Jilin Aodong subsidiary's naloxone injection gains quality approval

Jilin Aodong Pharmaceutical Group's controlled subsidiary, Jilin Aodong Pharmaceutical Group Yanji Co., Ltd., has received a "Drug Supplementary Application Approval Notification" for its Naloxone Hydrochloride Injection from the National Medical Products Administration. This approval signifies the drug has passed the consistency evaluation for quality and efficacy, aligning with generic drug standards. The approval encompasses changes to the drug's formulation, manufacturing process, raw material suppliers, quality standards, and direct-contact packaging materials.

The Naloxone Hydrochloride Injection is a chemical drug indicated as an opioid receptor antagonist. Its uses include reversing respiratory depression caused by opioid-compound anesthesia, managing opioid overdose, treating acute ethanol poisoning, and diagnosing acute opioid overdose. The drug's original approval number was H20066188, with a specification of 1ml: 0.4mg and a packaging size of 10 vials per box.

This regulatory milestone is expected to expand the drug's market share and boost the company's competitiveness. However, Jilin Aodong Pharmaceutical Group noted that drug production and sales are subject to national policies and market conditions, introducing uncertainty. The company anticipates this approval will not significantly impact its short-term financial performance.