BeyondSpring gets FDA Fast Track for plinabulin, sells China unit stake to fund trial
The FDA granted Fast Track status for plinabulin plus docetaxel in post-ICI NSCLC as BeyondSpring agreed to sell its Chinese subsidiary stake to Biolin Investment to fund the trial's China enrollment.
BeyondSpring Inc. announced on September 29, 2026 that the 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 without actionable genomic alterations 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.1 This is the patient population being studied in BeyondSpring's global Phase 3 DUBLIN-4 trial.1
Alongside the designation, the company disclosed a Share Purchase and Collaboration Agreement dated September 28, 2026 with Dalian Wanchunbulin Pharmaceuticals Ltd. ("Bulin"), a majority owned indirect subsidiary of the Company, and Biolin Investment Limited, a limited company formed under the laws of Hong Kong, to sell and transfer to the Investor the entire issued share capital in BeyondSpring Ltd., a BVI business company that indirectly holds the interests in Bulin.1 The obligation on the part of the Investor to conduct and complete the China portion of the ongoing trial constitutes the non-cash consideration for the sale, with no cash consideration paid by the Investor at closing.1
The DUBLIN-4 trial plans to randomize approximately 442 patients 1:1, with overall survival as the primary endpoint and PFS and objective response rate as secondary endpoints, including a prespecified interim analysis at 221 PFS events.1 China is expected to account for approximately half of the planned 442-patient global enrollment.1 Bulin must use commercially reasonable efforts to enroll a target number of patients determined by the Company during a three-year enrollment period following closing.1 If enrollment shortfalls reach 90% or more, the Investor must return one hundred percent of the equity interests to the Company.1
Separately, the company entered a Sales Agreement with Citizens JMP Securities, LLC on September 29, 2026 for an at-the-market program allowing sale of up to 9,200,000 ordinary shares.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.