Hanlikang® (rituximab injection), the first CD20 monoclonal antibody independently developed by Henlius and also the first biosimilar in China, was officially approved for listing and registration by the State Administration of Pharmaceutical Affairs (SDPA) on February 22, 2019, which fills the gaps of the domestically-produced CD20 monoclonal antibody and domestic biosimilar market, and enables more Chinese patients to benefit from it! Recently, the 5-year follow-up results of patients in the Phase III study of Hanlikon® were officially published in the journal BMC Cancer (HLX01-NHL03 open-label extension study, NCT04491721).

The results of the phase III HLX01-NHL03 study have demonstrated the bioequivalence of HLX01 (Hanlikon®, a rituximab biosimilar) compared to rituximab (Merovia®) in untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). Here, we report 5-year follow-up results from an open-label extension study. Patients were randomly assigned to receive rituximab (Merova®) + cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or HLX01 (Hanlikon®) + CHOP (H-CHOP), with HLX 01 (Hanlikon®) or rituximab (Merova®) at a dose of 375 mg/m2 administered intravenously once every 3 weeks, with 1 cycle every 3 weeks. Maximum of 6 cycles of treatment. Patients enrolled in the open extension study were those randomly assigned in the HLX01-NHL03 study who were willing to be followed for survival, disease progression, and treatment status. The primary efficacy endpoint was 5-year overall survival (OS) and the secondary efficacy endpoint was 5-year progression-free survival (PFS).

This study showed that the 5-year OS and PFS rates of previously untreated Chinese DLBCL patients treated with H-CHOP were comparable to those of R-CHOP treatment.

Rituximab has revolutionized the treatment of DLBCL over the past decades, and the rituximab-based R-base regimen remains the cornerstone regimen for the first-line treatment of DLBCL. As the first self-developed rituximab in China, the release of 5-year long-term data further confirms the consistency of the product's efficacy with that of the reference drug, and provides a more definitive evidence-based guarantee for use by more patients in the future!

https://mp.weixin.qq.com/s/2febOXVkGuyLSM4tjeCyvw