Hansoh Pharma's Class 1 New Drug Pegmolesatide Successfully Included in National Reimbursement Drug List as the World’s Only Approved EPO Mimetic Peptide

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On December 13, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security announced the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2023)" (hereinafter referred to as the "Medical Insurance Catalog"). Hansoh Pharma's self-developed Class 1 innovative drug, Serolait® (Pemodutide Injection), has successfully been included in the medical insurance for two indications, which is expected to open a new chapter in the long-term management of renal anemia.

Included in Medical Insurance within Six Months of Approval: Innovative Drugs Quickly Benefit People's Livelihood

HANSOH Pharma's自主研发的“全球唯一获批的EPO模拟肽”圣罗莱® (SRL-01) was approved for marketing by the National Medical Products Administration (NMPA) in June 2023. It is indicated for the treatment of anemia due to chronic kidney disease (CKD), including adult non-dialysis patients not receiving erythropoiesis-stimulating agent (ESA) therapy and adult dialysis patients receiving short-acting erythropoietin (EPO) therapy (this product is not suitable for replacing red blood cell transfusion in patients requiring immediate correction of anemia). 圣罗莱® is the seventh innovative drug approved for marketing by HANSOH Pharma and also its first innovative drug simultaneously approved for two indications.

The inclusion of Saint Laurent® in the new national medical insurance catalog within six months of its approval not only reflects the recognition and encouragement of the National Healthcare Security Administration for this innovative drug but also brings a more efficient, safe, convenient, accessible, and affordable innovative solution to patients in China suffering from anemia caused by chronic kidney disease (CKD). While improving patient survival benefits, it will significantly reduce the disease burden on CKD anemia patients and their families as well as society in China.

Chinese Original, Filling the Gap in Monthly Formulations for Renal Anemia Treatment

Renal anemia is one of the most common complications of CKD. Epidemiological data show that the prevalence of CKD among Chinese adults is 10.8%, with more than 50% of cases accompanied by anemia [1]. Moreover, as CKD progresses, the prevalence of renal anemia increases continuously. The overall prevalence of anemia in non-dialysis CKD patients ranges from 28.5% to 72.0%, while in dialysis patients, the prevalence of anemia is as high as 91.6%-98.2% [2]. Anemia not only affects the quality of life of patients with kidney disease but also promotes the progression of kidney disease, increasing the risk of end-stage renal disease, cardiovascular events, and mortality [2].

Insufficient production of erythropoietin (EPO) is one of the key reasons for renal anemia, and the use of erythropoiesis-stimulating agents (ESAs) is a critical treatment approach for renal anemia [2]. Currently, in China, short-acting recombinant human EPO remains the primary treatment for renal anemia. Despite its significant efficacy, clinical challenges such as low target achievement rates, hyporesponse, and safety concerns persist. Additionally, the need for frequent injections with short-acting ESAs often leads to poor patient compliance. In contrast, long-acting formulations have been widely adopted abroad, offering more effective improvement in renal anemia. As the world's only approved EPO mimetic peptide, Pemodutide, modified by third-generation branched polyethylene glycol, significantly extends its half-life and reduces immunogenicity. It shares no amino acid sequence homology with EPO, thus avoiding the induction of anti-EPO antibodies and the associated pure red cell aplasia (PRCA). Its molecular structure contains no free lysine residues, preventing carbamylation and loss of erythropoietic function. Moreover, it exhibits high affinity and specificity for the erythropoietin receptor, promoting stable erythropoiesis while maintaining safety. With just one subcutaneous injection every four weeks, it helps patients achieve stable target levels with good safety, filling the gap for monthly formulations in renal anemia treatment. This provides patients with a new, long-acting, stable, enduring, and safe treatment option.

Lancet Authoritative Recognition Promotes Research in the Field of Renal Anemia

On October 28, eClinicalMedicine (IF: 15.1), a subsidiary journal of the world's top medical journal The Lancet, published online the Phase III clinical research paper [3] of Hansoh Pharma's self-developed Class 1 innovative drug—Sunrolle® (Pemotecan Injection), led by Professor Chen Jianghua from the First Affiliated Hospital of Zhejiang University. This fully demonstrates its efficacy and safety in treating anemia in dialysis patients and also proves that the quality of clinical research for China-developed innovative drugs has reached an internationally advanced level. The publication of Pemotecan’s clinical data in international journals successfully promotes China’s research achievements in the field of renal anemia treatment to the forefront of international medicine, helping to further advance research in this field within China and even globally.

Hansoh Pharma is a leading innovation-driven pharmaceutical company in China, with subsidiaries including Hansoh Pharmaceuticals, Changzhou Hengbang Pharmaceuticals, and Hansoh Biologics. It has consistently ranked among the top 100 global pharmaceutical enterprises and within the top three best industrial enterprises in China's pharmaceutical R&D product lines for many years. Hansoh Pharma focuses on major therapeutic areas such as oncology, anti-infectives, central nervous system, metabolism, and autoimmune diseases, striving to improve the quality of human life through continuous innovation. To date, Hansoh Pharma has launched seven innovative drugs, all of which have been included in the National Reimbursement Drug List (NRDL). The company’s 2023 interim report shows that revenue from innovative drugs has reached 61.8%, becoming the core driver of the company’s performance growth.

References:

[1] Expert Group on the Diagnosis and Treatment of Renal Anemia, Branch of Nephrology, Chinese Medical Association. Chinese Expert Consensus on the Diagnosis and Treatment of Renal Anemia (2018 Revised Edition). Chinese Journal of Nephrology, November 2018, Vol. 34, No. 11;

[2] Renal Anemia Guidelines Working Group of the Nephrology Physicians Branch of the Chinese Medical Doctor Association. Clinical Practice Guidelines for the Diagnosis and Treatment of Renal Anemia in China [J]. National Medical Journal of China, June 1, 2021, Vol. 101, No. 20.

[3]Ping Zhang,et al.Pegmolesatide for the treatment of anemia in patients undergoing dialysis:a randomized clinical trial.EClinicalMedicine.2023 Oct 28;65:102273