Recently, the Chinese Journal of Nephrologyreleased the “Chinese Expert Consensus on Long-Acting Erythropoiesis-Stimulating Agents in the Treatment of Renal Anemia (2024)”[1](the “Consensus”), in whichHansoh Pharma’s pegmolesatide (trade name: Saint Luolai )was recommended in the Consensus for the first time.
According to the Consensus, long-acting agents in the treatment of renal anemia are commonly used in international markets, such as America, European countries and Japan, yet short-acting rHuEPOs are still a mainstay in China. Compared with short-acting rHuEPOs, long-acting agents that can effectively reduce the frequency of injections, relieve the workload of healthcare professionals, and enhance patient compliance, have become a significant direction in improving the treatment of renal anemia.
This Consensus recommends the clinical use of long-acting ESAs for the treatment of renal anemia in non-dialysis and dialysis-dependent CKD patients (with 1A evidence). This will further promote the clinical application of long-acting ESAs and improve the standard of renal anemia management in China.
The Consensus also suggests that attention be paid to safety monitoring during treatment with long-acting drugs, and it also points out that pegmolesatide does not have immune cross-reactivity with endogenous EPO due to lack of homology in the amino acid sequence of endogenous EPO, thus enabling greater protection against anti-EPO antibody-mediated pure red cell anemia (PRCA).
Independently developed by Hansoh Pharma, pegmolesatide is the only marketed EPO mimetic peptide worldwide. It was approved by the NMPA in June 2023, and included in the 2023 National Reimbursement Drug List (NRDL), opening a new chapter in the long-term effective management of renal anemia in Chinese patients with CKD. Unlike other long-acting drugs, the phase III clinical trial data on pegmolesatides is based on Chinese populations and has shown definite efficacy in both dialysis patients and non-dialysis CKD patients with anemia, thus providing better guidance for medication in Chinese patients with renal anemia.
In October 2023, eClinicalMedicine(IF:15.1), the electronic journal from the world's top medical journalThe Lancet, released a paper on the phase III clinical trial of pegmolesatide. The results of this randomized, open-label, active-comparator, non-inferiority phase III study on anemic patients undergoing dialysis and short-acting rHuEPO treatment showed that monthly subcutaneous injection of pegmolesatide was as effective and safe as conventional short-acting rHuEPO administrated one to three times a week. Despite the fact that it is a non-inferiority study, inferiority for pegmolesatide was established in the primary efficacy endpoint (between-group variance 0.29g/dL, 95% CI: 0.11～0.47, p=0.0018)[2].
As China's independently-developed Class 1 innovative drug, pegmolesatide was included in the NRDL, and recommended by the Concensus as soon as it hit the market, benefiting renal anemia patients with its clinical accessibility and affordability. Hansoh Pharma will continue to focus on areas where the company boasts advantages, tap into unmet clinical needs, and launch more breakthrough innovative drugs to improve the quality of human life.
References:
[1] Expert Committee of Nephrology & Dialysis Branch of China Non-Government Medical Institutions Association. Chinese Expert Consensus on Long-Acting Erythropoiesis-Stimulating Agents in the Treatment of Renal Anemia (2024) [J]Chinese Journal of Nephrology,2024,40(2):146-157.
[2] Ping Zhang, et al. Pegmolesatide for the treatment of anemia in patients undergoing dialysis: a randomized clinical trial.eClinicalMedicine. 2023 Oct 28; 65:102273
Note: this article is intended as a reference material for healthcare professionals, and shall not be used as a basis for treatment or recommendations.
