Hoʻolālā kēia haʻawina hoʻonaʻauao hoʻokahi-waena, randomized, double-blind, placebo-controlled phase I ka hoʻopaʻa inoa ʻana i nā kumuhana 56 e loiloi i ka tolerability, palekana a me nā ʻano pharmacokinetic ma hope o ka hoʻokele hoʻokahi/nui i nā limahana Kina olakino. ʻO Professor Wang Yongjun, Dean o Beijing Tiantan Hospital, Capital Medical University ka mea noiʻi nui. Ua hoʻokuʻu ʻia ke aʻo ʻana ma ka lā 2 o Dekemaba, 2021, me ka helu mua o 4 mau kumuhana i ka hui dosing mua i hoʻopau ʻia ma ka lā 8 o Dekemaba.

"ʻO ka hoʻomaka ʻana o ka dosing i ka noiʻi mua ʻana o Simcere o SIM0307 he hana koʻikoʻi ʻē aʻe i mua o ka hoʻomohala honua o AER-271 i ko mākou ʻimi ʻana e hoʻokumu i kahi lāʻau pono a kūpono no ka maʻi ischemic stroke," wahi a Mike Gresser, Luna Nui ʻepekema o Aeromics. . Ua hoʻohui ʻo Gresser, "ʻo ka tPA a me nā lāʻau thrombolytic ʻē aʻe ka hopena i ka reperfusion, pono ia, akā alakaʻi pinepine i ka hōʻeha reperfusion. ʻO ka hoʻomaʻamaʻa ʻana me AER-271 me ka thrombolytic therapy e manaʻo ʻia e kōkua i ka hōʻemi ʻana i ka edema ma ke komo ʻana i ke kaʻina hana inflammatory ma muli o ka reperfusion e tPA, manual thrombectomy a me nā lāʻau thrombolytic ʻē aʻe.

Ua komo ʻo Aeromics lāua ʻo Simcere i kahi hui like ʻana a me ka ʻaelike laikini kūʻokoʻa i Nowemapa 2019 no AER-271, kahi lāʻau lapaʻau anti-edema therapy e hoʻomohala ʻia e mālama i ka maʻi maʻi a me nā hōʻailona ʻē aʻe ma Kina Nui (ka ʻāina ʻo Kina, Hong Kong, Macau a me Taiwan). Wahi a ka ʻaelike, ʻo Simcere ke kuleana no ka hoʻomohala ʻana i ka lāʻau lapaʻau a me ke kālepa ʻana o AER-271 ma Greater China. I ʻApelila 2021, ua ʻae ka China National Medical Products Administration (NMPA) i kahi hoʻokolohua lapaʻau o SIM0307 no ka hōʻike ʻana i ka edema cerebral ma hope o ka maʻi ischemic koʻikoʻi.

"ʻOliʻoli loa mākou i ka ʻike ʻana i ka SIM0307 e hōʻea i kahi koʻikoʻi koʻikoʻi ma Kina." Wahi a Dr. Renhong Tang, Luna Hoʻokele a me Hope Pelekikena Nui o Simcere, "ʻO ka holomua wikiwiki o kēia mole e hōʻike ana i nā talena papa honua o Aeromics a me Simcere R&D, ka hoʻomohala ʻana i ke kino, ka hana ʻana, a me ka hoʻolaha ʻana."

"Ke hoʻomau nei mākou i ka mahalo i kā mākou pilina me Simcere i ka hana ʻana o kā mākou hui e holomua i kēia papahana. ʻO nā mea a pau a mākou i manaʻoʻiʻo ai e pili ana i kā lākou noiʻi, hoʻomohala a me ka ikaika o ka hana ʻana ua hōʻoia ʻoiaʻiʻo, a ʻo ke ʻano hui pū o kā lākou hui i ʻoi aku ma mua o kā mākou mau manaʻo. Hauʻoli mākou i ka ʻike ʻana i ka holomua o Simcere i ko mākou hoʻomākaukau ʻana no kā mākou Phase IIa proof-of-mechanism hoʻokolokolo ma ʻAmelika Hui Pū ʻIa. wahi a Thomas Zindrick, ka Luna Hoʻokele o Aeromics.

Ua hoʻopau ka Luna Hoʻokele a me Luna Nui o Simcere, ʻo Mr. Jinsheng Ren, "Haʻaheo mākou i ka hoʻomohala ʻana i ka SIM0307 (AER-271), ʻoiai mākou e unuhi i ka biology lanakila Nobel i loko o nā lāʻau lapaʻau kūpono no nā maʻi maʻi koʻikoʻi me nā koho lapaʻau liʻiliʻi loa. Eia hou, hiki i ka SIM0307 ke hui pū me nā huahana ʻē aʻe i loko o ka waihona CNS o Simcere e like me Sanbexin® e hoʻomaikaʻi hou i ka hopena o nā maʻi maʻi. Manaʻo mākou i ka holomua hoihoi i ka wā e hiki mai ana me ka hui pū ʻana me ka hui Aeromics.

He aha e lawe ʻia mai kēia ʻatikala:

“The start of dosing in Simcere’s first clinical study of SIM0307 is another important step forward in the global development of AER-271 as we seek to establish a needed, meaningful therapy for acute ischemic stroke,”.
Aeromics and Simcere entered into a collaboration and exclusive license agreement in November 2019 for AER-271, a clinical-stage anti-edema therapy being developed to treat stroke and other indications in Greater China (mainland China, Hong Kong, Macau and Taiwan).
The study was officially launched on December 2nd, 2021, with the first dose of 4 subjects in the first dosing group completed on the 8th of December.