Alphamab Oncology Wins CDE Approval for Phase II JSKN033 Cervical Cancer Trial

Reuters2025-12-29
Alphamab Oncology Wins CDE Approval for Phase II JSKN033 Cervical Cancer Trial

Alphamab Oncology announced that its Investigational New Drug $(IND)$ application for a phase II clinical trial of JSKN033 has been officially accepted by the Center for Drug Evaluation $(CDE)$. The trial will evaluate JSKN033, a high-concentration subcutaneous co-formulation of an anti-HER2 bispecific antibody-drug conjugate and a PD-L1 immune checkpoint inhibitor, in combination with platinum-based chemotherapy with or without bevacizumab as a first-line treatment for advanced cervical cancer. The company cautioned that successful development or marketing of JSKN033 is not guaranteed. No other beneficiary organizations were mentioned.

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