BeyondSpring Receives FDA Fast Track Designation for Plinabulin in NSCLC

FLORHAM PARK, N.J., Sept. 29, 2026 /CourierPR/ -- BeyondSpring, a clinical-stage biopharmaceutical company, has announced a significant regulatory milestone and a strategic transaction that will advance its Plinabulin drug toward a critical clinical milestone. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Plinabulin in combination with 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. This designation is for patients in the second- or third-line treatment setting.

The company has also entered into a strategic transaction with Biolin Investment Limited, a Hong Kong-based investor, to sell its majority equity interest in its Chinese subsidiary, Dalian Wanchunbulin Pharmaceuticals Ltd. Under the agreement, Biolin 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 is expected to substantially reduce BeyondSpring’s cash requirements for the DUBLIN-4 trial while supporting efficient enrollment and the generation of China clinical data for the global trial.

Plinabulin, a first-in-class small molecule agent, has an extensive clinical safety database with more than 700 cancer patients. Its differentiated immuno-modulating mechanism and previously reported encouraging clinical data from DUBLIN-3 and Study 303 support the trial design of DUBLIN-4 in Plinabulin mechanism-targeted post-ICI non-squamous NSCLC patients. In the Phase 3 DUBLIN-3 Trial, published in The Lancet Respiratory Medicine in 2024, Plinabulin combined with docetaxel demonstrated a statistically significant improvement in overall survival (OS) in second- and third-line EGFR wild-type NSCLC vs. docetaxel alone (n=559), showing superior OS benefit in non-squamous patients (n=332, OS HR 0.72, p=0.0078). The combination also demonstrated statistically significant improvements compared to docetaxel alone, including doubling 2-year and 3-year survival rates and improvements in progression-free survival (PFS) and objective response rate (ORR), while also significantly reducing grade 4 neutropenia (p<0.0001).

Importantly, a post hoc analysis of the DUBLIN-3 post-ICI subgroup showed a median OS of 15.8 months with Plinabulin plus docetaxel versus 11.7 months with docetaxel alone (HR 0.55), with an objective response rate (ORR) of 18.2% versus 8.0%, respectively. These findings support the clinical rationale for Plinabulin’s differentiated dendritic cell maturation mechanism and its further evaluation in DUBLIN-4.

Additionally, the Phase 2 Study 303 (n=47), presented at ASCO 2026, demonstrated encouraging anticancer activity. With a median follow-up of 28.8 months, the Plinabulin combination showed a median progression-free survival (PFS) of 7.0 months, a disease control rate of 79.5%, and a confirmed ORR of 18.2%, with a 2-year overall survival rate of 58%, nearly double the historical rate reported with docetaxel in a similar patient population.

BeyondSpring plans to host a conference call and webcast today at 8:00 a.m. ET to discuss these developments.