ALPHAMAB-B(09966): The IND application for a Phase II clinical trial of JSKN033 has been formally accepted by the CDE.

date
12:17 29/12/2025
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Concordia Healthcare-R (09966) announced that the new drug clinical trial application for the Phase II clinical trial of JSKN033 (a high-concentration subcutaneous injection compound formulation composed of a dual-specificity antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) coupled with a programmed cell death ligand 1 (PDL1) immune checkpoint inhibitor) in combination with platinum-based chemotherapy with or without pembrolizumab as first-line treatment for advanced cervical cancer has been formally accepted by the China Drug Evaluation Center (CDE) of the National Medical Products Administration.
ALPHAMAB-B (09966) announced that the new drug clinical trial application for JSKN033 (a high-concentration subcutaneous injection 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), in combination with platinum-based chemotherapy with or without bevacizumab, as a first-line treatment for advanced cervical cancer, has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. JSKN033-202 is an open-label, multicenter, Phase II clinical trial that aims to evaluate the safety, efficacy, pharmacokinetics/pharmacodynamics of JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab as a first-line treatment for patients with advanced cervical cancer. All patients will receive treatment with JSKN033 in combination with cisplatin or carboplatin, with or without bevacizumab, as determined by the investigators based on the specific circumstances of the patients.