{"id":50197,"date":"2025-12-08T22:07:27","date_gmt":"2025-12-08T14:07:27","guid":{"rendered":"https:\/\/flcube.com\/?p=50197"},"modified":"2025-12-08T22:07:29","modified_gmt":"2025-12-08T14:07:29","slug":"junshi-biosciences-roconkibart-psoriasis-nmpa-acceptance","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=50197","title":{"rendered":"Junshi Biosciences roconkibart psoriasis NMPA Acceptance"},"content":{"rendered":"\n

Shanghai Junshi Biosciences Co., Ltd.<\/strong> (HKG: 1877<\/a>, SHA: 688180<\/a>) announces that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for roconkibart injection (JS005)<\/strong> for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.<\/p>\n\n\n\n

Regulatory Milestone & Study Design<\/h2>\n\n\n\n
Attribute<\/th>Details<\/th><\/tr><\/thead>
Company<\/strong><\/td>Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180)<\/td><\/tr>
Product<\/strong><\/td>Roconkibart injection (JS005)<\/td><\/tr>
Regulatory Status<\/strong><\/td>NMPA NDA acceptance<\/td><\/tr>
Indication<\/strong><\/td>Moderate-to-severe plaque psoriasis (adult, systemic\/phototherapy candidates)<\/td><\/tr>
Study Design<\/strong><\/td>Multi-center, randomized, double-blind, parallel, placebo-controlled Phase 3<\/td><\/tr>
Study Name<\/strong><\/td>JS005-005-III-PsO (pivotal registrational)<\/td><\/tr>
Clinical Sites<\/strong><\/td>60 sites across China<\/td><\/tr>
Patients Enrolled<\/strong><\/td>747 patients<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

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

Roconkibart<\/strong> is a specific anti-IL-17A monoclonal antibody<\/strong> independently developed by Junshi Biosciences. The therapy targets the IL-17A cytokine, a key driver of psoriasis pathogenesis, to reduce inflammation and normalize skin cell turnover.<\/p>\n\n\n\n

Clinical Efficacy & Safety Data<\/h2>\n\n\n\n
Endpoint<\/th>Roconkibart Result vs Placebo<\/th>Clinical Significance<\/th><\/tr><\/thead>
PASI 75<\/strong><\/td>Significantly improved at 12 weeks<\/td>Superior skin clearance<\/td><\/tr>
PASI 90\/100<\/strong><\/td>Significantly improved at 12 weeks<\/td>Higher threshold responses<\/td><\/tr>
sPGA 0 or 1<\/strong><\/td>Significantly improved at 12 weeks<\/td>Physician-assessed clearance<\/td><\/tr>
Durability<\/strong><\/td>Stable efficacy through 52 weeks<\/td>Sustained treatment effect<\/td><\/tr>
Safety<\/strong><\/td>Overall favorable profile<\/td>Supports long-term use<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Key Finding<\/strong>: Treatment demonstrated significantly superior efficacy<\/strong> vs. placebo, with stable results throughout 52-week treatment period.<\/p>\n\n\n\n

Market Context & Strategic Outlook<\/h2>\n\n\n\n