{"id":78738,"date":"2026-09-04T15:36:44","date_gmt":"2026-09-04T07:36:44","guid":{"rendered":"https:\/\/flcube.com\/?p=78738"},"modified":"2026-09-04T15:36:45","modified_gmt":"2026-09-04T07:36:45","slug":"hengruis-drotokibart-bla-accepted-by-nmpa-for-moderate-to-severe-atopic-dermatitis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=78738","title":{"rendered":"Hengrui\u2019s drotokibart BLA Accepted by NMPA for Moderate-to-Severe Atopic Dermatitis"},"content":{"rendered":"\n

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276<\/a>; HKG: 1276<\/a>)<\/strong> announced that the National Medical Products Administration (NMPA)<\/strong> has accepted its Biologics License Application (BLA)<\/strong> for drotokibart (SHR-1819)<\/strong> in the treatment of adult patients with moderate-to-severe atopic dermatitis<\/strong> whose disease is inadequately controlled with topical therapies, or for whom such therapies are not advisable. The acceptance moves the company\u2019s independently developed IL-4R\u03b1 monoclonal antibody<\/strong> one step closer to potential approval in one of immunology\u2019s fastest-growing therapeutic categories.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/td>National Medical Products Administration (NMPA)<\/strong>, China<\/td><\/tr>
Approval Type<\/td>Biologics License Application (BLA) acceptance<\/td><\/tr>
Product<\/td>drotokibart (SHR-1819)<\/strong><\/td><\/tr>
Indication<\/td>Moderate-to-severe atopic dermatitis<\/strong> in adults inadequately controlled by, or unsuitable for, topical therapies<\/td><\/tr>
Date<\/td>03 Sept 2026<\/td><\/tr>
Next Steps<\/td>NMPA technical review leading to potential marketing approval in China<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile & Mechanism of Action<\/h2>\n\n\n\n