By Fineline Cube 
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that China’s National Medical Products Administration (NMPA) granted clinical approval for four Category 1 chemical drugs: HSK45019 (IBD), HSK50042 (respiratory disease), HSK55718 (acute pain), and HSK36357 (muscular dystrophy), advancing its innovative pipeline across multiple therapeutic areas.
Clinical Trial Approvals Overview
| Product | Formulation | Mechanism | Indication | Innovation Status |
|---|---|---|---|---|
| HSK45019 | Tablets | Small-molecule inhibitor | Inflammatory bowel disease (IBD) | Category 1, proprietary IP |
| HSK50042 | Tablets | Highly selective small-molecule inhibitor | Respiratory diseases | Category 1, oral administration |
| HSK55718 | Injection | Small-molecule analgesic | Acute pain | Category 1, non-addictive profile |
| HSK36357 | Capsules | Novel small-molecule drug | Muscular dystrophy (BMD/DMD) | Category 1, novel mechanism |
Individual Drug Profiles
HSK45019 – IBD Treatment
- Mechanism: Proprietary small-molecule inhibitor
- Potential: Novel therapeutic approach for IBD patients
- Market: China IBD market ¥8‑10 billion (≈ US$1.1‑1.4 B) with 10% CAGR
HSK50042 – Respiratory Disease
- Mechanism: Highly selective oral small-molecule inhibitor
- Preclinical Data: Improved lung disease pathology in model mice at low doses
- Safety: Good tolerability and wide safety margin
- Market: China respiratory drug market ¥25 billion (≈ US$3.5 B)
HSK55718 – Acute Pain Management
- Mechanism: Independently developed small-molecule analgesic
- Safety Profile: No significant cardiovascular, CNS, or respiratory effects at supratherapeutic doses
- Advantage: Effective analgesia with minimized adverse reactions and no addiction risk
- Market: Global acute pain market $12 billion; China segment ¥3 billion
HSK36357 – Muscular Dystrophy
- Mechanism: Novel small-molecule drug enhancing skeletal muscle contractility
- Preclinical Efficacy: Significant analgesic effect, improved muscle fatigue recovery in DMD models
- Safety: Good tolerability in animal studies
- Market: Global muscular dystrophy market $1.5 billion; China DMD/BMD population ~70,000
Strategic Implications
- For Haisco: Four simultaneous Category 1 approvals validate proprietary R&D platform and diversified therapeutic strategy; strengthens position in innovation‑driven drug development with potential for global out‑licensing.
- For Pipeline: Addresses high‑unmet‑need areas across immunology, respiratory, pain management, and rare diseases; reduces reliance on single‑asset risk.
- For Market: Demonstrates China’s accelerating Category 1 drug innovation; competitive advantages include proprietary IP, novel mechanisms, and improved safety profiles.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical trial timelines, market size estimates, and competitive positioning. Actual results may differ due to regulatory feedback, clinical risks, or competitive dynamics.-Fineline Info & Tech