China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its market filing for SHR8554, an injectable drug candidate for moderate to severe postoperative pain, has been accepted by the National Medical Products Administration (NMPA). The drug, a small-molecule μ-opioid receptor (MOR) agonist, met superiority standards in a Phase III trial for abdominal surgery pain in December 2021.
Drug Profile
SHR8554 is designed to address postoperative pain, a critical issue where inadequate management can lead to chronic pain and psychological effects. The drug activates the G protein-coupled pathway for analgesia while minimizing β-arrestin2 signaling to reduce side effects. Currently, no biased MOR agonists with strong analgesic effects and low adverse reactions are available in China.
Market Context
Opioids like morphine and fentanyl are standard for treating moderate to severe pain, but their side effects remain a concern. Hengrui’s SHR8554 aims to fill this gap, offering a novel therapy with a favorable safety profile. The NMPA’s review marks progress toward addressing unmet needs in postoperative pain management.-Fineline Info & Tech
