Haichuang Pharmaceutical (688302.SH) announced that the company has received approval from the USA Food and Drug Administration (referred to as "FDA"...)
According to the Zhitong Finance APP, Haichuang Pharmaceutical (688302.SH) announced that the company has received a continuation notice for clinical research from the USA Food and Drug Administration (referred to as "FDA"). The clinical trial application for HP568 tablets, independently developed by the company for the treatment of estrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer (ER+/HER2- advanced breast cancer), has been officially approved by the FDA. Previously, the clinical trial application for HP568 tablets for the same indication in China was approved by the National Medical Products Administration of China in October 2024.