• Clinical Development
  • Translational Medicine Research Center
  • Pipeline
  • Products
  • We focus on immuno-oncology and precision medicine with a well-balanced oncology portfolio of 15 innovative assets. CStone has received three NDA approvals. Among them, GAVRETO® (pralsetinib) and AYVAKIT® (avapritinib) have been approved by the National Medical Products Administration (NMPA) of China, and AYVAKIT® has been approved by the Taiwan Food and Drug Administration.

    • Ivosidenib (CS3010)
      A first-in-class, orally available, selective and potent IDH1m inhibitor
    • >>> Asset overview :

      Approved by the U.S. FDA in July 2018 for the treatment of R/R IDH1m AML
      Licensed from Agios Pharmaceuticals in 2018

      Approved by the U.S. FDA in May 2019 for the treatment of newly diagnosed AML patients with an IDH1 mutation who are ineligible for intensive chemotherapy

    • CS1001
      A fully human, full-length IgG4 monoclonal antibody against programmed death-ligand 1 (PD-L1)
    • >>> Asset overview :

      In Phase Ia study, CS1001 was well tolerated and demonstrated promising anti-tumor activities and PRs in several tumor types (data presented in ESMO 2018)

      In Phase Ib study, CS1001 demonstrated promising safety and efficacy in ESCC and GC/GEJ cancer as combo with chemotherapy; in CC/GBC and MSI-H/dMMR tumors as monotherapy (data presented at CSCO and ESMO 2019)

    • Fisogatinib (CS3008)
      A potentially first-in-class, orally available, potent, selective and irreversible inhibitor of FGFR4
    • >>> Asset overview :

      U.S. FDA designations: Orphan Drug
      Licensed in from Blueprint Medicines in 2018

    • CS1002
      A fully-human monoclonal antibody against cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
    • >>> Asset overview :

      A biosimilar of ipilimumab (Yervoy) ; In Phase Ia study, CS1002 monotherapy was well tolerated up to 10 mg/kg Q3W, and the overall clinical profile was consistent with that of ipilimumab (data presented at CSCO 2019)

    • CS1003
      A humanized IgG4 monoclonal antibody against programmed death receptor 1 (PD-1)
    • >>> Asset overview :

      A humanized IgG4 anti-PD-1 mAb that is cross-reactive to both human and mouse PD-1

      A Phase I bridging trial in China showed that CS1003 monotherapy was safe and tolerable at 60 mg and 200 mg Q3W, and preliminary anti-tumor activity of CS1003 was observed in multiple tumor types (data presented at CSCO 2019)

    • CS3006
      A highly selective MEK inhibitor
    • >>> Asset overview :

      An orally available, small molecule inhibitor of mitogen-activated extracellular signal regulated kinases 1 and 2 (MEK1 and MKE2)

    • CS3002
      A small molecule inhibitor targeting cyclin-dependent kinase 4 and 6 (CDK4/6)
    • >>> Asset overview :

      CDK4/6 inhibitors prevent G1-S phase cell cycle transition and induce cell cycle arrest of tumor cells. Small molecule inhibitors of CDK4/6 have become a standard treatment for certain solid tumors.

    • CS3003
      A small molecule inhibitor selectively targeting histone deacetylases 6 (HDAC6)
    • >>> Asset overview :

      Selective inhibition of HDAC6 may lead to better efficacy in multiple myeloma with an improved safety profile

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