Chinese partners Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that they have received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for JSKN003 versus trastuzumab emtansine in HER2-positive advanced breast cancer. This approval marks a significant milestone in the development of this HER2-targeted antibody drug conjugate (ADC).
Previous Approvals and Clinical Studies
JSKN003 has previously earned NMPA nods for Phase III clinical studies in HER2 low-expressing breast cancer and platinum-resistant ovarian cancer. The ADC has demonstrated better serum stability and a stronger bystander killing effect, showing a good tolerability and safety profile in clinical studies conducted in China and Australia.
Licensing Deal and Future Development
CSPC secured exclusive license and sub-license rights to JSKN003 through an RMB 3 billion licensing deal with Alphamab in September of last year. With the NMPA’s approval, the partners are poised to advance the clinical development of JSKN003, aiming to provide a new treatment option for patients with HER2-positive advanced breast cancer.-Fineline Info & Tech
