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Alphamab Oncology Announces Anti-HER2 Biparatopic ADC JSKN003 Received U.S. FDA IND Approval to Initiate a Phase II Clinical Study for Platinum-Resistant Ovarian Cancer
Alphamab Oncology (stock code: 9966.HK) announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical study in the United States (study number: JSKN003-202) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, not restricted to HER2 expression levels.
About this update from Alphamab Oncology
[{"type":"text","content":"SUZHOU, China, July 31, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical study in the United States (study number: JSKN003-202) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, not restricted to HER2 expression levels.","length":494,"tagName":"p"},{"type":"text","content":"JSKN003 is an anti-HER2 biparatopic ADC developed inhouse which can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exerting anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated significant differentiated advantages including better serum stability and stronger bystander effect, which effectively expands the therapeutic window. In multiple clinical studies at various stages in China and Australia, JSKN003 has shown promising tolerability, safety, and significant antitumor activity.","length":587,"tagName":"p"},{"type":"text","content":"In China, three Phase III clinical studies of JSKN003 for the treatment of HER2-low expressing breast cancer (BC), platinum-resistant ovarian cancer (PROC), and HER2-positive BC are currently undergoing smoothly. In March 2025, JSKN003 was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) for the treatment of PROC, not restricted to HER2 expression levels.","length":453,"tagName":"p"},{"type":"text","content":"JSKN003-202 is a randomized, open-label, multi-center Phase II clinical study aimed at evaluating the safety and efficacy of JSKN003 in the treatment of patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, and determine the recommended phase III dose (RP3D). The FDA approval of this U.S. Phase II trial marks a significant milestone in Alphamab Oncology's global development strategy for its innovative pipeline, which will further strengthen the Company's competitive edge in oncology therapeutics.","length":571,"tagName":"p"},{"type":"text","content":"About JSKN003","length":13,"tagName":"p"}...