Alphamab Oncology announces IND application for a Phase 3 clinical study of HER2 bispecific ADC subcutaneous co-formulation JSKN033 as first-line treatment of advanced cervical cancer was officially accepted by CDE

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29 December 2025: Alphamab Oncology announces IND application for a Phase 3 clinical study of HER2 bispecific ADC subcutaneous co-formulation JSKN033 as first-line treatment of advanced cervical cancer was officially accepted by CDE

Alphamab Oncology has received acceptance from China’s NMPA center for drug evaluation for the IND application of a Phase 3 clinical study evaluating JSKN033 as a first-line treatment for advanced cervical cancer
JSKN033 is a proprietary high-concentration subcutaneous co-formulation combining a HER2 bispecific antibody-drug conjugate with a PD-L1 immune checkpoint inhibitor, to be studied in combination with platinum-based chemotherapy, with or without bevacizumab
The open-label, multicenter Phase 3 trial will evaluate safety, efficacy, and PK/PD of JSKN033 in combination regimens, with investigator-selected platinum agents and optional bevacizumab, aiming to introduce a more innovative and convenient first-line treatment option for patients with advanced cervical cancer
The study addresses a significant unmet need in advanced cervical cancer, where current platinum-based chemotherapy regimens, despite recent immunotherapy advances, continue to deliver limited long-term survival due to tumor heterogeneity and suboptimal response rates

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