Haisco drug Anruikfen approved for chronic kidney disease pruritus

Haisco Pharmaceutical Group announced the National Medical Products Administration's approval of a new indication for its Class 1 innovative drug, Anruikfen injection (trade name: Soshuqing, research code: HSK21542). The drug is approved for treating moderate to severe pruritus in adult patients with chronic kidney disease undergoing maintenance hemodialysis. This new indication was granted under a priority review and approval process in July 2024.

Anruikfen injection is an internally developed, highly selective peripheral kappa opioid receptor (KOR) agonist. Clinical studies showed the injection significantly alleviated pruritus, with both primary and secondary efficacy indicators superior to the placebo group, and a favorable safety profile. This is Anruikfen's second approved indication, following its initial approval in May 2025 for mild to moderate pain after abdominal surgery.

A Phase III clinical study for Anruikfen injection in post-orthopedic surgery pain management is currently underway. Haisco Pharmaceutical Group reminds investors that future production and sales of this drug are subject to various uncertainties, including policy changes, market demand, and competition, urging caution in investment decisions.