{"id":52131,"date":"2025-12-29T12:02:03","date_gmt":"2025-12-29T04:02:03","guid":{"rendered":"https:\/\/flcube.com\/?p=52131"},"modified":"2025-12-29T12:02:04","modified_gmt":"2025-12-29T04:02:04","slug":"jjs-amivantamab-subcutaneous-wins-china-approval-for-nsclc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=52131","title":{"rendered":"J&J\u2019s Amivantamab Subcutaneous Wins China Approval for NSCLC"},"content":{"rendered":"\n

Johnson & Johnson<\/strong> (J&J, NYSE:\u202fJNJ<\/a>) announced that its Amivantamab Injection (Subcutaneous)<\/strong>, marketed as RYBREVANT<\/strong>, received approval from China\u2019s National Medical Products Administration (NMPA)<\/strong> for patients with advanced non\u2011small cell lung cancer (NSCLC)<\/strong> harboring EGFR mutations<\/strong>. The subcutaneous formulation offers an 80% reduction in infusion\u2011related reactions<\/strong> and 5\u2011minute administration<\/strong> versus the intravenous version.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Details<\/th><\/tr><\/thead>
Approval Date<\/strong><\/td>26\u202fDec\u202f2025<\/td><\/tr>
Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Product<\/strong><\/td>Amivantamab subcutaneous injection (RYBREVANT)<\/td><\/tr>
Indication<\/strong><\/td>Advanced NSCLC with EGFR mutations<\/td><\/tr>
Key Advantages<\/strong><\/td>5\u2011minute SC administration; 80% fewer infusion reactions vs. IV<\/td><\/tr>
Basis<\/strong><\/td>Phase\u202f3 PALOMA\u20113 and Phase\u202f2 PALOMA\u20112 studies<\/td><\/tr>
Pharmacokinetics<\/strong><\/td>Non\u2011inferior drug exposure vs. IV formulation<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence & Indications<\/h2>\n\n\n\n

SC Formulation Efficacy:<\/strong><\/p>\n\n\n\n