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China’s NMPA Accepts NDA for Akeso’s Gumokimab to Treat Moderate to Severe Psoriasis

Shots:

  • China’s NMPA has accepted an NDA for gumokimab (AK111) to treat mod. to sev. plaque psoriasis based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks.
  • Data showed short-term efficacy, with a PASI 75 response rate approaching 96% & an sPGA 0/1 response nearing 90%. PASI 90 hit ~80%, & PASI 100 reached >40%, with 80% patients achieving PASI 90 & ~50% achieving a PASI 100 response at 12wks.
  • Also, Gumokimab showed long-term efficacy for over 52wks. with PASI 75 response rate nearing to ~100% with stable sPGA 0/1 rates as well as PASI 90 & PASI 100 response rates improved to ~90% & ~65%, respectively. Safety was favorable

Ref: Prnewswire | Image: Akeso | Press Release

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