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Article History

Received: 3 April 2025

Accepted: 10 September 2025

First Online: 23 October 2025

Declarations

:

: All the authors are investigators of the phase 3 trial and report research funding and study drugs from Ignis Therapeutics as the trial sponsor. The authors declare no other conflict of interest.

: Not applicable.

: The protocol and subsequent amendments were approved before the start of the study by the institutional review board or independent ethics committee at each site that participated. The study was performed in accordance with the Declaration of Helsinki and Good Clinical Practice (2020) guidelines published by the China National Medical Products Administration.

: All study participants provided written informed consent at screening, before any study-related procedures or assessments were performed.

: The data underlying this article are not publicly available but may be shared on reasonable request to the corresponding author.

: L.L., M.W.F., C.H.R., C.R., Z.S.Q., Z.N.F., P.J.Y., and W.X.Y. conceived and designed the study. All the authors conducted the study. M.W.F., M.Z.L., Z.W., C.T., T.S.Y., and Z.W.H. analyzed and interpreted the data. L.Y.H., Z.X.Q., Y.H., T.M.Q., W.Z., and W.C.X. verified the data. C.H.R., D.L.Y., and M.W.F. drafted the manuscript with the assistance provided by Indegene Limited. All the authors reviewed and revised the manuscript, approved the final submitted version, and agreed to be accountable for the work.