Innovent Biologics achieves key milestone as PECONDLE delivers sustained efficacy in Phase 3 psoriasis trial

Innovent Biologics (HKEX: 01801) announced that PECONDLE (picankibart injection), its self-developed IL-23p19 monoclonal antibody, met all primary and key secondary endpoints in the pivotal Phase 3 CLEAR-2 study for moderate-to-severe plaque psoriasis. The randomized withdrawal and retreatment trial demonstrated robust long-term efficacy and sustained response even post-treatment discontinuation, positioning PECONDLE as a potential cornerstone in the biologics market for chronic psoriasis management.

The CLEAR-2 trial evaluated quarterly dosing regimens and retreatment outcomes, offering new insights into maintenance therapy for psoriasis. With over 566 patients enrolled across China, the study reinforces PECONDLE’s disease-modifying effect and confirms its durability both during maintenance and after withdrawal. Innovent received approval from China’s National Medical Products Administration (NMPA) in November 2025 for PECONDLE as the country’s first domestically developed IL-23p19 monoclonal antibody.

How was the CLEAR-2 trial structured and what endpoints did it target?

CLEAR-2 (NCT06049810) was designed as a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial with a randomized withdrawal and retreatment structure. All participants initially received picankibart for 32 weeks. Those who achieved at least a 90% improvement in the Psoriasis Area Severity Index (PASI 90) were then re-randomized into either a continued maintenance group (100 mg or 200 mg) or a placebo group for withdrawal.

The primary endpoint focused on the proportion of participants maintaining PASI 90 at Week 56. This metric serves as a validated benchmark for sustained skin clearance and long-term efficacy in psoriasis treatment. Secondary endpoints included PASI 75, PASI 100, static Physician Global Assessment (sPGA) scores of 0 or 1, and Dermatology Life Quality Index (DLQI) scores, assessing both symptom resolution and quality of life improvements.

What efficacy outcomes did PECONDLE achieve across all study arms?

At Week 56, both picankibart dosage groups significantly outperformed the withdrawal arms in maintaining PASI 90 response. Specifically, 89.3% of participants on 100 mg and 90.1% on 200 mg retained deep skin clearance, compared to only 37.7% and 51.7% in the placebo arms. These differences were highly statistically significant (P < 0.0001), confirming PECONDLE’s superiority as a maintenance treatment.

All key secondary endpoints were met. Higher proportions of patients in the maintenance arms achieved complete skin clearance (PASI 100), partial clearance (PASI 75), and favorable sPGA and DLQI scores. These findings indicate that PECONDLE not only sustains lesion control but also enhances overall quality of life for patients on a quarterly dosing schedule.

Even among patients who discontinued treatment, approximately half retained PASI 90 for up to 24 weeks post-last dose, illustrating the drug’s potential for long-term disease modification beyond active therapy.

What are the implications of picankibart’s post-withdrawal durability?

A notable outcome of the CLEAR-2 study was the prolonged efficacy observed in patients who discontinued picankibart treatment after achieving PASI 90. The withdrawal groups maintained their skin clearance for a median duration of 20.4 to 24.6 weeks (equivalent to 32.4 to 36.6 weeks post-last dose). While these patients eventually experienced relapse, the extended period of remission speaks to the drug’s durable pharmacodynamic effect.

However, the risk of losing PASI 90 response was significantly lower in the maintenance groups, reinforcing the importance of continuous therapy in chronic plaque psoriasis. The findings highlight the possibility of offering treatment holidays in select patients without immediate deterioration but also suggest that quarterly dosing remains optimal for long-term control.

What safety signals were observed during the CLEAR-2 study?

Picankibart maintained a favorable safety profile throughout the CLEAR-2 trial. Innovent Biologics confirmed that no new safety concerns emerged compared to earlier clinical data. This aligns with the safety expectations of IL-23p19 inhibitors, which are generally well-tolerated with lower infection risk than older biologics targeting broader cytokine pathways.

Innovent emphasized the lack of treatment-emergent serious adverse events and confirmed that the safety data will support further lifecycle expansion into related autoimmune indications such as ulcerative colitis and psoriatic arthritis.

What did clinical experts say about the results and treatment strategy?

Professor Shi Yuling of Shanghai Skin Disease Hospital, the principal investigator for the trial, stated that the CLEAR-2 data offer meaningful evidence supporting maintenance therapy with IL-23p19 inhibitors. According to her remarks, the study validates the long-term stability and remission potential of picankibart, as well as retreatment strategies for patients who relapse post-withdrawal.

Dr. Lei Qian, Chief R&D Officer of General Biomedicine at Innovent Biologics, positioned PECONDLE as a next-generation biologic offering deep remission, improved safety, and convenience via quarterly injections. He confirmed the company’s intention to expand indications and maintain lifecycle momentum through additional trials targeting adolescent psoriasis and psoriatic arthritis.

