Phunziro lachipatala lokhala ndi malo amodzi, losasinthika, losawoneka kawiri, loyang'aniridwa ndi placebo likukonza zolembetsa maphunziro a 56 kuti ayese kulekerera, chitetezo ndi makhalidwe a pharmacokinetic pambuyo pa kayendetsedwe kamodzi / kangapo mwa anthu odzipereka athanzi achi China. Pulofesa Wang Yongjun, Dean wa chipatala cha Beijing Tiantan, Capital Medical University ndiye wofufuza wamkulu. Kafukufukuyu adakhazikitsidwa mwalamulo pa Disembala 2, 2021, ndi mlingo woyamba wa maphunziro 4 mu gulu loyamba la dosing lomwe lidamalizidwa pa 8 Disembala.
"Kuyambira kwa dosing mu kafukufuku woyamba wa Simcere wachipatala wa SIM0307 ndi sitepe ina yofunika patsogolo pa chitukuko cha dziko lonse la AER-271 pamene tikufuna kukhazikitsa chithandizo choyenera cha ischemic stroke," anatero Mike Gresser, Chief Scientific Officer of Aeromics. . Gresser anawonjezera kuti, "tPA ndi mankhwala ena a thrombolytic amabweretsa kubwezeretsanso, komwe kuli kofunikira, koma nthawi zambiri kumayambitsa kuvulazidwanso. Chithandizo cha AER-271 pamodzi ndi thrombolytic therapy chikuyembekezeka kuthandizira kuchepetsa edema mwa kulowererapo koyambirira kwa kutupa komwe kumachitika chifukwa chobwezeretsanso ndi tPA, thrombectomy pamanja ndi chithandizo china cha thrombolytic.
Aeromics ndi Simcere adalowa mgwirizano ndi chilolezo chapadera mu Novembala 2019 kwa AER-271, chithandizo chamankhwala chothana ndi edema chomwe chikupangidwa kuti chithandizire kupha sitiroko ndi zisonyezo zina ku Greater China (ku China, Hong Kong, Macau ndi Taiwan). Malinga ndi mgwirizanowu, Simcere adzakhala ndi udindo pazachitukuko ndi malonda a AER-271 ku Greater China. Mu Epulo 2021, bungwe la China National Medical Products Administration (NMPA) lidavomereza kuyesa kwachipatala kwa SIM0307 kuti awonetse edema yaubongo pambuyo pa sitiroko yoopsa ya ischemic.
"Ndife okondwa kwambiri kuwona SIM0307 ikufika pachimake chofunikira kwambiri ku China." Anatero Dr. Renhong Tang, Mtsogoleri Wamkulu ndi Wachiwiri kwa Pulezidenti wa Simcere, "Kupita patsogolo kwa molekyuluyi kumatsimikizira luso lapamwamba la Aeromics ndi Simcere R & D, chitukuko chachipatala, kupanga, ndi malonda."
"Tikupitiriza kuyamika ubale wathu ndi Simcere pamene magulu athu akugwira ntchito limodzi kuti apititse patsogolo pulogalamuyi. Chilichonse chomwe timakhulupirira pa kafukufuku wawo, chitukuko ndi mphamvu zopanga zinthu zatsimikizika, ndipo mgwirizano wa gulu lawo waposa zomwe timayembekezera. Ndife okondwa kuona kupita patsogolo kwa Simcere pamene tikukonzekera mlandu wathu wa Phase IIa wotsimikizira njira zochitira umboni kuno ku United States.” atero a Thomas Zindrick, Executive Chairman wa Aeromics.
Wapampando wamkulu wa Simcere & CEO, a Jinsheng Ren adamaliza kuti, "Ndife onyadira kupanga SIM0307 (AER-271), pamene tikumasulira biology yopambana ya Nobel kukhala njira zochiritsira zothandiza kwa odwala omwe akudwala kwambiri omwe ali ndi njira zochepa zochizira. Kuonjezera apo, SIM0307 ili ndi mphamvu yogwirizanitsa ndi zinthu zina zomwe zili mu CNS portfolio ya Simcere monga Sanbexin® zomwe zingapititse patsogolo zotsatira za odwala sitiroko. Tikuyembekezera kupita patsogolo kosangalatsa kwamtsogolo mogwirizana ndi gulu la Aeromics. "
