
UB804
ProductEsomeprazole Sodium for Injection
Strength40mg
IndicationsGastroesophageal reflux disease; Peptic ulcer bleeding
TherapeuticsGastroenterology & Hepatology
GMPCN - NMPA
RegistrationChina
ModalitiesSmall Molecule
Exclusive Summary
- Originator patents have expired globally, presenting a mature blockbuster market with no IP barriers, enabling overseas agents to rapidly register and distribute.
- Indications cover acute upper GI bleeding and GERD (global prevalence over 13%), representing a massive and inflexible inpatient demand for intravenous formulations.
- As a new-generation PPI, it offers superior acid suppression compared to legacy omeprazole and is recommended by international guidelines as a first-line standard treatment when oral therapy is unsuitable.
- Leveraging China's integrated “API + lyophilized powder injection” supply chain, it possesses overwhelming advantages in massive production scale and highly competitive tender pricing.
- Equipped with comprehensive ICH-compliant CTD dossiers, the product empowers overseas distribution partners for fast-track market access in emerging regions like ASEAN, LATAM, and MENA.
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