Article Publication | Huaota HB0017 (IL-17A Monoclonal Antibody) Phase I Clinical Study Published

2023-10-18 467


Recently, Dr. Yongmin Yang, Vice General Manager of Clinical Research at Shanghai Huaota Biopharmaceutical Co., Ltd. (hereinafter referred to as "Huaota"), published a research paper as the corresponding author in the international academic journal British Journal of Dermatology. The paper is titled "Safety, tolerability, pharmacokinetics and efficacy of HB0017, a humanized monoclonal antibody that targets interleukin-17A, in healthy participants and patients with moderate-to-severe plaque psoriasis."

The main authors of the article include three co-first authors (Congjun Jiang, Yu Du, Xiaoyan Liu) and two co-senior authors and corresponding authors (Dr. Yifan Zhan, Dr. Xiangyang Zhu).

Project Overview of HB0017:

HB0017 is a monoclonal antibody developed independently by Huaota, targeting interleukin-17A (IL-17A). It is intended for the treatment of moderate-to-severe plaque psoriasis and ankylosing spondylitis.

Currently, HB0017 has completed Phase Ia studies in healthy individuals conducted in New Zealand, as well as Phase Ib studies in patients with moderate-to-severe plaque psoriasis conducted in China. Additionally, HB0017 has explored different dosing regimens for the treatment of moderate-to-severe plaque psoriasis in a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study. All patients have been enrolled, and it is expected to enter a crucial Phase III clinical study in Q1 2024.

Article Summary:

This study evaluates the effectiveness and safety of HB0017 in healthy subjects and patients with moderate-to-severe plaque psoriasis in a Phase I trial.

The research demonstrates that HB0017 exhibits good safety and tolerability in both healthy subjects and patients with moderate-to-severe plaque psoriasis. Particularly noteworthy is its pharmacokinetic profile, with a significantly longer half-life compared to other marketed drugs targeting the same pathway. This exceptional performance in pharmacokinetics will support future maintenance treatment plans, involving dosing once every 2-3 months, greatly enhancing patient convenience. Simultaneously, the preliminary and significant efficacy results confirm the enormous potential of HB0017 in the treatment of moderate-to-severe plaque psoriasis. Patients in the 300mg dosage group achieved a 100% PASI90 score, indicating substantial therapeutic impact.

Huaota Biopharmaceutical's General Manager, Dr. Xiangyang Zhu, stated that based on the outstanding performance of HB0017, they are looking forward to its swift market availability. They hope it will offer a long-lasting, safe, and effective treatment solution for patients worldwide who have long been suffering from chronic illnesses.


Dr. Xiangyang Zhu 's Profile:

Dr. Xiangyang Zhu, an expert in the field of biopharmaceutical research and process development, is recognized as a "National Talent Plan Expert" and a "Leading Talent of Zhejiang Province." He has extensive experience in monoclonal antibody screening and identification, engineering modifications of bispecific antibodies, establishment of cell lines, process development, technology transfer, and the design and construction of pilot production facilities. Currently, Dr. Xiangyang Zhu serves as the General Manager of Shanghai Huaota Biopharmaceutical Co., Ltd., overseeing the company's global biopharmaceutical research and development.

Dr. Xiangyang Zhu has worked extensively in various capacities and locations at Boehringer Ingelheim (BI) in the United States, Germany, and China. He has led and participated in research on over 20 monoclonal antibody and bispecific antibody projects. He served as the project leader and inventor for the early development of Risankizumab, a product that is currently marketed by AbbVie. Dr. Xiangyang Zhu earned his Ph.D. in Immunology from the University of Illinois.


Dr. Yongmin Yang 's Profile:

Dr. Yongmin Yang serves as the Vice General Manager of Clinical Research at Shanghai Huaota Biopharmaceutical Co., Ltd., where he is responsible for developing comprehensive clinical development strategies, managing medical affairs, and overseeing clinical trial operations.

Before joining Huaota, Dr. Yang was in charge of the large molecule bioanalysis teams at Wuxi AppTec and Covance in the United States. In these roles, he primarily supported clinical research on biologic drugs and biosimilars, contributing to hundreds of global clinical trials, including bioanalysis and pharmacokinetic analysis for Phase I, II, III, and IV clinical trials.

Dr. Yang graduated with a medical degree from Lanzhou Medical College and earned his Ph.D. in Microbiology and Immunology from the Chinese Academy of Preventive Medicine (now the Chinese Center for Disease Control and Prevention). He has been recognized as one of the primary authors for which the team was awarded the National Science and Technology Progress First Prize and the Ministry of Health Science and Technology Achievement First Prize.


Dr. Yifan Zhan s Profile:

Dr. Yifan Zhan is currently serving as the Chief Scientific Officer of New Drug Development at Shanghai Huaota Biopharmaceutical Co., Ltd. In this role, he is responsible for selecting new targets for large-molecule drugs, establishing conjugated drug platforms, and developing immunocellular functional platforms.

Dr. Yifan Zhan earned his Ph.D. in Immunology from the University of Melbourne in Australia and later worked at the Walter and Eliza Hall Institute of Medical Research in Australia. He has dedicated his career to research in the field of cellular immunology. He has made significant contributions to areas such as immune cell activation, differentiation, survival, cell interactions, and the production of cytokines and antibodies. Dr. Zhan has published over 100 academic papers in top international journals. His research focuses on the involvement of immune cells and cytokines in autoimmune diseases, cancer, and infectious diseases, both in terms of disease pathogenesis and treatment. Additionally, he has obtained related patents and products based on his research findings.


About Huaota:

Huaota Biopharmaceutical is a global biopharmaceutical research and development company primarily focused on independent research that concentrates on the development of biopharmaceuticals in areas such as oncology, autoimmune diseases, and retinal diseases. Currently, there are 11 projects in the clinical stage, including the first domestic IL-36R monoclonal antibody designed for pustular psoriasis (a rare disease), which is about to enter a critical Phase II trial. A PD-L1/VEGF bispecific antibody shows positive signals in clinical Phase II trials for endometrial cancer and renal cancer. Additionally, there is a core project like CD73-ADC, the first agent with dual-targeted killing effects for difficult-to-treat cancers like pancreatic cancer.

Huaota Biopharmaceutical is actively seeking domestic and international partners to collaborate and advance these projects that aim to provide high-quality, advanced biological drugs to the global market, meeting the demand for accessible and affordable biopharmaceuticals. The vision is to innovate and change the world through these efforts.