{"id":58304,"date":"2026-02-27T19:53:58","date_gmt":"2026-02-27T11:53:58","guid":{"rendered":"https:\/\/flcube.com\/?p=58304"},"modified":"2026-02-27T19:53:59","modified_gmt":"2026-02-27T11:53:59","slug":"akesos-manfidokimab-nda-accepted-by-nmpa-anti-il-4r%ce%b1-mab-targets-moderate-to-severe-atopic-dermatitis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=58304","title":{"rendered":"Akeso’s Manfidokimab NDA Accepted by NMPA \u2013 Anti-IL-4R\u03b1 mAb Targets Moderate-to-Severe Atopic Dermatitis"},"content":{"rendered":"\n

Akeso, Inc. (HKG:\u202f9926<\/a>)<\/strong> announced that China’s National Medical Products Administration (NMPA)<\/strong> has formally accepted the New Drug Application (NDA)<\/strong> for manfidokimab (AK120)<\/strong>, its self\u2011developed anti\u2011IL\u20114R\u03b1 monoclonal antibody<\/strong> for moderate\u2011to\u2011severe atopic dermatitis (AD)<\/strong>. The submission is supported by positive Phase III data<\/strong> from the AK120\u2011301 trial<\/strong>, which achieved all primary and key secondary endpoints<\/strong> with statistically significant and clinically meaningful results<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Akeso, Inc. (HKG:\u202f9926)<\/td><\/tr>
Product<\/strong><\/td>Manfidokimab (AK120)<\/td><\/tr>
Drug Class<\/strong><\/td>Humanized anti\u2011IL\u20114R\u03b1 monoclonal antibody<\/td><\/tr>
Development Status<\/strong><\/td>Independently developed<\/td><\/tr>
Regulatory Action<\/strong><\/td>NDA accepted by NMPA<\/td><\/tr>
Indication<\/strong><\/td>Moderate\u2011to\u2011severe atopic dermatitis (AD)<\/td><\/tr>
Supporting Study<\/strong><\/td>Phase III AK120\u2011301<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Mechanism of Action<\/h2>\n\n\n\n
Component<\/th>Function<\/th><\/tr><\/thead>
Target<\/strong><\/td>IL\u20114R\u03b1 (interleukin\u20114 receptor alpha)<\/strong><\/td><\/tr>
Shared Receptor<\/strong><\/td>Common subunit for IL\u20114<\/strong> and IL\u201113<\/strong> receptors<\/td><\/tr>
Mechanism<\/strong><\/td>Specific binding to IL\u20114R\u03b1 \u2192 dual blockade of IL\u20114 and IL\u201113 signaling<\/td><\/tr>
Therapeutic Effect<\/strong><\/td>Inhibition of Type 2 immune\u2011inflammatory responses driving AD pathogenesis<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Phase III AK120-301 Results<\/h2>\n\n\n\n
Endpoint Category<\/th>Achievement<\/th><\/tr><\/thead>
Primary Endpoints<\/strong><\/td>All achieved<\/td><\/tr>
Key Secondary Endpoints<\/strong><\/td>All achieved<\/td><\/tr>
Pre\u2011specified Secondary Endpoints<\/strong><\/td>Multiple achieved<\/td><\/tr>
Statistical Significance<\/strong><\/td>Yes<\/td><\/tr>
Clinical Meaningfulness<\/strong><\/td>Yes<\/td><\/tr>
Skin Lesion Improvement<\/strong><\/td>Marked improvement demonstrated<\/td><\/tr>
Pruritus (Itch) Relief<\/strong><\/td>Superior early efficacy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

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