BioCentury
ARTICLE | Company News

China approves first biosimilar, Shanghai Henlius’ HLX01

February 25, 2019 11:45 PM UTC

China's National Medical Products Administration (NMPA) approved last Friday the country’s first biosimilar, rituximab biosimilar HLX01 from Shanghai Henlius Biotech Inc. (Shanghai, China).

The chimeric mAb against CD20 was approved in China for the same indications as its reference drug, Rituxan rituximab from Roche (SIX:ROG; OTCQX:RHHBY), including for recurrent or drug-resistant follicular central lymphoma, CD20-positive stage III-IV follicular non-Hodgkin lymphoma (NHL) and CD20-positive diffuse large B cell lymphoma (DLBCL)...