Ye Hua, MD, MPH is the founder and CEO of BioNova Pharmaceuticals, a start-up biopharmaceutical company that is dedicated to the development and commercialization of innovative medicines for the treatment of cancers and other diseases with high unmet medical needs. The company focuses on building a robust pipeline through internal R&D programs, collaborations with global partners, and selective license and acquisitions. With a highly capable management team, cutting edge biotechnology, and substantial funding, BioNova is committed to delivering high quality innovative medicines to the patients in China and globally.
Prior to building up BioNova, Dr. Hua was Senior VP, Head of Clinical Development and Regulatory Affairs at Hutchison MediPharm, a leading R&D biotech company headquartered in Shanghai China. Managing the debvelopment organization, Dr. Hua was responsible for advancing clinical development pipeline and registering new drugs in China and ex-China. Under his leadership, the clinical development programs have grown from 5 small molecules in 7 Phase 1 oncology clinical trials to 8 small molecules in over 30 Phase 1-3 clinical trials in oncology and immunology in China, Australia, and USA. Dr. Hua led fruquintinib mCRC NDA submission via MAH policy and received NMPA approval in 2018.
Native from Shanghai, Dr. Hua graduated from Fudan University Shanghai Medical College in 1992. He worked as a cancer epidemiologist at Shanghai Cancer Institute between 1992 and 1996, and then went to McGill University in Montreal Canada to pursue a Master Degree in cancer epidemiology.
Dr. Hua is a senior drug developer who has 20 years’ global clinical development and new drug registration experience with track records in the pharmaceutical industry. He started his career in the pharmaceutical industry as a biostatistician at Pharmacia & Upjohn in 1999, and worked through the ranks. His most significant achievement as a statistician is leading the statistical team for the pivotal Phase 3 RA registration trial of Humira that won regulatory approval in the US and EU.
Often contributed to clinical programs beyond his role in statistics, Dr. Hua was well recognized and greatly appreciated by cross-functional development teams. In 2004, one year after joining Novartis, Dr. Hua successfully switched career track back to clinical. Being a medical monitor, he led a number of global Phase II/III registration trials in osteoarthritis, osteoporosis, infectious diseases, oncology and hematology disease areas. As clinical project leader, Dr. Hua contributed to the regulatory approval and life-cycle management for Reclast/Aclasta, Prexige, Zometa, Femara, Proleukin and Cardioxane in the US and EU. His last job in the US was Senior Director, Global Clinical Development, Celgene Corporation where he led several global clinical teams for Revlimid and Pomalyst NDA/sNDA in multiple myeloma indication, and eventually obtained regulatory approval in the US and EU. In addition, he led clinical subteam executed registration trials for Revlimid and Pomalyst in China, and successfully obtained Revlimid regulatory approval in multiple myeloma indication.