On 9 April 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has approved two new non-Hodgkin’s lymphoma indications for Hanlikang® (HLX01), biosimilar to Genentech/Biogen’s Rituxan®/MabThera® (rituximab).
The two new indications are:
- in combination with polatuzumab vedotin, cyclophosphamide, doxorubicin, and prednisone for first line treatment of previously untreated adult patients with diffuse large B‑cell lymphoma (DLBCL); and
- in combination with bendamustine and polatuzumab vedotin for the treatment of adult patients with relapsed or refractory DLBCL who are not candidates for hematopoietic stem cell transplant.
Rituximab was one of the first mAbs to become “biosimilar”, being first approved in the US on 26 November 1997. Henlius’ Hanlikang® was the first rituximab biosimilar approved in China in 2019, where its commercial sales are managed by Fosun Pharma. According to Henlius, Hanlikang® is approved for more indications in China than the reference product (being the only rituximab product approved in China to treat rheumatoid arthritis).
Other rituximab biosimilars approved in China include Innovent/Eli Lilly’s Halpryza® (approved October 2020) and Chia Tai Tianqing’s Delituo® (approved May 2023).