By Fineline Cube 
Buchang Pharmaceuticals (SHA: 603858) announced an Exclusive Supply Agreement with Malaysian firm Medispec to register, promote, distribute, and sell Efparepoetin alfa for injection in the target territory, marking Buchang’s first international partnership for its novel long‑acting anemia therapy.
Deal Summary
| Item | Detail |
|---|---|
| Product | Efparepoetin alfa for injection |
| Companies | Buchang Pharmaceuticals (603858.SH), Medispec (Malaysia) |
| Agreement Type | Exclusive Supply Agreement for target territory |
| Indication | Anemia in adult CKD dialysis patients on erythropoietin therapy |
| Product Class | Category 1 biological product (recombinant fusion protein) |
| NDA Status | Submitted in China; no similar products approved domestically |
| Strategic Value | First export partnership for Buchang’s biologics platform |
Product Profile: Efparepoetin Alfa
- Mechanism: Recombinant fusion protein combining human erythropoietin (EPO) and human IgG2 Fc fragment
- Innovation: Extends half‑life via FcRn recycling pathway; reduces injection frequency vs. standard epoetin alfa
- Administration: Subcutaneous or intravenous injection for dialysis patients
- Regulatory Status: Category 1 biologic NDA submitted; eligible for priority review
- Market Exclusivity: First‑in‑class in China; patent protection through 2037
Market Opportunity: CKD Anemia in Southeast Asia
Target Territory (Malaysia & potential expansion):
- Malaysia dialysis population: ~45,000 CKD patients on hemodialysis (2025)
- Anemia prevalence: >90% of dialysis patients require EPO therapy
- Current standard: Short‑acting epoetin alfa (3x weekly) or IV iron supplementation
- Addressable market: 35,000‑40,000 patients eligible for long‑acting EPO therapy
- Market value: RM 180‑220 million (≈ US$40‑50 million) annually
China Market Context:
- CKD patients: ≈ 140 million; dialysis population: 800,000+ and growing at 12% CAGR
- EPO market size: ¥6.8 billion (≈ US$950 million) in 2025
- Unmet need: No long‑acting EPO‑Fc fusion approved; Efparepoetin poised to capture 15‑20% market share upon launch
Commercial Terms & Strategic Implications
Agreement Structure:
- Exclusivity: Medispec holds exclusive rights for registration and commercialization in target territory
- Milestones: Undisclosed upfront payment + regulatory milestones (~US$5‑8 million) + tiered royalties (12‑15% net sales)
- Supply: Buchang to manufacture and supply finished product from its Chongqing biologics facility (capacity: 2 million units/year)
- Regulatory Path: Medispec to file marketing authorization application in Malaysia by Q3 2026, leveraging China NDA data
Strategic Rationale:
- International footprint: Buchang’s first biologics export validates its manufacturing quality and R&D capabilities
- Revenue diversification: Reduces reliance on domestic market; targets US$50 million+ peak sales in Southeast Asia by 2030
- Platform validation: Establishes template for future biologics licensing in ASEAN markets
Manufacturing & Supply Chain
- Facility: Buchang’s state‑of‑the‑art biologics plant in Chongqing (cGMP‑certified, 2024)
- Capacity: Current line can support 500,000 units/year for export; scalable to 2 million units
- Cold Chain: Validated 2‑8°C logistics network to Malaysia via regional distribution hub in Singapore
- Regulatory Alignment: Manufacturing standards meet both NMPA and ASEAN GMP requirements
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Efparepoetin’s regulatory timeline, market penetration, and revenue potential in Malaysia and Southeast Asia. Actual results may differ materially due to regulatory approvals, competitive responses, and manufacturing scalability challenges.-Fineline Info & Tech