Hansoh Pharma's Shenglailai® (Pegmolesatide) Included in China's National Reimbursement Drug List, Ushering in a New Era of Long-Acting Management for CKD-Related Anemia

Shanghai, December 13, 2023 /PR Newswire/ -- 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"). Two indications of Hansoh Pharma's self-developed Class 1 innovative drug, Shengluolai® (Pemostim Injection), have been successfully included in the medical insurance, 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 the People

Saint Loreal^®Developed independently by Hansoh Pharma, it is the "world's only approved EPO mimetic peptide." In June 2023, it was approved for marketing by the National Medical Products Administration (NMPA) for the treatment of anemia caused by chronic kidney disease (CKD). This includes adult non-dialysis patients who have not received erythropoiesis-stimulating agent (ESA) therapy and adult dialysis patients currently receiving short-acting erythropoietin (EPO) therapy (this product is not suitable as a substitute for red blood cell transfusion in patients requiring immediate correction of anemia). Saint Laurent^®Is the 7th innovative drug approved for marketing by Hansoh Pharma, and also the first innovative drug of Hansoh Pharma to be simultaneously approved for two indications.

The inclusion of Saint Laurent® in the new national medical insurance directory 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 rate of CKD in Chinese adults is 10.8%, of which more than 50% are complicated with anemia.^[1]; and as CKD progresses, the prevalence of renal anemia increases, with an overall anemia prevalence of 28.5%-72.0% in non-dialysis CKD patients, while the prevalence of anemia in dialysis patients 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 crucial in the treatment of renal anemia.^[2]Currently, the treatment of renal anemia in China is still dominated by short-acting recombinant human EPO. Despite its significant efficacy, clinical challenges such as low target achievement rates, hypo-responsiveness, and safety concerns remain. Moreover, the frequent injections required for short-acting ESAs lead to poor patient compliance. In contrast, long-acting formulations have been widely adopted abroad, offering more effective improvements in renal anemia. As the world’s only approved EPO mimetic peptide, Pemodutide, modified with third-generation branched polyethylene glycol, significantly extends the 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). Additionally, its molecular structure lacks free lysine residues, preventing carbamylation and loss of erythropoietic function. With high affinity and specificity for the erythropoietin receptor, it promotes stable erythropoiesis while maintaining safety. A single subcutaneous injection every four weeks helps patients achieve stable target levels with good safety, filling the gap for monthly formulations in renal anemia treatment. This provides a new long-acting, stable, enduring, and safe option for patient care.

Lancet Authoritative Recognition Promotes Research in the Field of Renal Anemia

On October 28, the sub-journal of The Lancet, a top global medical journaleClinicalMedicine(IF:15.1), published online the Phase 1 innovative drug—Sinolure, independently developed by Hansoh Pharma, led by Professor Chen Jianghua from the First Affiliated Hospital of Zhejiang University.^®Phase III Clinical Study Paper of (Pegmocept Injection)^[3], fully demonstrating its efficacy and safety in the treatment of anemia in dialysis patients, and also proving that the quality of clinical research for China's domestically developed innovative drugs has reached an internationally advanced level. The publication of Pemodutide's clinical data in international journals has successfully pushed China's research achievements in the field of renal anemia treatment to the forefront of international medicine, which will help further promote research and exploration in this field within China and even globally.

Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China, with subsidiaries including Hansoh Pharmaceuticals, Changzhou Hengbang Pharmaceuticals, and Hansoh Biologics. It has consistently ranked among the top 100 global pharmaceutical enterprises for many years and within the top three best industrial enterprises in China's pharmaceutical R&D product lines. Hansoh Pharma focuses on major therapeutic areas such as oncology, anti-infectives, central nervous system, metabolism, and autoimmune diseases, committed to improving human life quality 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). According to the 2023 interim report, revenue from innovative drugs accounted for 61.8% of its total revenue, making innovative drugs the core driver of the company’s performance growth.

References:

^[1] Expert Consensus 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, Volume 34, Issue 11;

^[2] Renal Anemia Guideline 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]. Chinese Medical Journal, 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