On December 13, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security of the People’s Republic of China jointly released the “National Medicines Catalogue for Basic Medical Insurance, Work Injury Insurance and Maternity Insurance (2023)” (hereinafter referred to as the “National Reimbursement Drug List”), Pegmolesatide Injection (brand name: Saint Luolai 圣罗莱), Hansoh Pharma’s Category 1 innovative drug researched and developed by the Group, is first included in the updated NRDL for its two indications approved this year: treating anemia in chronic kidney disease (CKD) for adult patients who have not received erythropoiesis-stimulating agents and not on dialysis; as well as those who are receiving short-acting erythropoietin treatment and on dialysis.
Another innovative drug of the Company, Tenofovir Amibufenamide Tablets (brand name: Hengmu 恒沐), also succeeded in renewal. The new version of the National Reimbursement Drug List (NRDL) will be enacted on January 1, 2024. As of today, all seven innovative drugs of Hansoh Pharma on the market have been included in NRDL.
The inclusion of Saint Luolai into the new version of NRDL within half a year of its marketing approval, on the one hand, reflects the recognition and endorsement of the National Healthcare Security Administration for this innovative drug; on the other hand, it also brings a more efficient, safe, convenient, accessible and affordable innovative solution for patients with anemia caused by chronic kidney disease (CKD) in China. It will improve the survival benefit of patients and significantly alleviate the burden of Chinese CKD patients with anemia as well as the burden of their families and the society at large.
Renal anemia is one of the most common complications of chronic kidney disease (CKD). Epidemiological data shows that the prevalence of CKD in Chinese adults is 10.8%, and more than 50% of cases are accompanied by anemia; furthermore, the occurrence of renal anemia increases with the progression of CKD, for which the morbidity rate ranges from 28.5%-72.0% in non-dialysis CKD patients, and up to 91.6%-98.2% in dialysis patients. Anemia not only affects the life quality of patients with renal diseases, but also contributes to the progression of renal diseases, and can increase the risk of end-stage renal diseases, cardiovascular events, and death.
One of the important factors causing renal anemia is inadequate erythropoietin (EPO) production, thus the use of erythropoiesis-stimulating agents (ESAs) has become key to renal anemia treatment. Currently, short-acting rhEPOs are still a mainstay in treating renal anemia in China. Although their efficacy may be remarkable, they can have issues such as a low compliance rate, low response, and safety. Moreover, short-acting ESAs require frequent injections, leading to poor patient compliance. Yet, long-acting formulations have been widely adopted in overseas markets, showing evidence of improved efficacy in renal anemia treatment.
Saint Luolai is the global unique EPO mimetic peptide, is modified by third-generation branched polyethylene glycol, with a significantly prolonged half-life and reduced immunogenicity; it has no similarity in amino acid sequences with EPO and does not induce anti-EPO antibodies, which may lead to anti-EPO antibody-mediated pure red cell aplasia (PRCA); without free lysine residues in its molecular structure, the drug does not undergo carbamylation, which means it does not affect erythropoiesis; it has high affinity and specificity for erythropoietin receptors, promoting sustained erythropoiesis while maintaining safety; administered through one subcutaneous injection every 4 weeks, the drug helps patients achieve the standard hemoglobin level stably and has a favorable safety, filling the gap that exists in monthly formulations for renal anemia treatment. It delivers a new treatment option that is effective, stable, long-lasting, and safe for patients.
As a pioneering innovation-driven pharmaceutical company in China, Hansoh Pharma will continue to focus on its advantageous fields, tap into the unmet needs of doctors and patients, strive to improve the accessibility and affordability of more high-quality, innovative drugs, and protect the health of the mankind.