By Fineline Cube 
Yabao Pharmaceutical Group Co., Ltd. (SHA: 600351) announced that China’s National Medical Products Administration (NMPA) approved a Phase clinical trial for GLX002, a Category 2.2 modified drug based on bosentan dispersible tablets, for the treatment of pulmonary arterial hypertension (PAH) WHO Group 1. The drug targets both pediatric patients (≥1 year) with idiopathic/congenital PAH and adults (WHO functional class II‑IV), aiming to improve exercise capacity and reduce clinical deterioration.
Regulatory Milestone
| Item | Details |
|---|---|
| Approval Date | 18 Dec 2025 |
| Agency | NMPA (China) |
| Product | GLX002 (Category 2.2 modified bosentan dispersible tablets) |
| Indication | Pulmonary arterial hypertension (PAH) WHO Group 1 |
| Target Population | • Pediatrics ≥1 year: improve PVR and exercise capacity • Adults WHO FC II‑IV: improve exercise capacity, reduce clinical deterioration |
| Original Drug | Tracleer (Johnson & Johnson’s bosentan dispersible tablets) |
| Competitive Status | No modified bosentan dispersible tablets launched domestically or internationally |
Drug Profile & Differentiation
| Attribute | GLX002 | Competitive Context |
|---|---|---|
| Mechanism | Endothelin receptor antagonist (ERA) | Improves pulmonary vascular resistance |
| Formulation | Modified dispersible tablets | Enhanced solubility/dosing convenience vs. original |
| Innovation | First modified bosentan dispersible tablet globally | Addresses unmet need in pediatric PAH dosing |
| Advantage | Pediatric‑friendly formulation with precise dosing | Expands treatment accessibility for young patients |
| Stage | Phase clinical trial approved | Ready for IIT/registrational study |
Market Opportunity
| Metric | Value | Context |
|---|---|---|
| China PAH Prevalence | ~100,000‑150,000 patients (2025) | Growing diagnosis rate; <20% receive targeted therapy |
| PAH Market Size | ¥3‑5 billion (≈ US$420‑700 M) | Dominated by sildenafil, bosentan, ambrisentan |
| Pediatric PAH | ~5,000‑8,000 eligible children | Limited approved pediatric formulations |
| GLX002 Peak Sales | ¥500‑800 million (≈ US$70‑112 M) by 2030 | 15‑20% share of dispersible tablet segment |
| Regulatory Pathway | Category 2.2 modification enables expedited review | Potential approval by 2028 |
Strategic Implications
- For Yabao: First‑mover in modified bosentan space; pediatric indication addresses high‑unmet‑need population; Category 2.2 status reduces development risk and timeline.
- For PAH Treatment: Dispersible tablet improves dosing flexibility for children; modified formulation may enhance bioavailability; proprietary modification creates market differentiation vs. generic bosentan.
- For Market: Demonstrates China’s capability in drug formulation innovation; modified drug pathway (Category 2.2) offers faster regulatory route; potential for global out‑licensing given lack of international competitors.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding GLX002’s clinical development timeline, market penetration, and regulatory approval. Actual results may differ due to clinical risks, competitive responses, or pricing negotiations.-Fineline Info & Tech