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Expanded Access Policy for QLS4131 for Injection

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Expanded Access Policy for QLS4131 for Injection

Release time：

2025-10-13

QLS4131 is a novel trispecific IgG1 antibody targeting human CD3, BCMA, and GPRC5D. It recruits T cells to the tumor site by specifically binding to CD3 on T cells and to BCMA and GPRC5D on tumor cells. This process promotes the survival and proliferation of effector T cell, and induce the release of granzyme and perforin, thereby facilitating T cell-dependent cellular cytotoxicity (TDCC) against tumor cells. With a Phase I monotherapy clinical study for multiple myeloma ongoing in China, we believe it participation in our clinical study would be an appropriate channel to therapeutically access QLS4131 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 Anova Innovation Limited* 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 QLS4131.

*: Anova Innovation Limited is part of the corporate group under the control of Qilu Pharmaceutical Group Co., Ltd.

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