Shanghai Shyndec Pharmaceutical (600420.SH): Ibrutinib Capsules Obtain Drug Registration Certificate.
China National Pharmaceutical Group (600420.SH) released an announcement that the company recently received the Drug Registration Certificate for Gefitinib Capsules approved and issued by the National Medical Products Administration.
Shanghai Shyndec Pharmaceutical (600420.SH) announced that recently, the company has received the "Drug Registration Certificate" issued by the National Medical Products Administration for Ibrutinib capsules.
It is reported that Ibrutinib capsules are an orally administered small molecule Bruton's tyrosine kinase (BTK) inhibitor, which belongs to targeted therapy drugs. As the world's first approved BTK inhibitor, it was first approved for clinical use in the United States in 2013 and entered the Chinese market in 2017. This drug irreversibly inhibits BTK, blocks the B-cell receptor signaling pathway, and is used to treat various B-cell malignancies. Its main indications include mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and Waldenstrom's macroglobulinemia (WM). According to the Menuity database, the sales of Ibrutinib capsules in public medical institutions and urban pharmacies nationwide in 2025 were 398 million yuan.
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