
Pipeline Database
UB161
Leuprorelin Acetate Microspheres for Injection
UB161
ProductLeuprorelin Acetate Microspheres for Injection
Strength3.75mg
IndicationsEndometriosis; Uterine leiomyoma; Breast cancer; Prostate cancer; Central precocious puberty
TherapeuticsOncology; Women's Health
GMPCN - NMPA
RegistrationChina
ModalitiesPeptide
Exclusive Summary
- - Core patents have largely expired; the 3.75 mg monthly depot is a global standard SKU suited for rapid entry via distribution.
- - Addresses large, durable demand in prostate cancer ADT and additional use in endometriosis/fibroids (pre-op) and CPP.
- - As a guideline-endorsed GnRH agonist and WHO EML-listed class, it enjoys strong hospital and payer acceptance.
- - JP/BP/EP-compliant API supports multi-country registration and tenders; differentiation is in reliable supply and value pricing, not redevelopment.
- - Versus originators (Lupron Depot/Procren/Enantone), typical savings of ~40–70% enable fast uptake in most markets.
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