HANXBIO-B (03378) Receives Approval for Clinical Trials of HX111 Injection in China

Stock News12-23 21:16

HANXBIO-B (03378) announced that its innovative drug, HX111 injection, has received approval from the National Medical Products Administration of China to commence clinical trials within the country. HX111 is a first-in-class (FIC) OX40-targeted antibody-drug conjugate (ADC). Preclinical studies indicate that OX40, a tumor-associated antigen (TAA), is overexpressed in certain malignant tumors (including some lymphomas) compared to normal tissues, making it a suitable target for ADC therapies like HX111. Additionally, OX40 is also overexpressed in regulatory T cells (Tregs) within the tumor microenvironment (TME), which are known to suppress anti-tumor immunity. Eliminating these Tregs represents a novel mechanism of action (MOA) in cancer immunotherapy, an effect achievable through HX111, with potential pan-cancer applications. HX111 is the third first-in-class molecule advanced to clinical development by the company, following HX009 and HX044, both FIC bispecific antibody (BsAb) therapies. The company remains committed to bringing more novel FIC drugs through clinical development and ultimately to market.

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