By Fineline Cube 
3SBio Inc. (HKG: 1530) announced that its Recombinant Human Thrombopoietin (rhTPO) injection received National Medical Products Administration (NMPA) approval for a new indication: treatment of chronic liver disease‑related thrombocytopenia (CLDT) in adult patients scheduled for surgical procedures (including diagnostic interventions). This expands rhTPO’s use beyond its existing oncology and immune thrombocytopenia approvals.
Regulatory Milestone
| Item | Details |
|---|---|
| Approval Date | 23 Dec 2025 |
| Agency | NMPA (China) |
| Product | Recombinant Human Thrombopoietin (rhTPO) injection |
| New Indication | CLDT in adults undergoing surgery |
| Previous Indications | • Chemotherapy‑induced thrombocytopenia (solid tumors) • Primary immune thrombocytopenia (adults) • Persistent/chronic immune thrombocytopenia (children/adolescents) |
| Mechanism | Stimulates bone marrow megakaryocytes to promote platelet formation/release; shares endogenous TPO amino acid sequence |
Disease Burden & Unmet Need
| Parameter | Value |
|---|---|
| CLDT Prevalence | 6% in non‑cirrhotic CLD, up to 78% in cirrhosis |
| Platelet Threshold | <100×10⁹/L |
| Current Strategies | Platelet transfusion, production stimulators, destruction prevention |
| Surgical Risk | Thrombocytopenia increases bleeding risk during procedures |
| Market Gap | Limited options for pre‑operative platelet elevation in CLD |
Market Opportunity
| Metric | Value | Context |
|---|---|---|
| China CLD Population | ~30‑40 million patients (2025) | 10‑15% have severe thrombocytopenia requiring intervention |
| China Hematology Market | ¥8‑10 billion (≈ US$1.1‑1.4 B) | Growing with aging population |
| rhTPO Peak Sales (CLDT) | ¥1.5‑2.5 billion (≈ US$210‑350 M) | 20‑30% share of eligible pre‑op CLD patients |
| Competitive Advantage | Proprietary rhTPO with proven safety profile across multiple indications | Cost‑effective vs. platelet transfusion |
| Launch Timeline | Q2 2026 (hospital formulary placement) |
Strategic Implications
- For 3SBio: Fourth indication approval strengthens rhTPO’s position as multi‑use thrombopoietin agent; expands addressable market beyond oncology/ITP; CLDT niche offers premium pricing and NRDL eligibility.
- For Patients: Pre‑operative platelet boost reduces bleeding risk and transfusion need; well‑characterized safety from existing oncology use; outpatient administration improves convenience.
- For Market: Demonstrates platform versatility of rhTPO across hematologic indications; CLDT represents high‑value orphan‑like segment within liver disease; surgical prophylaxis use case expands patient access.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding rhTPO’s market penetration, commercial launch timeline, and competitive positioning. Actual results may differ due to regulatory feedback, pricing negotiations, or competitive responses.-Fineline Info & Tech