Qilu Pharmaceutical Submits NDA for China's First Generic Ixazomib Capsules

On October 17, the CDE website showed that the listing application for Qilu Pharmaceutical's Ixazomib Citrate Capsules had been accepted. This is the first generic Ixazomib to be submitted for marketing in China.

The original research product Ixazomib is an oral, highly selective proteasome inhibitor developed by Takeda as a leading product for multiple myeloma under the pressure of its blockbuster drug bortezomib. It received FDA approval for the first time in November 2015 and was approved by the EU in November 2016, with the brand name Ninlaro. In April 2018, the product received approval from the China National Medical Products Administration (NMPA) for use in combination with lenalidomide and dexamethasone to treat adult patients with multiple myeloma who have received at least one prior therapy, with the brand name Enleer.

Since its launch, the sales of Ixazomib have steadily increased, with sales reaching 92.7 billion yen in 2022.

Multiple Myeloma: A Malignant Disease Caused by Clonal Proliferation of Abnormal Plasma Cells

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