Huaota's Anti-IL-17A Antibody HB0017 Achieves 95.7% PASI 75 in Phase III; NDA Accepted by China's NMPA for Moderate-to-Severe Plaque Psoriasis

Shanghai Huaota Biopharmaceutical Co., Ltd., a subsidiary of Huahai Pharmaceutical Co., Ltd., has taken a significant step toward commercializing its first autoimmune disease treatment, with China's drug regulator accepting its new drug application for HB0017, an anti-IL-17A monoclonal antibody injection targeting moderate-to-severe plaque psoriasis.

The Center for Drug Evaluation under China's National Medical Products Administration accepted the filing on June 24, 2026, assigning it the application number CXSS2600100. The filing covers HB0017 as a Class 1 innovative biologic drug for the treatment of moderate-to-severe plaque psoriasis, ankylosing spondylitis, and other autoimmune conditions.

The milestone marks Huaota's first product to reach the regulatory doorstep for commercial approval, a pivotal moment for the research-driven biopharmaceutical company that has been developing the drug independently.

HB0017 is a recombinant humanized monoclonal antibody that targets interleukin-17A (IL-17A), a key pro-inflammatory cytokine driving the inflammatory cascade in psoriasis and other autoimmune diseases. By blocking IL-17A from binding to its receptor, the drug effectively suppresses downstream inflammatory signaling pathways.

Strong Phase III Results

The core evidence underpinning the NDA comes from a pivotal Phase III clinical trial evaluating HB0017 in moderate-to-severe plaque psoriasis. The study was led by Professor Zhang Jianzhong and Professor Zhou Cheng at Peking University People's Hospital, with more than 40 research centers across China enrolling a total of 408 patients.

In November 2025, Huaota announced that the trial had successfully completed unblinding, meeting all prespecified primary and key secondary efficacy endpoints. Top-line data showed that after 12 weeks of treatment, 95.7% of patients in the HB0017 group achieved PASI 75 — a 75% or greater reduction in the Psoriasis Area and Severity Index — compared with just 7.4% in the placebo group.

In the secondary endpoints, 87.0% of patients in the treatment arm achieved a static Physician's Global Assessment score of 0 or 1 (sPGA 0/1), indicating clear or almost clear skin, versus 1.9% in the placebo group. Meanwhile, 88.0% of patients achieved PASI 90 — a 90% or greater improvement — also significantly outperforming the placebo arm.

Maintenance Dosing Advantage

Perhaps the most commercially compelling aspect of HB0017 lies in its maintenance-phase dosing regimen. During the maintenance period, the dosing interval could be extended to once every eight weeks while sustaining stable efficacy. At the 52-week mark, 92.3% of patients in the every-four-weeks group maintained an sPGA 0/1 response, and 79.1% maintained PASI 100 — complete clearance. In the every-eight-weeks group, the sPGA 0/1 maintenance rate was 85.9%, and the PASI 100 maintenance rate reached 65.8%.

The every-eight-weeks maintenance schedule represents a differentiated advantage over existing IL-17A monoclonal antibody products on the market, potentially offering significantly improved convenience for patients managing a chronic condition.

On safety, the types and severity of adverse events observed were within expected ranges, with no new safety signals identified.

Expanding Into Ankylosing Spondylitis

Beyond psoriasis, Huaota is simultaneously advancing a Phase III trial of HB0017 for ankylosing spondylitis. An earlier Phase II study in this indication had already demonstrated statistically significant and clinically meaningful improvements.

To date, Huaota has invested approximately RMB 372 million (about $51 million) in cumulative research and development spending on the HB0017 program.

A Crowded but Booming Market

The IL-17A pathway has become one of the most competitive battlegrounds in autoimmune disease therapeutics. Globally, Novartis AG's secukinumab (branded Cosentyx) and Eli Lilly & Co.'s ixekizumab (Taltz) hold dominant market positions. In China, several domestic competitors have already secured approvals, including Sauniqimab from Genoray Biopharma and Funazhumab from Hengrui Medicine.

With its robust Phase III data and a differentiated eight-week maintenance dosing regimen, HB0017 is well positioned to carve out a meaningful share in this intensely competitive market — provided it can navigate the final stretch of regulatory review successfully.