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Bao Pharma's IND Application Gains US FDA Approval for Bacterial Infection Therapy

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Shanghai Bao Pharmaceuticals (HKG:2659) said it has received investigational new drug clearance from the U.S. Food and Drug Administration for subcutaneous infusion of BJ007, according to a Wednesday Hong Kong bourse filing.

The clearance enables the company to begin a clinical trial evaluating the pharmacokinetic characteristics, absolute bioavailability, and PK/PD efficacy of BJ007 compared with intravenous ceftriaxone sodium in healthy participants, the filing said.

BJ007 is a subcutaneous ceftriaxone sodium candidate being developed for the treatment of bacterial infections.

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