On December 13, 2023, the National Health Insurance Administration and the Ministry of Human Resources and Social Security announced the National Drug Catalogue for Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance (2023), a Category 1 innovative drug independently developed by Hansoh PharmaceuticalSan Rolle (pemosatide injection).Two indications were successfully included in the medical insurance, opening a new chapter in the long-term management of renal anemia.
This new drug may be relatively unfamiliar to kidney friends, because it only took half a year from the listing to the medical insurance catalog, so what benefits can this new drug bring to kidney friends? Let's take a look!
1. The results of the phase III clinical study of pemosatide are authoritatively certified
eClinicalMedicine (IF: 151)**Released the results of a phase III clinical study of anemia in dialysis patients, a Class 1 innovative drug, pemoxatide**.
The study demonstrated that 1 monthly subcutaneous injection of pemosatide was as effective and safe as routine administration of epoetin alfa alpadin (i.e., recombinant human erythropoietin) 1 3 times a week as anaemia** in dialysis patients in China, and even showed a trend of superiority and a lower risk of adverse cardiovascular events.
Professor Jianghua Chen, principal investigator of the phase III 302 study of pemosatide and chairman of the 11th Chairman of the Nephrology Branch of the Chinese Medical Association, said
The results of the study of eClinicalMedicine, a sub-journal of the Lancet, fully confirmed that pemosatide has definite efficacy and good safety in anemia in ** CKD dialysis patients, and one injection a month can keep the hemoglobin stable and up to the standard, providing clinicians with a new option for **renal anemia, and it is hoped that more patients with renal anemia will be able to benefit from pemosatide ** in the future.
2. Mode of action and effect of pemosatide injection
According to studies, the incidence of renal anemia in the dialysis population is as high as 916%~98.2%, which can seriously affect the long-term prognosis and quality of life of kidney friends.
Pemosatide injection is a polypeptide erythropoietin receptor agonist, which is an artificially synthesized compound that can bind to and activate EPO (erythropoietin) receptors, which can promote the proliferation of erythroid directed group cells in the bone marrow, differentiate to morphologically recognizable precursor cells, accelerate the proliferation and differentiation of precursor cells, and promote the release of reticulocytes from the bone marrow and promote the synthesis of erythrocytes.
In terms of efficacy, the hemoglobin level of kidney friends remained stable and did not fluctuate significantly after switching from a short-acting formulation to a subcutaneous injection of pemosatide every 4 weeks.
For kidney patients, reducing the frequency of administration from three times a week to once a week can reduce the pain of subcutaneous injection.
3. Promote research in the field of renal anemia
At present, renal anemia in China is still dominated by short-acting recombinant human EPO, and although the efficacy is remarkable, there are still problems such as low compliance rate, low response and safety in clinical practice, and the need for frequent injection of short-acting ESA will lead to poor compliance of kidney friends.
Within half a year of its approval, Saint Lolai was quickly included in the new version of the National Medical Insurance Catalogue, bringing more efficient, safe, convenient, accessible and affordable innovative solutions for anemia kidney patients caused by chronic kidney disease (CKD) in China.
Fourth, the use of pemosatide injection
Non-dialysis kidney patients who have not received ESA **:
When the haemoglobin (Hb) level is less than 10g DL, start this product**. The initial dosing dose of this product is 004 mg kg, subcutaneously every 4 weeks.
Dialysis kidney patients who are receiving short-acting erythropoietin**:
After receiving the last dose of short-acting erythropoietin, the first dose of pemosatide should be given one week apart. Dialysis kidney patients who are currently receiving Luxeate** can switch to this product**, and the dose conversion table is as follows:
Pemosatide injection is the first domestic ESA stimulant, which timely fills the gap of a new generation of ESA preparations in China and even the world, and provides a new choice for the majority of kidney patients with renal anemia.
Love Kidney Network will always pay attention to the latest ** anemia drugs for kidney friends' reference.