{"id":50388,"date":"2025-12-11T00:00:24","date_gmt":"2025-12-10T16:00:24","guid":{"rendered":"https:\/\/flcube.com\/?p=50388"},"modified":"2025-12-11T00:00:25","modified_gmt":"2025-12-10T16:00:25","slug":"innovents-pecondle-meets-phase-3-il-23-psoriasis-endpoints-with-quarterly-dosing","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=50388","title":{"rendered":"Innovent\u2019s PECONDLE Meets Phase\u202f3 IL\u201123 Psoriasis Endpoints with Quarterly Dosing"},"content":{"rendered":"\n

Innovent Biologics, Inc.<\/strong> (HKG: 1801<\/a>) announced that PECONDLE (picankibart injection, IBI112)<\/strong>, its self\u2011developed anti\u2011IL\u201123p19<\/strong> monoclonal antibody, achieved both primary and key secondary endpoints<\/strong> in the Phase\u202f3 CLEAR\u20112<\/strong> study, a randomized withdrawal and retreatment trial in Chinese patients with moderate\u2011to\u2011severe plaque psoriasis.<\/p>\n\n\n\n

CLEAR\u20112 Study Design<\/h2>\n\n\n\n
Parameter<\/th>Details<\/th><\/tr><\/thead>
Trial ID<\/strong><\/td>NCT06049810<\/td><\/tr>
Design<\/strong><\/td>Prospective, multicenter, randomized, double\u2011blind, placebo\u2011controlled Phase\u202f3 with withdrawal\/retreatment<\/td><\/tr>
Population<\/strong><\/td>Chinese participants with moderate\u2011to\u2011severe plaque psoriasis; N\u202f=\u202f566<\/strong><\/td><\/tr>
Treatment Phase<\/strong><\/td>All participants received picankibart through Week\u202f32<\/strong><\/td><\/tr>
Randomization<\/strong><\/td>Responders achieving PASI\u202f90<\/strong> at Week\u202f32 were re\u2011randomized at Week\u202f32 to:
\u2022 Maintenance:<\/strong> picankibart 100\u202fmg or 200\u202fmg
\u2022 Withdrawal:<\/strong> placebo<\/td><\/tr>
Primary Endpoint<\/strong><\/td>Proportion maintaining PASI\u202f90<\/strong> at Week\u202f56<\/strong><\/td><\/tr>
Key Secondary Endpoints<\/strong><\/td>PASI\u202f75, PASI\u202f100, sPGA\u202f0\/1, sPGA\u202f0, DLQI\u202f0\/1 at Week\u202f56<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Efficacy Results at Week\u202f56<\/h2>\n\n\n\n
Endpoint<\/th>Picankibart 100\u202fmg Maintenance<\/th>Picankibart 200\u202fmg Maintenance<\/th>Corresponding Withdrawal Group<\/th>P\u2011value<\/th><\/tr><\/thead>
PASI\u202f90 (Primary)<\/strong><\/td>89.3%<\/strong><\/td>90.1%<\/strong><\/td>37.7% (100\u202fmg cohort)
51.7% (200\u202fmg cohort)<\/td>		<\u202f0.0001<\/strong> (both)<\/td><\/tr>
PASI\u202f75<\/strong><\/td>94.1%<\/td>95.3%<\/td>48.2% \/ 62.1%<\/td><\u202f0.0001<\/td><\/tr>
PASI\u202f100<\/strong><\/td>65.7%<\/td>68.4%<\/td>12.3% \/ 18.9%<\/td><\u202f0.0001<\/td><\/tr>
sPGA\u202f0\/1<\/strong><\/td>91.2%<\/td>92.5%<\/td>42.1% \/ 55.8%<\/td><\u202f0.0001<\/td><\/tr>
sPGA\u202f0<\/strong><\/td>58.9%<\/td>61.2%<\/td>9.8% \/ 14.5%<\/td><\u202f0.0001<\/td><\/tr>
DLQI\u202f0\/1<\/strong><\/td>71.3%<\/td>73.6%<\/td>22.4% \/ 31.2%<\/td><\u202f0.0001<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Robust data demonstrate that quarterly dosing of PECONDLE provides sustained and reliable superior efficacy compared to treatment withdrawal.<\/strong><\/p>\n\n\n\n

Market Opportunity & Competitive Landscape<\/h2>\n\n\n\n
Metric<\/th>Value<\/th>Implication<\/th><\/tr><\/thead>
China Psoriasis Prevalence<\/strong><\/td>~\u202f6.5\u202fmillion moderate\u2011to\u2011severe patients (2024)<\/td>Growing diagnosis rate; <\u202f15% receive biologics<\/td><\/tr>
China IL\u201123\/IL\u201117 Market Size<\/strong><\/td>\u00a54.2\u202fbillion (\u2248\u202fUS$585\u202fM)<\/td>Dominated by Skyrizi<\/strong> (AbbVie) and Tremfya<\/strong> (J&J)<\/td><\/tr>
PECONDLE Differentiation<\/strong><\/td>Quarterly dosing<\/strong> (vs. Skyrizi q8w, Tremfya q8w); local manufacturing cost advantage<\/strong><\/td><\/td><\/tr>
Peak Sales Forecast (2030)<\/strong><\/td>\u00a51.8\u20112.2\u202fbillion<\/strong> (\u2248\u202fUS$250\u2011305\u202fM)<\/td>12\u201115% share of IL\u201123 class, driven by dosing convenience<\/td><\/tr>
Regulatory Status<\/strong><\/td>NMPA approved Nov\u202f2025 for moderate\u2011to\u2011severe plaque psoriasis; NRDL negotiation slated for 2026<\/td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

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