Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its innovative injectable drug candidate, HB0052. The drug is initially intended for evaluation in patients with general advanced solid tumors.
HB0052 is an antibody-drug conjugate (ADC) that targets the CD73 antigen, coupled with a topoisomerase inhibitor (TOPOi) as its cytotoxic payload. This precision medicine approach is designed to harness the dual power of antibody-mediated immune system regulation and the direct cytotoxicity of the small-molecule payload, aiming to create a synergistic anti-tumor effect. Pre-clinical studies in animal models have demonstrated HB0052’s potent anti-tumor capabilities.
Pharmacokinetic evaluations in non-human primates have shown that HB0052 possesses linear pharmacokinetic properties, plasma stability, minimal non-specific shedding, and an extended half-life. Additionally, toxicological studies have indicated that HB0052 has an acceptable safety and tolerability profile. Notably, HB0052 was previously granted clearance for clinical trials in the United States in November of the previous year.- Flcube.com
