{"id":52135,"date":"2025-12-29T12:28:55","date_gmt":"2025-12-29T04:28:55","guid":{"rendered":"https:\/\/flcube.com\/?p=52135"},"modified":"2025-12-29T12:28:57","modified_gmt":"2025-12-29T04:28:57","slug":"livzons-lecankitug-accepted-by-nmpa-as-first-domestic-dual-il-17a-f-psoriasis-drug","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=52135","title":{"rendered":"Livzon\u2019s Lecankitug Accepted by NMPA as First Domestic Dual IL\u201117A\/F Psoriasis Drug"},"content":{"rendered":"\n

Livzon Pharmaceutical Group Inc.<\/strong> (HKG: 1513<\/a>) announced that China\u2019s National Medical Products Administration (NMPA)<\/strong> accepted the marketing authorization application for lecankitug injection<\/strong>, a Category\u202f1 therapeutic biological product<\/strong> and the first domestically developed dual IL\u201117A\/F inhibitor<\/strong> for moderate\u2011to\u2011severe plaque psoriasis. The drug demonstrated superior efficacy to secukinumab in a head\u2011to\u2011head Phase\u202fIII trial.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Details<\/th><\/tr><\/thead>
Application Date<\/strong><\/td>26\u202fDec\u202f2025<\/td><\/tr>
Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Product<\/strong><\/td>Lecankitug injection<\/td><\/tr>
Drug Class<\/strong><\/td>Category\u202f1 therapeutic biological product<\/td><\/tr>
Mechanism<\/strong><\/td>Dual IL\u201117A\/F inhibitor (blocks both IL\u201117A and IL\u201117F)<\/td><\/tr>
Innovation<\/strong><\/td>First domestically developed<\/strong> dual IL\u201117A\/F inhibitor; second globally<\/strong><\/td><\/tr>
Indication<\/strong><\/td>Moderate\u2011to\u2011severe plaque psoriasis<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence<\/h2>\n\n\n\n
Endpoint<\/th>Lecankitug<\/th>Secukinumab (Active Control)<\/th>Outcome<\/th><\/tr><\/thead>
PASI\u202f100 at Week\u202f12<\/strong><\/td>Superior<\/td>Baseline<\/td>Primary endpoint met<\/strong><\/td><\/tr>
PASI\u202f75 at Week\u202f4<\/strong><\/td>Superior<\/td>Baseline<\/td>Rapid onset<\/strong> demonstrated<\/td><\/tr>
PASI\u202f100 at Week\u202f52<\/strong><\/td>Superior<\/td>Baseline<\/td>Long\u2011term durability<\/strong><\/td><\/tr>
Safety Profile<\/strong><\/td>Favorable<\/td>Comparable incidence<\/td>Well\u2011tolerated<\/strong><\/td><\/tr>
Dosing Frequency<\/strong><\/td>Lower than secukinumab<\/td>Standard<\/td>Reduced treatment burden<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Opportunity<\/h2>\n\n\n\n
Metric<\/th>Value<\/th>Context<\/th><\/tr><\/thead>
China Psoriasis Prevalence<\/strong><\/td>~6\u20117\u202fmillion patients (2025)<\/td>~30% have moderate\u2011to\u2011severe disease<\/td><\/tr>
China IL\u201117\/IL\u201123 Market<\/strong><\/td>\u00a58\u201110\u202fbillion<\/strong> (\u2248\u202fUS$1.1\u20111.4\u202fB)<\/td>Dominated by secukinumab, ixekizumab, guselkumab<\/td><\/tr>
Lecankitug Peak Sales<\/strong><\/td>\u00a53\u20115\u202fbillion<\/strong> (\u2248\u202fUS$420\u2011700\u202fM) by 2032<\/td>15\u201120% share of China biologics segment<\/td><\/tr>
Competitive Advantage<\/strong><\/td>Dual IL\u201117A\/F blockade<\/strong> vs. single\u2011target competitors<\/td>Addresses broader inflammatory pathway<\/td><\/tr>
Pricing Strategy<\/strong><\/td>Premium pricing justified by superior efficacy<\/td>NRDL negotiation planned for 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

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