By Fineline Cube 
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced that the National Medical Products Administration (NMPA) has approved the initiation of clinical trials for its oral immunomodulator HSK47388 in a newly identified autoimmune disease. The drug, already cleared for psoriasis trials in August 2025, is poised to broaden the company’s therapeutic portfolio.
Trial Expansion Highlights
- New Indication – NMPA clearance covers a distinct autoimmune disorder, marking a strategic expansion beyond psoriasis.
- Oral Delivery – HSK47388 is a potent, highly selective small‑molecule, offering patient‑friendly dosing.
- Regulatory Momentum – The August 2025 psoriasis trial approval demonstrates Haisco’s regulatory agility and strong data package.
Preclinical Profile
| Parameter | Finding |
|---|---|
| Model | Rat colitis (TNBS‑induced) |
| Efficacy | Significant, dose‑dependent therapeutic response |
| Safety | Excellent tolerability; wide safety margin observed in repeated‑dose studies |
These data underscore HSK47388’s therapeutic promise and support its progression into human studies.
Strategic Implications
- Portfolio Diversification – Adding a new autoimmune indication reduces reliance on a single disease area and enhances long‑term growth prospects.
- Competitive Edge – Oral, selective agents with robust safety profiles are highly sought after in the autoimmune market.
- Investor Appeal – The swift regulatory approvals signal operational efficiency and a clear path toward commercialization.
Next Steps
- Phase I/II Study Design – The company will design a dose‑escalation study to confirm safety, tolerability, and pharmacodynamics in the new disease context.
- Biomarker Development – Parallel biomarker studies will inform patient selection and therapeutic monitoring.
- Global Expansion – Upon successful Chinese trials, Haisco plans to pursue approvals in key international markets.-Fineline Info & Tech