By Fineline Cube 
Humanwell Healthcare (Group) Co., Ltd. (SHA: 600079) announced that it has begun a Phase 2 clinical trial of its novel acute‑pain therapy, HW231019 tablets, aimed at reducing post‑operative pain after abdominal surgery.
Trial Overview
| Item | Details |
|---|---|
| Phase | Phase 2 |
| Condition | Post‑operative acute pain – abdominal surgery |
| Primary Aim | Evaluate efficacy & safety of HW231019 |
| Secondary Aim | Optimize dosing regimen for post‑operative analgesia |
| Recruitment Goal | 200‑250 patients across 10 hospitals in China |
Humanwell’s trial design follows the regulatory framework for analgesic drugs in China, with primary endpoints including pain intensity scores (VAS) and opioid‑free analgesic consumption over 48 hrs post‑operation.
Market Context – Acute‑Pain Therapeutics in China
- Competitive Landscape:
- 1 company has progressed to Phase 2/3 for a drug targeting the same mechanism.
- 4 companies remain in Phase 2 of similar acute‑pain agents.
- 2 companies are at Phase 1.
- Regulatory Opportunity:
- The Chinese National Medical Products Administration (NMPA) encourages development of novel, non‑opioid analgesics with improved safety profiles.
- Successful Phase 2 data could accelerate a 30‑day Phase 3 launch, potentially capturing > $500 M of the domestic post‑operative analgesia market.
Humanwell’s Position
- Innovation: HW231019 utilizes a selective receptor subtype modulation strategy that has shown promising pre‑clinical safety data.
- Portfolio Synergy: The company’s existing pipeline in pain management and hospital‑based therapies positions it well for rapid scale‑up.
- Commercial Outlook: If Phase 2 proves positive, Humanwell plans to pursue NMPA approval and a parallel U.S. filing to align with a global commercialization strategy.
Forward‑Looking Statements
This brief contains forward‑looking statements concerning Humanwell’s clinical program, regulatory prospects, and commercial potential. Actual results may differ materially due to clinical, regulatory, and market risks.-Fineline Info & Tech