Core Viewpoint - Hansa Biopharma-B (03378.HK) 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, which is a first-in-class (FIC) OX40-targeted antibody-drug conjugate (ADC) [1] Group 1: Product Development - HX111 is identified as a first-in-class OX40-targeted ADC, which shows overexpression in several malignancies, including certain lymphomas, compared to normal tissues, making it a suitable target for ADC therapies [1] - Preclinical studies indicate that OX40 is a tumor-associated antigen (TAA) and is overexpressed in regulatory T cells (Treg) within the tumor microenvironment (TME), which are known to suppress anti-tumor immunity [1] - The mechanism of action (MOA) for HX111 involves the elimination of Tregs, representing a novel approach in cancer immunotherapy with potential applications across various cancers [1] Group 2: Company Strategy - HX111 is the third first-in-class molecule to advance to clinical development following the company's previous dual-specific antibody (BsAb) therapies, HX009 and HX044 [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.HK)：获批准于中国境内开展注射用HX111临床试验