mutation-positive locally advanced or metastatic NSCLC who progressed after previous EGFR-TKI treatment were enrolled. The objective response rate (ORR) assessed by the Independent Review Committee (IRC) was 68.8%, the disease control rate (DCR) was 92.4%, the median duration of response (DoR) was 11.1 months, and the median progression-free survival (PFS) was 11.0 months. Among patients with assessable intracranial lesions (CNS patients), the best ORR assessed by IRC was 65.9%, and the median PFS for patients was 10.6 months, indicating that Leratinib has good efficacy for CNS patients. The main adverse reactions of Leratinib are consistent with reports from previous similar EGFR TKI treatments, and it has good tolerability. The approval of Leratinib provides a new treatment option for lung cancer patients. During the development of this new drug, multiple teams from the Shanghai Institute of Materia Medica, including safety evaluation, formulation, pharmacokinetics, and quality control, undertook relevant work and provided strong support. 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