By Fineline Cube 
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced that the China National Medical Products Administration (NMPA) has granted additional approval for its Category 1 innovative drug, Anrikefon Injection (trade name: Sishujing, development code: HSK21542). The new indication covers moderate‑to‑severe pruritus in adult patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis.
Drug Profile
- Mechanism – Anrikefon is a highly selective peripheral κ‑opioid receptor (KOR) agonist developed independently by Haisco Pharma.
- Clinical Data – Phase 2 trials show that Anrikefon significantly reduces pruritus, outperforming placebo on both primary and secondary endpoints while maintaining a favorable safety profile.
- Existing Approvals – The drug was first approved in May 2025 for mild‑to‑moderate pain after abdominal surgery.
- Ongoing Studies – A Phase 3 program evaluating Anrikefon for postoperative analgesia after orthopedic surgery is progressing smoothly.
Market Significance
Pruritus is a common, debilitating symptom in CKD patients on hemodialysis, with limited effective therapies. The NMPA approval positions Anrikefon as a first‑in‑class treatment in China’s growing CKD therapeutics market, projected to reach $3.2 billion by 2030.
Haisco Pharma’s strategic focus on peripheral opioid pathways aligns with global trends toward safer, non‑central nervous system‑acting analgesics, potentially expanding the drug’s appeal beyond China.
Company Outlook
Haisco’s robust pipeline and strong regulatory track record reinforce its reputation as a leading innovator in China’s biopharmaceutical sector. The new approval for Anrikefon is expected to accelerate revenue growth and strengthen the company’s presence in the nephrology and pain management markets.-Fineline Info & Tech