On October 28, eClinicalMedicine (IF:15.1), part of THE LANCET Discovery Science, released its phase III clinical research paper on Saint Luolai (pegmolesatide injection), a class 1 innovative drug independently developed by Hansoh Pharma. The trials were led by Professor Jianghua Chen from the First Affiliated Hospital of Zhejiang University School of Medicine. It marks the first publication of clinical data on pegmolesatide in an international journal, fully demonstrating its efficacy and safety in the treatment of anemia in dialysis patients, and is also a testament to the quality of clinical research on innovative drugs originating in China reaching an advanced international standards.
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Professor Jianghua Chen, the principal investigator of the phase III 302 study on pegmolesatide and the current chairman of the Chinese Society of Nephrology, stated: "As an original class 1 new drug from China, pegmolesatide has filled the gap as a long-acting monthly formulation for the treatment of renal anemia in China. Coming from the highly trusted eClinicalMedicine, this release provides strong evidence that pegmolesatide, as the only marketed EPO mimetic peptide in the world, has definite therapeutic effects and good safety in the treatment of anemia in CKD dialysis patients. Patients only need to be administered a subcutaneous injection once a month to achieve stable hemoglobin targets. This provides a safe, effective, and convenient new option for the vast number of patients suffering from renal anemia, and it is hoped that more patients with renal anemia will benefit from treatment with Saint Luolai in the future."
As the clinical data on pegmolesatide were published for the first time in an international journal, the study results on renal anemia treatment in China have been successfully brought to the forefront of international medicine, which will help to further promote the research and exploration in this field within the medical community in China and globally. Hansoh Pharma will continue on its mission to innovate and bring more high-quality and effective treatment options to patients.
Background
This randomized, open-label, active-comparator, non-inferiority phase III trial was conducted at 43 dialysis centers in China, and included 372 patients with chronic kidney disease (CKD) who were on dialysis (hemodialysis or peritoneal dialysis) and had received routine short-acting erythropoietin (rHuEPO) therapy for at least 8 weeks prior to enrollment. Patients were randomly assigned (at a ratio of 2: 1) to receive pegmolesatide subcutaneous injection once every four weeks or epoetin alfa IV injection one to three times per week to maintain hemoglobin within the target range (10.0 to 12.0 g/dL).
Results
Pegmolesatide was not inferior to epotin alfa in terms of its primary efficacy endpoint (the mean change in hemoglobin level from the baseline level to the level during the efficacy evaluation period), and even exhibited superior efficacy. Pegmolesatide was generally well tolerated, and most adverse events related to treatment were mild to moderate with no severe anaphylaxis, and the incidence of composite cardiovascular events was lower when using pegmolesatide compared with epotin alfa (2.4% vs. 4.0%, HR 0.47).
Conclusion
Monthly subcutaneously injection of pegmolesatide was as safe and effective in treating anemia in Chinese dialysis patients as conventional epoetin alfa administrated one to three times a week.
