Kaomi ma aneʻi e hōʻike i kāu mau hae ma kēia ʻaoʻao a uku wale no ka holomua

Nuhou Uea

Hoʻohana ʻia ka maʻi mua no ka mālama ʻana i ka osteoporosis

i kakauia ma hoʻoponopono

Ua hoʻolaha ʻo Transcenta Holding Limited i ka holomua ʻana o ka maʻi maʻi ma Kina Phase I Study o TST002 no ka mālama ʻana i ka osteoporosis.

ʻO kēia Phase I clinical trial he randomized a pālua-makapō, placebo-controlled, hoʻokahi-piʻi-dose, multi-center study i hoʻolālā ʻia e loiloi i ka palekana, tolerability, a me pharmacokinetics profile o TST002 ma ke ʻano he lapaʻau i nā maʻi me ka osteoporosis.

ʻO TST002 (Blosozumab) he kanaka anti-sclerostin monoclonal antibody ma ke ʻano he moho lāʻau no ka osteoporosis a me nā maʻi poho iwi ʻē aʻe. Loaʻa iā ia ka hopena ʻelua e loaʻa ana i nā hopena anabolic a me nā hopena anti-resorptive, e hoʻoulu ai i ka hoʻokumu ʻana o ka iwi a pale i ka absorption iwi, e hopena i ka hoʻonui wikiwiki ʻana i ka nui o ka mineral iwi a me ka ikaika o ka iwi. ʻO ka pale ʻana i ka hana sclerostin i loko o ke kanaka i mālama ʻia me ka anti-sclerostin antibody a i ʻole me ka hoʻopau ʻana i ke ʻano kūlohelohe i hōʻike ʻia he ala kūpono i ka hoʻonui ʻana i ka iwi mineral density (BMD) a me ka hōʻemi ʻana i ka haʻihaʻi iwi. I kēia manawa, ʻaʻohe mea i ʻae ʻia ka anti-sclerostin antibody therapy ma Kina akā ʻoiai ua ʻae ʻia ʻo Romosozumab mai Amgen ma United States, Europe a me Iapana.

ʻO Transcenta i laikini ʻia ʻo Blosozumab (TST002) mai Eli Lilly a me Hui ("Eli Lilly") no ka hoʻomohala ʻana a me ka hoʻolaha ʻana ma Greater China i ka makahiki 2019. Ua hoʻopau ʻo Eli Lilly i nā haʻawina lapaʻau ma ka pae II o Blosozumab ma ʻAmelika Hui Pū ʻIa a me Iapana a loaʻa iā ia ka ʻike palekana palekana. a me ka ʻikepili pono. Ua hoʻopau maikaʻi ʻo Transcenta i ka hoʻololi ʻenehana, hoʻokumu i ka hana hana ma kāna keʻena Hangzhou HJB, a hoʻopau i ka hana GMP no ka hoʻohana lapaʻau a me nā haʻawina preclinical hou e like me ke koi ʻia e ka CDE no ka noi TST002 IND ma Kina. IND no ka TST002 China haʻawina i hoʻomaʻemaʻe ʻia mai ka NMPA ma Sept. 22nd, 2021 no ka hoʻāʻo ʻana iā TST002 pololei i nā maʻi me ka osteopenia.

"Hiki i ka TST002 ke lilo i ka lua anti-sclerostin monoclonal antibody i ka honua." wahi a Kauka Michael Shi, EVP, ke poʻo o Global R&D a me CMO o Transcenta. "Ke kakali nei mākou i ka hana ʻana i ka noiʻi hohonu e loiloi hou i ka palekana a me ka hoʻomanawanui o TST002 a lawe mai i nā koho lapaʻau ʻoi aku ka maikaʻi a me nā ʻano like ʻole no nā poʻe maʻi Kina me ka osteoporosis."

I kēia manawa aia ma luna o 100 miliona o ka poʻe me nā ʻano like ʻole o ka osteoporosis ma Kina a ʻoi aku ma mua o 4 miliona o lākou e loaʻa ana i nā haʻihaʻi osteoporotic. Ke piʻi nei kēia mau helu ma muli o ka hopena o ke ʻano o ka nohona, ka meaʻai a me ka heluna kanaka ʻelemakule, e hopena i nā kaumaha nui o ke olakino, ka waiwai a me ka pilikanaka e pili ana i nā haʻihaʻi pili osteoporosis. Loaʻa nā pono kūpono ʻole i kēia wahi maʻi ʻoi aku ka nui o nā poʻe maʻi me ka osteoporosis koʻikoʻi ʻoiai ka loaʻa ʻana o kekahi mau mea hana anti-resorptive e like me ka bisphosphonate a me ka anti-RANKL inhibitor a me ka mea anabolic e kuhikuhi ana i ka PTH.

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