【News】Bao Pharma's Recombinant Human Hyaluronidase Successfully Registered in the U.S. FDA DMF

On May 13, 2025, Bao Pharma’s recombinant human hyaluronidase HYSORPTASE was successfully registered with the U.S. Food and Drug Administration (FDA) under Drug Master File (DMF) number 041587. This registration enables our clients to directly reference the relevant information and data of HYSORPTASE when filing their product applications with the FDA.

The DMF dossier for HYSORPTASE comprehensively covers key aspects including product characteristics, the manufacturing process, quality control and product stability, providing essential support for clients’ IND submissions for subcutaneous injection drugs.

In accordance with the FDA’s DMF management regulations, Bao Pharma issues Letters of Authorization (LOAs) to facilitate rapid information referencing by clients conducting simultaneous China–U.S. filings, thereby accelerating their regulatory submissions.

This achievement marks an important step in Bao Pharma’s internationalization journey. The company will continue to enhance its quality management system in compliance with cGMP standards, laying a solid foundation to support clients’ global project advancement.