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Innovative drug R&D in China

Nature Reviews Drug Discovery volume 10, pages 333–334 (2011)Cite this article

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However, information on the output of innovative drug R&D in China is limited. With the aim of addressing this issue, we have collected and analysed information from the Chinese State Food and Drug Administration (SFDA) and the Center for Drug Evaluation of the SFDA (CDE) for all novel pharmaceuticals for which new drug applications (NDAs) and investigational new drug applications (INDs) were approved in China between 2003 and 2010. The novel pharmaceuticals discussed in this article only include chemical drugs in classes 1.1 and 1.2 and biological drugs in class 1, which are defined by the SFDA as not being previously approved for marketing as a drug anywhere else in the world. Thus, the scope of novel drugs in this article is narrower than that of the new chemical entities (NCEs) used by the US Food and Drug Administration (FDA). For example, if a drug was first approved by the FDA or the European Medicines Agency, it would not be qualified as a class 1 new drug by the SFDA when its approval is later sought in China. Multinational pharmaceutical companies usually market their drugs in developed countries first, and in our survey, all the innovative drugs approved as class 1 by the SFDA are from domestic Chinese pharmaceutical companies. Consequently, the class 1 approvals by the SFDA reflect the status of innovative drug development solely in domestic Chinese pharmaceutical companies. Additionally, traditional Chinese medicine and vaccines are not discussed here.

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Figure 1: Annual number of approved INDs and NDAs for innovative drugs from Chinese companies.
Figure 2: Characteristics of novel investigational drugs in China.

References

  1. IMS Intelligence Applied. IMS Health forecasts global pharmaceutical market growth of 5-7 percent in 2011, reaching $880 billion. IMS website [online], (2010).

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Authors and Affiliations

  1. Jingzong Qi and Xin Chen are at FusoGen Pharmaceuticals, 19F-A, Ping An Building B, 59 Machang Road, Hexi District, Tianjin 300203, China.,

    Jingzong Qi & Xin Chen

  2. Qingli Wang is at the Center for Drug Evaluation, State Food and Drug Administration, Beijing 100038, China.,

    Qingli Wang

  3. Zhenhang Yu is at the China National Center for Biotechnology Development, Beijing 100039, China.,

    Zhenhang Yu

  4. Fengshan Wang is at the Institute of Biochemical and Biotechnological Drugs, School of Pharmaceutical Sciences, Shandong University, Jinan 250012, Shandong, China.,

    Fengshan Wang

Authors
  1. Jingzong Qi
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  2. Qingli Wang
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  3. Zhenhang Yu
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  4. Xin Chen
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  5. Fengshan Wang
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Corresponding author

Correspondence to Fengshan Wang.

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Qi, J., Wang, Q., Yu, Z. et al. Innovative drug R&D in China. Nat Rev Drug Discov 10, 333–334 (2011). https://doi.org/10.1038/nrd3435

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