Iyeza elitsha le-Brain Edema

Eli ziko elilodwa, i-randomized, i-double-blind-blind, i-placebo-controlled controlled phase I-placebo iceba ukubhalisa izifundo ze-56 ukuvavanya ukunyamezela, ukhuseleko kunye neempawu ze-pharmacokinetic emva kolawulo olulodwa / oluninzi kumavolontiya aseTshayina aphilileyo. Unjingalwazi uWang Yongjun, uDean weSibhedlele saseBeijing Tiantan, iYunivesithi yezoNyango eyiNtloko ngumphandi oyintloko. Uphononongo lwaphehlelelwa ngokusemthethweni nge-2 kaDisemba, ngo-2021, kunye nedosi yokuqala yezifundo ezi-4 kwiqela lokuqala le-dosing eligqitywe nge-8 kaDisemba.

"Ukuqala kwedosi kuphononongo lokuqala lweklinikhi lukaSimcere lwe-SIM0307 lelinye inyathelo elibalulekileyo eliya phambili kuphuhliso lwehlabathi lwe-AER-271 njengoko sifuna ukuseka unyango oluyimfuneko, olunentsingiselo ye-acute ischemic stroke," utshilo uMike Gresser, iGosa eliyiNtloko lezeNzululwazi leAeromics. . UGresser wongeze wathi, "i-tPA kunye nolunye unyango lwe-thrombolytic lukhokelela ekubuyiseleni kwakhona, okuyimfuneko, kodwa kaninzi kukhokelela kumonzakalo wokubuyisela kwakhona. Unyango nge-AER-271 ecaleni konyango lwe-thrombolytic kulindeleke ukuba luncede ekunciphiseni i-edema ngokungenelela kwangoko kwinkqubo yokukrala okubangelwa kukuphinda kufakwe i-tPA, i-thrombectomy ye-manual kunye nolunye unyango lwe-thrombolytic.

I-Aeromics kunye ne-Simcere bangene kwintsebenziswano kunye nesivumelwano selayisensi ekhethekileyo ngo-Novemba ka-2019 kwi-AER-271, unyango lwe-anti-edema lwenqanaba leklinikhi oluphuhliswayo ukunyanga i-stroke kunye nezinye izibonakaliso kwi-Greater China (ilizwe lase-China, i-Hong Kong, i-Macau ne-Taiwan). Ngokwesivumelwano, i-Simcere iya kuba noxanduva lophuhliso lweklinikhi kunye nokuthengiswa kwe-AER-271 kwi-Greater China. Ngo-Epreli ka-2021, i-China National Medical Products Administration (NMPA) yamkele uvavanyo lweklinikhi lwe-SIM0307 lokubonisa i-cerebral edema emva kokuhlaselwa kwe-ischemic eyingozi kakhulu.

"Kuyasivuyisa ukubona iSIM0307 ifikelela kwinqanaba elibalulekileyo eTshayina." utshilo uGqr Renhong Tang, uMlawuli oyiNtloko kunye noSekela Mongameli oLawulayo weSimcere, "Ukuqhubela phambili ngokukhawuleza kwale molekyuli kugxininisa iitalente zehlabathi ezidibeneyo ze-Aeromics kunye ne-Simcere R & D, uphuhliso lwezonyango, ukuveliswa kunye nokuthengisa."

“Siyaqhubeka nokubuxabisa ubudlelwane bethu noSimcere njengoko amaqela ethu esebenza ngokusondeleyo ukuqhubela phambili le nkqubo. Yonke into ebesiyikholelwa malunga nophando lwabo, uphuhliso kunye namandla okwenza izinto zingqineke ziyinyani, kwaye imo yentsebenziswano yeqela labo igqithile besilindele. Kuyasivuyisa ukubona inkqubela kaSimcere njengoko silungiselela ulingo lwethu lweSigaba IIa sobungqina benkqubo apha eUnited States.” utshilo uThomas Zindrick, uSihlalo oLawulayo weAeromics.

USihlalo oLawulayo we-Simcere kunye ne-CEO, uMnu. Jinsheng Ren uqukumbele ngelithi, “Siyazingca ngokuphuhlisa i-SIM0307 (AER-271), njengoko siguqulela ibhayoloji ephumelele iNobel kunyango olunentsingiselo kwizigulana ezigula kakhulu ezinokhetho olunqongopheleyo lonyango. Ukongezelela, i-SIM0307 inamandla okudibanisa kunye nezinye iimveliso kwipotifoliyo ye-CNS ye-Simcere efana ne-Sanbexin® enokuthi iphucule ngakumbi umphumo wezigulane ze-stroke.ephuhliswe ukuguqulela . Sijonge phambili kwinkqubela phambili eyonwabisayo kwixesha elizayo ngentsebenziswano kunye neqela leAeromics. "