On December 6, 2024, the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that Zencore Biologics Co., Ltd. has successfully registered its "Hyaluronidase" as a pharmaceutical excipient, with the registration number "F20240000634."

(Screenshot from the CDE official website)

This Zencore product is human hyaluronidase-based and is manufactured using recombinant DNA technology on a CHO cell line, followed by cell culture and purification processes. Compared to products derived from extraction, it represents a significant improvement in purity and potency, thereby providing a solid foundation for the success of biopharmaceuticals in terms of safety, efficacy, and consistency.

Hyaluronidase catalyzes the hydrolysis of β-1,4 glycosidic bonds in hyaluronic acid, resulting in the production of low molecular weight hyaluronic acid or oligosaccharides, which enhances tissue permeability and fluid penetration. In clinical applications, it has been used as a drug permeation agent, anesthetic adjunct, or postoperative anti-inflammatory agent. Several global biopharmaceutical giants have formulated hyaluronidase with high-concentration antibody products, opting for subcutaneous injection over intravenous infusion for the treatment of cancers or autoimmune diseases. However, the development of hyaluronidase-based subcutaneous products is hindered by issues of accessibility, purity, and cost associated with hyaluronidase.

This registration underscores Zencore's strengths in CMC, manufacturing, and QC for recombinant protein products. The introduction of Zencore hyaluronidase will help overcome one of the bottlenecks in the development of subcutaneous high-concentration protein therapeutics. Zencore looks forward to collaborating with global drug developers in the area of subcutaneous drug delivery.