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Manufacturing
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Expanded Access Policy for QLS5132 for Injection
Release time：
2025-06-13
As a novel antibody-drug conjugate (ADC), QLS5132 can specifically recognize the tumor cell surface antigen CLDN6 through antibodies, deliver the payload to the targeted site, and enter the cell via endocytosis. The linker is cleaved inside the cell, releasing the small-molecule cytotoxic drug that subsequently kills tumor cells. Additionally, as the linker is cleaved inside the cell, a bystander effect may occur, inhibiting neighboring tumor cells. 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 QLS5132 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 QLS5132.
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