Majinyaci Na Farko Ana Yi Don Maganin Osteoporosis

A KYAUTA Kyauta 5 | eTurboNews | eTN
Avatar na Linda Hohnholz
Written by Linda Hohnholz

Kamfanin Transcenta Holding Limited ya sanar da nasarar yin amfani da alluran majiyyaci na farko a China Phase I Study na TST002 don maganin osteoporosis.

Wannan gwaji na asibiti na Mataki na I shine bazuwar da makafi biyu, mai sarrafa wuribo, kashi-kashi mai hawa-hawa, bincike-bincike da yawa da aka tsara don kimanta amincin, juriya, da bayanan pharmacokinetics na TST002 azaman jiyya a cikin marasa lafiya tare da osteoporosis.

TST002 (Blosozumab) wani anti-sclerostin monoclonal antibody ne na ɗan adam a matsayin ɗan takarar magani don osteoporosis da sauran cututtukan asara. Yana da tasiri mai dual wanda ke da tasirin anabolic da anti-resorptive, wanda ke haifar da samuwar kashi kuma yana hana ƙwayar kashi, yana haifar da karuwa mai sauri a cikin ma'adinan kashi da ƙarfin kashi. Kashe ayyukan sclerostin a cikin ɗan adam da aka yi da maganin anti-sclerostin ko tare da gogewar kwayoyin halitta da ke faruwa a zahiri an nuna shi ya zama hanya mai inganci don haɓaka ƙimar ma'adinan kashi (BMD) da rage karyewar kashi. A halin yanzu babu wani maganin anti-sclerostin da aka amince da shi a cikin Sin har yanzu kodayake an amince da Romosozumab daga Amgen a Amurka, Turai da Japan.

Transcenta in-lasisi Blosozumab (TST002) daga Eli Lilly da Kamfanin ("Eli Lilly") don haɓakawa da kasuwanci a cikin Babban China a cikin 2019. da ingancin bayanai. Transcenta ya sami nasarar kammala canja wurin fasaha, kafa tsarin masana'antu a cikin ginin Hangzhou HJB, kuma ya kammala samar da GMP don amfani da asibiti gami da ƙarin ƙarin nazarin bincike kamar yadda CDE ta buƙata don aikace-aikacen TST002 IND a China. IND don TST002 binciken China an share shi daga NMPA ranar 22 ga Satumba, 2021 don gwada TST002 kai tsaye a cikin marasa lafiya da osteopenia.

"TST002 na iya zama na biyu anti-sclerostin monoclonal antibody a duniya." in ji Dr. Michael Shi, EVP, Shugaban Global R&D da CMO na Transcenta. "Muna sa ran gudanar da zurfafa bincike don kara kimanta aminci da jurewar TST002 da kuma kawo mafi inganci da hanyoyin magani iri-iri ga marasa lafiya na kasar Sin masu fama da osteoporosis."

A halin yanzu akwai sama da mutane miliyan 100 da ke da nau'in ciwon kashi daban-daban a kasar Sin kuma sama da miliyan 4 daga cikinsu suna fama da karaya. Wadannan lambobi suna karuwa saboda tasirin salon rayuwa, abinci da yawan tsufa, wanda ke haifar da mahimmancin kiwon lafiya, tattalin arziki da kuma zamantakewar al'umma da ke da alaka da osteoporosis. Akwai mahimman buƙatun da ba a cika su ba a cikin wannan yanki na cutar musamman a cikin marasa lafiya tare da osteoporosis mai tsanani duk da kasancewar yawancin wakilai na anti-resorptive kamar bisphosphonate da anti-RANKL inhibitor da wakilin anabolic da ke niyya PTH.

Game da marubucin

Avatar na Linda Hohnholz

Linda Hohnholz

Edita a shugaba don eTurboNews bisa ga eTN HQ.

Labarai
Sanarwa na
bako
0 comments
Bayanin Cikin Lissafi
Duba duk maganganu
0
Za a son tunanin ku, don Allah sharhi.x
()
x
Share zuwa...