
UB002
ProductDalteparin Sodium Injection
Strength0.2ml:5000IU; 0.3ml:7500IU
IndicationsVenous thromboembolism; Venous thromboembolism prophylaxis; Unstable coronary artery disease; Extracorporeal circuit thrombosis prophylaxis
TherapeuticsCardiovascular
GMPCN - NMPA; EU - EMA
RegistrationChina
ModalitiesPolysaccharide
Exclusive Summary
- EU-EMA GMP certified with BP/EP/USP compliant API, enabling fast-track registration and high-end market entry universally without extensive clinical hurdles.
- Although originator patents have expired, high manufacturing and raw material barriers for complex low-molecular-weight heparins limit generic saturation, providing a highly profitable market opportunity.
- Positioned as a first-line gold standard by global guidelines (ASCO/ESMO/ACCP) for cancer-associated thrombosis (CAT), addressing massive demand driven by roughly 10 million annual VTE cases worldwide.
- Backed by China's dominant position in the global heparin API supply chain, it offers highly competitive pricing, robust supply stability, and attractive profit margins for overseas distributors.
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