Magacaabista Dawooyinka Agoonta ee Cusub ee loogu talagalay Daawaynta Lymphoma Follicular

January 21, 2022
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CASI Pharmaceuticals, Inc., oo ah shirkad Maraykan ah oo biopharmaceutical ah oo diiradda saarey horumarinta iyo ganacsiga dawooyinka cusub ee dawooyinka iyo dawooyinka, ayaa maanta ku dhawaaqday, in Maamulka Cuntada iyo Dawooyinka ee Maraykanka (FDA) ay siisay Magaca Agoonta ee Daroogada (ODD) lammaanaheeda BioInvent International AB, BI-1206, antibody-ka-hortagga FcyRllB ee baadhista, ee daawaynta lymfoma follicular (FL), nooca ugu caansan ee lymphoma Non-Hodgkin (NHL).

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BI-1206 waa musharraxa dawada hogaanka ah ee BioInvent waxaana hadda lagu baarayaa laba tijaabo oo waji 1/2 ah. Mid ayaa qiimeynaysa isku-dhafka BI-1206 ee leh rituximab ee daawaynta Non-Hodgkin lymfoma, oo ay ku jiraan bukaanada qaba FL, MCL iyo lymphoma aagga marginal (MZL) kuwaas oo dib u soo noqday ama ka soo horjeeda rituximab. Tijaabada Wajiga labaad ee 1/2 ayaa baaraya BI-1206 marka lagu daro daawaynta ka hortagga PD1 Keytruda® (pembrolizumab) ee burooyinka adag.

Dr. Wei-Wu He, Guddoomiyaha CASI, iyo maamulaha guud ayaa faallo ka bixiyay, "BioInvent waxay sii waddaa inay horumar ka samayso qaabka horumarinta iyo sharciyeynta BI-1206. Oggolaanshaha CTA ee Shiinaha Diseembar 2021 iyo Naqshadeynta Dawooyinka Agoonta ee FDA ee dhowaan waxay muujineysaa awoodda xoogga leh ee ka hortagga heerka koowaad. CASI waxay leedahay xuquuqaha ganacsi ee Shiinaha ee BI-1026, kooxdeenu waxay isu diyaarinaysaa daraasadda caafimaad ee Shiinaha. CASI iyo BioInvent waa shuraakooyin aan kala go 'lahayn waxayna leeyihiin hadaf guud si ay uga faa'iidaystaan ​​bukaanada leh tignoolajiyada cusub ee dawooyinka."

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Tifaftiraha madaxa eTurboNew waa Linda Hohnholz. Waxay ku salaysan tahay eTN HQ ee Honolulu, Hawaii.

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