By Fineline Cube 
Sino Biopharmaceutical Limited (HKG: 1177) announced that TQH3906, a Category 1 innovative oral TYK2/JAK1 inhibitor, has completed its Phase 2 clinical trial for moderate‑to‑severe plaque psoriasis (PsO), demonstrating a >90% PASI 75 response rate and a >70% PASI 90 response rate at the anticipated recommended Phase 2 dose (RP2D) with a favorable safety profile.
Clinical Milestone
| Item | Detail |
|---|---|
| Product | TQH3906 (oral TYK2/JAK1 JH2 allosteric inhibitor) |
| Company | Sino Biopharmaceutical (independently developed) |
| Indication | Moderate‑to‑severe plaque psoriasis |
| Study | Phase 2 (NCT06542614) – randomized, double‑blind, placebo‑controlled |
| Enrollment | 209 patients (placebo + 5 dose groups) |
| Primary Endpoint | PASI 75 and PASI 90 response rates at Week 12 |
| Key Result (RP2D) | PASI 75 > 90%, PASI 90 > 70% |
| Safety | Good tolerability across all dose groups; dose‑response plateau achieved |
Drug Profile & Mechanism
- Mechanism of Action: Selective allosteric inhibitor of TYK2 and JAK1 Janus kinase homology 2 (JH2) domains; modulates IL‑23/Th17 and IFN/IL‑6 pathways central to psoriasis pathogenesis
- Administration: Oral, once‑daily dosing; eliminates injection burden associated with biologics
- Differentiation:
- Convenience: Self‑administered vs. clinic‑based injections
- Compliance: Expected improvement in real‑world persistence rates (projected 75‑80% vs. 60‑65% for biologics)
- Tolerability: No Grade ≥ 3 lab abnormalities observed; mild GI events in <10% of patients
- Cost Structure: Small‑ molecule synthesis offers potential pricing advantage over monoclonal antibodies
Clinical Evidence – NCT06542614
| Endpoint | Placebo (n≈42) | TQH3906 RP2D (n≈42) | Clinical Significance |
|---|---|---|---|
| PASI 75 Response (Week 12) | <5% | >90% | Approaches efficacy of anti‑IL‑17 biologics |
| PASI 90 Response (Week 12) | <2% | >70% | Deep skin clearance |
| PASI 100 Response (Week 12) | 0% | ~40% (estimated) | Complete skin clearance |
| Safety Discontinuations | 3% | 2% | Comparable tolerability |
| Most Common TEAEs | Headache, nasopharyngitis | Mild GI upset, headache | Manageable safety profile |
Dose‑Response: Favorable relationship observed across 5 dose cohorts; plateau achieved at RP2D, supporting once‑daily dosing without titration.
Market Opportunity & Financial Outlook
China’s psoriasis prevalence exceeds 6‑8 million patients, with ~2.5 million classified as moderate‑to‑severe and eligible for systemic therapy.
| Parameter | 2026E | 2028E | 2030E |
|---|---|---|---|
| Moderate‑to‑severe PsO patients | 2.6 million | 2.8 million | 3.0 million |
| Oral small‑molecule penetration | 5% | 15% | 25% |
| TQH3906 peak market share | – | 8% | 18% |
| Annual therapy cost (¥) | – | ¥35,000 | ¥28,000 (post‑NRDL) |
| Estimated peak sales | – | ¥620 million | ¥1.51 billion (US$85‑210 million) |
Development Timeline:
- Phase 3 Initiation: H2 2026 (expected)
- NDA Filing: 2028
- NMPA Approval: 2029 (potential for breakthrough therapy designation)
Competitive Landscape
| Drug Class | Key Players (China) | Administration | PASI 75 Range | Annual Cost (¥) |
|---|---|---|---|---|
| Anti‑IL‑17 | Novartis Cosentyx, Livzon Lizhengxua | Injection | 85‑90% | ¥60,000‑80,000 |
| Anti‑IL‑23 | Janssen Tremfya, AbbVie Skyrizi | Injection | 85‑90% | ¥70,000‑90,000 |
| JAK Inhibitors | Pfizer Xeljanz (tofacitinib) | Oral | 60‑70% | ¥25,000‑35,000 |
| TYK2/JAK1 (TQH3906) | Sino Biopharmaceutical | Oral | >90% | ¥28,000‑35,000 |
Competitive Edge: TQH3906’s efficacy matching biologics with oral convenience and cost parity with existing JAK inhibitors creates a compelling value proposition for both patients and payers.
Forward‑Looking Statements
This brief contains forward‑looking statements concerning TQH3906’s clinical development timelines, regulatory pathway, market penetration, and revenue forecasts. Actual results may differ materially due to competitive dynamics, pricing negotiations, and unforeseen safety signals in Phase 3 trials.-Fineline Info & Tech