Alphamab Oncology’s Anti-HER2 Biparatopic ADC JSKN003 Receives Approval for Ovarian Cancer Treatment
Tuesday, March 18, 2025
Alphamab Oncology and CSPC Pharmaceutical have announced that the anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has been granted Breakthrough Therapy Designation by the Centre for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).
Ovarian cancer is among the most common gynaecological malignancies in China, with an increasing incidence and the highest mortality rate among these cancers. Standard treatment involves surgery combined with platinum-based chemotherapy and maintenance therapy using targeted treatments.
Around 80% of ovarian cancer cases eventually recur, progressing to platinum-resistant disease. Patients with PROC have limited treatment options, with existing therapies offering only modest benefits.
JSKN003 is an anti-HER2 bispecific ADC developed using Alphamab’s proprietary glycan-specific conjugation platform. It binds to HER2 on tumour cells and releases topoisomerase I inhibitors (TOPIi) through cellular endocytosis, exerting anti-tumour effects.
Compared with other ADCs, JSKN003 has demonstrated improved serum stability and a stronger bystander effect, potentially expanding its therapeutic application.
The designation applies to the treatment of platinum-resistant recurrent epithelial ovarian cancer (PROC), primary peritoneal cancer, or fallopian tube cancer, regardless of HER2 expression levels.
The Breakthrough Therapy Designation for JSKN003 is supported by pooled analysis from two clinical studies: JSKN003-101 and JSKN003-102.
A Phase III clinical trial for JSKN003 in this indication is currently enrolling participants and progressing well. As a novel bispecific ADC, JSKN003 incorporates enzyme catalysis and click chemistry mechanisms, enhancing serum stability and bystander effects while improving therapeutic efficacy.
The Breakthrough Therapy Designation is expected to accelerate its development, review, and approval process, potentially making the treatment available to patients with PROC more quickly.
Source: alphamabonc.com
