{"id":64373,"date":"2026-04-30T22:47:58","date_gmt":"2026-04-30T14:47:58","guid":{"rendered":"https:\/\/flcube.com\/?p=64373"},"modified":"2026-04-30T22:47:59","modified_gmt":"2026-04-30T14:47:59","slug":"avistone-biotechnologys-andatinib-receives-china-conditional-approval-for-egfr-ex20ins-nsclc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=64373","title":{"rendered":"Avistone Biotechnology’s Andatinib Receives China Conditional Approval for EGFR Ex20ins NSCLC"},"content":{"rendered":"\n

Beijing Avistone Biotechnology Co., Ltd.<\/strong> announced that its self-developed EGFR exon 20 insertion (ex20ins) inhibitor<\/strong>, andatinib benzoate capsules (PLB-1004)<\/strong>, has received conditional market approval<\/strong> from China’s National Medical Products Administration (NMPA)<\/strong> for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)<\/strong> harboring EGFR ex20ins mutations<\/strong> who have progressed on or are intolerant to platinum-based chemotherapy.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/strong><\/td>National Medical Products Administration (NMPA), China<\/td><\/tr>
Approval Type<\/strong><\/td>Conditional market approval<\/td><\/tr>
Product<\/strong><\/td>Andatinib benzoate capsules (PLB-1004)<\/td><\/tr>
Indication<\/strong><\/td>EGFR ex20ins-mutant NSCLC post-platinum chemotherapy<\/td><\/tr>
Patient Population<\/strong><\/td>Locally advanced or metastatic NSCLC with EGFR ex20ins mutations<\/td><\/tr>
Development Status<\/strong><\/td>First-in-class approval in China for this specific molecular subtype<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Disease Context & Unmet Need<\/h2>\n\n\n\n
Aspect<\/th>Analysis<\/th><\/tr><\/thead>
EGFR ex20ins Prevalence<\/strong><\/td>0.3%-2.9% of all NSCLC patients in China; 2%-5% of EGFR-mutated NSCLC cases<\/td><\/tr>
Current Treatment Challenge<\/strong><\/td>Intrinsic resistance to first-, second-, and third-generation EGFR-TKIs due to unique molecular structure<\/td><\/tr>
Post-Chemotherapy Outcomes<\/strong><\/td>Median progression-free survival (PFS) of only 2-4 months after platinum-based chemotherapy<\/td><\/tr>
Clinical Gap<\/strong><\/td>Severe lack of effective targeted therapy options represents significant unmet medical need<\/td><\/tr>
Market Opportunity<\/strong><\/td>Addresses approximately 8,000-15,000 annual incident cases in China with high unmet need<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile & Key Characteristics<\/h2>\n\n\n\n

Andatinib Benzoate (PLB-1004)<\/h3>\n\n\n\n