
UB916
ProductAbemaciclib Tablet
Strength50mg, 100mg, 150mg, 200mg
IndicationsHR-positive, HER2-negative advanced breast cancer; HR-positive, HER2-negative metastatic breast cancer
TherapeuticsOncology
GMPCN - NMPA
RegistrationChina
ModalitiesSmall Molecule
Exclusive Summary
- Targets the world's most common cancer (specifically the HR+/HER2- subtype accounting for 70% of breast cancer cases) and is the ONLY CDK4/6 inhibitor approved for early-stage adjuvant therapy, ensuring a massive patient base.
- Scheduled for US FDA filing in 2026, offering FDA-level cGMP quality endorsement and a complete range of dosage strengths (50/100/150/200mg) perfectly suited for expedited global registrations.
- Strategically timed to hit the 2027-2029 global patent cliff, ranking in the first tier of generic development to help partners secure first-to-market or early-market entry opportunities.
- Provides overwhelming cost advantages compared to the >$14,000/month originator, making it highly competitive for national tenders and out-of-pocket markets via distribution partnerships.
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