Haisco's Major New Drug Approved for New Indication, Filling a Domestic Gap
Haisco pharmaceutical's innovative drug "Sishujing®" (Anrikefon Injection) has been approved for a new indication, which can be used for the treatment of moderate to severe pruritus in adult patients with chronic kidney disease (CKD) undergoing hemodialysis. This is China's first highly selective peripheral κ-opioid receptor agonist approved for this indication.
On September 15, 2025, the National Medical Products Administration (NMPA) of China officially approved the marketing of Sishujing® (Anrikefon Injection), a Class 1 innovative drug independently developed by Haisco Pharmaceutical, for an additional indication. This new indication is for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adult patients undergoing maintenance hemodialysis. As the first domestically approved highly selective peripheral κ-opioid receptor agonist for this indication in China, the launch of this drug will bring new hope to a large number of CKD-aP patients in the country.
It is reported that the incidence rate of CKD-aP among patients receiving maintenance hemodialysis in China is as high as 40%-60%. Moderate-to-severe pruritus not only causes skin scratches, crusting, and even secondary infections in patients, but also leads to severe sleep disorders, anxiety, and depression, and is even associated with an increased mortality rate. Previously, clinical treatments relied on antihistamines, topical hormones, and other methods, which had limited efficacy and were often accompanied by side effects such as drowsiness and dizziness, leaving long-unmet clinical needs.
The innovation of anrikefon lies in its precise mechanism of action: it has high affinity and strong selectivity for κ-opioid receptors, and barely acts on μ-opioid receptors, fundamentally avoiding the risks of addiction and respiratory depression associated with traditional opioid drugs. At the same time, due to its extremely low ability to cross the blood-brain barrier, it can avoid central nervous system side effects such as drowsiness and hallucinations. The phase III clinical trial data supporting its approval has been published in the British Medical Journal. This study included 545 patients, and the results showed that after 12 weeks of treatment, the proportion of patients in the anrikefon group with an improvement of ≥4 points in pruritus intensity score was significantly higher than that in the placebo group (P<0.001). The quality-of-life scores also increased simultaneously, and the adverse reactions were mainly mild-to-moderate dizziness and hypotension, showing excellent safety.
Compared with similar global drugs, such as nalfurafine (which may cause central nervous system side effects) and difelikefalin (with potential safety risks), anrikefon has significant advantages in both efficacy and safety. This approval not only marks that the treatment of CKD-aP in China has entered a new stage of "peripheral precise intervention", but also promotes the upgrading of China's pharmaceutical innovation from "treating diseases" to "improving quality of life", injecting a shot in the arm into the development of original drugs in niche fields.