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Zipalertinib (CLN-081/TAS6417)

EGFR Exon 20+ NSCLC (Relapsed/Refractory)

NDA SubmittedRolling Submission Completed

Key Facts

Indication
EGFR Exon 20+ NSCLC (Relapsed/Refractory)
Phase
NDA Submitted
Status
Rolling Submission Completed
Company

About Cullinan Therapeutics

Cullinan Therapeutics is a clinical-stage biopharma focused on translating deep immunology expertise into high-impact therapies for autoimmune diseases and cancer. The company employs a disciplined 'thriller or killer' portfolio strategy, yielding a focused pipeline of novel bispecific T cell engagers and kinase inhibitors. Recent milestones include completing a rolling NDA submission for zipalertinib in EGFR exon 20 NSCLC and reporting promising early clinical data for its bispecific candidates in hematology and autoimmune indications, positioning 2025 as a catalyst-rich year.

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About Cullinan Therapeutics

Cullinan Therapeutics is a clinical-stage biopharma focused on translating deep immunology expertise into high-impact therapies for autoimmune diseases and cancer. The company employs a disciplined 'thriller or killer' portfolio strategy, yielding a focused pipeline of novel bispecific T cell engagers and kinase inhibitors. Recent milestones include completing a rolling NDA submission for zipalertinib in EGFR exon 20 NSCLC and reporting promising early clinical data for its bispecific candidates in hematology and autoimmune indications, positioning 2025 as a catalyst-rich year.

View full company profile