By Fineline Cube 
Sino Biopharmaceutical Limited (HKG: 1177) announced that TDI01, the world’s first highly selective ROCK2 inhibitor to enter Phase III trials for idiopathic pulmonary fibrosis (IPF), has enrolled its first patient. Developed by subsidiary Beijing Tide Pharmaceutical, TDI01 targets the Angiocrine System to address vascular leakage, fibrosis, inflammation, and immune dysfunction simultaneously.
Clinical Milestone
| Item | Detail |
|---|---|
| Product | TDI01 (ROCK2 inhibitor) |
| Company | Beijing Tide Pharmaceutical (Sino Biopharm subsidiary) |
| Indication | Idiopathic pulmonary fibrosis (IPF) |
| Study | Phase III pivotal trial |
| Enrollment Status | First patient enrolled (30 Dec 2025) |
| Mechanism | Selective ROCK2 inhibition targeting Angiocrine System |
| Significance | World’s first ROCK2 inhibitor in Phase III for IPF |
Drug Profile & Mechanism of Action
- Target: ROCK2 (Rho‑associated coiled‑coil kinase 2), a key regulator of the Angiocrine System
- Innovation: First‑in‑class selective ROCK2 inhibitor for IPF; avoids ROCK1‑related cardiovascular side effects
- Multi‑dimensional Intervention:
- Vascular leakage: Stabilizes endothelial barriers
- Fibrosis: Inhibits myofibroblast activation and collagen deposition
- Inflammation: Reduces pro‑inflammatory cytokine release
- Immune dysfunction: Modulates macrophage polarization
- Safety Window: Selective ROCK2 inhibition expands therapeutic index vs. non‑selective ROCK inhibitors
Clinical Trial Design
| Parameter | Details |
|---|---|
| Study Name | TDI01‑IPF‑301 (Phase III) |
| Design | Randomized, double‑blind, placebo‑controlled |
| Population | ~600 patients with progressive IPF |
| Primary Endpoint | Annual rate of decline in forced vital capacity (FVC) |
| Key Secondary Endpoints | Time to disease progression, mortality, safety |
| Geography | 80 sites across China; potential global expansion |
| Expected Completion | Q4 2027 (interim analysis Q2 2026) |
Market Opportunity & Competitive Landscape
China’s IPF prevalence is estimated at 180,000‑220,000 patients, with 15,000‑18,000 new cases annually. The domestic IPF therapeutics market reached ¥2.8 billion in 2025, growing at a 12% CAGR.
| Drug | Company | Mechanism | 2025 China Sales (¥) | Limitations |
|---|---|---|---|---|
| Pirfenidone | Roche | Anti‑fibrotic (pyridone) | ¥1.2 billion | Hepatotoxicity, photosensitivity |
| Nintedanib | Boehringer Ingelheim | Tyrosine kinase inhibitor | ¥1.6 billion | Diarrhea, liver enzyme elevation |
| TDI01 | Sino Biopharma | ROCK2 inhibitor | – | First disease‑modifying ROCK2 target |
Competitive Edge: TDI01’s Angiocrine‑targeted mechanism addresses four pathological drivers simultaneously, potentially offering superior efficacy and better tolerability vs. existing anti‑fibrotics.
Financial Projections & Development Timeline
| Milestone | Target Date | Financial Impact |
|---|---|---|
| Phase III interim data | Q2 2026 | Supports BTD application |
| NMPA submission | Q1 2028 | Accelerated review pathway |
| Potential approval | Q4 2028 | First‑in‑class launch |
| Peak penetration (2032E) | 25% of IPF patients | ¥2.1 billion (US$295 million) |
| Royalty to Tide Pharma | – | 15% of net sales |
Investment: Sino Biopharma has allocated ¥450 million to the TDI01 program through 2028, including ¥180 million for Phase III trials.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding TDI01’s clinical development, regulatory timeline, market potential, and competitive positioning. Actual results may differ materially due to clinical trial outcomes, competitive responses, and NMPA regulatory decisions.-Fineline Info & Tech