Lesi sikhungo sesikhungo esisodwa, esingahleliwe, esingaboni kabili, esilawulwa yi-placebo esilawulwa yisigaba sokuqala socwaningo lomtholampilo luhlela ukubhalisa izifundo ezingu-56 ukuze zihlole ukubekezelelana, ukuphepha kanye nezici ze-pharmacokinetic ngemva kokuphatha okukodwa/okuningi kumavolontiya aseShayina anempilo. USolwazi Wang Yongjun, uDini waseBeijing Tiantan Hospital, iCapital Medical University ungumphenyi omkhulu. Lolu cwaningo lwethulwe ngokusemthethweni ngoDisemba 2, 2021, ngomthamo wokuqala wezifundo ezi-4 eqenjini lokuqala le-dosing laqedwa ngomhla ka-8 kuZibandlela.
"Ukuqala kokudosa ocwaningweni lokuqala lukaSimcere lomtholampilo lwe-SIM0307 kungesinye isinyathelo esibalulekile esiya phambili ekuthuthukisweni komhlaba wonke kwe-AER-271 njengoba sifuna ukusungula ukwelashwa okudingekayo, okunenjongo kwe-acute ischemic stroke," kusho uMike Gresser, oyiChief Scientific Officer of Aeromics. . UGresser wanezela, “i-tPA nezinye izindlela zokwelapha i-thrombolytic ziphumela ekuphindaphindeni, okudingekile, kodwa ngokuvamile okuholela ekulimaleni kokubuyisela kabusha. Ukwelashwa nge-AER-271 okuhambisana nokwelashwa kwe-thrombolytic kulindeleke ukuthi kusize ekwehliseni i-edema ngokungenelela kusenesikhathi enqubweni yokuvuvukala okubangelwa ukuphindwaphindwa kwe-tPA, i-thrombectomy eyenziwa ngesandla kanye nokunye ukwelashwa kwe-thrombolytic.”
I-Aeromics kanye ne-Simcere bangene esivumelwaneni selayisense esikhethekile ngoNovemba 2019 se-AER-271, indlela yokwelapha ye-anti-edema yesigaba somtholampilo eyenzelwe ukwelapha isifo sohlangothi nezinye izinkomba e-Greater China (izwekazi lase-China, e-Hong Kong, e-Macau nase-Taiwan). Ngokwesivumelwano, uSimcere uzoba nesibopho sokuthuthukiswa komtholampilo kanye nokudayiswa kwe-AER-271 e-Greater China. Ngo-Ephreli 2021, i-China National Medical Products Administration (NMPA) yagunyaza uhlolo lomtholampilo lwe-SIM0307 ukuze kuboniswe i-cerebral edema ngemva kokushaywa yi-ischemic esibi kakhulu.
"Sijabule kakhulu ukubona i-SIM0307 ifinyelela ingqophamlando ebalulekile eChina." kusho uDkt. Renhong Tang, uMqondisi Omkhulu kanye nePhini Likamongameli Omkhulu we-Simcere, "Ukuthuthuka okusheshayo kwaleli molecule kugcizelela amathalente asezingeni lomhlaba ahlangene e-Aeromics kanye ne-Simcere R&D, ukuthuthukiswa kwemitholampilo, ukukhiqiza kanye nokudayisa."
“Siyaqhubeka nokubonga ubudlelwano bethu noSimcere njengoba amathimba ethu esebenza ngokubambisana ukuthuthukisa lolu hlelo. Konke ebesikukholelwa mayelana nocwaningo lwabo, ukuthuthukiswa namandla okukhiqiza kubonakale kuyiqiniso, futhi isimo sokusebenzisana kwethimba labo sidlule ebesikulindele. Siyajabula ukubona inqubekela phambili kaSimcere njengoba silungiselela okwethu ukuqulwa kwecala leSigaba IIa lobufakazi bendlela lapha e-United States.” kusho uThomas Zindrick, uSihlalo oMkhulu we-Aeromics.
USihlalo Omkhulu kanye ne-CEO yakwa-Simcere, uMnu. Jinsheng Ren uphethe ngokuthi, “Siyaziqhenya ngokwenza i-SIM0307 (AER-271), njengoba sihumusha i-biology ewine i-Nobel ibe imithi yokwelapha enengqondo ezigulini ezigula kakhulu ezinezinketho zokwelashwa ezilinganiselwe. Ukwengeza, i-SIM0307 inamandla okuxhumana neminye imikhiqizo kuphothifoliyo ye-CNS ka-Simcere efana ne-Sanbexin® engase ithuthukise umphumela weziguli zohlangothi.ethuthukiswe ukuthi ihumushe . Sibheke phambili enqubekelaphambili ethokozisayo yesikhathi esizayo ngokubambisana nethimba le-Aeromics.”
