Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has announced the acceptance of its new drug clinical trial application for JSKN033, a combination therapy for advanced cervical cancer, by the National Medical Products Administration (NMPA) [1] Group 1: Clinical Trial Details - JSKN033 is a high-concentration subcutaneous compound formulation consisting of a bispecific antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) and a programmed death ligand 1 (PDL1) immune checkpoint inhibitor [1] - The clinical trial, identified as JSKN033-202, is an open-label, multicenter, Phase II study aimed at evaluating the safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics of JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with advanced cervical cancer [1] - All participants will receive treatment with JSKN033 in combination with either cisplatin or carboplatin, and the choice of platinum drug and the inclusion of bevacizumab will be determined by the researchers based on individual patient circumstances [1]
康宁杰瑞制药-B(09966):JSKN033的一项II期临床试验的IND申请获CDE正式受理