China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its generic version of US-based Intra-Cellular Therapies’ Caplyta (lumateperone). This Category 3 chemical drug, with no similar product approved in China, is set for evaluation in schizophrenia treatment.
Drug Profile and Mechanism
Lumateperone, an atypical antipsychotic of the butyrophenone class, was approved in the US for schizophrenia and depressive episodes associated with bipolar I and II disorders in 2019 and 2021, respectively. It acts as a receptor antagonist of the 5-HT2A receptor and antagonizes several dopamine receptors (D1, D2, and D4) with lower affinity, while also exhibiting moderate serotonin transporter reuptake inhibition.-Fineline Info & Tech
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