On July 12, China National Medical Products Administration Drug Evaluation Center (CDE) announced on its website that 3SBio (01530) recombinant human erythropoietin injection (CHO cells) had submitted a new drug application for listing and had been accepted.
Zhongtong Finance App learned that on July 12, the China National Medical Products Administration Drug Evaluation Center (CDE) announced on its website that 3SBio's recombinant human erythropoietin injection (CHO cells) had submitted a new drug application for listing and had been accepted. According to 3SBio's public information, this is its product long-acting erythropoietin SSS06. In January this year, 3SBio announced that a phase III clinical trial of its long-acting erythropoietin SSS06 for the treatment of chronic renal failure anemia patients undergoing blood dialysis had achieved the preset primary endpoint.
According to a previous news release by 3SBio, SSS06 is a highly glycosylated long-acting recombinant protein product, which locates and mutates the rHuEPO gene using gene recombination technology, adding three N-glycosylation sites. The restructured rESP retains its original biological activity while having longer stability and half-life, reducing the frequency of medication and facilitating clinical use.
3SBio has completed the "Multicenter, Randomized, Parallel Controlled Phase III Clinical Trial on the Effectiveness and Safety of Comparing Recombinant Human Erythropoietin Injection (CHO cells) and EPOETIN-α in Chronic Renal Failure Anemia Patients Undergoing Maintenance Therapy in Hemodialysis". Statistical analysis showed that the mean difference in the evaluation period of the trial group (rESP, QOW administration) and the control group (EPOETIN-α, maintenance screening period administration dose and frequency) was -1.87g/L vs -1.85g/L, 0.122. The lower confidence interval was greater than the non-inferiority margin of -7.5g/L, demonstrating non-inferiority. There was no significant difference in the incidence or severity of adverse events between the trial group and the control group. According to the official website of the China Clinical Trial Registration and Information Publicity Platform, SSS06 was used in this study by intravenous injection once every two weeks.