Acknowledgement
15 Days
Jiangsu Alphamab Biopharmaceuticals Co., Ltd.
EA Therapies for Single Patient

Currently, the therapy available through our single-patient expanded access (EA) program is JSKN003 , intended for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer (PROC).

EA Policies for Single Patient

Consistent with U.S. FDA’s guidelines, expanded access may be appropriate when all the following apply:
• Patient has a serious or immediately life-threatening disease or condition.
• There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
• Patient enrollment in a clinical trial is not possible.
• Potential patient benefit justifies the potential risks of treatment.
• Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.