I-AffaMed Therapeutics, okuyinkampani yomhlaba wonke yesiteji somtholampilo we-biotechnology ezinikele ekuthuthukiseni nasekuthengiseni imikhiqizo eshintshashintshayo yemithi, yedijithali neyokuhlinzwa, namuhla imemezele ukuthi i-United States Food and Drug Administration (FDA) isisusile isicelo sayo se-Investigational New Drug (IND) sokuthuthukiswa komtholampilo. I-AM712 (ASKG712), i-molecule ye-bispecific biologic inoveli evimba kokubili i-vascular endothelial growth factor (VEGF) ne-angiopoietin-2 (Ang-2) yokwelapha izifo ze-retinal vascular.
Ngaphansi kwale IND, i-AffaMed maduze izoqala ucwaningo lweSigaba 1 e-United States ukuze iphenye ukuphepha, ukubekezelelana, i-pharmacokinetics, kanye nempumelelo ye-AM712 ezifundweni ezine-neovascular AMD.
I-AffaMed Therapeutics isanda kungena esivumelwaneni selayisensi ne-AskGene Pharma Inc. samalungelo akhethekile okuthuthukisa, ukukhiqiza nokudayisa i-AM712 ezindaweni ezaziyi-Asia kanye ne-Japan emhlabeni jikelele.
"Sijabule ukusebenzisana ne-AskGene futhi sithole imvume yethu yokuqala ye-IND evela ku-FDA." UDkt. Dayao Zhao, oyi-CEO ye-AffaMed ubeke amazwana: ” Njengengxenye yesu lethu le-China-for-Global innovation ukuze kuthuthukiswe ukuba khona okuqinile kwe-AffaMed e-China nase-US ukuthuthukisa izindlela zokwelapha ezihlukene ezimakethe zomhlaba, lesi sivumelwano selayisense siqinisa nakakhulu ipayipi lethu le-Ophthalmology emhlabeni jikelele. . Ngijabule kakhulu ukubona ukuqaliswa kwethu ngokushesha kwaleli su kusukela ekunikezeni amalayisense ukuya e-US IND imvume futhi ngibheke ngabomvu ukubambisana kwethu ne-AskGene. "
“I-AskGene izibophezele ekuletheni ngokushesha imithi ephephile nesebenzayo ezigulini ngokusebenzisa ubuchwepheshe obusha. Sijabula kakhulu ukubambisana ne-AffaMed ukuthuthukisa i-anti-VEGF/ANG2 bispecific molecule ethembisayo i-AMG712(ASKG712) ukuze kuzuze iziguli” kusho i-CEO ye-AskGene uDkt. Jeff Lu: “Ubuchwepheshe obukhethekile bomhlaba wonke bethimba le-AffaMed endaweni ye-Ophthalmology bekuwumsebenzi ukucatshangelwa okubalulekile ngokubambisana kwethu. Ngokusebenzisana, singasheshisa ukuthuthukiswa kwe-ASKG712 emhlabeni jikelele.”
UDkt Ji Li, uMongameli we-AffaMed waphawula: “Sikholelwa ukuthi i-AM712 inamandla okuba i-anti-VEGF/Ang-2 bispecific bispecific molecule ye-bispecific esezingeni eliphezulu ukuze ibhekane nezidingo zezokwelapha ezingahlangatshezwana neziguli ezinezifo zemithambo ye-retinal. Sijabule kakhulu ukukhombisa amandla ethu okubulala aqinile ekutholeni imvume ye-US IND phakathi nezinyanga ezi-2 ngemuva kokugcwalisa isivumelwano sethu selayisense ne-AskGene.”
