Livzon Pharmaceutical Group Inc. (HKG: 1513) announced that China’s National Medical Products Administration (NMPA) accepted the marketing authorization application for lecankitug injection, a Category 1 therapeutic biological product and the first domestically developed dual IL‑17A/F inhibitor for moderate‑to‑severe plaque psoriasis. The drug demonstrated superior efficacy to secukinumab in a head‑to‑head Phase III trial.
Regulatory Milestone
Item
Details
Application Date
26 Dec 2025
Agency
NMPA (China)
Product
Lecankitug injection
Drug Class
Category 1 therapeutic biological product
Mechanism
Dual IL‑17A/F inhibitor (blocks both IL‑17A and IL‑17F)
Innovation
First domestically developed dual IL‑17A/F inhibitor; second globally
Indication
Moderate‑to‑severe plaque psoriasis
Clinical Evidence
Endpoint
Lecankitug
Secukinumab (Active Control)
Outcome
PASI 100 at Week 12
Superior
Baseline
Primary endpoint met
PASI 75 at Week 4
Superior
Baseline
Rapid onset demonstrated
PASI 100 at Week 52
Superior
Baseline
Long‑term durability
Safety Profile
Favorable
Comparable incidence
Well‑tolerated
Dosing Frequency
Lower than secukinumab
Standard
Reduced treatment burden
Market Opportunity
Metric
Value
Context
China Psoriasis Prevalence
~6‑7 million patients (2025)
~30% have moderate‑to‑severe disease
China IL‑17/IL‑23 Market
¥8‑10 billion (≈ US$1.1‑1.4 B)
Dominated by secukinumab, ixekizumab, guselkumab
Lecankitug Peak Sales
¥3‑5 billion (≈ US$420‑700 M) by 2032
15‑20% share of China biologics segment
Competitive Advantage
Dual IL‑17A/F blockade vs. single‑target competitors
Addresses broader inflammatory pathway
Pricing Strategy
Premium pricing justified by superior efficacy
NRDL negotiation planned for 2026
Strategic Implications
For Livzon:First‑in‑class domestic innovation validates R&D platform; dual‑target mechanism differentiates from imported IL‑17 inhibitors; Category 1 status ensures market exclusivity; potential for global out‑licensing based on China data.
For Patients:Superior PASI 100 rates vs. secukinumab offer hope for complete skin clearance; rapid onset and long‑term durability improve quality of life; lower dosing frequency reduces injection burden.
For Market: Demonstrates China’s capability to develop best‑in‑class biologics; dual IL‑17A/F inhibition could become new standard in psoriasis; competitive pressure on multinational players to innovate.
Forward‑Looking Statements This brief contains forward‑looking statements regarding lecankitug’s regulatory review timeline, market penetration, and competitive positioning. Actual results may differ due to NMPA feedback, competitive responses, or pricing negotiations.-Fineline Info & Tech
By Fineline Cube