Shanghai Securities News China Securities Network (Reporter Zhang Xue) — On January 31, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that Pfizer had submitted the marketing application for elranatamab injection in China, which has been accepted. Meanwhile, the product is also proposed by the CDE to be included in the priority review, targeting adult patients with relapsed or refractory multiple myeloma (MM) who have previously received at least three prior lines of therapy.
Elranatamab is a subcutaneously injected BCMA×CD3 bispecific antibody, which received accelerated approval from the U.S. FDA in August 2023 for the treatment of patients with relapsed/refractory MM.
According to publicly available information from Pfizer, elranatamab is a subcutaneously injectable bispecific antibody targeting BCMA and CD3. One end binds to BCMA on myeloma cells, while the other end binds to the CD3 receptor on the surface of T cells, bringing them together and activating the T cells to kill myeloma cells. Additionally, elranatamab is administered to patients via subcutaneous injection, which is more convenient than intravenous injection and may reduce the occurrence of potential side effects such as cytokine release syndrome (CRS).