Lub Tebchaws Cov Khoom Noj thiab Tshuaj Yeeb Tshuaj ntawm Tuam Tshoj Muab Tsho Chaw Muag Khoom BioMed FcRn Lub Hom Phiaj Antibody Bartolizumab Qhov Tsoo Tshuaj Txhaum!

Harbor BioMed nyuam qhuav tshaj tawm tias nws cov khoom lag luam txhim kho, bartolizumab (HBM9161), tsis ntev los no tau tso cai rau kev txhim kho kev txhim kho los ntawm Lub Chaw Saib Xyuas Tshuaj (CDE) ntawm National Medical Products Administration (NMPA).

Cov kev tsim nyog ntawm kev sib tsoo tshuaj kho mob yog tsim los nrawm txhim kho cov tshuaj tshiab rau cov kab mob loj uas tau pom tias nws zoo dua li kev kho mob uas twb muaj lawm hais txog kev ua tau zoo lossis kev nyab xeeb hauv kev sim ua ntej. Tau txais kev tsim cov tshuaj tshiab uas tuaj yeem tuaj yeem ua rau cov tshuaj tau txais CDE tshuaj xyuas sai, thiab nws tuaj yeem sib txuas lus nrog CDE zoo thiab tau txais kev taw qhia, yog li ua kom nrawm tsim cov tshuaj tshiab thiab daws cov kev xav tau tsis txaus ntseeg ntawm cov neeg mob Suav ua ntej. Cov chaw lag luam kws tshuaj xws li Takeda thiab AstraZeneca kuj tau pom zoo nyob rau tib lub sijhawm.

Myasthenia gravis (MG) yog tus mob neuromuscular kho los ntawm cov kab mob IgG uas cuam tshuam loj heev rau lub neej zoo. Hauv Suav teb, muaj kwv yees li 250,000 tus neeg mob uas tau mob los ntawm myasthenia gravis. Cov kev kho mob niaj hnub tuaj yeem tswj tsis tau tus kab mob. Cov kev kho mob tshiab uas tseem ceeb thiab tsis muaj teeb meem yog yam xav tau tam sim.

Neonatal Fc receptor (FcRn) yog lub xov tooj ntawm tes uas khi cov txheej txheem IgG tiv thaiv kab mob thiab qhia kev thauj cov tshuaj tiv thaiv kab mob los ntawm hlwb. FcRn ua lub luag haujlwm tseem ceeb hauv kev tiv thaiv kev ua tsis taus ntawm IgG cov tshuaj tiv thaiv. Yog li, FcRn inhibition (piv txwv li, los ntawm kev siv FcRn tsom lub cev tiv thaiv kab mob) tau pom tias yuav txo tau cov qib ntawm cov kab mob tiv thaiv kabmob IgG. Soj ntsuam kev sim ntawm lwm cov tshuaj tiv thaiv FcRn hauv IgG-mediated autoimmune kab mob tau ua tiav cov txiaj ntsig zoo hauv kev soj ntsuam, qhia tias FcRn yog lub hom phiaj tseem ceeb tshuaj rau kev kho cov kabmob no.

Bartolizumab (HBM9161) yog cov tshuaj tiv thaiv kab mob tshiab (human monoclonal antibody) (mAb) tshiab rau lub hom phiaj FcRn, uas tuaj yeem tiv thaiv kev khi ntawm FcRn-IgG rau ib leeg, ua kom sai sai ntawm kev tshem tawm ntawm IgG lub cev, thiab ua tiav kev kho mob ntawm tus kab mob IgG Mediated los ntawm autoimmune. kab mob. Cov ntaub ntawv pov thawj muaj qhia tau hais tias kev txo qis ntawm IgG ntau ntau hauv cov neeg mob myasthenia gravis (MG) cuam tshuam nrog cov txiaj ntsig kev soj ntsuam. Cov kev tshawb fawb thaum ntxov tau pom tias bartolizumab muaj kev tiv thaiv zoo thiab tuaj yeem txo tau tag nrho IgG sai. Cov kev tshawb fawb kuj tau qhia tias bartolizumab yog thawj qhov kev siv tshuaj tiv thaiv FcRn lub hom phiaj uas tau muab pov thawj kom tsis tu ncua txo qis IgG tom qab txhaj tshuaj subcutaneous (SC) hauv Suav thiab Caucasian.

Bartolizumab (HBM9161) tau qhia nyob rau hauv daim ntawv tso cai los ntawm HanAll Biopharma los ntawm Harbor BioMed. Chaw nres nkoj BioMed muaj txoj cai los tsim, tsim khoom thiab ua lag luam tshuaj nyob hauv Suav Tebchaws Loj (suav nrog Hong Kong, Macau thiab Taiwan). Raws li lub tswv yim tshiab no thiab qhov tsis tau muaj kev kho mob siab tshaj plaws nyob rau hauv Suav teb, Harbor BioMed tau pib ua ntau qhov kev tshawb fawb los soj ntsuam HBM9161 hauv kev kho mob ntawm ntau cov kab mob autoimmune, suav nrog: kev tiv thaiv kabmob thrombocytopenia, mob ntsig txog lub qog, thiab myasthenia gravis, Neuromyelitis optica spectrum kab mob, autoimmune hemolytic anemia, mob ntev demyelinating polyneuropathy.

Dr. Wang Jinsong, tus tsim, tus thawj coj thiab CEO ntawm Harbor BioMed, tau hais tias: "Bartolizumab yog thawj cov khoom lag luam hauv Harbour keeb kwm uas tau tsim nyog los ua cov tshuaj txau tshuaj rau thawj zaug. Cov tshuaj tiv thaiv kab mob kis los ntawm kev sib deev IgG, suav nrog myasthenia gravis, tiv thaiv kab mob thrombocytopenia thiab neuromyelitis optica spectrum kab mob, thiab lwm yam. Peb cia siab tias yuav coj kev kho mob tshiab rau cov neeg mob uas myasthenia gravis sai sai."