AnHeart Therapeutics
Dr. Hua Zheng is Senior Vice President & Head of Global Regulatory Affairs at AnHeart Therapeutics. He has more than 25 years of experience in regulatory strategy to advance global product development and registration. He has served in executive regulatory positions in a number of leadership roles (Vice President, Global Franchise Regulatory Lead, China Lead), and has held various positions at multi-national companies such as Pfizer, J&J, Celgene, Amgen and biotech companies Advaxis and Sorrento. He has also served at the U.S. FDA. He has led and directed regulatory activities across all phases of global drug development, including the US, China, Europe and Asia Pacific, in gaining approvals. Notably, he served in critical leadership roles leading to market registrations for Yondelis, Edurant, Revlimid, and Vidaza in different countries with diverse regulatory challenges. Dr. Zheng holds a Ph.D. in Toxicology from the University of California, Irvine. He has an M.Sc. in Pathology and completed his medical training at the former Beijing Medical University. He conducted postdoctoral research at the National Cancer Institute, Kansas University Medical Center and the University of California, San Diego.
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AnHeart Therapeutics
AnHeart Therapeutics (“AnHeart”) is a clinical-stage global biopharmaceutical company developing a broad pipeline of novel precision oncology therapeutics with high unmet medical needs. Its lead asset, taletrectinib, is a potential best-in-class next-generation ROS1 inhibitor currently in Phase 2 trials for ROS1 TKI-naïve and TKI-pretreated patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC). Taletrectinib has received Breakthrough Therapy Designation (BTD) from both the US FDA and China NMPA for the treatment of patients with advanced or metastatic ROS1+ NSCLC, who are either ROS1 TKI treatment naïve or previously treated with crizotinib. The Company’s pipeline also includes AB-218, a mIDH1 inhibitor in Phase 2 trials with good brain penetration for multiple solid tumors with mIDH1 mutations and AB-329, an AXL inhibitor in Phase 1 studies to be used in combination with checkpoint inhibitor or chemotherapies in NSCLC or other solid tumors. The Company operates from offices in the US and China.