By Fineline Cube Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) announced that China’s National Medical Products Administration (NMPA) has accepted the marketing authorization application for Bemiparin Sodium Injection (Acceptance No.: CYHS2602247). The filing positions the company to challenge the originator‑only landscape for the ultra‑low molecular weight heparin (second‑generation LMWH) in China, where to date no generic version is marketed.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Filing Status | Marketing authorization application accepted (technical review pending) |
| Acceptance No. | CYHS2602247 |
| Product | Bemiparin Sodium Injection |
| Drug Class | Ultra‑low molecular weight heparin (second‑generation LMWH) |
| Indications | Prevention of coagulation in the extracorporeal circuit during hemodialysis; prevention of thromboembolic disease in general surgery and orthopedic surgery |
| Announcement Date | 10 Sep 2026 |
| Next Steps | NMPA review and approval; timeline not disclosed |
Drug Profile & Mechanism of Action
- Molecule: Bemiparin sodium, a low molecular weight heparin obtained by depolymerization of porcine‑derived heparin sodium.
- Class Differentiation: Its molecular weight is lower than that of other LMWHs, earning the designation ultra‑low molecular weight heparin — a second‑generation anticoagulant class distinct from first‑generation LMWHs such as enoxaparin and dalteparin.
- Pharmacological Profile: Compared with other LMWHs, bemiparin sodium exhibits a smaller molecular weight, lower anti‑IIa activity, and a higher anti‑Xa/anti‑IIa ratio — a profile favoring more selective inhibition of coagulation factor Xa. Specific ratio values: Not disclosed.
- Indications: Prevention of coagulation in the extracorporeal circuit during hemodialysis, and prevention of thromboembolic disease in patients undergoing general surgery and orthopedic surgery.
- Global Footprint: Bemiparin sodium is currently marketed in more than 60 countries worldwide, providing an established clinical track record outside China.
China Market Structure – Originator Exclusivity
- Sole Marketed Product: In China, only the originator Hibor, marketed by Spain’s Laboratorios Farmacéuticos ROVI, S.A., is currently available for bemiparin sodium.
- No Generic Competition: No generic versions have been marketed in China to date — meaning Dongcheng’s accepted application, if approved, would enter as the first domestic generic in this niche anticoagulant segment.
- Therapeutic Context: LMWHs are mainstays of venous thromboembolism (VTE) prophylaxis in surgical settings and of anticoagulation during hemodialysis, two areas with sustained institutional demand driven by China’s large and aging population and its extensive dialysis infrastructure. Quantitative market figures: Not disclosed.
Market Impact & Outlook
- First‑Mover Opportunity: With Hibor as the only incumbent, an approved Dongcheng generic could capture share through pricing leverage in hospital tendering and national procurement channels — a common pathway for first generics in China. Bidding and pricing details: Not disclosed.
- Portfolio Expansion: The filing extends Yantai Dongcheng’s (SHE: 002675) anticoagulant and injectable portfolio into the differentiated second‑generation LMWH class.
- Regulatory Watch: Acceptance of the application (No. CYHS2602247) marks the start of formal NMPA technical review; approval timing and any required supplementary data remain subject to the review process.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the NMPA review process, potential approval of Bemiparin Sodium Injection, and commercial expectations in the Chinese market. Actual results may differ materially due to risks including review outcomes and timelines, competitive entry, pricing and procurement dynamics, and manufacturing and supply‑chain considerations. Acceptance of a marketing authorization application does not guarantee eventual approval.-Fineline Info & Tech