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HBW-016-K is a novel, orally available small molecule pan-KRAS inhibitor developed by Hyperway Pharmaceutical. It is designed to target both the active (GTP-bound, ON) and inactive (GDP-bound, OFF) states of various KRAS mutant subtypes, including G12D, G12V, and G12C, while maintaining high selectivity over wild-type KRAS and other RAS isoforms such as NRAS and HRAS. Preclinical studies have demonstrated that HBW-016-K possesses favorable pharmacokinetic properties and significant tissue penetration, particularly in the lung, intestine, and pancreas. In vivo models of KRAS-driven cancers, including lung, colorectal, and pancreatic cancer, have shown dose-dependent anti-tumor activity and sustained tumor regression. Preliminary toxicity studies support its advancement into clinical development, showing a favorable safety profile and excellent tolerability.
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