Biosimilar
[INQ. NO. 2310C23] CKD Nesbell is the world’s first biosimilar of NESP.
This product is an Erythropoiesis-Stimulating Agent(ESA) used to treat anemia in patients with chronic kidney failure and those undergoing chemical cancer treatments.
Non-clinical and clinical studies have confirmed the similarity and comparability of PK, safety and efficacy to the original darbepoetin alfa.
Compared to the first-generation Epoetin, Nesbell, a second-generation continuous ESA formulation, boasts a longer action time and higher activity. Its extended half-life has increased the administration frequency from 2-3 times a week to just once every one to four weeks, enhancing the convenience for patients.
This advancement not only extends the dosing frequency but also consistently reduces the weekly dosing amount for improving anemia symptoms. Over a 20-week study period, the weekly dosage of Darbepoetin alfa required to maintain a consistent Hb concentration decreased by an average of 25%.
For patients previously prescribed a high dose of first-generation Epoetin, the weekly dosage reduced by an average of 37%. These signifi cant clinical benefi ts, including
decreased Hb variability, reduced dosage change frequency, and decreased ESA resistance index, were observed.
Successfully acquiring a formulation patent in nine countries, including the USA and Europe in 2014, the export of Nesbell is continuously expanding, reaching Korea, Japan, Southeast Asia, and the Middle East, demonstrating its global impact.
Chong Kun Dang Pharmaceutical Corp. a leading pharmaceutical company in South Korea, oversees the entire manufacturing process from API development to the creation of refi ned finished product.
With a history spanning over 80 years, Chong Kun Dang consistently develops superior pharmaceuticals, contributing to human health and the realization of a welfare society.
The company’s continuous efforts in global new drug development, including the Nesbell Prefilled Syringe, affirm its commitment to presenting a better life to patients worldwide, offering over 300 products targeting various ailments.
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