
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

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 orally administered, highly selective proteasome inhibitor. It is a leading product for multiple myeloma launched by Takeda under the pressure of its blockbuster drug bortezomib. It was first approved by the FDA for marketing in November 2015 and received EU approval in November 2016, with the trade name Ni.nlaro。In April 2018, the product was approved by the China Food and Drug Administration for use in combination with lenalidomide and dexamethasone to treat adult patients with multiple myeloma who have received at least one prior therapy, marketed under the brand name Ninlaro.
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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