Johnson & Johnson (JNJ.US) obtained domestic approval for the new indication of subcutaneous formulation of Darzalex (daratumumab)

According to the Zhixun Finance APP, on May 14th, the official website of the China Drug Evaluation (CDE) showed that the new indication application for Johnson & Johnson's Darzalex (daratumumab) subcutaneous injection has been accepted. This product is classified as category 3.1 for registration, which means it is a biopharmaceutical produced overseas and already marketed overseas but not yet marketed domestically. Based on publicly available information and clinical progress, the Insight database infers that the indication for this application is for use in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma patients eligible for hematopoietic stem cell transplantation.