Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has received formal acceptance from the National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for JSKN027, a dual-specific antibody-drug conjugate (ADC) targeting PD-L1 and VEGFR2, aimed at treating advanced malignant solid tumors [1] Group 1: Clinical Trial Details - The company plans to conduct a Phase I clinical study of JSKN027 to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with advanced malignant solid tumors [1] - The study will also determine the maximum tolerated dose and/or recommended dose for Phase II trials [1] Group 2: Unique Positioning and Preclinical Data - JSKN027 is the first PD-L1/VEGFR2 dual-targeting ADC to enter clinical research globally, with no other ADCs targeting VEGFR2 alone or both pathways simultaneously currently in clinical studies [1] - Preclinical data shows that JSKN027 exhibits significant tumor suppression activity in both in vitro and in vivo models [1] - GLP toxicology studies indicate good tolerability of the drug at the highest doses [1] Group 3: Mechanism of Action and Potential Impact - JSKN027 is expected to provide new treatment options for various solid tumors due to its multiple mechanisms of action, including cytotoxicity, anti-angiogenesis, and immune modulation [1]
康宁杰瑞制药-B(09966)：JSKN027 IND申请获CDE正式受理