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The National Medical Products Administration has recently issued a "Acceptance Notice," officially notifying the acceptance of the marketing license application for the innovative drug Anruikefen Injection by Haisco, intended for use in treating postoperative pain.

Source of image:National Medical Products Administration Drug Evaluation Center

Anrexfen Injection is an innovative peripheral Kappa opioid receptor (KOR) agonist independently developed by Haixike. It possesses high selectivity and affinity. Under the participation of G proteins, it co-regulates potassium and calcium ion flows. It can block the signaling pathways of pain and itching. By inhibiting the excitability of the dorsal root ganglia and peripheral sensory nerves, it reduces the release of inflammatory factors and neurotransmitters, thereby providing analgesic and antipruritic effects. This product does not pass through the blood-brain barrier. While exerting peripheral analgesic and antipruritic effects, it avoids central opioid-related side effects such as hallucination, addiction, and respiratory depression.

Anruikefen Injection received the "Indication for treating mild to moderate pain after abdominal surgery" and "Indication for adult patients with chronic kidney disease-related moderate to severe itching during maintenance hemodialysis" Drug Registration Certificates in May 2025 and September 2025 respectively (Drug Approval Number: Guoyao Zhunzi H20250014). The application currently under consideration is the marketing license application for the "post-operative pain indication".

Based on three well-designed randomized double-blind phase III clinical studies, Anruikefen injection has been confirmed to be effective and safe in treating postoperative pain. The clinical study results show that Anruikefen injection has a good analgesic effect, rapid onset, and long duration of analgesia; at the same time, it has good overall safety and tolerability, without morphine-like adverse effects such as respiratory depression, dizziness, or constipation. The satisfaction of subjects and study doctors is high. Additionally, when this product was first approved for market, experts from multiple ministries including the National Health Commission, Ministry of Public Security, and National Medical Products Administration did not recommend including it in the Narcotic and Psychotropic Drugs List. It is the first opioid analgesic drug with an analgesic indication that does not require management under the narcotic and psychotropic drugs list. If approved successfully, it will cover patients with mild to moderate postoperative pain, offering broad market prospects.