CSPC PHARMA's Long-Acting Ropivacaine Injection Receives Clearance for Clinical Trials in China

Stock News
Feb 16

CSPC PHARMA (01093) announced that its long-acting ropivacaine injection (SYH9089 injection) has received approval from the National Medical Products Administration of China to commence clinical trials in the country. The product works by inhibiting sodium ion channels in nerve cells, blocking the influx of sodium ions into nerve fiber cell membranes, thereby producing a reversible blockade of impulse conduction along nerve fibers. It also reduces dosing frequency, meeting the clinical need for sustained postoperative analgesia, decreasing patient reliance on opioid medications, and avoiding risks associated with continuous analgesic devices, such as infection or displacement, thereby significantly improving treatment compliance and medication safety. Leveraging the group's long-acting drug delivery technology platform, this product can extend the duration of analgesia from a single dose to up to one week, positioning it to potentially become China's first ultra-long-acting analgesic with a week-long duration. Preclinical studies indicate that the product showed no systemic toxicity or new toxic target organs and demonstrated significant advantages in long-lasting analgesia compared to commercially available ropivacaine injections, exhibiting a favorable safety and efficacy profile. The approved clinical indication is for postoperative pain management. The clearance for clinical trials of this product is expected to address an urgent clinical need in the field of ultra-long-acting postoperative analgesia and represents a significant achievement for the group in the central nervous system therapeutic area.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10