{"id":49341,"date":"2025-11-28T20:17:38","date_gmt":"2025-11-28T12:17:38","guid":{"rendered":"https:\/\/flcube.com\/?p=49341"},"modified":"2025-11-28T20:17:41","modified_gmt":"2025-11-28T12:17:41","slug":"innovents-picankibart-wins-nmpa-approval-for-psoriasis-as-il-23p19-inhibitor","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=49341","title":{"rendered":"Innovent’s Picankibart Wins NMPA Approval for Psoriasis as IL-23p19 Inhibitor"},"content":{"rendered":"\n

Innovent Biologics, Inc.<\/strong> (HKG: 1801<\/a>) announced that Picankibart Monoclonal Antibody Injection (IBI112)<\/strong>, branded XINMEIYUE<\/strong>, received National Medical Products Administration (NMPA) marketing approval<\/strong> for adult patients with moderate\u2011to\u2011severe plaque psoriasis<\/strong>, becoming the latest IL\u201123p19 inhibitor to enter China\u2019s dermatology market.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Product<\/strong><\/td>Picankibart (IBI112) \u2013 XINMEIYUE<\/td><\/tr>
Company<\/strong><\/td>Innovent Biologics (HKG: 1801)<\/td><\/tr>
Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Approval Type<\/strong><\/td>Marketing authorization (Category\u202f1 innovative drug)<\/td><\/tr>
Indication<\/strong><\/td>Moderate\u2011to\u2011severe plaque psoriasis (adult systemic therapy candidates)<\/td><\/tr>
Mechanism<\/strong><\/td>IL\u201123p19 subunit inhibitor (blocks IL\u201123 receptor signaling)<\/td><\/tr>
Study Basis<\/strong><\/td>CLEAR\u20111 Phase\u202fIII trial (NCT05645627)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence \u2013 CLEAR\u20111 Trial<\/h2>\n\n\n\n
Endpoint<\/th>Week\u202f16 (Picankibart vs. Placebo)<\/th>Week\u202f52 (Maintenance)<\/th><\/tr><\/thead>
PASI\u202f90<\/strong><\/td>80.3% vs. 2.0%<\/strong> (P\u202f<\u202f0.0001)<\/td>Sustained high response (100\u202fmg\/200\u202fmg q12w)<\/td><\/tr>
sPGA\u202f0\/1<\/strong><\/td>93.5% vs. 13.1%<\/strong> (P\u202f<\u202f0.0001)<\/td>Sustained clearance<\/td><\/tr>
PASI\u202f75\/100<\/strong><\/td>Significantly higher vs. placebo (P\u202f<\u202f0.0001)<\/td>Maintained efficacy<\/td><\/tr>
Special Sites<\/strong><\/td>Improved scalp, nail, palmoplantar, perineal psoriasis<\/td>\u2013<\/td><\/tr>
Safety<\/strong><\/td>Most common: upper respiratory tract infection; no new signals<\/td>Favorable long\u2011term profile<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Context & Outlook<\/h2>\n\n\n\n
Metric<\/th>Value<\/th><\/tr><\/thead>
China Psoriasis Patients<\/strong><\/td>~6.5\u202fmillion<\/strong> (moderate\u2011to\u2011severe: 2.1\u202fmillion)<\/td><\/tr>
Biologics Penetration<\/strong><\/td>~25% (525,000 patients)<\/td><\/tr>
IL\u201123 Inhibitor Market Size<\/strong><\/td>\u00a54.8\u202fbillion (~US$660\u202fmillion)<\/td><\/tr>
Growth CAGR<\/strong><\/td>22% (2024\u20112030)<\/td><\/tr>
Peak Sales Forecast (Picankibart)<\/strong><\/td>\u00a52.5\u20113.2\u202fbillion<\/strong> (~US$340\u2011440\u202fmillion) by 2031<\/td><\/tr>
Market Share Target<\/strong><\/td>15\u201120% of IL\u201123 class (competing with Janssen\u2019s Tremfya<\/strong>, AbbVie\u2019s Skyrizi<\/strong>)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n