Huahai Pharmaceutical announced on November 24 that recently, the clinical trial application for HB0045 injection, independently developed by its subsidiary Shanghai Huaota Biopharmaceutical Co., Ltd. ("Huaota"), for the treatment of advanced solid tumors has been approved by the U.S. Food and Drug Administration (FDA). To date, the company has invested approximately 47.72 million yuan in research and development expenses for this project.
HB0045 is a compound preparation targeting human CD73 (also known as ecto-5'-nucleotidase). With its unique compound advantages, it can completely inhibit both membrane-bound and soluble CD73 enzyme activity through dual mechanisms of allosteric modulation and steric hindrance without affecting the binding of the substrate AMP (adenosine monophosphate), thereby reducing adenosine production in the tumor microenvironment (TME) and promoting TME immune cell activation to suppress tumor growth. In preclinical studies, compared with other similar CD73 antibodies, HB0045 is the only one that simultaneously targets the catalytic region and N-terminus of CD73, achieving 100% maximum inhibition of CD73 activity, and has demonstrated stronger anti-tumor efficacy in various preclinical animal models. As the first compound preparation targeting CD73 both domestically and internationally, the company will carry out differentiated clinical development based on the drug’s characteristics and mechanism of action, aiming to bring benefits to cancer patients.