Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) has received formal acceptance from the National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for JSKN027, a bispecific antibody-drug conjugate (ADC) targeting PD-L1 and VEGFR2, aimed at treating advanced malignant solid tumors [1] Group 1 - The company plans to conduct Phase I clinical research for JSKN027 to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with advanced malignant solid tumors [1] - JSKN027 is the first PD-L1/VEGFR2 bispecific ADC to enter clinical research globally, with no other ADCs targeting VEGFR2 alone or both PD-L1 and VEGFR pathways currently in clinical studies [1] - Preclinical data shows that JSKN027 exhibits significant tumor suppression activity in both in vitro and in vivo models, and GLP toxicology studies indicate good tolerability at the highest doses [1] Group 2 - The multiple mechanisms of action of JSKN027, including cytotoxicity, anti-angiogenesis, and immune modulation, suggest it may provide new treatment options for various solid tumors [1]
康宁杰瑞制药-B(09966.HK):“JSKN027”IND申请获CDE正式受理