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BeyondSpring's Next Move Uncertain After Plinabulin CRL

Limited Impact On China Partner Hengrui?

 
• By Brian Yang

Chinese firm BeyondSpring dealt a setback after the US FDA refuses to approve plinabulin for chemotherapy-induced neutropenia.

Business uncertainty and risk showing a winding road high above the clouds showing the concept of danger and challenges faced in business and the corporate world of finance and financial services.
BEYONDSPRING'S PLINABULIN GETS US CRL, NEXT MOVE UNCERTAIN • Source: Alamy

On 1 December, Chinese biotech BeyondSpring Inc. said it had received a Complete Response Letter (CRL) from the US Food and Drug Administration, under which the agency refused to approve its drug plinabulin for chemotherapy-induced neutropenia due to results from the single Phase III registrational trial being “not sufficiently robust to demonstrate benefits" and meaning a second well-controlled trial will be required.

The small molecule treatment is designed for use in combination with granulocyte colony-stimulating factor (G-CSF) for cancer patients with reduced white blood cell counts due to chemotherapy.

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