[News] Bao Pharma Completes Pharmaceutical Excipient Registration for Hyaluronidase

On November 21, 2024, the “Pharmaceutical Excipient Registration Data” section of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) listed the registration number F20240000658 for Bao Pharma’s pharmaceutical excipient hyaluronidase.

Bao Pharma’s hyaluronidase is produced through DNA recombinant technology, expressing the human hyaluronidase enzyme, followed by fermentation and purification. Compared to animal-derived extraction products, this recombinant version offers enhanced safety and purity.

Hyaluronidase is an endoglycosidase that degrades hyaluronic acid (HA). It hydrolyzes β-1,4 glycosidic bonds in high-molecular-weight HA, generating low-molecular-weight fragments or oligosaccharides, thereby increasing tissue permeability and enhancing fluid diffusion. Clinically, hyaluronidase is widely used as a drug permeation enhancer, anesthetic adjuvant, and postoperative anti-edema agent. It facilitates the diffusion of locally administered drugs, exudates, or blood, accelerating drug absorption, reducing tissue tension and pain, and promoting the absorption and resolution of edema and inflammatory exudates.

The application of hyaluronidase enables the transition of intravenous drugs to subcutaneous injection, improving drug safety, ease of administration, and patient adherence—a growing trend in antibody drug development.

The successful CDE registration of hyaluronidase as a pharmaceutical excipient marks a significant miles***e for Bao Pharma. Leveraging its expertise in recombinant protein research and manufacturing, the company continues to drive innovation to meet the diverse needs of the pharmaceutical industry. This achievement is particularly significant in overcoming volume limitations in subcutaneous drug delivery, enabling high-dose administration in a rapid, convenient, and safe manner.

Note: Hyaluronidase is also referred to as recombinant human hyaluronidase.