Huahai Pharmaceutical Subsidiary's HB0017 Injection Receives NDA Acceptance from NMPA for Moderate-to-Severe Plaque Psoriasis

Zhitong Finance APP News: Huahai Pharmaceutical (600521.SH) announced that its subsidiary, Shanghai Huaota Biopharmaceutical Co., Ltd. (“Huaota”), recently received the “Notice of Acceptance” from the National Medical Products Administration for the domestic production and marketing authorization application of HB0017 Injection. The indicated indication is for the treatment of adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy or phototherapy.

HB0017 Injection is a monoclonal antibody independently developed by Huaota, targeting interleukin-17A (IL-17A). It is intended for the treatment of moderate-to-severe plaque psoriasis (domestic marketing application has been accepted), ankylosing spondylitis (Phase III clinical trials in progress), and other autoimmune diseases. As of now, the company's total R&D investment in the HB0017 Injection project amounts to approximately RMB 454.03 million.