WuXi Biologics Subsidiary Huaota Submits NDA for IL-17A Antibody HB0017 in China

▎Armstrong

On June 24, 2026, the marketing application for Huaota Biologics’ HB0017 injection, a subsidiary of Huahai Pharmaceutical, was accepted by the NMPA.

HB0017 is an IL-17A antibody independently developed by Huaota, and it is the second new drug for which the company has submitted a marketing application. Previously, the IL-36R antibody HB0034 had already been submitted for marketing approval for the treatment of generalized pustular psoriasis.

In November 2025, Huaota announced HB0017 Phase III Clinical Trial for Moderate-to-Severe Plaque Psoriasis Achieves All Primary and Key Secondary Efficacy EndpointsAt Week 12 of treatment, the proportion of patients achieving PASI 75 in the experimental group was 95.7%, significantly superior to the 7.4% in the placebo group (p<0.0001); the proportion of patients with sPGA 0/1 in the experimental group was 87.0%, significantly superior to 1.9% in the placebo group (p<0.0001). The key secondary endpoints were also successfully met; at 12 weeks of treatment, the proportion of patients in the experimental group achieving PASI 90 was 88.0%, significantly superior to the 1.9% observed in the placebo group (p <0.0001）。During the maintenance dosing phase, the dosing interval for HB0017 was extended to 8 weeks, with relevant efficacy endpoints remaining stable and durable. At Week 52 of treatment, the proportions of subjects achieving sPGA 0/1 were 92.3% in the Q4W group and 85.9% in the Q8W group; the proportions of subjects achieving PASI 100 were 79.1% in the Q4W group and 65.8% in the Q8W group. The maintenance regimen holds promise for extending the dosing intervals of existing therapies.

Summary

Huaota strategically focuses on two major therapeutic areas: oncology and autoimmune diseases. In oncology, the company is advancing both IO 2.0 and ADC 2.0 platforms; its PD-1/VEGF bispecific antibody has entered Phase III clinical trials, while its PTK7/FAP bispecific antibody-drug conjugate (ADC) is in the IND-enabling stage. In the autoimmune sector, its IL-17A and IL-36R antibodies have been submitted for marketing approval, with subsequent development focused on autoimmune bispecific antibodies, including an IL-17A/IL-36R bispecific antibody and a TSLP/IL-11 bispecific antibody.