AffaMed Therapeutics, k'hamphani ea lefats'e ea biotechnology e ikemiselitseng ho nts'etsapele le ho rekisa lihlahisoa tse fetolang tsa meriana, tsa dijithale le tsa ho buoa, kajeno e phatlalalitse hore Tsamaiso ea Lijo le Lithethefatsi ea United States (FDA) e hlakotse kopo ea eona ea Investigational New Drug (IND) bakeng sa nts'etsopele ea bongaka. AM712 (ASKG712), novel proprietary bispecific biologic molecule e thibelang bobeli ba vascular endothelial growth factor (VEGF) le angiopoietin-2 (Ang-2) bakeng sa phekolo ea mafu a retinal vascular.
Tlas'a IND ena, haufinyane AffaMed e tla qala thuto ea Mokhahlelo oa 1 United States ho fuputsa polokeho, mamello, pharmacokinetics, le katleho ea AM712 lithutong tse nang le neovascular AMD.
AffaMed Therapeutics e sa tsoa kena tumellanong ea laesense le AskGene Pharma Inc. bakeng sa litokelo tse khethehileng tsa ho nts'etsapele, ho etsa le ho rekisa AM712 libakeng tsa khale tsa Asia le Japane lefatšeng ka bophara.
"Re thabetse ho sebelisana 'moho le AskGene le ho fumana tumello ea rona ea pele ea IND ho tsoa ho FDA." Dr. Dayao Zhao, CEO oa AffaMed o itse: "E le karolo ea leano la rona la China-for-Global innovation ho matlafatsa boteng bo matla ba AffaMed Chaena le US ho ntšetsa pele mekhoa e fapaneng ea phekolo bakeng sa mebaraka ea lefats'e, tumellano ena ea laesense e matlafatsa le ho feta phaephe ea rona ea lefats'e ea mahlo. . Ke thabile haholo ho bona ts'ebetso ea rona e potlakileng ea leano lena ho tloha ho laesense ho isa ho tumello ea US IND mme re lebelletse tšebelisano ea rona e haufi le AskGene. ”
"AskGene e ikemiselitse ho tlisa meriana e sireletsehileng le e sebetsang ka potlako ho bakuli ka tšebeliso ea mahlale a macha. Re thabetse haholo ho sebelisana le AffaMed ho nts'etsapele molek'hule e tšepisang ea anti-VEGF/ANG2 bispecific AMG712(ASKG712) ho thusa bakuli" ho boletse Mookameli oa AskGene Dr. Jeff Lu: "Boitseanape bo ikhethang ba lefats'e ka sehlopha sa AffaMed sebakeng sa ophthalmology e ne e le mosebetsi bohlokoa ho nahanela tšebelisano ea rona. Ha re sebetsa 'moho, re ka potlakisa nts'etsopele ea ASKG712 lefats'eng ka bophara.
Dr Ji Li, Mopresidente oa AffaMed o ile a re: "Re lumela hore AM712 e na le monyetla oa ho ba molek'hule e ntle ka ho fetisisa ea anti-VEGF / Ang-2 bispecific biologic ho sebetsana le litlhoko tse phahameng tsa bongaka tse sa finyelloang har'a bakuli ba nang le mafu a retinal vascular. Re thabetse ho bonts'a bokhoni ba rona ba ts'ebetso e matla ea ho amohela tumello ea US IND nakong ea likhoeli tse peli kamora ho qeta tumellano ea rona ea laesense le AskGene. "
