Huaota Biopharma Announces Completion of Patient Enrollment in Pivotal Phase III Trial of HB0017 (IL-17A Monoclonal Antibody) for Moderate-to-Severe Plaque Psoriasis

Aug 23, 2024 17:19 CST Updated 17:19

Huaota

Biological New Drug Developer

Abstract

Shanghai Huaota Biopharmaceutical Co., Ltd. (hereinafter referred to as "Huaota") announced that the pivotal Phase III clinical trial of its self-developed HB0017 injection,Deadline2024Year8Month23The Date, All Subjects Have Successfully Completed Enrollment.

HB0017 is a monoclonal antibody independently developed by Huaota, targeting interleukin-17A (IL-17A), intended for the treatment of moderate to severe plaque psoriasis and other autoimmune diseases. Previously, HB0017 has completed two Phase I clinical studies and one Phase II clinical study.Research data shows,HB0017The injection has shown positive efficacy and good safety in the treatment of plaque psoriasis.Based on these encouraging data, Huaota rapidly advanced to Phase III clinical trials.

This Phase III clinical trial was conducted by Peking University People's HospitalHospitalProf. Zhang Jianzhong and Prof. Zhou ChengPullHead, received active responses from researchers and patients at more than 40 research centers across China.China-wide Enrollment408Example subject.The data from these patients will provide crucial evidence for the efficacy and safety of HB0017. The trial is expected to complete all visits by 2025.

Huaota looks forward to HB0017 bringing a breakthrough in the treatment of plaque psoriasis, benefiting more patients.

About Psoriasis

Psoriasis is a chronic, recurrent, immune-mediated inflammatory skin disease that affects the skin and other organ systems throughout the body. The prevalence of psoriasis in China is0.5%Left and right, can occur at all ages, approximately80%To90%The cases of psoriasis are plaque psoriasis.Patients with psoriasis often have other systemic diseases, such as cardiovascular disease, metabolic disorders, liver and kidney diseases, autoimmune diseases, etc.;At the same time, patients also suffer from immense mental distress; mental illnesses such as depression, anxiety, and suicidal tendencies caused by physical and mental suffering are relatively common among psoriasis patients.Therefore, psoriasis is a disease that seriously affects the physical and mental health of patients and is a worldwide urgent medical issue that needs to be addressed.

About Huaota

Huaota Biopharmaceuticals is a biopharmaceutical company focused on independent research and development with a global perspective. It specializes in the R&D of novel biologics for oncology, autoimmune diseases, and retinal disorders.Currently available11Projects in the clinical stage: including those that have entered pivotal clinical trials, the first self-developed in China for pustular psoriasis (a rare disease).IL-36RMonoclonal Antibody; and Current ClinicalIIIn the period, positive signals were observed in multiple tumor diseases such as endometrial cancer and non-small cell lung cancer.PD-L1/VEGFDual-targeting antibody; The first with dual killing effects targeting refractory tumorsCD73-ADCAnd other core projects.

Huaota is currently actively seeking domestic and international partners to jointly advance and co-develop, with the aim of providing high-quality, cutting-edge biopharmaceuticals to the global market. The goal is to meet the needs of a wide range of patients for accessible and affordable biologics, striving to change the world through innovation!