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Current CMC challenges in oligonucleotide API development: from IND to NDA.

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Title: Current CMC challenges in oligonucleotide API development: from IND to NDA.
Authors: Chen D; Chemical Pharmaceutical Research Center, Changchun GeneScience Pharmaceutical Co., Ltd, Shanghai, 200120, P.R. China. chendaoqian0203@gmail.com., Zhang X; Chemical Pharmaceutical Research Center, Changchun GeneScience Pharmaceutical Co., Ltd, Shanghai, 200120, P.R. China. zhangxiaobing@genscigroup.com., Xu S; Chemical Pharmaceutical Research Center, Changchun GeneScience Pharmaceutical Co., Ltd, Shanghai, 200120, P.R. China., Liu D; Chemical Pharmaceutical Research Center, Changchun GeneScience Pharmaceutical Co., Ltd, Shanghai, 200120, P.R. China.
Source: Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents [Med Chem Res] 2026 Apr; Vol. 35 (4), pp. 711-725. Date of Electronic Publication: 2026 Apr 25.
Publication Type: Journal Article; Review
Journal Info: Publisher: Springer Country of Publication: United States NLM ID: 9211347 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1554-8120 (Electronic) Linking ISSN: 10542523 NLM ISO Abbreviation: Med Chem Res Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Current CMC challenges in oligonucleotide API development: from IND to NDA.
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  Data: <searchLink fieldCode="AU" term="%22Chen+D%22">Chen D</searchLink>; Chemical Pharmaceutical Research Center, Changchun GeneScience Pharmaceutical Co., Ltd, Shanghai, 200120, P.R. China. chendaoqian0203@gmail.com.<br /><searchLink fieldCode="AU" term="%22Zhang+X%22">Zhang X</searchLink>; Chemical Pharmaceutical Research Center, Changchun GeneScience Pharmaceutical Co., Ltd, Shanghai, 200120, P.R. China. zhangxiaobing@genscigroup.com.<br /><searchLink fieldCode="AU" term="%22Xu+S%22">Xu S</searchLink>; Chemical Pharmaceutical Research Center, Changchun GeneScience Pharmaceutical Co., Ltd, Shanghai, 200120, P.R. China.<br /><searchLink fieldCode="AU" term="%22Liu+D%22">Liu D</searchLink>; Chemical Pharmaceutical Research Center, Changchun GeneScience Pharmaceutical Co., Ltd, Shanghai, 200120, P.R. China.
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  Data: <searchLink fieldCode="JN" term="%229211347%22">Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents</searchLink> [Med Chem Res] 2026 Apr; Vol. 35 (4), pp. 711-725. <i>Date of Electronic Publication: </i>2026 Apr 25.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Springer%22">Springer </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>9211347 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1554-8120 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2210542523%22">10542523 </searchLink><i>NLM ISO Abbreviation: </i>Med Chem Res <i>Subsets: </i>MEDLINE
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        Value: 10.1007/s00044-026-03569-8
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      – Code: eng
        Text: English
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      – TitleFull: Current CMC challenges in oligonucleotide API development: from IND to NDA.
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            NameFull: Chen D
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            NameFull: Zhang X
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            NameFull: Xu S
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              M: 04
              Text: 2026 Apr
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              Y: 2026
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            – TitleFull: Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents
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