3SBio Inc. (HKG: 1530), a leading biopharmaceutical company based in China, has announced that the National Medical Products Administration has accepted its filing for market approval of SSS06, a recombinant erythropoiesis stimulating protein injection (rESP, CHO cells). This development marks a significant milestone for the company as it aims to provide a novel treatment option for adult dialysis patients undergoing erythropoietin therapy. Earlier this year, in January, SSS06 successfully achieved its pre-set primary endpoint in a pivotal Phase III clinical study.
Anemia is a prevalent complication among patients suffering from chronic kidney disease, and effective erythropoiesis-stimulating agents (ESAs) are crucial in managing this condition. SSS06 is a high glycosylated, long-acting recombinant protein product. It is engineered through point mutation of the rhEPO gene using gene recombination technology, with the addition of three N-glycosylation sites designed to enhance its therapeutic efficacy.- Flcube.com
