The Center for Drug Evaluation (CDE) website has announced that Shanghai Fosun Pharmaceutical (Group) Co., Ltd’s (SHA: 600196, HKG: 2196) novel small-molecule chemical drug FCN-159 has been granted breakthrough therapy designation (BTD) status for the treatment of histiocyte tumors.
FCN-159’s Mechanism and Impact
FCN-159 is a highly selective MEK1/2 inhibitor with a unique mechanism of action. It significantly inhibits the proliferation of tumor cells with Ras/RAF mutations by inhibiting the phosphorylation of MEK kinase, blocking the phosphorylation of ERK protein in cells, and halting the cell cycle in the G0/G1 phase while inducing apoptosis. This drug is under development for the treatment of advanced solid tumors, type I neurofibroma, and histiocyte tumors. In May of the previous year, it received approval for a Phase II study in histiocyte tumors in China.
Global MEK Inhibitor Landscape
Globally, MEK inhibitors that are available include Pfizer’s selumetinib and binimetinib, Exelixis’s cobimetinib, and Novartis’s trametinib, which was approved for marketing in China in 2019. The addition of FCN-159 to this list could provide an alternative treatment option for patients with histiocyte tumors, potentially improving outcomes and offering a more targeted approach to treatment.
Conclusion
The breakthrough therapy designation for FCN-159 by the CDE is a significant milestone for Fosun Pharmaceutical, highlighting the drug’s potential to offer a novel treatment for histiocyte tumors. This development positions FCN-159 as a promising candidate in the global MEK inhibitor market and underscores Fosun Pharmaceutical’s commitment to advancing targeted cancer therapies.-Fineline Info & Tech
