Core Insights - HYP-6589, a selective SOS1 small molecule inhibitor developed by the company's subsidiary, has received acceptance for clinical trial application in combination with Osimertinib for treating advanced non-small cell lung cancer with target-driven gene positivity [1][2] - The drug is classified as a Class 1 innovative chemical drug and is currently undergoing clinical research for monotherapy in advanced solid tumors in China [1] - There are no similar products approved for market in both domestic and international markets as of the announcement date [1] Group 1 - HYP-6589 has received the acceptance notice from the National Medical Products Administration for clinical trials [1] - The drug is designed to enhance the efficacy of Osimertinib and potentially overcome resistance mechanisms associated with it [2] - Preclinical studies indicate that the combination of SOS1 inhibitors and Osimertinib can achieve deeper and more sustained inhibition of MAPK and PI3K signaling pathways [2] Group 2 - SOS1 is a crucial regulator in the RTK-RAS signaling pathway, which is activated by receptor tyrosine kinases [2] - The activation of SOS1 leads to the formation of RAS-GTP, which is essential for downstream signaling pathways [2] - Inhibition of SOS1 has shown potential to address unmet clinical needs in the context of Osimertinib resistance [2]
汇宇制药:HYP-6589片联合用药获得药物临床试验申请受理通知书