Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that an approval filing for its drug candidate suvemcitug (also known as sevacizumab; APX-003; BD-0801) has been submitted in China and accepted for review by the National Medical Products Administration (NMPA). The filing seeks the first indication approval for the molecule in combination with chemotherapy for the treatment of recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in patients who have failed platinum-based chemotherapy.
Suvemcitug is characterized as a next-generation recombinant humanized anti-VEGF rabbit monoclonal antibody. It is under co-development by Simcere and Pyxis Oncology, Inc. (NASDAQ: PYXS). Simcere initially acquired the rights to develop the drug in the greater China territory under a 2008 deal with US firm Epitomics Inc., which later passed the rights to its spin-off Apexigen Inc. In August 2023, Apexigen was acquired by Pyxis.
Preclinical studies have indicated that suvemcitug exhibits stronger affinity and anti-tumor effects than bevacizumab at equivalent doses. Initial clinical data for the molecule in treating stage Ib ovarian cancer in China have shown promising safety and efficacy signals. The Phase III SCORES study, which evaluated suvemcitug combined with chemotherapy in recurrent platinum-resistant epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer, achieved its primary endpoint in January 2024.- Flcube.com
