BAO PHARMA-B (02659) Receives NMPA Approval for Recombinant Human Hyaluronidase Injection

Stock News
04/08

BAO PHARMA-B (02659) announced that on March 31, 2026, its self-developed, leading recombinant human hyaluronidase injection (Baoshuyi®, project code KJ017), with a specification of 385U per vial, has received marketing approval from the National Medical Products Administration (NMPA). The product is indicated for use as an aid in subcutaneous fluid administration, such as with sodium chloride injection and lactated Ringer's injection. KJ017 is a highly glycosylated recombinant human hyaluronidase that specifically breaks down hyaluronic acid in the subcutaneous tissue. It temporarily and locally increases the permeability of the extracellular matrix in the subcutaneous tissue, enabling safe, rapid, and high-volume subcutaneous drug delivery. This provides a new option for patients with difficult venous access. Compared to traditional animal-derived hyaluronidase, which carries allergy risks, requires skin testing prior to use, and has inconsistent batch-to-batch quality, KJ017 is produced using recombinant gene technology and a controlled manufacturing process. This ensures high batch-to-batch consistency, improved safety, and a significantly reduced risk of immunogenicity. The product does not require skin testing before use, enhancing both the convenience and safety of clinical administration.

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