Livzon/Kanova’s Lecankitug Gets China Approval After Beating Secukinumab in Phase 3 Psoriasis Trial
China’s National Medical Products Administration (NMPA) has approved lecankitug (LZM012/XKH004), an IL-17A/IL-17F-targeting monoclonal antibody jointly developed by Livzon Pharmaceutical Group and Beijing Kanova Biopharmaceutical, for the treatment of moderate-to-severe plaque psoriasis.
The approval covers adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. According to Livzon’s regulatory disclosure, the subcutaneous formulation will be marketed in China under the brand name LIBETAN (丽倍坦).
The approval establishes lecankitug as the first domestically developed IL-17A/F dual-targeting biologic approved in China, adding a new treatment option to an increasingly competitive psoriasis market. (paper.cnstock.com)
Dual Blockade of IL-17A and IL-17F
Lecankitug is a humanized monoclonal antibody designed to simultaneously neutralize interleukin-17A (IL-17A) and interleukin-17F (IL-17F), two closely related pro-inflammatory cytokines that play important roles in the pathogenesis of psoriasis.
The antibody targets IL-17A/IL-17F signaling, including the IL-17A/A and IL-17F/F homodimers as well as the IL-17A/F heterodimer, potentially providing broader suppression of IL-17-driven inflammation than agents targeting IL-17A alone.
IL-17A and IL-17F are structurally related cytokines produced prominently by activated Th17 cells. Both contribute to the inflammatory cascade underlying psoriatic skin lesions, making simultaneous blockade of the two cytokines an increasingly validated therapeutic strategy.
According to Livzon Pharmaceutical Group, lecankitug is jointly developed by its subsidiary Zhuhai Livzon MABPharm and Beijing Kanova Biopharmaceutical. Livzon describes the therapy as China’s first independently developed IL-17A/F dual-targeting innovative biologic. (paper.cnstock.com)
Phase III Trial Shows Superiority to Secukinumab
The NMPA approval follows compelling results from a randomized, multicenter, double-blind Phase III head-to-head trial comparing lecankitug directly against secukinumab (Cosentyx), a well-established IL-17A inhibitor.
Rather than relying on placebo as its principal comparator, the study used an active control and selected PASI 100 at Week 12 — complete skin clearance — as its primary efficacy endpoint, setting a high bar for demonstrating clinical benefit.
At Week 12, 49.5% of patients receiving lecankitug achieved PASI 100, compared with 40.2% of patients receiving secukinumab.
The result established not only non-inferiority but also statistical superiority of lecankitug over secukinumab for the primary endpoint. (livzon.com.cn)
Faster Onset of Action
Lecankitug also demonstrated an early separation from secukinumab.
At Week 4, 65.7% of lecankitug-treated patients achieved PASI 75, compared with 50.3% in the secukinumab group.
Notably, patients receiving lecankitug had received only their initial Week 0 injection by this point, whereas the secukinumab regimen involved dosing at Weeks 0, 1, 2 and 3.
The finding suggests that dual IL-17A/F blockade with lecankitug can produce a particularly rapid clinical response despite requiring fewer initial injections. (livzon.com.cn)
Complete Skin Clearance Reaches 75.9% at Week 52
The benefits observed early in treatment were sustained — and increased — over longer-term follow-up.
Among patients receiving lecankitug 320 mg every four weeks (Q4W) as maintenance treatment, the PASI 100 response rate reached 75.9% at Week 52.
Patients switched to the less frequent 320 mg every eight weeks (Q8W) maintenance regimen achieved a Week 52 PASI 100 rate of 62.6%.
By comparison, the Week 52 PASI 100 response rate with secukinumab 300 mg Q4W was 61.6%.
That means lecankitug’s Q4W regimen produced a substantially higher complete-clearance rate than the active comparator, while its Q8W regimen maintained a numerically comparable response despite doubling the interval between maintenance doses. (livzon.com.cn)
The reported Week 52 results were:
- Lecankitug 320 mg Q4W: PASI 100 — 75.9%
- Lecankitug 320 mg Q8W: PASI 100 — 62.6%
- Secukinumab 300 mg Q4W: PASI 100 — 61.6%
Livzon reported that the overall incidence and spectrum of adverse events with lecankitug were comparable to those observed in the secukinumab group. (livzon.com.cn)
Potential Dosing Advantage
The dosing profile could become an important differentiator for lecankitug in China’s competitive psoriasis biologics market.
According to Livzon, lecankitug does not require an initial intensive induction period, reducing the number of injections compared with the secukinumab regimen evaluated in the Phase III trial.
The Q8W maintenance results are also noteworthy. Achieving a 62.6% PASI 100 rate at Week 52 with dosing once every eight weeks suggests that some patients could potentially maintain complete or near-complete disease control with substantially fewer injections.
This combination of rapid onset, high complete-clearance rates and potentially less frequent maintenance dosing could help differentiate lecankitug from established IL-17 therapies.
A Growing IL-17A/F Drug Class
The approval also underscores growing interest in simultaneously targeting IL-17A and IL-17F rather than IL-17A alone.
IL-17A-targeting therapies have already transformed treatment for moderate-to-severe plaque psoriasis, but dual inhibition seeks to suppress a broader component of the IL-17 inflammatory pathway.
Lecankitug’s head-to-head Phase III results provide clinical support for that approach: the therapy achieved a higher complete skin-clearance rate than the established IL-17A inhibitor secukinumab at both Week 12 and Week 52 with the Q4W regimen.
Livzon said approximately RMB 223.31 million had been directly invested in the development of lecankitug as of its latest announcement. The company estimates that China has more than 7 million psoriasis patients, with plaque psoriasis accounting for approximately 80% of cases. (paper.cnstock.com)
Beyond Psoriasis
Lecankitug’s development program is also extending beyond plaque psoriasis.
Kanova is evaluating the antibody for ankylosing spondylitis, another inflammatory disease in which IL-17 signaling plays an important pathogenic role. A randomized Phase III program has been conducted in patients with moderately to severely active ankylosing spondylitis. (pmc.ncbi.nlm.nih.gov)
The NMPA approval in plaque psoriasis therefore represents both a commercial milestone for Livzon and Kanova and an important clinical validation of their dual IL-17A/F antibody platform.
With a 49.5% PASI 100 rate at Week 12, 75.9% complete skin clearance at Week 52 with Q4W maintenance, rapid Week 4 responses, and the potential for Q8W maintenance dosing, lecankitug could emerge as an important new competitor in China’s rapidly evolving biologics market for psoriasis.
References
- Livzon Pharmaceutical Group. Voluntary Announcement — Obtaining the Drug Registration Certificate for Lecankitug Injection (Subcutaneous Injection). August 27, 2026. HKEX announcement
- Livzon Pharmaceutical Group. Announcement on Obtaining the Drug Registration Certificate for Lecankitug. August 28, 2026. NMPA approval disclosure via Shanghai Securities News
- Livzon Pharmaceutical Group. LZM012 Head-to-Head Phase III Clinical Study Versus Secukinumab Reports Results. July 22, 2025. Read the Livzon Phase III announcement
- Chinese Securities Journal. Phase III Clinical Trial of Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection Meets Primary Endpoint. July 22, 2025. Read the Phase III disclosure
- Kaplon H, et al. Antibodies to watch in 2026. Review of monoclonal antibodies progressing toward regulatory approval, including lecankitug. Read the article on PubMed Central
