Qilu Pharmaceutical Co.,Ltd.’s Carfilzomib for Injection Approved for Market Launch

Qilu Pharmaceutical Co.,Ltd’s  Carfilzomib for Injection has received market approval from the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory multiple myeloma.

Multiple myeloma is a hematologic malignancy characterized by the abnormal proliferation of clonal plasma cells. It predominantly affects middle-aged and elderly individuals and currently remains incurable. Commonly used therapeutic agents include proteasome inhibitors (e.g., Carfilzomib, Bortezomib), immunomodulatory agents (e.g., Lenalidomide), and monoclonal antibodies (e.g., Daratumumab, and the recently approved Isatuximab).

Proteasome inhibitors serve as a cornerstone in the treatment of multiple myeloma. As a second-generation proteasome inhibitor, Carfilzomib induces apoptosis in myeloma cells by irreversibly binding to and efficiently inhibiting the proteasome‘s function. Studies indicate that Carfilzomib maintains stable efficacy in combination therapies and retains therapeutic potential even for patients who have developed resistance to other proteasome inhibitors. Carfilzomib was first approved in the United States in July 2012 and subsequently gained approval in China in July 2021.

Owing to its high selectivity, low neurotoxicity, and favorable patient tolerability, Carfilzomib has been recommended by numerous domestic and international clinical guidelines, including the Chinese Guidelines for the Diagnosis and Management of Multiple Myeloma (2022), the NCCN Clinical Practice Guidelines in Oncology for Multiple Myeloma (2022), and the CSCO Guidelines for Malignant Hematology (2022). Furthermore, its inclusion in China‘s National Reimbursement Drug List (NRDL) has significantly improved drug accessibility, benefiting a broader patient population.

In pharmaceutical development, the synthesis, identification, and study of impurities, particularly those derived from intermediates, are critical steps. Carfilzomib may generate various impurities during production and storage, making effective control of these impurities essential for ensuring the drug‘s safety and efficacy.

SZEB (ShenZhen Excellent Biomedical Technology Co., Ltd.) supplies a comprehensive range of Carfilzomib impurity reference standards/standard substances and Bortezomib impurity reference standards/standard substances readily available from stock. This provides comprehensive support for pharmaceutical companies engaged in the R&D, production, and quality control of Carfilzomib and related drugs.

For more details on our impurity portfolio, please visit our official website: www.ex-biotech.com ，contact us by E-mail :sales@ex-biotech.com .