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Manufacturing
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Expanded Access Policy for QLS1304 Tablets
Release time：
2025-05-20
Expanded Access Policy for QLS1304 Tablets
As a novel, oral and highly selective small molecule inhibitor targeting lysine acetyltransferase 6 A/B (KAT 6 A/B), QLS1304 suppresses tumor growth by inhibition of histone H3 acetylation, estrogen receptor (ER) target gene expression, cell cycle progression, MYC and other significant cell signaling pathways. With a Phase I monotherapy clinical study for advanced solid tumors ongoing in China, we believe it participation in our clinical study would be an appropriate channel to therapeutically access QLS1304 at this stage.
With recent grant of the fast track desgination by the FDA, we are progressing the clinical study of this promising therapy, aiming to expanding therapeutic benefits to all patients by obtaining regulatory approvals.
It is noteworthy that Shanghai Qilu Pharmaceutical Research and Development Center has not initiated expanded access program (EAP) for this investigational drug, we constantly encourage eligible patients to give priority in consideration of participating in the clinical study of QLS1304.
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