Against the backdrop of continuous advancements in lymphoma treatment in China, domestic biosimilars are steadily expanding their clinical boundaries.

On April 9, Shanghai Henlius Biotech announced that its rituximab injection Hanlikang® (HLX01) has received approval from the National Medical Products Administration for two new indications in non-Hodgkin lymphoma (NHL), further strengthening its presence in the lymphoma treatment landscape.

The newly approved indications focus on diffuse large B-cell lymphoma (DLBCL), the most common and aggressive subtype, and cover key treatment settings. One indication is in combination with polatuzumab vedotin, cyclophosphamide, doxorubicin, and prednisone for previously untreated adult patients.

The other is in combination with bendamustine and polatuzumab vedotin for adult patients with relapsed or refractory disease who are not eligible for hematopoietic stem cell transplantation. Together, these approvals extend coverage across both first-line and relapsed/refractory settings.

From a product perspective, Hanlikang® is the first biosimilar approved in China and the first monoclonal antibody developed and approved under the 2015 Technical Guidelines for the Development and Evaluation of Biosimilars (Trial).

To date, its indications fully cover all approved indications of the reference rituximab in China, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis (which was not approved in China for the originator), making it one of the rituximab products with the broadest range of approved indications in the country.

Clinical data demonstrate that Hanlikang® is highly similar to the reference rituximab in terms of structure, biological characteristics, and pharmacokinetics/pharmacodynamics. The Phase III HLX01-NHL03 study (published in BMC Cancer) showed comparable efficacy between the H-CHOP and R-CHOP regimens in DLBCL treatment, with 5-year overall survival rates of 81.0% vs 75.4% and progression-free survival rates of 77.7% vs 73.0%, supporting its clinical equivalence.

Meanwhile, the Fosun Pharma group is accelerating Hanlikang®’s global expansion. The product has already partnered with companies such as Abbott and Eurofarma, and has been approved in multiple Latin American markets, reflecting steady progress in its internationalization strategy.

Overall, the approval of these two new indications not only further consolidates Hanlikang®’s leading position in China’s rituximab market, but also enhances its role across the full treatment continuum of DLBCL.

From demonstrated clinical equivalence to improved accessibility, biosimilars in China are increasingly becoming a key driver in optimizing oncology treatment systems. In this context, China-based pharmaceutical wholesaler DengYueMed continues to monitor the latest developments in oncology therapies and support improved drug accessibility worldwide.