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The study showed that orelabrutinib was safe and well tolerated in participants with SLE.
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This is the first NDA acceptance for BTK inhibitor orelabrutinib in autoimmune diseases. No BTK inhibitors have been approved in China for ITP.
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Orelabrutinib (HIBRUKA®) has been approved by TGA in Australia, offering a new treatment option for patients with R/R MCL in the region.
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InnoCare announced key clinical development progress, including the completion of patient enrollment of multiple Phase III registrational trials.
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Orelabrutinib demonstrated outstanding efficacy and well-tolerated safety profile in patients with SLE who had received 48 weeks of treatment.
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Orelabrutinib has demonstrated remarkable efficacy and safety in multiple lymphoma studies, including MZL, MCL, CLL/SLL, PCNSL and DLBCL.
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InnoCare's HIBRUKA (orelabrutinib) has been approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with R/R MZL.