By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its independently developed Category 1 innovative drug Hengqu (hetrombopag olamine tablets) has been approved for two additional indications: chemotherapy‑induced thrombocytopenia (CTIT) in adult patients undergoing anti‑tumor therapy primarily consisting of chemotherapy for solid tumors, and chronic primary immune thrombocytopenia (ITP) in pediatric patients aged ≥6 years who had an inadequate response to prior treatments such as glucocorticoids and immunoglobulins.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Approval Type | Category 1 innovative drug — label expansion (two new indications) |
| Product | Hengqu (hetrombopag olamine tablets), oral |
| New Indication ① | Adult CTIT caused by anti‑tumor therapy primarily consisting of chemotherapy for solid tumors |
| New Indication ② | Pediatric chronic primary ITP (aged ≥6 years) after inadequate response to glucocorticoids/immunoglobulins — to increase platelet counts and reduce or prevent bleeding; restricted to patients whose thrombocytopenia and clinical condition result in an increased risk of bleeding |
| Approval Date | 11 Sep 2026 (announced) |
| Prior Approvals | 2021: adult chronic primary ITP; adult severe aplastic anemia (SAA) post‑immunosuppressive therapy (IST). Mar 2026: combination with IST for previously untreated SAA (aged ≥15 years) |
| Reimbursement | All previously approved indications included in China’s medical insurance catalog |
Drug Profile & Mechanism of Action
- Molecule: Hetrombopag olamine — China’s first independently developed non‑peptide oral TPO receptor agonist (TPO‑RA).
- Target: Activates TPO‑R‑mediated signalling pathways — including STAT, PI3K/AKT and ERK/MAPK — promoting megakaryocyte proliferation, differentiation and platelet production.
- Formulation Advantage: Oral, non‑peptide small molecule, offering a convenient alternative to injectable thrombopoietic agents.
- Indication Breadth: With the new approvals, hetrombopag now spans adult ITP, pediatric ITP, SAA (both post‑IST and first‑line combination) and CTIT — one of the broadest TPO‑RA labels in China.
Clinical Evidence – Two Pivotal Phase III Studies
| Study / Population | Endpoint | Hetrombopag | Control | Outcome |
|---|---|---|---|---|
| SHR8735‑301 – Adults with CTIT | Treatment response rate | 75.7 % | 39.4 % | Significantly higher |
| SHR8735‑301 – Adults with CTIT | Platelet counts during maintenance period | Median and mean above >100×10⁹/L at all visit time points | Lower than treatment group | Sustained elevation |
| HR‑TPO‑ITP‑III‑PED – Pediatric ITP | Platelet response ≥50×10⁹/L at Week 10 | 61.4 % | 9.7 % (placebo) | Significantly higher |
| HR‑TPO‑ITP‑III‑PED – Pediatric ITP | Sustained platelet response, Weeks 5–12 | 43.9 % | 0 % | Significantly improved |
Hetrombopag demonstrated a favorable safety profile in both Phase III studies. The SHR8735‑301 study supported the adult CTIT approval, showing continuous dosing produced markedly higher response rates and platelet counts maintained above the bleeding‑risk threshold throughout the maintenance period. The HR‑TPO‑ITP‑III‑PED study supported the pediatric ITP approval, with both the Week 10 response and the sustained‑response endpoints achieving statistical significance versus placebo.
Market Impact & Outlook
- Oncology Supportive Care Entry: The CTIT indication opens the large supportive‑care market across solid‑tumor chemotherapy, where thrombocytopenia frequently drives dose delays and reductions — positioning hetrombopag as a tool to preserve chemotherapy intensity.
- Pediatric First‑Mover Edge: Approval for pediatric ITP (≥6 years) extends hetrombopag into a population with limited oral TPO‑RA options, strengthening its position against competing agents.
- Reimbursement Tailwind: With all existing indications already in China’s medical insurance catalog, inclusion of the two new indications in future catalog updates would materially accelerate uptake; timeline not disclosed.
- Portfolio Momentum: Following the March 2026 first‑line SAA combination approval, this dual expansion underscores Hengrui’s strategy of maximizing the lifecycle value of its homegrown Category 1 innovator drug across hematology and oncology.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding reimbursement decisions, market adoption and clinical utilization of hetrombopag olamine tablets. Actual results may differ materially due to risks including medical insurance catalog negotiation outcomes, prescriber uptake, competitive dynamics and evolving treatment guidelines.-Fineline Info & Tech