HENLIUS Wins NMPA Nod to Broaden Hanlikang’s Rituximab Label for Two DLBCL Regimens

Bulletin Express04-09 18:42

Shanghai Henlius Biotech, Inc. (HENLIUS) announced that China’s National Medical Products Administration has approved two supplementary applications that expand the indication scope of Hanlikang, the company’s rituximab biosimilar.

The new approvals cover: 1) first-line combination therapy with polatuzumab vedotin, cyclophosphamide, doxorubicin and prednisone for adults with previously untreated diffuse large B-cell lymphoma (DLBCL); and 2) combination therapy with bendamustine and polatuzumab vedotin for adults with relapsed or refractory DLBCL who are ineligible for hematopoietic stem-cell transplantation.

Hanlikang was first commercialised in Mainland China in February 2019 and is already cleared for multiple indications in Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia and Rheumatoid Arthritis. The drug is also approved in Nicaragua and Bolivia.

Market context: IQVIA data show that Mainland China sales of rituximab injections reached RMB3.47 billion in 2025.

Management expects the broadened label to widen Hanlikang’s clinical reach and provide additional treatment options for DLBCL patients in China.

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