HY016

HY016 is an investigational Class 1 innovative small molecule drug developed by Tianjin Botai Pharmaceutical Technology for the treatment of advanced solid tumors. It is formulated as a lyophilized powder for injection. In early 2026, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) approved the clinical trial application (IND) for HY016. An ongoing first-in-human, open-label, dose-escalation Phase 1 clinical trial (CTR20263855) is evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of HY016 in adult patients with histologically or cytologically confirmed advanced solid tumors (including breast, gastric, lung, colorectal, ovarian, pancreatic, and head and neck cancers) who have failed standard therapy, are intolerant to standard therapy, or have no standard treatment options.