Fosun Pharma's New Oral Drug for Vitiligo Gets Green Light for Phase III Trials

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Yesterday

Shanghai Fosun Pharmaceutical (Group) Co.,Ltd. has announced that its oral candidate FXS5626 tablets (formerly project code AC-201) have received clinical trial approval from the National Medical Products Administration to proceed with a seamless adaptive Phase II/III study targeting non-segmental vitiligo.

In the competitive landscape, Pfizer's ritlecitinib and InnoCare Pharma's soficitinib are leading the pack in the first tier, having already posted positive Phase II/III results. Fosun Pharma's FXS5626, along with Huadong Medicine's VC005 and Hengrui's amiselimib, are positioned roughly in the second tier of development.

Notably, FXS5626 stands out as the only candidate in China's oral vitiligo pipeline explicitly designated as a dual TYK2/JAK1 inhibitor target.

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