Hinova Pharmaceuticals Receives FDA Proceed Authorization for its IND Application for HP568, an Orally Bioavailable Chimeric Degrader Targeting ER for ER+/HER2- Advanced Breast Cancer Treatment

Hinova Pharmaceuticals Inc. (688302.SH), a leading biopharmaceutical company dedicated to developing innovative cancer therapies, recently announced that the US Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for HP568，an investigational drug targeting Estrogen Receptor （ER）for the treatment of ER-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. 

About HP568

HP568 is an oral ER Proteolysis Targeting Chimera (PROTAC) protein degrader that degrades both wild-type ER and ERαmutants. In preclinical studies, HP568 has demonstrated promising antitumor activity in animal models, showcasing significant tumor reduction and a favorable safety profile both in vivo and in vitro.Breast cancer is one of the most common malignant tumors among women worldwide, accounting for 2.31 million new cases of breast cancer globally according to globocan cancer statistics 2022. Women with ER+/HER2- breast cancer ≤50 years old accounts for 65%, and 75% ≥ 50 years old. 

HP568 is a potent PROTAC ER degrader, and it’s IND application has been approved by the US FDA and the National Medical Products Administration (NMPA) in China. The Chinese Phase Ⅰ/Ⅱ clinical trial application was approved by the NMPA in October 2024, and the FPI was completed in January 2025. 

About Hinova Pharmaceuticals Inc. 

Hinova is an international and clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for treating cancer and metabolic diseases. The company’s pipeline includes multiple investigational drugs targeting a variety of cancer types and metabolic disorders, all aimed at addressing significant unmet medical needs and improving patient outcomes. 

Contact:

bd@hinovapharma.com

Note to Editors:

For more information about HP568 and ongoing studies, please visit Hinova’s website at https://www.hinovapharma.com/en/