Healthcare Oct 08, 2021 10:27 AM (GMT+8)
On October 8, 2021, Yiyi bio, a global biopharmaceutical company committed to developing new biotherapy, announced that the European Drug Administration (EMA) had officially accepted Yiyi bio ryzneuta ™ Application for marketing authorization (MAA) for the treatment of neutropenia (CIN) caused by chemotherapy, and a centralized review procedure has been initiated.
The listing application will be reviewed by the EMA human drugs Committee (CHMP) according to the centralized review procedure. The approval of the centralized review will be applicable to all 27 EU Member States, as well as Norway, Iceland and Liechtenstein. The listing application is based on data from three phase III critical clinical trials. Ryzneuta ™ The primary and secondary indicators were achieved in all three trials, and the preset clinical efficacy and safety were fully demonstrated.
Said Dr. Jubo Liu, CEO of Yiyi biology. "The EU is ryzneuta ™ As an important area of global commercialization, we look forward to working with EU regulators to bring this new biotherapy to CIN patients in the EU and other regions. "
This text is a result of machine translation.