BeyondSpring Inc. (NASDAQ: BYSI) announced on September 29, 2026, that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Plinabulin in combination with docetaxel. The designation applies to the treatment of patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations who have progressed following prior anti-PD-(L)1 antibody therapy and platinum-based chemotherapy. This patient population is the focus of the company’s global Phase 3 DUBLIN-4 trial.
In addition to the regulatory milestone, BeyondSpring entered into a strategic transaction involving its Chinese subsidiary. The company executed a Share Purchase and Collaboration Agreement with Dalian Wanchunbulin Pharmaceuticals Ltd. (Bulin) and Biolin Investment Limited. Under the terms of the agreement, BeyondSpring will sell its majority equity interest in BeyondSpring Ltd., the entity that indirectly holds the interests in Bulin, to Biolin.
The transaction is structured as a non-cash deal. Biolin will provide funding to conduct and complete the China portion of the DUBLIN-4 trial. The agreement stipulates that Bulin must use commercially reasonable efforts to enroll a specific number of patients determined by BeyondSpring to satisfy regulatory needs over a three-year period. If Bulin fails to achieve the target enrollment, Biolin is required to transfer a proportional portion of the equity interests back to BeyondSpring.
BeyondSpring retains global rights to Plinabulin outside of Greater China. The company intends for the data generated in China to form part of an integrated global clinical dataset supporting its registration strategy. The transaction is expected to substantially reduce the company's cash requirements for the DUBLIN-4 trial while supporting efficient enrollment, which is anticipated to represent approximately 50% of the planned global enrollment of 442 patients.
Separately, BeyondSpring entered into an Open Market Sale Agreement with Citizens JMP Securities, LLC. This agreement allows the company to sell up to 9,200,000 ordinary shares via an at-the-market offering program. The agent is entitled to a commission of up to 3.0% of the gross proceeds from these sales.
