Fosun Pharma (SHA: 600196, HKG: 2196) and the Helsinn Healthcare SA announced a strategic cooperation agreement to localize the production of the anti‑emetic injectable formulation fosnetupitant/palonosetron concentrated solution for injection, the next‑generation version of the proven oral drug Akynzeo.
Key Highlights
- Exclusive local manufacturing of fosnetupitant/palonosetron injection in mainland China, Hong Kong, and Macau.
- Streamlined supply chain for a drug that has achieved National Reimbursement Drug List (NRDL) status since 2023.
- Regulatory milestone: Marketing authorization application for the injection has been accepted by the National Medical Products Administration (NMPA).
Strategic Cooperation Agreement
| Element | Detail |
|---|---|
| Parties | Fosun Pharma & Helsinn Group |
| Scope | Licensing, distribution, promotion, and local manufacturing of fosnetupitant/palonosetron injection |
| Geographic Reach | Mainland China, Hong Kong, Macau |
| Timeline | Agreement signed 22 Oct 2025; production to commence Q4 2025 |
Background on Akynzeo
- Approved 2019 in China; NRDL inclusion 2023.
- Synergistic anti‑emetic: combines fosnetupitant (half‑life ~96 h) with palonosetron (half‑life ~40 h).
- Clinical impact: 97.6 % no‑rescue‑therapy rate for delayed chemotherapy‑induced nausea and vomiting (CINV).
- Market position: Only oral anti‑emetic in China demonstrating synergistic efficacy.
Why an Injectable Formulation?
- Improved patient compliance in inpatient settings.
- Rapid onset of action for peri‑operative CINV management.
- Extended shelf life and easier storage compared with oral capsules.
Regulatory Status
- NMPA accepted marketing authorization application for the injection.
- Clinical data: Phase III trial data support safety and efficacy profile identical to oral Akynzeo.
Implications for Oncology Supportive Care
- Enhanced access for Chinese oncology centers and hospitals.
- Cost‑effective solution aligned with NRDL pricing.
- Potential for global expansion as Fosun and Helsinn leverage their joint manufacturing capabilities.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech
