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.

Biotechnology

Health Care

AnHeart Therapeutics

Junyuan Jerry Wang

Xin (Shaun) Yang

Huan Huang

Eric Kong

Dawn Spooner

Chen Lu

Hua Zheng

Qinying Zhao

Shuanglian Lian Li

Bing Yan

The Regulatory Affairs Team at AnHeart Therapeutics is responsible for ensuring that all drug development processes comply with global regulatory requirements. This includes preparing and submitting regulatory documentation to health authorities, managing communications with agencies such as the US FDA and China NMPA, and staying current with evolving regulations to support the approval and ongoing compliance of AnHeart's precision oncology therapeutics.

Regulatory Affairs Team

Medical and Clinical Team

Leadership Team

Legal and Strategy Team

Regulatory Affairs Team

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Medical and Clinical Team

Leadership Team

Legal and Strategy Team