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Hutchmed Begins Registration Stage for Phase 2/3 Trial of Investigational Autoimmune Disorder Drug
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Hutchmed Begins Registration Stage for Phase 2/3 Trial of Investigational Autoimmune Disorder Drug
Mar 22, 2024 2:31 AM

05:04 AM EDT, 03/22/2024 (MT Newswires) -- Hutchmed ( HCM ) said late Thursday it has started the registration stage for a phase 2/3 clinical trial of investigational drug sovleplenib for adult patients with warm antibody autoimmune hemolytic anemia in China.

The move follows "positive data" from the proof-of-concept phase 2 stage of the trial and a consultation with the China National Medical Products Administration, and the first phase 3 patient received an initial dose on Wednesday, the company said.

If positive, the data from the trial may be used to support a future new drug application filing.

Antibody autoimmune hemolytic anemia is an autoimmune disorder characterized by red blood cell destruction.

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