{"id":58521,"date":"2026-03-02T13:19:10","date_gmt":"2026-03-02T05:19:10","guid":{"rendered":"https:\/\/flcube.com\/?p=58521"},"modified":"2026-03-02T13:19:11","modified_gmt":"2026-03-02T05:19:11","slug":"hansoh-pharmas-mirdametinib-plus-almonertinib-nda-accepted-by-nmpa-dual-target-combination-for-egfr-mutant-nsclc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=58521","title":{"rendered":"Hansoh Pharma’s Mirdametinib Plus Almonertinib NDA Accepted by NMPA \u2013 Dual\u2011Target Combination for EGFR\u2011Mutant NSCLC"},"content":{"rendered":"\n

Hansoh Pharmaceutical Group Company Limited (HKG:\u202f3692<\/a>)<\/strong> announced that China’s National Medical Products Administration (NMPA)<\/strong> has accepted its New Drug Application (NDA)<\/strong> for the combination of mirdametinib<\/strong> and almonertinib mesylate tablets (Aumseqa)<\/strong>. The dual\u2011target therapy<\/strong> is indicated for locally advanced or metastatic non\u2011small cell lung cancer (NSCLC)<\/strong> patients with EGFR mutations and MET amplification<\/strong> who have progressed after EGFR tyrosine kinase inhibitor (TKI)<\/strong> therapy.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Hansoh Pharmaceutical Group Company Limited (HKG:\u202f3692)<\/td><\/tr>
Combination<\/strong><\/td>Mirdametinib + Almonertinib (Aumseqa)<\/td><\/tr>
Regulatory Action<\/strong><\/td>NDA accepted by NMPA<\/td><\/tr>
Indication<\/strong><\/td>Advanced NSCLC with EGFR mutations + MET amplification post\u2011EGFR TKI progression<\/td><\/tr>
Drug 1<\/strong><\/td>Mirdametinib (HS\u201110241) \u2013 selective oral c\u2011MET TKI<\/td><\/tr>
Drug 2<\/strong><\/td>Almonertinib (Aumseqa) \u2013 third\u2011generation EGFR\u2011TKI<\/td><\/tr>
Development Status<\/strong><\/td>Both assets self\u2011developed by Hansoh Pharma<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Asset Profiles<\/h2>\n\n\n\n

Mirdametinib (HS\u201110241)<\/h3>\n\n\n\n
Feature<\/th>Detail<\/th><\/tr><\/thead>
Class<\/strong><\/td>Highly selective oral c\u2011MET tyrosine kinase inhibitor<\/strong><\/td><\/tr>
Target<\/strong><\/td>c\u2011MET receptor (encoded by proto\u2011oncogene MET)<\/td><\/tr>
Mechanism<\/strong><\/td>Blocks HGF\u2011mediated signaling \u2192 inhibits tumor cell proliferation, transformation, and metastasis<\/td><\/tr>
Origin<\/strong><\/td>Independently developed by Hansoh Pharma<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Almonertinib (Aumseqa)<\/h3>\n\n\n\n
Feature<\/th>Detail<\/th><\/tr><\/thead>
Class<\/strong><\/td>Third\u2011generation EGFR\u2011TKI<\/strong><\/td><\/tr>
Significance<\/strong><\/td>China’s first domestically developed<\/strong> third\u2011gen EGFR\u2011TKI<\/td><\/tr>
Target<\/strong><\/td>EGFR mutations including T790M resistance<\/td><\/tr>
Origin<\/strong><\/td>Hansoh Pharma proprietary pipeline<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Mechanistic Rationale<\/h2>\n\n\n\n
Pathway<\/th>Target<\/th>Therapeutic Role<\/th><\/tr><\/thead>
EGFR Signaling<\/strong><\/td>Almonertinib<\/td>Inhibits primary driver mutation and resistance mechanisms<\/td><\/tr>
MET Amplification<\/strong><\/td>Mirdametinib<\/td>Blocks bypass signaling pathway driving acquired resistance to EGFR\u2011TKIs<\/td><\/tr>
Combined Effect<\/strong><\/td>Dual inhibition<\/td>Addresses co\u2011occurring EGFR\/MET alterations<\/strong> in TKI\u2011resistant NSCLC<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Strategic Implications<\/h2>\n\n\n\n