CSPC Pharma (01093): Ropivacaine long-acting injection (SYH9089 injection) has been approved for clinical trials in China.
Simcere Pharmaceutical Group (01093) announced that the long-acting injection of ropivacaine developed by the group (SYH9089 injection) has been approved by the National Medical Products Administration of the People's Republic of China and can conduct clinical trials in China.
CSPC PHARMA (01093) announced that the long-acting ropivacaine injection (SYH9089 injection) developed by the group has been approved by the National Medical Products Administration of the People's Republic of China and can be used for clinical trials in China.
The product can inhibit sodium ion channels in nerve cells, block the influx of sodium ions into nerve fiber cells, and produce reversible blockade of impulse conduction along nerve fibers; it can also reduce the frequency of administration, meet the sustained pain relief needs of clinical postoperative patients, reduce patient dependence on opioid drugs, and avoid the risk of infection or displacement of continuous pain relief devices, significantly improving treatment compliance and drug safety. With the group's long-acting drug delivery technology platform, this product can extend the duration of pain relief to one week with a single administration, potentially becoming the first long-acting pain relief product in China with a duration of one week.
Preclinical studies have shown that the product has no systemic or additional toxic effects on target organs, and compared to commercially available ropivacaine injections, it demonstrates significant advantages in long-lasting pain relief, with good safety and efficacy.
The approved clinical indication for this product is postoperative pain relief. The approval of clinical trials for this product is expected to meet the urgent clinical need for long-lasting postoperative pain relief and is an important achievement for the group in the central nervous system field.
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