ALPHAMAB-B (09966): JSKN027 IND Application Officially Accepted by CDE

Stock News12-17

ALPHAMAB-B (09966) announced that the Investigational New Drug (IND) application for its self-developed PD-L1/VEGFR2 bispecific antibody-drug conjugate (ADC) JSKN027 has been officially accepted by the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA). The company plans to initiate a Phase I clinical study of JSKN027 for the treatment of advanced malignant solid tumors, aiming to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in this patient population, as well as to determine the maximum tolerated dose and/or recommended Phase II dose. Currently, no ADC targeting VEGFR2 alone or simultaneously targeting PD-L1 and VEGFR pathways has entered clinical studies globally. JSKN027 is the world's first PD-L1/VEGFR2 bispecific ADC to advance into clinical research. Preclinical data indicate that JSKN027 demonstrates significant tumor suppression activity in both in vitro and in vivo models. GLP toxicology studies show the drug is well-tolerated at the highest dose. With its multi-mechanistic actions—including cytotoxic killing, anti-angiogenesis, and immune modulation—JSKN027 holds promise as a novel therapeutic option for various solid tumors.

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