November 18, 2014 I Chong Kun Dang Pharmaceutical Corp.(CKD Pharm), one of leading company in Korea and developing Darbepoetin-alfa biosimilar products, announced that Phase I trials was successfully completed and will initiate phase III trial in end of 2014.
In its Phase I Pharmacokinetics study of CKD-11101 and NESP after SC and IV Administration in Health Male Volunteers, CKD-11101 was showed a comparable PK, PD, and tolerability profile to that of NESP® (Darbepoetin alfa) and there were no issues of Adverse Events after administration of CKD-11101.
Darbepoetin alfa is 2nd generation of erythropoietin. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.
Two original brands of Darbepoetin alfa, Amgen’s Aranesp® and Kyowa Hakko Kirin’s Nesp® are currently marketed. Aranesp and Nesp had 2013 sales of US $2.4 billion making it not surprising that biosimilar developers have targeted the drug.
The patents on Aranesp are set to expire in Europe in 2016, in the US in 2024 and Nesp(Amgen & KIRIN) are set to expire in the Japan in 2019.
CKD Pharm is planning to start Phase III clinical study in end of 2014 and expect to submit NDA for Korea approval in 2018.
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Chong Kun Dang Pharmaceutical Corp.(CKD) has been one of the leading Korean pharmaceutical companies since 1941, and our sales turnover achieved over $462 M in 2013. We’re growing as a fully integrated company with operating R&D, manufacture, distribution and marketing by our own organization and human resource. In R&D, CKD has been developing innovative NCE, IMD, and biologic products. We’re operating above 20 projects for chemical, biologic, IMD compounds and platform technology. Our pipelines are being developed on major therapeutic areas such as endocrinology, metabolic disease, cardiovascular disease and cancer. CKD was the first company to establish a Research Institute in 1972 among Korean pharmaceutical companies. Through continuous research, CKD had launched two new drugs in Korea market by in house development; Camtobell® in 2004 (anticancer drug) and Duvie in 2014 (anti-diabetic drug).
For more information, please contact us at leebj@ckdpharm.com
SOURCE: Chong Kun Dang Pharmaceutical Corp
Post Views: 44
November 18, 2014 I Chong Kun Dang Pharmaceutical Corp.(CKD Pharm), one of leading company in Korea and developing Darbepoetin-alfa biosimilar products, announced that Phase I trials was successfully completed and will initiate phase III trial in end of 2014.
In its Phase I Pharmacokinetics study of CKD-11101 and NESP after SC and IV Administration in Health Male Volunteers, CKD-11101 was showed a comparable PK, PD, and tolerability profile to that of NESP® (Darbepoetin alfa) and there were no issues of Adverse Events after administration of CKD-11101.
Darbepoetin alfa is 2nd generation of erythropoietin. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.
Two original brands of Darbepoetin alfa, Amgen’s Aranesp® and Kyowa Hakko Kirin’s Nesp® are currently marketed. Aranesp and Nesp had 2013 sales of US $2.4 billion making it not surprising that biosimilar developers have targeted the drug.
The patents on Aranesp are set to expire in Europe in 2016, in the US in 2024 and Nesp(Amgen & KIRIN) are set to expire in the Japan in 2019.
CKD Pharm is planning to start Phase III clinical study in end of 2014 and expect to submit NDA for Korea approval in 2018.
*******************************************************************
Chong Kun Dang Pharmaceutical Corp.(CKD) has been one of the leading Korean pharmaceutical companies since 1941, and our sales turnover achieved over $462 M in 2013. We’re growing as a fully integrated company with operating R&D, manufacture, distribution and marketing by our own organization and human resource. In R&D, CKD has been developing innovative NCE, IMD, and biologic products. We’re operating above 20 projects for chemical, biologic, IMD compounds and platform technology. Our pipelines are being developed on major therapeutic areas such as endocrinology, metabolic disease, cardiovascular disease and cancer. CKD was the first company to establish a Research Institute in 1972 among Korean pharmaceutical companies. Through continuous research, CKD had launched two new drugs in Korea market by in house development; Camtobell® in 2004 (anticancer drug) and Duvie in 2014 (anti-diabetic drug).
For more information, please contact us at leebj@ckdpharm.com
SOURCE: Chong Kun Dang Pharmaceutical Corp
Post Views: 44
