BAO PHARMA-B(02659.HK): Subcutaneous Infusion Ceftriaxone Sodium BJ007 FDA IND Approval
NewTimeSpaceNews: Shanghai Bao Pharmaceuticals Co., Ltd. (02659.HK) released a voluntary announcement on June 10, 2026. On May 27, 2026, the IND application for its self-developed subcutaneous infusion ceftriaxone sodium BJ007 was approved by the U.S. Food and Drug Administration (FDA), permitting clinical trial initiation.
The approved trial is a randomized, open-label clinical study designed to evaluate the pharmacokinetic (PK) profile, absolute bioavailability, and PK/PD efficacy of subcutaneous infusion ceftriaxone sodium BJ007 versus intravenous ceftriaxone sodium injection in healthy subjects.
Ceftriaxone sodium is a third-generation cephalosporinβ-lactam antibiotic widely used to treat bacterial infections including lower respiratory tract infections, urinary tract infections, biliary tract infections, intra-abdominal infections, pelvic inflammatory disease, skin and soft tissue infections, bone and joint infections, bacterial sepsis, meningitis, and surgical prophylaxisBaopharma. Although ceftriaxone sodium has been marketed globally for over 40 years and is typically administered intravenously, venous access challenges persist in certain patient populations.
Enabled by the Company’s proprietary recombinant human hyaluronidase (rHuPH20)-based large-volume subcutaneous delivery systemBaopharma, BJ007 is strategically developed to replace intravenous infusion with subcutaneous injection for ceftriaxone, offering a more convenient, safer, and cost-effective administration option.
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