[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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