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Zelgen's gipacasinib succeeds in phase III ankylosing spondylitis trial

October 20, 2025 at 08:39 AM UTCBy FilingReader AI

Suzhou Zelgen Biopharmaceuticals announced that its self-developed Class 1 new drug, gipacasinib hydrochloride tablets, achieved its primary efficacy endpoint in a phase III clinical trial for the treatment of active ankylosing spondylitis. The trial demonstrated statistically significant results (p<0.0001) for the 100mg Bid dose group compared to placebo, showing good safety and tolerability.

This positive outcome will accelerate the market launch process for gipacasinib hydrochloride tablets in this indication. The company will now proceed with communications with the CDE, submit a new drug application, and undergo technical review and on-site inspections.

Gipacasinib hydrochloride, an innovative JAK and ACVR1 dual inhibitor, is also approved for myelofibrosis and has an NDA pending for severe alopecia areata. Investors are advised to exercise caution due to the long development cycles and inherent risks in pharmaceutical product development.

This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com

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