Ma Nowemapa 24, 2021, ua hoʻolaha ʻo Kintor Pharma ua hoʻomālamalama ka China's National Medical Products Administration (NMPA) i ka protocol no ka haʻawina pivotal phase III o KX-826.
Ma Dekemaba 20, 2021, ua hoʻokō maikaʻi ʻia ka hui kickoff ma waena o nā mea noiʻi koʻikoʻi no ka KX-826 phase III hoʻokolohua lapaʻau. Ua alakaʻi ʻo Peking University People's Hospital a me Huashan Hospital i pili i ke Kulanui ʻo Fudan i ka hoʻokolokolo, me 26 mau halemai e komo. Ma hope o ke alakaʻi ʻana i ka hoʻokolohua lapaʻau ʻo KX-826 ma Kina no ka mālama ʻana iā AGA, ua hui pū ʻo Polofesa Zhang Jianzhong mai ka Halemai Kanaka o ke Kulanui o Peking a me Profesor Yang Qinping mai ka Halemai Huashan i hui pū ʻia me ke Kulanui ʻo Fudan e lilo i poʻokela poʻokela. alakaʻi i nā PI) o ka pivotal Phase III Clinical Trial o KX-826. Ma ka hui noiʻi, kokoke 100 mau loea mai 26 mau haukapila ma Kina i hoʻolohe i ka hōʻike e pili ana i ka pono a me ka palekana o ka hoʻokolohua lapaʻau Phase II o KX-826. Ua hoʻopau ʻo Polofesa Zhang Jianzhong i ka hālāwai a paipai i kēlā me kēia PI e hana me kēia haʻawina koʻikoʻi me ka maikaʻi a me ka maikaʻi.
Ua ʻōlelo ʻo Kauka Youzhi Tong, ka mea nāna i hoʻokumu, luna hoʻomalu, a me ka Luna Nui o Kintor Pharma, "Ua hoʻokō ka hui o Kintor me ka hana kiʻekiʻe mai ka ʻae ʻana o NMPA a hiki i ka hoʻopaʻa mua ʻana o kēia pae III hoʻokolohua lapaʻau ma kahi o hoʻokahi mahina. E hoʻokō ʻia kēia hoʻokolohua lapaʻau III ma 26 mau keʻena lapaʻau dermatology kiʻekiʻe ma Kina. Manaʻo mākou i ka hoʻopau ʻana i nā kumuhana 416 i hoʻolālā ʻia e Iune 2022, a me ka loiloi olakino ma hope (6 mahina haʻawina + 1 mahina hahai) i loko o ka makahiki. Me ka pahuhopu o ka hoʻopau ʻana i ka hoʻokolohua lapaʻau pae III i kēia makahiki, ke wikiwiki nei mākou i ke kaʻina hana a ke manaʻo nei e pōmaikaʻi ʻo KX-826 i nā poʻe maʻi honua i ka hiki ke hiki.
He aha e lawe ʻia mai kēia ʻatikala:
- After successfully co-leading the phase II clinical trial of KX-826 in China for the treatment of AGA, Professor Zhang Jianzhong from Peking University People’s Hospital and Professor Yang Qinping from Huashan Hospital affiliated to Fudan University cooperate again to be the leading principal investigators (leading PIs) of the pivotal Phase III Clinical Trial of KX-826.
- At the investigator meeting, nearly 100 experts from 26 hospitals across China listened to the report on the efficacy and safety of the KX-826’s Phase II clinical trial.
- With the goal of completing the phase III clinical trial this year, we are speeding up the process and expecting that KX-826 would benefit global patients as soon as possible.
