This section highlights FDA-related milestones and regulatory updates for drugs developed by BeyondSpring (BYSI).
Over the past two years, BeyondSpring has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
plinabulin and Plinabulin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
plinabulin - FDA Regulatory Timeline and Events
plinabulin is a drug developed by BeyondSpring for the following indication: Patients with non-small cell lung cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- plinabulin
- Announced Date:
- July 7, 2025
- Indication:
- Patients with non-small cell lung cancer
Announcement
BeyondSpring Inc. announced publication of a human clinical study in Med (Cell Press) demonstrating that Plinabulin, when combined with radiation and a checkpoint inhibitor, induces dendritic cell (DC) maturation and elicits tumor responses in patients across multiple cancer types who had failed prior ICI therapy.
AI Summary
BeyondSpring Inc. announced a human clinical study published in Med (Cell Press) showing that Plinabulin, when combined with radiation and a checkpoint inhibitor, can trigger dendritic cell maturation in patients with various cancers who had previously failed immune checkpoint inhibitor (ICI) therapy. The study found an overall response rate of 23% and a disease control rate of 54% in non-irradiated lesions, suggesting promising clinical activity. Researchers discovered that Plinabulin works through the GEF-H1–dependent pathway to mature dendritic cells, which may allow doctors to predict which patients will benefit from the treatment by examining a baseline GEF-H1 immune signature. Dr. Steven Lin highlighted the potential of this new approach to reverse resistance to ICI therapy, indicating that Plinabulin could offer renewed hope for patients with treatment-resistant cancers.
Read Announcement- Drug:
- plinabulin
- Announced Date:
- June 3, 2025
- Indication:
- Patients with non-small cell lung cancer
Announcement
BeyondSpring Inc. announces that it presented interim phase 2 data on the 303 Study, a study in 2L/3L non-small cell lung cancer (NSCLC) after disease progression on 1L PD-1/L1 inhibitors with and without chemotherapy (NCT05599789), with financial support from Merck's (Rahway, NJ USA) Investigator Studies Program and provision of study drug, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, on May 31st, 2025 in Chicago, IL.
AI Summary
BeyondSpring Inc. presented interim Phase 2 data from its 303 Study at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, IL, on May 31, 2025. The study focused on patients with metastatic non-small cell lung cancer (NSCLC) who experienced disease progression after first-line treatment with PD-1/L1 inhibitors, with or without chemotherapy. Financial support and study drug were provided by Merck’s Investigator Studies Program. In this trial involving 47 patients, the combination of Plinabulin, pembrolizumab, and docetaxel showed promising results, with a median progression-free survival of 6.8 months and a 15-month overall survival rate of 78%. These findings suggest that the triple therapy might help re-sensitize tumors to immunotherapy, offering a potential new treatment option for patients with limited choices following failure of standard PD-1/L1 therapies.
Read Announcement- Drug:
- plinabulin
- Announced Date:
- March 27, 2025
- Indication:
- Patients with non-small cell lung cancer
Announcement
BeyondSpring Inc. Highlights Key Clinical & Strategic Milestones
AI Summary
BeyondSpring Inc. marked a pivotal year in 2024 by achieving major clinical and strategic milestones. The company’s lead candidate, Plinabulin, demonstrated a statistically significant overall survival benefit in second- and third-line NSCLC (EGFR wild-type) compared to standard docetaxel treatment. These positive Phase 3 results, published in The Lancet Respiratory Medicine, support the company’s plan to submit regulatory applications in China and other regions.
Alongside this, BeyondSpring is exploring Plinabulin’s potential as an immuno-oncology agent. An ongoing Phase 2 study has shown promising results when Plinabulin is combined with PD-1 inhibitors, suggesting it may help re-sensitize tumors that have become resistant to current therapies. Additionally, the company’s co-founded SEED Therapeutics made strategic progress by entering a research collaboration with Eisai, with possible milestone payments of up to $1.5 billion, and closing a $24 million Series A-3 financing round.
Read Announcement
Plinabulin (Trial 103 - DUBLIN-3) - FDA Regulatory Timeline and Events
Plinabulin (Trial 103 - DUBLIN-3) is a drug developed by BeyondSpring for the following indication: Refractory - Non small cell lung cancer (NSCLC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Plinabulin (Trial 103 - DUBLIN-3)
- Announced Date:
- September 16, 2024
- Indication:
- Refractory - Non small cell lung cancer (NSCLC)
Announcement
BeyondSpring Inc. presented final data on Dublin-3 study (2L/3L EGFR wild-type NSCLC) focusing on safety outcomes on September 14, 2024 at European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. Full data on Dublin-3 study was published on September 9, 2024 in the Lancet Respiratory Medicine
AI Summary
BeyondSpring Inc. recently presented final data on the Dublin-3 study at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona on September 14, 2024. This study focused on 2L/3L EGFR wild-type non-small cell lung cancer (NSCLC) patients and mainly evaluated the safety outcomes of its treatment regimen. The findings indicated a favorable safety profile, with adverse effects that were manageable and consistent with expectations for patients in this setting. The full set of data from the Dublin-3 study was published in the Lancet Respiratory Medicine on September 9, 2024, offering detailed insights into the treatment’s tolerability and potential for addressing unmet needs in advanced lung cancer care. These results underscore BeyondSpring’s ongoing efforts to develop and refine innovative therapies for NSCLC, aiming to improve safety and outcomes for patients with challenging cancer profiles.
Read Announcement- Drug:
- Plinabulin (Trial 103 - DUBLIN-3)
- Announced Date:
- September 10, 2024
- Indication:
- Refractory - Non small cell lung cancer (NSCLC)
Announcement
BeyondSpring Inc. announces Dublin-3 final phase 3 efficacy data of its late clinical-stage agent Plinabulin in combination with docetaxel in second/third line (2L/3L) advanced and metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) wild-type.
AI Summary
BeyondSpring Inc. announced final phase 3 data from the Dublin-3 study, which evaluated the efficacy of its late-stage drug Plinabulin combined with docetaxel in patients with advanced and metastatic non-small cell lung cancer (NSCLC) who have EGFR wild-type. The study, conducted in a second/third line setting after platinum-based therapy failure, showed that the plinabulin/docetaxel combination significantly improved overall survival, progression free survival, and the objective response rate compared with docetaxel alone. Additionally, the combination reduced the occurrence of severe (Grade 4) neutropenia, a common and serious side effect of docetaxel. The encouraging efficacy and safety results were presented at the ISLAC 2024 World Conference on Lung Cancer and published in Lancet Respiratory Medicine, suggesting a promising new treatment option for this challenging patient population.
Read Announcement
