China-based Alphamab Oncology (HKG: 9966) announced receiving Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) for its JSKN033, a HER2-targeted antibody drug conjugate (ADC) for the treatment of platinum-resistant recurrent epithelial ovarian cancer (PROC), primary peritoneal cancer, or fallopian tube cancer, regardless of HER2 expression levels.
Drug Profile and Mechanism
JSKN033 is a HER2-targeted ADC featuring improved serum stability and a stronger bystander killing effect. This mechanism allows the drug to exert therapeutic effects even in tumors with low HER2 expression, broadening its potential application.
Strategic Partnership
In September last year, CSPC Pharmaceutical Group Ltd (HKG: 1093) secured exclusive license and sub-license rights to JSKN033 through an RMB 3 billion licensing deal with Alphamab. CSPC becomes the sole Marketing Authorization Holder (MAH) for the drug in oncology indications in mainland China, while Alphamab retains exclusive manufacturing rights.-Fineline Info & Tech
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