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Alphamab Oncology Announces IND Application for a Phase II 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 (Stock Code: 9966.HK) announced that the IND application for a Phase II clinical study of JSKN033 (a proprietary high-concentration subcutaneous co-formulation consisting of HER2 bispecific antibody-drug conjugate (ADC) and PD-L1 immune checkpoint inhibitor) in combination with platinum-based chemotherapy with or without bevacizumab as first-line treatment of advanced cervical cancer (Study Number: JSKN033-202), has been officially accepted by the Center for Drug Evaluation (CD
About this update from Alphamab Oncology
[{"type":"text","content":"SUZHOU, China, Dec. 29, 2025 /PRNewswire/ -- Alphamab Oncology (Stock Code: 9966.HK) announced that the IND application for a Phase II clinical study of JSKN033 (a proprietary high-concentration subcutaneous co-formulation consisting of HER2 bispecific antibody-drug conjugate (ADC) and PD-L1 immune checkpoint inhibitor) in combination with platinum-based chemotherapy with or without bevacizumab as first-line treatment of advanced cervical cancer (Study Number: JSKN033-202), has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).","length":603,"tagName":"p"},{"type":"text","content":"Cervical cancer is the most common gynecological malignancy and the fourth leading cause of cancer-related deaths among women. Patients with early-stage disease often experience recurrence or metastasis within two years after treatment, while those with advanced disease have a poor prognosis, with a five-year survival rate of less than 20%. Currently, platinum-based (cisplatin or carboplatin) chemotherapy combined with bevacizumab represents the guideline-recommended first-line standard of care. Although immune checkpoint inhibitors have also achieved breakthrough progress, tumor heterogeneity in cervical cancer still leads to suboptimal responses in some patients, highlighting a clear unmet clinical need.","length":715,"tagName":"p"},{"type":"text","content":"In recent years, multiple clinical studies have confirmed the synergistic potential of combining ADCs with immunotherapy and anti-angiogenic agents. As a first-in-class co-formulation of ADC and immune checkpoint inhibitor, JSKN033 leverages a dual mechanism of action, combining targeted tumor killing with immune activation. In early-stage clinical studies, JSKN033 monotherapy has demonstrated promising efficacy and a manageable safety profile in patients with cervical cancer who have failed standard therapies.","length":516,"tagName":"p"},{"type":"text","content":"JSKN033-202 is an open-label, multicenter phase II clinical trial designed to evaluate the safety, efficiency and pharmacokinetics (PK)/pharmacodynamics (PD) of JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, as first-line treatment for patients with advanced cervical cancer. All patients will receive treatment with JSKN033 plus...