Core Viewpoint - The company has received formal acceptance from the National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for JSKN027, a dual-targeting antibody-drug conjugate (ADC) aimed at treating advanced malignant solid tumors [1] Group 1: Drug Development - JSKN027 targets both Programmed Death Ligand 1 (PD-L1) and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2), making it the first ADC to enter clinical research that specifically targets these pathways [1] - The planned Phase I clinical study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of JSKN027, as well as determine the maximum tolerated dose and/or recommended dose for Phase II [1] Group 2: Market Position - Currently, there are no ADCs targeting VEGFR2 alone or simultaneously targeting both PD-L1 and VEGFR2 in clinical research globally [1] - Preclinical data indicates that JSKN027 exhibits significant tumor suppression activity in both in vitro and in vivo models [1] Group 3: Safety and Efficacy - Good tolerability was observed in GLP toxicology studies at the highest dose [1] - 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：JSKN027 IND申请获CDE正式受理