Shanghai Huaota Biopharmaceutical Co., Ltd. (aka ‘Huaota’) was established in September 2013. Huaota is a subsidiary of Zhejiang Huahai Pharmaceutical Co., Ltd.
Driven by innovation and development, Huaota has built comprehensive and integrated platforms to develop novel biologics. The R&D platform at Huaota supports the identification and development of new monoclonal antibodies, bispecific antibodies, fusion proteins, ADC drugs, etc. Empowered by an effective quality system，the pilot platform for DS and DP production is in compliance with applicable GMP standards and received the Manufacture License of Pharmaceutical Production in 2020. Disposable technology and the world's leading 200L and 1000L disposable bioreactors from GE were employed in the DS pilot production. The DP workshop is equipped with complete sets of vials and prefilled syringe filling lines imported from BOSCH Germany, capable of supporting the production of up to 17,000 PFS/hour and 12,000 vials/hour. The quality control lab has a variety of advanced analytical instruments fulfilling the analytical needs, such as product release and stability studies, of supporting production, registration, and clinical trials.
Independent research and development drive innovation. Huaota has a diverse product pipeline covering therapeutic areas such as tumors and autoimmune diseases. At present, there are over twenty projects under development. Many of them have obtained IND approval and multiple clinical trials are undertaken in the United States, New Zealand, and China. Over the years, Huaota has completed many science and technology projects in collaboration with universities, research institutes, and other research organizations in China and globally. In 2019, Huaota was certified as High- and New-Technology Enterprise. By now, Huaota has applied for several domestic and international invention patents.
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. Jason Lu is the Chief Business Officer, responsible for business development and licensing. Internally, his team will work with other functions to position the R&D programs for best value, while actively seek collaboration globally with other biopharma companies to create market wining strategies. Prior to Huaota role, he was the Chief Business Officer at Adlai Nortye Biopharma, responsible for business development at Betta Biopharma and Chongqing Porton and Merck Research Laboratory of MSD, having executed deals of billion dollar value. Dr. Lu graduated from Shanghai Jiaotong University School of Medicine, and received his doctoral degree on Biochemistry from Rutgers University, New Jersey of US. He finished his postdoctoral training at AstraZeneca and PMP training of PMI.
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. Yang is the vice president of clinical development and mainly responsible for clinical development strategy, medical affairs, and clinical operations at Huaota.
Prior to joining Huaota, Dr. Yang led large molecule bioanalytical team of WuXi AppTec and Covance mainly supporting clinical trials of various large molecule drugs as well as biosimilars, participated in hundreds of global clinical trials including phase I, II, III, and IV supporting bioanalytical and pharmacokinetics.
Dr. Yang worked among institutions such as MPI research, IGE Therapeutics, Pharmacia, Genset and University of Arizona etc. for nearly 18 years with increasing responsibilities from research scientist, Sr. scientist, and Chief scientist involving therapeutic protein/antibody development, functional genomics, molecular microbiology, tumor biology and molecular pathology.
Dr. Yang received Bachelor of Medicine (equivalent to MD) from Lanzhou Medical School and obtained his Ph.D. in Microbiology and Immunology from Chinese Academy of Preventive Medicine now Chinese CDC.
Dr. Yang is also the main contributor for the First Prize of National Science and Technology Award and First Prize of Science and Technology Award by the Ministry of Public Health.
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.
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, Huaota completed the shareholding system reform and 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 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