CSPC Pharmaceutical Group Limited (the Group) obtained clearance from the National Medical Products Administration of China to conduct clinical trials for its Ropivacaine Long-acting Injection (SYH9089 Injection). This injection is designed to block sodium ion channels to help manage post-operative pain, aiming to lower dosing frequency and reduce reliance on opioid medications.
According to information released, the product can extend the analgesic duration of a single administration to one week, potentially becoming the first ultra-long-acting analgesic with such duration in China. Preclinical studies demonstrated no systemic toxicity or new target organs for toxicity, while exhibiting a favorable safety and long-acting analgesic effect compared with currently marketed alternatives.
The approved indication for this trial focuses on post-operative analgesia, representing a significant step in addressing the clinical need for more effective ultra-long-acting pain management solutions in the central nervous system field.