ʻO ka hōʻailona hōʻeuʻeu hou no ka maʻi maʻi cervical

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Ua hoʻolaha ʻo Innovent Biologics, Inc. ua hāʻawi ka Center for Drug Evaluation (CDE) o China's National Medical Products Administration (NMPA) i ka Breakthrough Therapy Designation (BTD) no IBI310 i hui pū ʻia me ka sintilimab no ka mālama ʻana i nā maʻi me ka maʻi maʻi ʻāʻī a i ʻole metastatic cervical cancer.

Hoʻokumu ʻia ka NMPA BTD no IBI310 ma nā hopena mai ka hapa mua o kahi hoʻāʻo Phase 2 (CDE Registration No. CTR20202017). Ua hoʻopaʻa inoa kēia haʻawina i nā maʻi maʻi 205 i nā maʻi me ka maʻi maʻi maʻi ʻāʻī. Ua kūlike ka ʻike palekana i kēia haʻawina me ka mea i ʻike ʻia i nā haʻawina i hōʻike mua ʻia, a ʻaʻohe hōʻailona palekana hou i ʻike ʻia no ka hui ʻana o IBI310 a me sintilimab. E paʻi ʻia nā hopena haʻawina pili i kahi hālāwai kūkā olakino e hiki mai ana ma 2022.

"ʻOliʻoli mākou i ka ʻike ʻana i ka hāʻawi ʻana i ka NMPA Breakthrough Therapy Designation ma muli o nā hopena o ka ʻāpana mua o ka Phase 2 data o IBI310," wahi a Kauka Hui Zhou, Hope Pelekikena Nui o Innovent. "ʻO nā poʻe maʻi me ka maʻi maʻi maʻi cervical i kēia manawa he mau koho lapaʻau. ʻO ka poʻe maʻi i mālama ʻia me ka chemotherapy e hōʻike i nā pōmaikaʻi lapaʻau liʻiliʻi a ua kaupalena ʻia ke ola holoʻokoʻa i kekahi mau mahina. ʻO nā hopena o ka ʻāpana mua o ka haʻawina Phase 2 o IBI310 i hui pū ʻia me ka sintilimab e hōʻike ana i ka hiki no kēia hui ʻana ma ke ʻano he koho lapaʻau hou no nā maʻi i nele. Manaʻo mākou i ka loaʻa ʻana o nā ʻikepili hou aʻe mai ka hoʻāʻo pivotal Phase 2 e hiki ke kākoʻo i kahi noi hoʻoponopono e hiki mai ana ma Kina no IBI310 i hui pū ʻia me ka sintilimab i ka maʻi maʻi cervical recurrent a metastatic.

ʻO ka NMPA Breakthrough Therapy Designation i manaʻo ʻia e hoʻomaʻamaʻa a wikiwiki i ka hoʻomohala ʻana a me ka loiloi ʻana i kahi lāʻau noiʻi e mālama ai i kahi maʻi koʻikoʻi a i ʻole ke kūlana i ka wā e hōʻike ai nā hōʻike lapaʻau mua ua hōʻike ka lāʻau lapaʻau i ka hoʻomaikaʻi nui ʻana ma mua o nā lāʻau lapaʻau o kēia manawa. ʻAʻole hiki i ka BTD ke koho wale i kahi moho lāʻau no ka loaʻa ʻana o ke kūlana no ka loiloi wikiwiki ʻana e ka CDE, akā e ʻae ia i ka mea kākoʻo e loaʻa i ka ʻōlelo aʻoaʻo a me ka kamaʻilio kūpono mai ka CDE e hoʻolalelale i ka ʻae ʻia a me ka hoʻomaka ʻana e hoʻoponopono i ka hemahema o nā maʻi maʻi. he holo wikiwiki. Kaomi ma aneʻi no ka papa inoa o nā lāʻau lapaʻau i hāʻawi ʻia i ka BTD e NMPA.

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Linda Hohnholz

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