I-New Orphan Drug Designation for Treatment of Follicular Lymphoma

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I-CASI Pharmaceuticals, Inc., inkampani yase-US biopharmaceutical egxile ekuthuthukiseni nasekuthengiseni imikhiqizo emisha yokwelapha kanye nemikhiqizo yemithi, imemezele namuhla, ukuthi i-US Food and Drug Administration (FDA) inikeze i-Orphan Drug Designation (ODD) kumlingani wayo i-BioInvent International AB, ukuze I-BI-1206, i-anti-FcyRllB antibody yophenyo, yokwelapha i-follicular lymphoma (FL), uhlobo oluvame kakhulu lwe-Non-Hodgkin lymphoma (NHL) ekhula kancane.

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I-BI-1206 iyikhandidethi lezidakamizwa elihamba phambili le-BioInvent futhi okwamanje isaphenywa ezivivinyweni ezimbili zeSigaba 1/2. Enye ihlola inhlanganisela ye-BI-1206 ne-rituximab yokwelapha i-Non-Hodgkin lymphoma, ehlanganisa iziguli ezine-FL, MCL kanye ne-marginal zone lymphoma (MZL) ezibuyele emuva noma eziphikisa i-rituximab. Uhlolo lweSigaba 1/2 sesibili luphenya i-BI-1206 ngokuhlanganiswe ne-anti-PD1 yokwelapha i-Keytruda® (pembrolizumab) kumathumba aqinile.

UDkt. Wei-Wu He, uSihlalo kanye ne-CEO ye-CASI ubeke amazwana, “I-BioInvent isaqhubeka nokuthuthuka ngohlaka lokuthuthukiswa nokulawula lwe-BI-1206. Ukugunyazwa kwe-CTA e-China ngoDisemba 2021 kanye ne-FDA Orphan Drug Designation yakamuva ibonisa amandla aqinile aleli qembu lokuqala le-antibody. I-CASI inamalungelo okuhweba ase-China e-BI-1026, futhi ithimba lethu lilungiselela ucwaningo lwase-China lomtholampilo. I-CASI kanye ne-BioInvent bangozakwethu abangenazihibe futhi banomgomo ofanayo wokusiza iziguli ngobuchwepheshe obusha bokwenza imithi.”

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