Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Paul Johns
Trade Marks

Harbour BioMed Resubmits Batoclimab BLA to China’s NMPA with Additional Safety Data

Jun 27, 2024

On 27 June 2024, Harbour Biomed announced that it has resubmitted its Biologics License Application (BLA) for batoclimab (HBM9161) to the China’s National Medical Products Administration (NMPA) for the treatment of generalized myasthenia gravis. The resubmission voluntarily includes new safety data following a Phase 3 trial extension period.

In December 2023, Harbour BioMed’s subsidiary Nona Biosciences announced that it has entered into an exclusive license agreement with Pfizer for the global clinical development and commercialisation of HBM9033, Nona’s MSLN-targeted antibody-drug conjugate (ADC).