Huaotai Submits NDA for HB0017, an Anti-IL-17A Monoclonal Antibody, with Phase III Psoriasis Trial Achieving 95.7% PASI 75 Response Rate

HB0017 Injection is a recombinant humanized monoclonal antibody targeting interleukin-17A (IL-17A), independently developed by Huaota, intended for the treatment of moderate-to-severe plaque psoriasis, ankylosing spondylitis, and other autoimmune diseases.

IL-17A is a key pro-inflammatory cytokine in the inflammatory response of autoimmune diseases such as psoriasis. By blocking the binding of IL-17A to its receptor, HB0017 can effectively inhibit downstream inflammatory signaling.

The core support for this marketing application comes from the pivotal Phase III clinical trial of HB0017 in the treatment of moderate-to-severe plaque psoriasis.

This study was led by Professor Zhang Jianzhong and Professor Zhou Cheng from Peking University People’s Hospital, with the participation of more than 40 research centers across China, enrolling a total of 408 Chinese patients.

In November 2025, Huaota announced the successful unblinding of its Phase III study, which met all prespecified primary and key secondary efficacy endpoints. Top-line data showed that at Week 12, 95.7% of patients in the treatment group achieved PASI 75, significantly superior to 7.4% in the placebo group; 87.0% achieved sPGA 0/1, compared to 1.9% in the placebo group; and 88.0% achieved PASI 90, also significantly outperforming the placebo group. During the maintenance phase, the dosing interval for HB0017 could be extended to 8 weeks with sustained and stable efficacy. At Week 52, the sPGA 0/1 maintenance rates were 92.3% in the every-4-weeks dosing group and 85.9% in the every-8-weeks dosing group, while PASI 100 maintenance rates reached 79.1% and 65.8%, respectively.

This dosing regimen offers differentiated advantages over existing IL-17A monoclonal antibody products and is expected to significantly enhance medication convenience for patients. In terms of safety, the types and severity of common adverse events were within the expected range, with no new safety signals identified.

In addition to psoriasis, the Phase III clinical trial of HB0017 for ankylosing spondylitis is also progressing concurrently. The previous Phase II clinical study has already demonstrated improvements with both statistical and clinical significance.

To date, Huaota has incurred cumulative R&D expenses of approximately RMB 372 million for the HB0017 project.

From the perspective of market landscape, the IL-17A target has become one of the most competitive areas in the field of autoimmune diseases.

Novartis’s secukinumab and Eli Lilly’s ixekizumab hold leading positions in the global market, while China’s Zhixiang Jintai’s selikizumab and Hengrui Medicine’s funakizumab have also been successively approved.

With its robust Phase III data and a maintenance regimen featuring once-every-8-weeks dosing, HB0017 is well-positioned to secure a place in this highly competitive landscape.