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, has announced that China's Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for HB0017, a Class 1 innovative anti-IL-17A monoclonal antibody injection for the treatment of moderate-to-severe plaque psoriasis, with application number CXSS2600100, as of June 24, 2026. This marks Huaota's first product to reach the regulatory milestone for commercial approval. The pivotal Phase III clinical trial, led by Professor Zhang Jianzhong and Professor Zhou Cheng at Peking University People's Hospital, enrolled 408 patients across more than 40 research centers in China. Top-line data revealed that after 12 weeks of treatment, 95.7% of patients in the HB0017 group achieved PASI 75, compared with only 7.4% in the placebo group. Additionally, 87.0% of patients achieved sPGA 0/1 (clear or almost clear skin) versus 1.9% for placebo, and 88.0% achieved PASI 90. A key differentiator of HB0017 is its maintenance-phase dosing advantage, with the dosing interval extendable to once every eight weeks while sustaining stable efficacy. At 52 weeks, 92.3% of patients in the every-four-weeks group maintained sPGA 0/1 response, and 79.1% maintained PASI 100 (complete clearance), while the every-eight-weeks group showed 85.9% sPGA 0/1 and 65.8% PASI 100 maintenance rates. The safety profile was consistent with expectations, with no new safety signals identified. Beyond psoriasis, Huaota is also advancing a Phase III trial of HB0017 for ankylosing spondylitis. With cumulative R&D investment of approximately RMB 372 million, HB0017 is well positioned to compete in the rapidly growing IL-17A monoclonal antibody market in China, alongside existing products from Novartis, Eli Lilly, Genoray Biopharma, and Hengrui Medicine.