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Source: Guanlan Pharmaceutical
Today (March 22), the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that the parsaclisib tablet jointly declared by Innovent and Incyte has been included in the proposed breakthrough treatment product, and the proposed indication is recurrent or Refractory follicular lymphoma.
Parsaclisib is a powerful, highly selective, new-generation phosphatidylinositol 3-kinase δ (PI3Kδ) oral inhibitor discovered and developed by Incyte.
The PI3K signaling pathway plays an important role in regulating cell growth, movement, survival, metabolism and angiogenesis.
Public information shows that as a new oral inhibitor against PI3Kδ, parsaclisib plays an important role in inhibiting PI3Kδ in the growth and survival of malignant B-cell lymphoma.
According to the information on the CDE website, parsaclisib has obtained a number of clinical trials implied licenses in China for indications including myelofibrosis, relapsed/refractory follicular lymphoma, and marginal zone lymphoma.
Screenshot source: CDE official website
At the 62nd American Society of Hematology (ASH) in December 2020, Cinda Bio announced two parsaclisib for the treatment of relapsed or refractory follicular lymphoma (CITADEL-203) and marginal zone lymphoma Phase 2 study data of tumor (CITADEL-204).
According to reports, in the study, eligible patients received 20 mg of parsaclisib once a day for eight weeks, followed by 20 mg twice a week (weekly dose group [WG]) or 2.
Research data for relapsed or refractory follicular lymphoma showed that the objective remission rate of patients in the DG group was 75%, and the objective remission rate of all patients was 73%; the median duration of remission of patients in the DG group was 14.
Follicular lymphoma is a type of B-cell lymphoma, which is caused by the uncontrolled division of specific types of B cells in the central cell and central blast.
It is hoped that the follow-up study of parsaclisib will proceed smoothly and be approved for marketing as soon as possible, bringing new treatment options to patients.
