Hanlikang (rituximab biosimilar)

Patients were randomised to either rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or HLX01 plus CHOP (H-CHOP) every 21 days for up to six cycles. Treatment outcomes did not differ between groups regardless of IPI score and were consistent with the primary analysis. H-CHOP and R-CHOP provided no significant difference in 5-year OS or PFS in previously untreated patients with low or low-intermediate risk DLBCL.

During induction phase, pts received rituximab biosimilar (Henliritux ® Shanghai Henlius Biotech) 375 mg/m 2 intravenous infusion on d1. Peg-IFN-α2b (Pegberon ® , Xiamen Amoytop Biotech) was given at a dose of 135ug, subcutaneously, on d1,8...Simultaneously, CHB pts orally treated with entecavir continuously... Rituximab biosimilar plus pegylated interferon α-2b provided favorable response in newly diagnosed advanced iBCL and was well tolerated. No hepatitis B virus reactivation was observed. Further investigation is warranted.

Treatment with HLX01 was safe and well tolerated in Chinese patients with B-cell lymphoma. HLX01 and rituximab-CN have similar pharmacokinetic, pharmacodynamic and safety profiles.

Domestic biotechnology company Innovent in collaboration with Eli Lilly followed shortly with an application for IBI301 in CD20-Positive Lymphoma which was accepted for review in June 2019. However, with an active trial in iBCL, HLX01 may be seeking to demonstrate clinical benefit in targeted patient subgroups that are more difficult-to-treat in the on-label indications as compared to rituximab. This would potentially improve physician perceptions of biosimilars and their willingness to prescribe and use in clinical practice.

P, N=407, Enrolling by invitation, Chinese Academy of Medical Sciences