Milestones
Milestones
  • 2000
    Founded;
  • 2003
    Jitai® (Thymalfasin for Injection) approved and launched in China
  • 2004~2009
    Sales maintained  increasing by 50%;
  • 2010
    Acquired Hainan Weile Pharmaceuticals Co., Ltd;
  • 2012
    Initial public offering in 2012;
  • 2013
    Passed USFDA GMP inspection for peptide API facility;
  • 2014
    Establised holding subsidiary in Ningbo;
  • 2016
    Passed USFDA unannounced GMP inspection;
    Passed EMA on-site inspection for sterile drug product Thymalfasin FDA & API;
  • 2017
    Received Italian MA decree for Thymalfasin for Injecion;
    Passed the USFDA PAI for Bivalirudin API & FDF;
  • 2018
    Received USFDA tentative approval for Bivalirudin for Injection;
    Submitted quality consistency evaluation of Thymalfasin for Injection to NMPA;
  • 2019
    US FDA unannounced GMP inspection;
    Successfully challenged the patent of RLD of Bivalirudin for Injection and received US FDA final approval;
    Received US FDA approval for Pregabalin Capsule;
    Passed the US FDA PAI for memantine Hydrochloride Tablets
  • 2020
    Received US FDA MA approval for Memantine Hydrochloride Tablets;
    Exported Bivalirudin for Injection to US