By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA) has accepted a new indication filing for Ruitanning (fosrolapitant, palonosetron), seeking approval for preventing acute and delayed nausea and vomiting in adult patients receiving moderately emetogenic anti‑cancer agents. The fixed‑dose combination drug, first approved in May 2025 for highly emetogenic chemotherapy, is already listed on the National Reimbursement Drug List (NRDL).
Regulatory Status & Filing Details
| Item | Detail |
|---|---|
| Company | Jiangsu Hengrui Pharmaceuticals (SHA: 600276, HKG: 1276) |
| Drug | Ruitanning (fosrolapitant + palonosetron) |
| Current Status | NRDL‑listed since 2025 |
| New Indication | Prevention of nausea/vomiting from moderately emetogenic chemotherapy |
| Previous Approval | May 2025 for highly emetogenic chemotherapy |
| Filing Acceptance | NMPA review initiated January 2026 |
| Clinical Basis | Phase III trial (HR20013‑302) |
Drug Profile & Mechanism
- Dual Pathway Inhibition: Simultaneously antagonizes NK1 and 5‑HT3 receptors, blocking the vomiting reflex through two distinct mechanisms
- Formulation: Fixed‑dose combination capsule offering convenience over separate agents
- Strategic Advantage: Addresses unmet need for simplified prophylaxis in moderate‑risk chemotherapy regimens, expanding beyond high‑risk settings
Phase III Clinical Data (HR20013-302)
| Endpoint | Result |
|---|---|
| Trial Design | Multicenter, randomized, controlled |
| Participants | 706 patients |
| Primary Comparison | Ruitanning vs. control (standard antiemetic regimen) |
| Delayed Phase Complete Response | Significantly better than control (p < 0.05) |
| Overall Complete Response Rate | Significantly better than control (p < 0.05) |
| Safety Profile | Good safety, comparable to control |
Market Impact & Commercial Outlook
- China Antiemetics Market: Valued at ¥8 billion : (~US$1.1 billion) in 2025, growing at 12% CAGR driven by expanding cancer treatment access
- Moderate Emetogenic Opportunity: Represents 40–50% of all chemotherapy regimens, doubling addressable patient population vs. high‑emetogenic setting
- NRDL Advantage: Existing reimbursement listing ensures rapid market penetration upon approval; no additional pricing negotiations required
- Revenue Potential: Analysts project ¥1.5–2.0 billion (US$210–280 million) incremental annual sales from moderate‑emetogenic indication by 2028
- Strategic Value: Expands Hengrui’s supportive oncology franchise, complementing its core chemotherapy and targeted therapy portfolio
- Next Steps: NMPA technical review expected 6–9 months; potential approval Q4 2026
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory review timelines, commercial expectations, and revenue projections for Ruitanning. Actual results may differ due to NMPA review outcomes, competitive dynamics, and market adoption rates.-Fineline Info & Tech