China’s first imported PD-L1 subcutaneous formulation approved! Atezolizumab subcutaneous formulation receives NMPA approval for market launch
December 30, 2025
Source: drugdu
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Atezolizumab is a monoclonal antibody targeting PD-L1. This approval of the subcutaneous (SC) formulation of atezolizumab is based on positive results from the IMscin001 study. IMscin001 was a two-part dose-exploration (Phase Ib) and confirmatory (Phase III) study designed to evaluate the pharmacokinetics of subcutaneous (SC) administration of atezolizumab compared to intravenous (IV) administration in patients with locally advanced or recurrent metastatic non-small cell lung cancer (NSCLC). Clinical endpoints included objective response rate (ORR), progression-free survival (PFS) or overall survival (OS), serious adverse events, adverse events of particular concern, grade 3–5 adverse events, infusion-related reactions, and injection site reactions related to safety.
The results showed [1] that the C trough and AUC 0-21 d of atezolizumab SC were consistent with those of atezolizumab IV. The PFS [hazard ratio (HR) 1.08 (95% CI [0.82-1.41]], ORR (SC: 12% vs. IV: 10%), and incidence of adverse events (SC: 19.5% vs. IV: 13.9%) were similar between the SC and IV groups, and no new safety issues were found.
https://bydrug.pharmcube.com/news/detail/428097382aa8c940312a83a3d3beaca0
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