ABOUT US
Shanghai Huaota Biopharmaceutical Co., Ltd. (aka ‘Huaota’) was established in September 2013. Huaota is a subsidiary of Zhejiang Huahai Pharmaceutical Co., Ltd.
Since its inception, Huaota has been continuously dedicated to innovation and development, having established a comprehensive, integrated biologics new drug R&D platform and system, including monoclonal antibody, bispecific antibody, fusion protein, and ADC drug discovery platforms, as well as GMP-compliant drug substance and drug product pilot-scale manufacturing facilities. Huaota's drug substance production adopts single-use technology and utilizes Cytiva bioreactors. The drug product manufacturing facility is equipped with a complete set of Bosch vial and pre-filled syringe filling lines imported from Germany, supporting various administration routes. The analytical platform is equipped with high-precision advanced analytical and testing instruments. A robust quality assurance system has also been established to support manufacturing, registration, and clinical research.We are an innovative drug company driven by R&D, with an integrated biologics new drug R&D platform, focusing on R&D, manufacturing, and commercialization in the two major therapeutic areas of oncology and autoimmune diseases. Currently, we have over 20 programs in the pipeline, with multiple candidates having advanced into clinical trials being conducted in the United States, New Zealand, and China. In 2019, Huaota was recognized as a "National High-Tech Enterprise" and has successively undertaken and completed multiple science and technology projects in Shanghai and Zhejiang Province, with multiple domestic and international invention patent applications filed.
In today’s fast lane of biopharmaceuticals development，Huaota is inspired by the mission of ‘Innovation brings the future, Quality makes the brand’. With a culture of open-mindedness, innovation, and dedication Huaota continues to develop a variety of innovative yet affordable biological drugs to meet the unmet medical needs globally.
Dr. Zhu is a well-recognized expert in antibody drug discovery, process development, and manufacture facility construction. Prior to joining Huahai, he worked at Boehringer Ingelheim for more than 8 years in different function areas at multiple locations (Ridgefield, USA; Biberach, Germany; and Shanghai, China). He led and engaged in over 20 global biological research projects including current clinic Phase I-III projects and market products especially the successful development of blockbuster biologics, Skyrizi at BI. Before BI, Dr. Zhu had worked in the field of antibody drug discovery and process development with more than 20 years of industrial experience
Dr. Zhu holds a Ph.D. degree in microbiology and immunology from the University of Illinois at Chicago.
Dr. Zhan is the vice president of antibody discovery and mainly responsible for identifying new targets, designing new antibody molecules and developing the RD technical platforms at Huaota.
Dr. Zhan has long been engaged in research in the field of cellular immunity and has made significant contributions in the fields of immune cell activation/differentiation/survival, cell interaction, production of cytokine and antibody. Dr. Zhan has published more than 100 peer-reviewed papers in top international journals. His research focuses on the participation of immune cells and cytokines in the onset and treatment of tumors, autoimmune diseases, and infectious diseases, and has obtained related patents and products.
Dr. Zhan received his Ph.D. degree in immunology from the University of Melbourne, Australia, and then worked at the Walter and Eliza Hall Institute of Medical Research in Australia.
Dr. Chen is the vice president of quality and compliance and mainly responsible for managing the quality and compliance related activities at Huaota.
Dr. Chen has about 15 years of pharmaceutical research and development experience. Prior to joining Huaota, Dr. Chen had served at several positions in different countries with increasing responsibilities in Boehringer Ingelheim and Johnson & Johnson, primarily in the fields of analytics, quality and compliance.
Dr. Chen holds a bachelor’s degree from Shanghai Medical College of Fudan University, a master’s degree from Shanghai institute of Organic Chemistry, Chinese Academy of Sciences, and a Ph.D. degree from the Pennsylvania State University.
Huaota Biopharmaceutical has announced a global collaboration and licensing agreement with Almirall for the research and development of an innovative monoclonal antibody in the field of medical dermatology.
Merging of Zhejiang Huahai Biopharmaceuticals Co., Ltd. as a subsidiary of Huaota focusing on manufacturing of phase III clinical trial supplies and commercial products
Multiple projects obtained IND approval (HB0025 from FDA, HB0030 from CDE, HB0034 from New Zealand)
In January, Huaota received Manufacture License of Pharmaceutical Products
Multiple projects obtained IND approval （HB0017 ，HOT-1030，HB0025， HB002.1M）
In June, Huaota entered into an agreement with Shanghai Junshi Biosciences Co., Ltd; Junshi acquired the Avastin monoclonal antibody biosimilar (project code "HOT-1010") from Huaota
In December, Huaota was certified as High –and New-Technology Enterprise
In November, Huabo Biopharm was certified as High –and New-Technology Enterprise
In March, renamed “Shanghai Huaota Biopharmaceutical Co., Ltd.”
In March, Huaota started the first clinical trial: Phase I study of HB002.1M, a VEGFFR1-Fc for ophthalmic injection
In September, Huahai Pharmaceutical reached a strategic collaboration with Korea Eutilex Co., Ltd.
In June, Huaota received the first IND approval for clinical trial of the project HB002.1M, a VEGFFR1-Fc for ophthalmic injection
In September, Huaota completed the shareholding system reform
In August, Huaota’s pilot plant was officially launched.
In September, Huaota was established
In May，Huahai Pharmaceutical reached a strategic collaboration with US Oncobiologics Inc.
In June, Huabo Biopharm was established
Innovation brings the future， Quality makes the brand
To establish a world class biopharma developing high-quality yet affordable novel biologics to address unmet medical needs globally
Innovation, Quality, Perseverance
Open-mindedness, Collaboration, Integrity, Dedication
