BeyondSpring secures Fast Track status and trades China subsidiary for trial funding

BeyondSpring ($BYSI) said the FDA granted Fast Track designation to plinabulin plus docetaxel for a defined previously treated non-squamous lung-cancer population. Separately, it signed an agreement to sell the holding company controlling its Chinese subsidiary to Biolin Investment. The consideration is noncash: Biolin’s obligations to support the China portion of the Phase III DUBLIN-4 trial and related development activities.

China is expected to supply approximately 221 of the planned 442 patients, potentially reducing BeyondSpring’s funding burden while preserving access to trial data. The company will retain plinabulin rights outside Greater China following the transaction. Fast Track facilitates regulatory interaction but is not approval, and no new DUBLIN-4 efficacy result was announced. The trial’s main endpoint is overall survival, with a prespecified interim analysis after 221 progression-free-survival events.

Sources:

• BeyondSpring GlobeNewswire release, reproduced by StockTitan