Core Viewpoint - The company has received approval from the National Medical Products Administration of the People's Republic of China to conduct clinical trials for its innovative drug HX111, a first-in-class OX40-targeted antibody-drug conjugate (ADC) [1] Group 1: Product Development - HX111 is a first-in-class (FIC) OX40-targeted antibody-drug conjugate (ADC) [1] - Preclinical studies indicate that OX40 is overexpressed in several malignancies, including certain lymphomas, making it a suitable target for ADCs like HX111 [1] - OX40 is also overexpressed in regulatory T cells (Treg) within the tumor microenvironment (TME), which are known to suppress anti-tumor immunity [1] Group 2: Mechanism of Action - The elimination of Tregs represents a novel mechanism of action (MOA) for cancer immunotherapy, which can be achieved through HX111 [1] - HX111 has potential applications across various cancers due to its unique mechanism [1] Group 3: Future Development - HX111 is the third first-in-class molecule to advance to clinical development following HX009 and HX044, both of which are bispecific antibody therapies [1] - The company aims to continue its efforts in clinical development to bring more innovative FIC drugs to market [1]
翰思艾泰-B(03378)获批准于中华人民共和国开展注射用HX111临床试验