UB305
ProductDecitabine for Injection
Strength25mg; 50mg
IndicationsMyelodysplastic syndrome; Therapy-related myelodysplastic syndrome; Refractory anaemia; Refractory anaemia with ring sideroblasts; Refractory anaemia with excess blasts; Refractory anaemia with excess blasts in transformation; Chronic myelomonocytic leukaemia
TherapeuticsOncology
GMPCN - NMPA
RegistrationChina
ModalitiesSmall Molecule
Exclusive Summary
- - Fully off-patent globally with broad generic entry since the mid-2010s, enabling rapid registration and distribution.
- - Large, aging AML and higher-risk MDS populations with multi-cycle HMA use drive steady, predictable demand.
- - Endorsed by NCCN/ELN/ESMO, including as a standard option with venetoclax for unfit AML.
- - Dual strengths (25 mg/50 mg) cut vial wastage for small-BSA/dose-adjustment patients and improve pharmacoeconomics.
- - Significant price headroom versus originator and oral alternatives supports competitive tender wins and access expansion.
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