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.
BeyondSpring's Next Move Uncertain After Plinabulin CRL
Limited Impact On China Partner Hengrui?
Chinese firm BeyondSpring dealt a setback after the US FDA refuses to approve plinabulin for chemotherapy-induced neutropenia.
