BAO PHARMA-B (ASX: 02659) has announced that its Investigational New Drug (IND) application for BJ007, a subcutaneous formulation of ceftriaxone sodium, has been approved by the U.S. Food and Drug Administration (FDA). The approval, granted on May 27, 2026, permits the initiation of clinical trials.

The approved trial is a randomized, open-label study designed to evaluate the pharmacokinetic profile, absolute bioavailability, and PK/PD efficacy of subcutaneous BJ007 compared to intravenous (IV) ceftriaxone sodium injection in healthy subjects. BJ007 is a product intended for the treatment of bacterial infections via subcutaneous administration.

Data from Frost & Sullivan indicates that, to date, no subcutaneous formulation of ceftriaxone sodium has been approved globally. BJ007 is the first and only candidate in this category to have entered the clinical stage.

Ceftriaxone sodium is a third-generation cephalosporin β-lactam antibiotic. It works by binding to and inactivating penicillin-binding proteins (PBPs) on bacterial cell walls, disrupting the cross-linking of peptidoglycan chains essential for cell wall strength, thereby weakening the wall and causing cell lysis. Its time-dependent bactericidal activity means efficacy is primarily determined by the duration the drug concentration remains above the minimum inhibitory concentration (MIC).

This antibiotic is widely used to treat various bacterial infections, including lower respiratory tract, urinary tract, and biliary tract infections, as well as gonorrhea, intra-abdominal infections, pelvic inflammatory disease, skin and soft tissue infections, bone and joint infections, bacterial sepsis, meningitis, and for surgical prophylaxis.

Although intravenous ceftriaxone has been available globally for over 40 years with well-established efficacy and safety, intravenous administration presents challenges for patients with difficult intravenous access (DIVA).

Leveraging a high-volume subcutaneous delivery system supported by the company's core recombinant human hyaluronidase product, BJ007 was strategically developed to convert the existing intravenous administration of ceftriaxone to a subcutaneous injection. This innovation reduces the need for vascular access and long-term IV catheters, offering a more convenient, safer, and potentially lower-cost alternative.

Consequently, BJ007 aims to provide comparable therapeutic benefits while potentially avoiding the risks, discomfort, and costs associated with infusion lines typically required for longer courses of ceftriaxone, thereby addressing a major challenge in treating DIVA patients.