New Orphan Drug Designation for Chithandizo cha Follicular Lymphoma

January 21, 2022
by mkonzi
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Written by mkonzi

CASI Pharmaceuticals, Inc., kampani yaku US biopharmaceutical yomwe imayang'ana kwambiri kupanga ndi kugulitsa mankhwala opangira mankhwala ndi mankhwala, yalengeza lero kuti US Food and Drug Administration (FDA) yapereka Orphan Drug Designation (ODD) kwa mnzake BioInvent International AB, chifukwa BI-1206, anti-FcyRllB antibody, yochizira follicular lymphoma (FL), yofala kwambiri ya Non-Hodgkin lymphoma (NHL) yomwe ikukula pang'onopang'ono.

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BI-1206 ndiye wotsogolera mankhwala osokoneza bongo a BioInvent ndipo pano akufufuzidwa m'mayesero awiri a Gawo 1/2. Mmodzi akuwunika BI-1206 kuphatikiza ndi rituximab pochiza Non-Hodgkin lymphoma, yomwe imaphatikizapo odwala FL, MCL ndi marginal zone lymphoma (MZL) omwe ayambiranso kapena akukana rituximab. Kuyesa kwachiwiri kwa Gawo 1/2 ndikufufuza BI-1206 kuphatikiza ndi anti-PD1 therapy Keytruda® (pembrolizumab) mu zotupa zolimba.

Dr. Wei-Wu He, Wapampando wa CASI, ndi CEO adati, "BioInvent ikupitabe patsogolo ndi chitukuko ndi ndondomeko yoyendetsera BI-1206. Chivomerezo cha CTA ku China mu Disembala 2021 komanso mawonekedwe aposachedwa a FDA Orphan Drug Designation akuwonetsa kuthekera kwamphamvu kwa anti-gulu loyambali. CASI ili ndi ufulu wamalonda waku China wa BI-1026, ndipo gulu lathu likukonzekera kafukufuku wakuchipatala waku China. CASI ndi BioInvent ndi othandizana nawo opanda msoko ndipo ali ndi cholinga chimodzi chothandizira odwala omwe ali ndi umisiri wamakono wamankhwala. "

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mkonzi

Mkonzi wamkulu wa eTurboNew ndi Linda Hohnholz. Amakhala ku eTN HQ ku Honolulu, Hawaii.

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