On August 19, 2022 Huahui Health, a Beijing-based, clinical stage biotechnology company focused on discovering and developing virology, hepatology and oncology therapies, reported that its "First-in-Class" anti-tumor drug candidate HH-009 has completed the first patient dose in a Phase Ia clinical trial conducted in China (Press release, Huahui Health, AUG 19, 2022, View Source [SID1234642185]). It marked the first molecule amongst those investigational therapies of the same target in the world that entered clinical development stage. Currently, Huahui has brought 5 products with "First-in-Class" or "Best-in-Class" potential into clinical stage, including 3 anti-viral and 2 anti-tumor clinical assets.
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As a potential "First-in-Class" anti-tumor therapy, HH-009 initiated a Phase Ia clinical study to evaluate its safety, tolerability and pharmacokinetic in solid tumors. Compared to other small-molecule inhibitors of the same target, HH-009 is a fully human monoclonal antibody with a novel mechanism of action, offering potential safety advantages over small-molecule drug candidates.
HH-009 has also planned to open an IND in the US by end of 2022.