#product_announcement

Takeda Pharmaceutical announces that the U.S. FDA has accepted the new drug application for rusfertide, co-developed with Protagonist Therapeutics, and granted it priority review designation. The target date for review completion is Q3 2026.

Shionogi & Co., Ltd. has applied for manufacturing and marketing approval of the 0.5% lotion formulation of the atopic dermatitis treatment "Collectim®." Safety and bioequivalence were confirmed through Phase 1 skin safety and Phase 3 bioequivalence studies.

Takeda Pharmaceutical has announced that the FDA has accepted the new drug application for oveporexton, a treatment for narcolepsy type 1, and designated it for priority review. The target date for review completion is Q3 2026.

Subsidiary ExaMD submitted a clinical trial notification for the cognitive function AI diagnostic support app to PMDA and commenced clinical trials. Target number of cases is up to 100, with a 3-month subject enrollment period planned.

In the Phase 3 clinical trial of Zasositinib, the primary endpoints were achieved at week 16, with more than half of patients reaching PASI 90 and approximately 30% achieving PASI 100 indicating complete clearance of skin lesions. Safety profile was favorable.

Consolidated subsidiary Gyre Therapeutics has completed prior consultation with China's CDE and confirmed that NDA submission utilizing the conditional approval system for F351 is possible and qualifies for priority review. NDA submission is targeted for the first half of 2026.