BeyondSpring Announces FDA Fast Track Designation for Plinabulin in Post-ICI Non-Squamous NSCLC and Strategic Transaction to Advance Global Phase 3 DUBLIN-4 Trial Toward Planned Interim Analysis
Key Highlights
- ➤FDA grants Plinabulin Fast Track designation for post-ICI non-squamous NSCLC (BYSI)
- ➤Biolin funds China portion of DUBLIN-4 trial through strategic transaction
- ➤China expected to enroll approximately 221 of 442 planned global patients
- ➤DUBLIN-4 interim analysis planned at 221 PFS events
- ➤BeyondSpring retains Plinabulin rights outside Greater China (BYSI)
Expert Statements
Min Qiu, CEO of BeyondSpring
“We believe the FDA Fast Track designation, an FDA-aligned global Phase 3 strategy, and funding to support China-generated clinical data would meaningfully strengthen our ability to advance Plinabulin and DUBLIN-4 toward the trial’s next major clinical milestone—the prespecified interim analysis at 221 PFS events.”
Min Qiu, CEO of BeyondSpring
“Fast Track designation underscores the significant unmet medical need for the DUBLIN-4 patient population in NSCLC patients whose disease has progressed following ICI and without AGAs, with limited options and docetaxel as the standard of care.”
Min Qiu, CEO of BeyondSpring
“Importantly, the strategic transaction provides a time- and capital-efficient approach to executing our global Phase 3 clinical strategy.”
Min Qiu, CEO of BeyondSpring
“Positive results from the interim analysis could represent a meaningful value inflection point for BeyondSpring.”
* FDA Fast Track designation represents an important regulatory milestone for the Plinabulin and docetaxel combination as an anticancer regimen in 2L/3L advanced or metastatic non-squamous NSCLC without actionable genomic alterations (AGAs) following progression on immune checkpoint inhibitor (ICI) and chemotherapy. * BeyondSpring enters into a strategic transaction to sell its majority equity interest in its Chinese subsidiary to an investor who will fund the China portion of the Phase 3 DUBLIN-4 trial, which is expected to represent approximately 50% of the planned global enrollment of 442 patients. * This non-dilutive transaction provides a financially efficient path toward the next major clinical milestone for Plinabulin, which is DUBLIN-4 interim analysis of 221 Progression-Free Survival (PFS) events. * Management will host a conference call and webcast today at 8:00 a.m. ET to discuss these developments. FLORHAM PARK, N.J., Sept. 29, 2026 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage company developing innovative therapies for the treatment of cancer and other diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to Plinabulin and docetaxel for the treatment of patients with advanced or metastatic non-squamous non-small cell lung cancer (“NSCLC”) without actionable genomic alterations (AGAs) whose disease has progressed following prior anti-PD-(L)1 antibody therapy and platinum-based chemotherapy, representing patients in the second- or third-line treatment setting. This is the patient population being studied in BeyondSpring’s global Phase 3 DUBLIN-4 trial.
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