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InnoCare Announces the Acceptance of the New Indication Application for Orelabrutinib in the Treatment of Relapsed/Refractory Waldenström's Macroglobulinemia in China

 Last Update: 2022-05-27
 Source: Internet
 Author: User

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BEIJING, March 14, 2022 /PRNewswire/ -- Nuocheng Jianhua, a high-tech biopharmaceutical company, announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted its Bruton's tyrosine New indication application (sNDA) for the acid kinase (BTK) inhibitor orelabrutinib for the treatment of patients with relapsed/refractory Waldenström macroglobulinemia (WM)

Professor Zhou Daobin, director of the Department of Hematology at Peking Union Medical College Hospital, said: "According to the evaluation results of the Independent Review Committee (IRC) and the investigators, orelabrutinib at a dose of 150 mg once daily in patients with relapsed/refractory WM both met the primary endpoint of the study.

Dr.

Orelabrutinib was approved in China on December 25, 2020 for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and relapsed/refractory mantle cell lymphoma ( MCL) for two indications

About Waldenstrom's Macroglobulinemia

Waldenström's macroglobulinemia is a relatively indolent B-cell lymphoma that manifests as an invasion of the bone marrow by lymphoplasmacytic cells that secrete monoclonal immunoglobulin M (IgM)

About orelabrutinib

Orelabrutinib is a class 1 innovative drug developed by Nuocheng Jianhua.

Orelabrutinib was granted Breakthrough Therapy Designation by the Food and Drug Administration (FDA) in the United States for the treatment of relapsed/refractory mantle cell lymphoma (R/R MCL)

Based on excellent target selection and clinical safety, orelabrutinib is conducting a global phase II clinical study in the field of autoimmune diseases for the treatment of multiple sclerosis (MS), as well as for the treatment of systemic lupus erythematosus (SLE), primary immune A Chinese Phase II clinical trial in Induced Thrombocytopenia (ITP)

Source: Nuocheng Jianhua

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