Bao Pharma’s Human Hyaluronidase Injection Receives NMPA Marketing Approval

Bulletin Express04-08

Shanghai Bao Pharmaceuticals Co., Ltd. (Bao Pharma) announced that its internally developed product “Human Hyaluronidase for Injection” (brand name: 葆舒宜®, project code: KJ017) in the 385U/vial dosage strength obtained marketing approval from the National Medical Products Administration of the PRC on 31 March 2026.\n\nThe recombinant human hyaluronidase degrades hyaluronic acid in subcutaneous tissue, temporarily increasing extracellular matrix permeability. This mechanism supports safe, rapid and large-volume subcutaneous administration and offers an alternative for patients with difficult intravenous access.\n\nKJ017 employs recombinant gene technology to address safety and consistency concerns linked to traditional animal-derived hyaluronidase. The controlled manufacturing process delivers high batch-to-batch consistency, eliminates the need for pre-use skin testing and reduces immunogenicity risk, thereby enhancing clinical convenience and safety.\n\nThe company reiterated the Listing Rules warning that there is no assurance KJ017 will ultimately be successfully developed and marketed.

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