By Fineline Cube 
Betta Pharmaceuticals Co., Ltd. (SHE: 300558) announced today the signing of a Strategic Cooperation Framework Agreement and a Commercial Cooperation Agreement with Gensciences. The partnership gives Betta Pharma full responsibility for the research, development, clinical‑trial execution, manufacturing, registration, and sales promotion of Gensciences’ pipeline in China, and grants it exclusive general distribution rights for the recombinant coagulation product FRSW117 (Recombinant Human Coagulation Factor VIII‑Fc Fusion Protein for Injection) across the Greater‑China region (Mainland China, Hong Kong SAR, Macao SAR, and Taiwan).
Strategic Cooperation Highlights
| Area of Collaboration | Betta Pharma’s Role |
|---|---|
| R&D & Clinical Trials | Provide local scientific expertise, site management, and regulatory liaison for ongoing and future studies. |
| Manufacturing & Production | Support technology transfer, scale‑up, and quality‑control activities at Betta’s GMP‑certified facilities. |
| Regulatory Registration | Lead submission of the New Drug Application (NDA) to the National Medical Products Administration (NMPA). |
| Sales & Marketing | Design and execute market‑entry strategies, physician education, and patient‑support programs. |
Commercial Agreement Details
- Product: FRSW117 – Recombinant Human Coagulation Factor VIII‑Fc Fusion Protein for Injection
- Therapeutic Class: Category 1 therapeutic biologic (long‑acting recombinant Factor VIII)
- Indication: Routine prophylaxis, on‑demand treatment, and peri‑operative bleeding management in patients with hemophilia A.
- Dosing Frequency: Once‑weekly for prophylaxis (significantly reduces treatment burden).
- Market Status: First domestically produced long‑acting recombinant Factor VIII to receive Chinese regulatory approval (pending).
Market Impact & Outlook
- Unmet Need: China currently has no approved domestic long‑acting recombinant Factor VIII products, creating a large therapeutic gap for the estimated >30,000 hemophilia A patients.
- Revenue Potential: Bloomberg estimates the Chinese hemophilia market could exceed USD 1.2 billion by 2028; a weekly‑dosed product like FRSW117 is positioned to capture a sizable share.
- Competitive Edge: Betta’s established distribution network and clinical‑trial infrastructure give the product a faster go‑to‑market timeline than foreign competitors.
- Regulatory Timeline: Phase 3 trial data have been submitted; Betta expects NMPA filing Q2 2026 with a potential approval window in late‑2026.
About Betta Pharmaceuticals
Betta Pharma is a China‑focused biopharmaceutical company specializing in the development, manufacturing, and commercialization of innovative biologics. The firm leverages a state‑of‑the‑art GMP platform and a nationwide sales force to bring high‑value therapies to Chinese patients.
About Gensciences
Gensciences is a global biotech firm with a pipeline centered on recombinant protein therapeutics for rare bleeding disorders and other specialty indications. Its flagship product, FRSW117, is a Fc‑fusion engineered Factor VIII designed for extended half‑life and reduced dosing frequency.
Forward‑Looking Statements
This release contains forward‑looking statements regarding the strategic partnership, product development, regulatory approvals, and market potential. Actual results may differ materially due to risks including regulatory outcomes, clinical trial results, and market acceptance.-Fineline Info & Tech