Bao Pharma Secures U.S. FDA IND Clearance to Begin Clinical Trials of Subcutaneous Ceftriaxone Candidate BJ007

Bulletin Express06-10

Shanghai Bao Pharmaceuticals Co., Ltd. (“Bao Pharma”) announced that the U.S. Food and Drug Administration granted Investigational New Drug (IND) clearance on 27 May 2026 for BJ007, a subcutaneous (SC) formulation of ceftriaxone sodium. The approval allows the company to initiate a randomized, open-label clinical study comparing the pharmacokinetics, absolute bioavailability and PK/PD efficacy of BJ007 (SC) with the standard intravenous (IV) formulation of ceftriaxone sodium in healthy volunteers.

BJ007 is positioned as the first and only SC-administered ceftriaxone sodium in clinical development, according to Frost & Sullivan. By leveraging Bao Pharma’s proprietary large-volume SC delivery system incorporating recombinant human hyaluronidase, the candidate aims to offer comparable therapeutic effect to IV ceftriaxone while eliminating the need for vascular access and long-term IV catheters—an important advantage for patients with difficult intravenous access (DIVA).

Ceftriaxone sodium, a third-generation cephalosporin antibiotic, has been marketed for over four decades for a wide range of bacterial infections. Transitioning its administration route from IV to SC could improve convenience, reduce healthcare costs and minimize catheter-related risks during prolonged therapy.

The company cautioned that development timelines and outcomes remain subject to clinical and regulatory uncertainties.

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