Recently, during the 2023 Annual Conference of the Chinese Nephrologist Association (CNA), the "First National Medical Information Publication of Pegmolesatide (PERA, Saint Luolai®)" hosted by Hansoh Pharma, was grandly held at the CNA closing ceremony special session. The conference gathered top experts in the field of kidney disease along with professionals from industry, academia, and research. They engaged in in-depth discussions around the complex and varied needs and challenges in the clinical practice of chronic kidney disease (CKD) in China, sparking collisions of cutting-edge ideas and lively debates on many issues.
Hansoh Pharmas' Pegmoesatide, the global unique once-monthly peptide-based highly specific EPO receptor activator was granted market approval on June 30, 2023, officially ushering in a new era for the treatment of CKD-related anemia in China. At the special session, Professor Wang Rong from Shandong Provincial Hospital released and provided a detailed interpretation of the data regarding the studies on the "Efficacy and Safety of Pegmolesatide for the Treatment of Anemia in CKD Non-Dialysis Patients" and the "Efficacy and Safety of Pegmolesatide for the Treatment of Anemia in CKD Dialysis Patients".
Hansoh Pharmas' Pegmolesatide, the global unique once-monthly peptide-based highly specific EPO receptor activator was granted market approval on June 30, 2023, officially ushering in a new era for the treatment of CKD-related anemia in China. At the special session, Professor Wang Rong from Shandong Provincial Hospital released and provided a detailed interpretation of the data regarding the studies on the "Efficacy and Safety of Pegmolesatide for the Treatment of Anemia in CKD Non-Dialysis Patients" and the "Efficacy and Safety of Pegmolesatide for the Treatment of Anemia in CKD Dialysis Patients".
Pharmaceutics studies showed that:
Pegmolesatide has a high selectivity for the EPO receptor (EPOR) and a strong binding ability with the EPOR homodimer that promotes erythrocyte formation. Its erythropoietic action is comparable to traditional ESAs, but it has a lower binding ability with the heterodimer (EPOR/CD131) that does not have erythropoietic effects, giving the drug a potential advantage in safety. The molecular structure of Pegmolesatide does not contain lysine, so the drug does not undergo amidation caused by lysine like other ESAs. Compared with short-acting ESAs drugs, Pegmolesatide is modified with polyethylene glycol (PEG), significantly extending its half-life. As a result, it is administered only once every four weeks, greatly reducing the frequency of dosing. This feature brings considerable convenience to patients and helps improve treatment compliance.
Clinical studies showed that:
During the 24-week efficacy evaluation of the Phase III clinical study in non-dialysis CKD patients with anemia, Pegmolesatide and rHuEPO showed no statistically significant difference in the Hb attainment rate. However, during the 52-week extension period, compared with the rHuEPO control group, the Pegmolesatide group had a much better maintenance rate of Hb after anemia correction, and lower incidences of adverse events (AEs).
For dialysis CKD patients with anemia, the Pegmolesatide group and the rHuEPO control group showed no statistical difference in Hb attainment rate. However, in certain specific populations, such as those: under 65 years old, male, on peritoneal dialysis, with HgB ≥ 11.5 g/dL, and in all New York Heart Association Functional Classification subgroups, the Pegmolesatide group achieved superior efficacy and showed less variability in Hb levels. Moreover, while the overall safety profile was similar, the occurrence rates of composite safety events and other cardiovascular events were significantly lower in the Pegmolesatide group compared with the rHuEPO control group.
Professor Cai Guangyan, the Chairman of the Conference, and a Professor from Beijing 301 Hospital, stated that: "As a Chinese original innovative drug, Pegmolesatide has filled the gap of once-monthly agents under the new category of ESAs in both China and the world. We are pleased to see the encouraging results of Pegmolesatide in the treatment of CKD renal anemia. It brings a new choice to effectively improve the clinical treatment ability and enhance the current treatment situation for patients.”
Forge ahead and ascend the peak. As a leading innovation-driven pharmaceutical company in China, Hansoh Pharma always adheres to scientific innovation, and closely cooperates with experts, scholars, and various sectors of society to accelerate the transformation and clinical application of innovative research results. The company is committed to continuously launching accessible, affordable, and high-quality innovative medicines, and helping patients unlock more possibilities in life.
