Guangzhou Gloria Biosciences Co., Ltd, a biopharmaceutical company based in China, has received approval from the Hainan Medical Products Administration for its CXCR4 antagonist motixafortide (BL-8040) as a special drug for import due to clinical urgency. The drug will be implemented and administered by Hainan Boao Lu Medical Hospital, a non-profit, comprehensive Class 3 hospital located in the Lecheng pilot zone.
Motixafortide, marketed under the brand name Aphexda, is an innovative CXCR4 inhibitor that was granted approval by the US FDA in September 2023. It is used in combination with filgrastim, a granulocyte colony-stimulating factor (G-CSF), to mobilize stem cells in patients with multiple myeloma who are preparing for a stem-cell transplant. In 2023, Gloria Bio entered into a licensing agreement with Israel’s BioLineRx, securing exclusive rights to develop, manufacture, and commercialize the drug in Asia.
Building on the expected absence of racial differences in Asian subject data from the globally approved multicenter Phase III GENESIS study, Gloria Bio received approval from the Center for Drug Evaluation of NMPA in May 2024 to conduct a Phase III bridging study. This study will evaluate the mobilization of hematopoietic stem cells using G-CSF in combination with autologous transplantation in patients with multiple myeloma. Concurrently, the company initiated new drug application (NDA) filings in Macau and Singapore.- Flcube.com
