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Research and development of innovative antibody-based drugs
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Bo-ning LIU, Jian-hui LUO*
Acta Pharmaceutica Sinica | 2017, 52(12) : 1811 - 1819
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Acta Pharmaceutica Sinica | 2017, 52(12): 1811-1819
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Research and development of innovative antibody-based drugs
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Bo-ning LIU, Jian-hui LUO*
Affiliations
  • Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China
Published: 2017-12-15 doi: 10.16438/j.0513-4870.2017-0973
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With the development of antibody manufacturing technology and improvement in new drug research and development (R&D) capabilities in domestic industry, more and more innovative antibody-based drugs were registered at the Investigational New Drug (IND). This type of drugs could be divided into three categories:new sequence antibodies (biobetter or new target antibodies), bispecific antibodies (or antibody cocktails), and antibody drug conjugates. Comparing with biosimilar antibodies, the innovative antibodies R&D was characterized by some significant features including "innovation", "clinical phase-appropriate" and "progressing". The minimum requirements of Chemical, Manufacturing and Control (CMC) content for innovative antibodies were obviously different from biosimilar antibodies. Here, the recent progress of antibody engineering and IND date of innovative antibodies in domestic are summarized. The general regulatory requirement and special considerations for representative innovative antibodies were proposed. Some common problems concerning innovative antibodies R&D are discussed.

innovative antibodies  /  antibody engineering  /  antibody-drug conjugates  /  bispecific antibodies  /  programmed cell death 1 receptor
Bo-ning LIU, Jian-hui LUO. Research and development of innovative antibody-based drugs[J]. Acta Pharmaceutica Sinica, 2017 , 52 (12) : 1811 -1819 . DOI: 10.16438/j.0513-4870.2017-0973
Year 2017 volume 52 Issue 12
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Article Info
doi: 10.16438/j.0513-4870.2017-0973
  • Receive Date:2017-09-28
  • Online Date:2026-01-14
  • Published:2017-12-15
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History
  • Received:2017-09-28
  • Revised:2017-11-14
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    Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China
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表12种不同金属材料的力学参数

Family
属数
Number of
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种数
Number of
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种数
Number of
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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