How does picankibart compare to existing biologics in China’s psoriasis market?

Since 2019, China’s psoriasis treatment landscape has increasingly embraced biologics, with IL-23p19 inhibitors gaining traction for their favorable safety and efficacy profiles. Compared to older options like methotrexate, cyclosporine A, and retinoic acids, biologics such as picankibart offer faster onset, more robust lesion clearance, and reduced relapse risk.

Picankibart is the first IL-23p19 inhibitor developed and approved domestically in China, competing with international products such as guselkumab (Janssen) and risankizumab (AbbVie). Its long-lasting response, coupled with a quarterly dosing schedule, may provide a strategic edge in improving patient adherence and access within China’s growing psoriasis population, which exceeds 7 million.

Analysts tracking Innovent’s biologics pipeline suggest that PECONDLE could become a high-value anchor therapy in the firm’s autoimmune portfolio, especially if pricing remains favorable compared to imported biologics.

What other clinical programs are underway for picankibart?

Innovent confirmed that PECONDLE is being evaluated across multiple indications. In addition to CLEAR-2, the company has completed CLEAR-1, a Phase 3 trial in moderate-to-severe plaque psoriasis, a Phase 3 trial in biologics-experienced psoriasis patients, and a Phase 2 trial in moderate-to-severe ulcerative colitis.

All of these studies have met their respective primary endpoints. A Phase 3 study known as CLEAR-3 remains ongoing, alongside new trials exploring efficacy in adolescent psoriasis and adult psoriatic arthritis. The expansive clinical roadmap signals Innovent’s intent to position picankibart as a multipurpose IL-23 inhibitor across dermatologic and gastroenterological indications.

What is Innovent’s broader pipeline and strategic positioning in autoimmune diseases?

Founded in 2011, Innovent Biologics has launched 17 products across oncology, cardiovascular, metabolic, autoimmune, and ophthalmic categories. The Chinese biopharma firm maintains over 15 assets in early-stage clinical development, 4 pivotal-stage candidates, and 1 product under regulatory review.

In autoimmune and inflammatory disease, Innovent is increasingly focused on lifecycle depth and competitive differentiation through proprietary innovation. Its global partnerships with companies like Eli Lilly, Takeda, and LG Chem enable pipeline synergy and global market access.

For picankibart specifically, the company’s strategy centers on lifecycle expansion into gastroenterology and rheumatology, real-world data generation for label optimization, and pricing parity with imported IL-23 agents.

What are the institutional takeaways and outlook for Innovent’s psoriasis franchise?

The CLEAR-2 results offer institutional investors a clear validation point for Innovent’s autoimmune expansion strategy. The ability to demonstrate maintenance superiority and durable efficacy post-withdrawal is particularly meaningful in the chronic disease market, where long-term adherence, dosing convenience, and quality-of-life improvements can directly influence market uptake and formulary access.

While Innovent Biologics does not yet report PECONDLE sales figures, analysts believe it could contribute meaningfully to revenue growth from 2026 onward. Given its domestic-first development strategy and favorable safety profile, the drug may also find traction in cost-conscious healthcare segments.

Investor sentiment on Innovent remains broadly positive following NMPA approval in November 2025 and the strong data readout from CLEAR-2. The next set of catalysts will likely come from international licensing agreements, real-world data collection, and potential label expansions into ulcerative colitis and psoriatic arthritis.

What are the key takeaways from Innovent Biologics’ PECONDLE Phase 3 CLEAR-2 trial?

• Innovent Biologics’ picankibart (PECONDLE) met all primary and secondary endpoints in the Phase 3 CLEAR-2 trial for plaque psoriasis.
• The trial showed 89–90% PASI 90 maintenance in the picankibart groups at Week 56 vs. 37–52% in placebo withdrawal groups.
• Secondary endpoints including PASI 75, PASI 100, sPGA, and DLQI scores were all significantly improved in the treatment arms.
• Post-withdrawal durability showed ~24 weeks of sustained response, confirming long-acting benefits of IL-23p19 blockade.
• The safety profile remained consistent with no new safety signals detected.
• Experts highlighted the study’s importance as the first of its kind in China using randomized withdrawal and retreatment design.
• Innovent plans further trials in adolescent psoriasis, ulcerative colitis, and psoriatic arthritis.
• Institutional sentiment remains optimistic, with analysts forecasting commercial ramp-up from 2026 onward.
• PECONDLE could help Innovent gain significant ground in China’s growing biologics market for autoimmune diseases.
• Global partnerships and lifecycle management are central to Innovent’s next phase of commercialization.