By Fineline Cube 
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) China and Belief BioMed Inc. issued a joint statement announcing the official termination of their commercialization collaboration for dalnacogene ponparvovec injection (trade name: Xinjiuning), a hemophilia B gene therapy, effective August 2. Despite being China’s first approved domestic AAV-based gene therapy, the product has not recorded a single prescription to date, and Belief BioMed now plans to independently advance its commercialization while maintaining medical support for relevant patients.
Transaction & Regulatory Background
| Item | Detail |
|---|---|
| Parties | Takeda China and Belief BioMed Inc. |
| Action | Termination of commercialization collaboration for Xinjiuning (dalnacogene ponparvovec) |
| Effective Date | 02 Aug 2026 |
| Original Agreement | Oct 2023 – Takeda China obtained commercialization rights for mainland China, Hong Kong and Macau |
| Product Approval | Apr 2025, NMPA |
| Indication | Adult patients with moderate to severe hemophilia B (congenital coagulation factor IX deficiency) |
| Next Steps | Belief BioMed to independently advance commercialization and patient medical support |
Drug Profile & Commercial History
- Molecule: dalnacogene ponparvovec (Xinjiuning), an AAV-based gene therapy delivering factor IX for hemophilia B
- Milestone Status: First approved domestic AAV-based gene therapy in China (Apr 2025)
- Initial Pricing: RMB 93,000 per vial, with total patient out-of-pocket costs reaching several million yuan depending on body weight
- Access Measures: Patient assistance programs, inclusion of city-level supplemental health insurance (Huiminbao) support, and subsequent price reductions were implemented
- Commercial Outcome: Despite these measures, Xinjiuning has yet to record a single prescription to date
Strategic Commentary
- Dr. Xiao Xiao, co-founder, chairman and chief scientist of Belief BioMed, described the termination as a mutual business decision driven by strategic refocusing at both parties
- The termination does not signal a pause in Xinjiuning’s commercialization; Belief BioMed will independently take over the product’s market launch and ongoing medical support arrangements for relevant patients
- Takeda exits a collaboration that had paired its global rare-disease commercial expertise with a first-in-class domestic gene therapy
Market Impact & Outlook
- Affordability challenge: The case underscores the structural barriers facing high-cost, weight-based gene therapies in China, where multi-million-yuan out-of-pocket burdens persist even after assistance programs and Huiminbao coverage
- Commercial model reset: Gene therapy launch strategies in China are being recalibrated toward sustainable reimbursement pathways rather than reliance on patient assistance alone
- Belief BioMed’s burden and upside: Full commercial ownership concentrates both execution risk and potential reward on the company, whose next steps will test the viability of independent rare-disease launches
- Sector signal: The split adds to growing evidence that global pharma–biotech partnerships in China are being reassessed where commercial traction lags
Forward‑Looking Statements: This brief is for informational purposes only and does not constitute investment advice or an offer to buy or sell any security. Statements regarding commercialization plans, pricing dynamics and market potential are forward-looking and subject to risks and uncertainties, including reimbursement policy changes, competitive developments and execution outcomes. Actual results may differ materially. Readers should conduct their own due diligence before making investment decisions.-Fineline Info & Tech