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Korea’s CJ Healthcare shares biosimilar technology with China Posted 06/04/2018

South Korea’s CJ HealthCare, announced that it has signed a contract with China’s NCPC GeneTech Biotechnology on 31 January 2018 to export CJ-40001, a biosimilar version of darbepoetin alfa which is used for the treatment of renal anaemia. South Korea has well-established guidelines for biosimilars [1], whilst China has finalized the technical guidance for the development and evaluation of copy biologicals in February 2015 [2].

The contract states that CJ HealthCare will transfer its technology that facilitates the production of second-generation [3] erythropoietin (EPO) biosimilar CJ-40001, to NCPC GeneTech Biotechnology. In return, CJ HealthCare will receive annual sales royalties and licensing fees. With this technology transfer agreement, NCPC GeneTech Biotechnology, a subsidiary of the North China Pharmaceutical Company (NCPC), will become the only company entitled to conduct clinical trials regarding CJ-40001 and produce and sell the biosimilar in China. Based on this, NCPC is expected to soon account for a third of the second-generation EPO Chinese market.

Another South Korean biotechnology company, Celltrion, has already made advances to its biosimilar rituximab and trastuzumab programmes in China and Japan, respectively [4]. The China Food and Drug Administration (CFDA) approved the start of clinical trials for Celltrion’s rituximab biosimilar, making it the first foreign company to initiate clinical trials of an antibody biosimilar in China.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Regulations for biosimilars in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 6]. Available from: www.gabionline.net/Guidelines/Regulations-for-biosimilars-in-South-Korea
2. GaBI Online - Generics and Biosimilars Initiative. Chinese guidelines for copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 6]. Available from: www.gabionline.net/Guidelines/Chinese-guidelines-for-copy-biologicals 
3. GaBI Online - Generics and Biosimilars Initiative. Glossary of key terms [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 6]. Available from: www.gabionline.net/Biosimilars/General/Glossary-of-key-terms
4. GaBI Online - Generics and Biosimilars Initiative. Celltrion making progress with biosimilars in China and Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 6]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-making-progress-with-biosimilars-in-China-and-Japan

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