Haisco(SZ:002653) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-09-16 02:16Core Viewpoint - The company has received approval from the National Medical Products Administration for its innovative drug, Anruikefen Injection (HSK21542), which is indicated for treating moderate to severe pruritus in adult patients undergoing maintenance hemodialysis [1][2]. Group 1: Drug and Application Information - Drug Name: Anruikefen Injection - Acceptance Number: CXHS2400097 - Certificate Number: 2025S02878 - Approval Number: National Drug Standard H20250014 - Application: Drug registration (domestic production) - Registration Category: Class 1 chemical drug - Dosage Form: Injection - Specification: 1ml: 0.1mg - Indication: For moderate to severe pruritus in adult patients with chronic kidney disease undergoing maintenance hemodialysis [1]. Group 2: R&D Project Overview - HSK21542 is a highly selective peripheral kappa opioid receptor agonist developed by the company - Clinical research indicates that HSK21542 Injection significantly alleviates pruritus, with primary and secondary efficacy indicators showing significant improvement over the placebo group - The safety profile of HSK21542 Injection is reported to be good and controllable - The newly approved indication was included in the priority review and approval process in July 2024 and is now approved for market release, providing better options for patients suffering from pruritus - Anruikefen Injection was first approved in May 2025 for treating mild to moderate pain after abdominal surgery, and a Phase III clinical study for its use in postoperative pain relief in orthopedic surgery is ongoing [2].