Onco-Summaries: Daily Oncology Updates at a Glance

20/12/2025

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• Alphamab & CSPC's JSKN003 ADC received the FDA Breakthrough Therapy Designation for the Treatment of PROC 

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Alphamab & CSPC's JSKN003 ADC received the FDA Breakthrough Therapy Designation for the Treatment of PROC (Ref)

The US FDA granted the breakthrough therapy designation to Alphamab Oncology and CSPC Pharma's JSKN003 (biparatopic HER2-targeting ADC) for the treatment of adult patients with advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal, or fallopian tube cancers (PROC) expressing HER2 who have received prior treatment with bevacizumab.

• The BTD is based on the pooled analysis of the Phase 1 JSKN003-101/NCT05494918 trial in Australia and the Phase 1/2 JSKN003-102/NCT05744427 trial in China