Postoperative pain is acute pain that occurs immediately after surgery. Inadequate management of postoperative pain may lead to a variety of psychological and physiological negative effects, such as persistent pain and the possibility of turning into a chronic state. Opioids are the most commonly used drugs for the treatment of moderate to severe acute and chronic pain. Classical μ-opioid receptor (MOR) agonists, including morphine and fentanyl, are among the more potent analgesic classes of opioids and can activate both the G protein-coupled pathway and the β-arrestin2 signaling pathway.Activation of the G protein-coupled pathway is conducive to a potent central analgesic effect, whereas activation of the β-arrestin2 signaling pathway causes gastrointestinal side effects, such as gastrointestinal dysphoria. Side effects. Currently, there are no biased MOR agonists with good analgesic effects and low incidence of adverse effects on the market in China, and there is an unmet clinical need.

In December 2023, the results of the primary study endpoint of the phase II/III clinical study to evaluate the efficacy and safety of SHR8554 injection for postoperative analgesia after orthopedic surgery (protocol no. SHR8554-203) met the preset superiority criteria of the protocol. The study was conducted by Prof. Yu Weifeng and Prof. Li Peiying of Renji Hospital, Shanghai Jiao Tong University School of Medicine, as the principal investigators, with the participation of 43 centers across China. A total of 441 subjects were enrolled in this study, and the primary efficacy index was the time-weighted sum of the differences in resting-state pain intensity within 24 hours after the start of the infusion of the loading dose of the test drug (SPID24). The results of the study showed that SHR8554 injection was effective in treating moderate-to-severe pain after orthopedic surgery, reducing the amount of remedial medication, and significantly improving subjects' satisfaction with analgesic treatment.

SHR8554 injection, a Class 1 new drug independently developed by Hengrui Pharmaceuticals, is a small molecule drug targeting the μ-opioid receptor (MOR), which can activate the MOR receptor, and is suitable for postoperative analgesic treatment. Previously, SHR8554 injection for post-abdominal surgery pain indication has also been accepted by the State Drug Administration.

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