On June 24, the CDE official website showed that the New Drug Application (NDA) for HB0017 Injection, filed by Huahai Pharmaceutical and its subsidiary Huaota Biopharmaceutical, has been accepted. According to clinical trial progress, the Insight database speculates that the indication is for the treatment of psoriasis.
HB0017 is a monoclonal antibody targeting interleukin-17A (IL-17A), independently developed by Huaota for the treatment of moderate-to-severe plaque psoriasis, ankylosing spondylitis, and other autoimmune diseases. In November 2025, Huahai Pharmaceutical announced that the Phase III clinical trial of HB0017 for psoriasis met all primary and key secondary efficacy endpoints. This was a multicenter, randomized, double-blind, placebo-controlled Phase III study enrolling 408 Chinese patients with moderate-to-severe plaque psoriasis.
The study results showed that compared with marketed products targeting the same target, HB0017 demonstrated competitive efficacy advantages in both the core treatment period (first 12 weeks) and the maintenance treatment period (weeks 12–52). At 12 weeks of treatment, 95.7% of patients in the treatment group achieved PASI 75, significantly superior to 7.4% in the placebo group (p <0.0001); 87.0% of patients in the treatment group achieved sPGA 0/1, significantly superior to 1.9% in the placebo group (p <0.0001). The key secondary endpoint was also met, with 88.0% of patients in the treatment group achieving PASI 90, compared with 1.9% in the placebo group (p <0.0001). During the maintenance phase, the dosing interval of HB0017 was extended to 8 weeks with stable and durable efficacy. At 52 weeks, the proportion of patients maintaining sPGA 0/1 was 92.3% in the Q4W group and 85.9% in the Q8W group; the proportion achieving PASI 100 was 79.1% in the Q4W group and 65.8% in the Q8W group. In terms of safety, HB0017 demonstrated good overall safety and tolerability, with common adverse event types and severity within the expected range and no new safety signals identified.
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