Unibest

Pipeline Database

UB420

Mifanertinib Maleate Tablets

UB420

ProductMifanertinib Maleate Tablets
Strength40mg; 80mg
IndicationsLocally advanced non-small cell lung cancer; Metastatic non-small cell lung cancer
TherapeuticsOncology
GMPCN - NMPA
RegistrationChina
ModalitiesSmall Molecule

Exclusive Summary

  • - Differentiated first-line option for EGFR L858R and uncommon mutations (G719X/S768I/L861Q), directly addressing current SOC gaps.
  • - Backed by NMPA-CDE Breakthrough Therapy and originator patents, with a clear near- to mid-term global “no-generic” window suitable for distribution.
  • - Tangible annual target pool of ~150–200k L858R and ~40–70k uncommon-mutation patients worldwide.
  • - 40/80 mg strengths enable individualized titration and AE management, improving real-world adherence and access.
  • - Well-suited for rapid launch via reliance/abbreviated pathways in APAC, LATAM, and MENA under a Distribution model.

How can we help you?

Receive insights into the latest events and regulatory updates

Sent directly to your email

Get industry insights and Unibest news here

Contact Us →