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DRUG:

Halpryza (rituximab biosimilar)

i
Other names: IBI301
Associations
Company:
Eli Lilly, Innovent Biologics
Drug class:
CD20 inhibitor
Related drugs:
Associations
almost4years
Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20 B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study. (PubMed, Sci Rep)
IBI301 was PK bioequivalent to rituximab in patients with CD20 B-cell lymphoma. The PD, safety, and immunogenicity profiles of IBI301 were similar to those of rituximab.
Clinical • PK/PD data • Journal
|
CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
|
CD20 positive
|
Halpryza (rituximab biosimilar)
4years
[VIRTUAL] Biosimilar in China- Will Indication-Based Approach Help Improve Patient Access? (ISPOR-EU 2020)
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.
Clinical
|
CD20 (Membrane Spanning 4-Domains A1)
|
CD20 positive
|
Halpryza (rituximab biosimilar) • Hanlikang (rituximab biosimilar)
4years
Trial completion • Preclinical • Trial completion date
|
CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
|
CD20 positive
|
Rituxan (rituximab) • Halpryza (rituximab biosimilar)
over4years
A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients (clinicaltrials.gov)
P3, N=420, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Recruiting --> Completed | Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Sep 2019
Clinical • Trial completion • Trial completion date • Trial primary completion date • Combination therapy
|
CD20 (Membrane Spanning 4-Domains A1)
|
CD20 positive
|
Rituxan (rituximab) • Halpryza (rituximab biosimilar) • vindesine