BYSI News & Events

BeyondSpring announced a leadership transition. The leadership changes become effective July 1. The board has appointed Min Qiu as CEO of BeyondSpring, effective July 1. Qiu has been actively involved in BeyondSpring's corporate development for five years. Na Li has been appointed CFO of BeyondSpring, effective July 1. She has served as CFO of Dalian Wanchunbulin Pharmaceutical since November 2020. "This is not a routine management change. It is a considered strategic decision to give BeyondSpring and SEED Therapeutics the leadership structures they each need at this precise moment in their development," said Lan Huang, chairman of BeyondSpring and co-founder, chairman, and CEO of Seed Therapeutics. "Plinabulin's GEF-H1 mechanism has produced compelling Phase 3 results in NSCLC - doubling survival rates, reducing neutropenia - and our new AACR data extend that same logic into the ADC setting. The science is strong and the IP runway is long. DUBLIN-4 is our confirmatory moment, and it demands focused, disciplined execution. Min has the mandate, the relationships, and the operational depth to deliver it. I look forward to supporting BeyondSpring as Chairman while directing my full attention to SEED Therapeutics and the scientific technology we are building there."

BeyondSpring announced updated efficacy and safety data from the investigator-initiated Phase 2 303 Study evaluating pembrolizumab plus Plinabulin and docetaxel in patients with metastatic non-small cell lung cancer after progression on first-line immune checkpoint inhibitor therapy, either alone or in combination with chemotherapy. The data were presented at the 2026 American Society of Clinical Oncology, or ASCO, annual meeting. All patients had secondary resistance, defined as prior ICI treatment with progression-free survival of at least six months. Pembrolizumab (200 mg), Plinabulin and docetaxel were all dosed intravenously on day 1 of a 21-day cycle. As of the February 28 data cutoff, the median follow-up was 28.8 months. Three patients remained on treatment, and 24 patients remained alive in survival follow-up. Among the 47 enrolled patients, the median age was 67 years; 80.9% were male and 19.1% were female; 72.3% were current or former smokers; and histology included 63.8% non-squamous and 36.2% squamous NSCLC. The key results at the database lock are summarized below. Median progression-free survival of 7 months compared favorably with historical docetaxel data in similar post-ICI patient populations, including TROPION-Lung01 and EVOKE-01, which reported median PFS of 3.7 months and 3.9 months, respectively. Median duration of response of 9.3 months indicating durable response. Disease control rate of 79.5% indicating clinical benefit in the majority of patients who progressed on prior PD-1/L1 inhibitor-based therapy. Confirmed objective response rate of 18.2% compared favorably with historical 5-12% ORR for docetaxel, demonstrating anti-tumor activity in metastatic NSCLC patients with secondary resistance to prior ICI. Twelve-month overall survival rate of 78.1%; 24-month OS rate of 58%, with median OS not reached compared favorably with historical docetaxel data in similar patient populations, including TROPION-Lung01 and EVOKE-01, which reported median OS of 11.8 months and 9.8 months, respectively. The combination demonstrated a generally manageable safety profile. 53.2% of patients experienced grade 3 or higher treatment-related adverse events, including hypertension in 17%, gastrointestinal disorders in 14.9%, neutrophil decrease in 17%, decreased white blood cell count in 6.4%, and febrile neutropenia in 2.1%.

BeyondSpring announced results from the Asian subset of its global Phase 3 DUBLIN-3 trial evaluating Plinabulin plus docetaxel compared to docetaxel alone in second- or third-line EGFR wild-type non-small cell lung cancer. Dublin-3's global intent-to-treat patient data was published in Lancet Respiratory Medicine in 2024. These new findings were presented by Dr. Baohui Han of Shanghai Chest Hospital at the European Society for Medical Oncology Asia Congress 2025. In this large Asian intent-to-treat cohort, Plinabulin + docetaxel achieved a statistically significant improvement in overall survival compared to docetaxel: DP 10.8 months vs. D 8.8 months, HR 0.81, p=0.0426. In the mechanism-based non-squamous subgroup, the hazard ratio was 0.69 with a median OS benefit of 3 months, highlighting enhanced benefit in patients whose disease biology aligns with Plinabulin's immune-modulating and tumor vasculature-targeting mechanisms. The combination also doubled 2-year and 3-year survival rates, reflecting durable benefit consistent with Plinabulin's first-in-class dendritic-cell maturation mechanism. Plinabulin demonstrated a marked reduction in docetaxel-induced grade 4 neutropenia, while maintaining a favorable tolerability profile. This safety improvement supports better treatment exposure, an important driver of chemotherapy benefit. "These data from nearly 500 Asian patients further strengthen the robust global evidence supporting Plinabulin's potential to become a new standard of care for EGFR wild-type NSCLC," said Dr. Lan Huang, CEO. "The consistent survival benefit, particularly in the mechanism-aligned non-squamous population, together with the marked reduction in severe neutropenia, reflects Plinabulin's first-in-class immune-modulating mechanism and its ability to improve chemotherapy tolerability. These results reinforce our confidence as we advance Plinabulin into a global Phase 3 confirmatory study."

BeyondSpring announced new post-hoc analyses from its global Phase 3 DUBLIN-3 Study showing that Plinabulin plus docetaxel provides clinically meaningful benefit for patients with EGFR wild-type non-squamous non-small cell lung cancer, or NSCLC, who progressed after anti-PD-(L) immunotherapy. More than 60% of NSCLC patients eventually develop resistance to anti-PD-(L)1 therapy, yet no new treatments have been approved in a decade. Plinabulin is a late-stage therapeutic candidate that has demonstrated consistent survival benefit in this rapidly growing population with major unmet medical need. In a subset analysis of DUBLIN-3, non-squamous EGFR WT NSCLC patients who progressed after anti-PD-(L)1 therapy with at least 3 months of prior clinical benefit, Plinabulin + docetaxel, or DP, combination showed clinically meaningful improvement compared to docetaxel alone. Median overall survival: DP 15.8 months vs. D 11.7 months; median progression-free survival: DP 5.6 vs. D 3.8 months; objective response rate: 18.2% vs. 8.0%. BeyondSpring plans to initiate a global Phase 3 DUBLIN-4 trial following its End-of-Phase 2 meeting with the U.S. FDA. DUBLIN-4, together with DUBLIN-3, is expected to support a future NDA submission in non-squamous EGFR wild-type NSCLC following progression on anti-PD-(L)1 therapy. Plinabulin significantly reduced docetaxel-induced grade 4 neutropenia. Plinabulin combination had significantly decreased exposure-adjusted grade 3/4 adverse events vs. docetaxel, supporting prolonged treatment exposure and contributing to improved clinical outcomes.