Wodwala Woyamba Kumwedwa kwa Chithandizo cha Osteoporosis

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Written by Linda Hohnholz

Transcenta Holding Limited yalengeza za kuyezetsa kopambana kwa wodwala woyamba ku China Phase I Study ya TST002 pochiza osteoporosis.

Mayesero achipatala a Phase I ndi osadziwika bwino komanso akhungu awiri, omwe amayendetsedwa ndi placebo, mlingo umodzi wokwera, kafukufuku wambiri wopangidwa kuti ayese chitetezo, tolerability, ndi pharmacokinetics mbiri ya TST002 monga chithandizo kwa odwala osteoporosis.

TST002 (Blosozumab) ndi anti-sclerostin monoclonal antibody ngati mankhwala ochiritsira osteoporosis ndi matenda ena otaya mafupa. Lili ndi mphamvu ziwiri zomwe zimakhala ndi anabolic komanso anti-resorptive zotsatira, zomwe zimalimbikitsa mapangidwe a mafupa ndikulepheretsa kuyamwa kwa mafupa, zomwe zimapangitsa kuti mafupa achuluke kwambiri komanso mphamvu za mafupa. Kuletsa ntchito ya sclerostin mwa anthu omwe amathandizidwa ndi anti-sclerostin antibody kapena kufufutidwa mwachilengedwe kwawonetsedwa kuti ndi njira yabwino yowonjezerera kuchulukira kwa mafupa a mafupa (BMD) ndikuchepetsa kuthyoka kwa mafupa. Pakadali pano ku China kulibe chithandizo chovomerezeka cha anti-sclerostin antibody ngakhale kuti Romosozumab waku Amgen wavomerezedwa ku United States, Europe ndi Japan.

Transcenta in-licenced Blosozumab (TST002) yochokera ku Eli Lilly and Company (“Eli Lilly”) kuti ipititse patsogolo komanso kugulitsa malonda ku Greater China mu 2019. Eli Lilly wamaliza gawo lachiwiri la maphunziro azachipatala ku Blosozumab ku United States ndi Japan ndipo adapeza mbiri yodalirika yotetezedwa. ndi deta yothandiza. Transcenta inamaliza bwino kusamutsa ukadaulo, idakhazikitsa njira yopangira zinthu m'malo ake a Hangzhou HJB, ndikumaliza kupanga GMP kuti igwiritsidwe ntchito pachipatala komanso maphunziro owonjezera achipatala monga amafunikira CDE pakugwiritsa ntchito TST002 IND ku China. IND ya kafukufuku wa TST002 China idachotsedwa ku NMPA pa Sept. 22nd, 2021 poyesa TST002 mwachindunji kwa odwala osteopenia.

"TST002 ikhoza kukhala anti-sclerostin monoclonal antibody yachiwiri padziko lapansi." adatero Dr. Michael Shi, EVP, Mtsogoleri wa Global R & D ndi CMO wa Transcenta. "Tikuyembekeza kuchititsa kafukufuku wozama kuti tiwone bwinobwino chitetezo ndi kulolera kwa TST002 ndikubweretsa njira zothandizira komanso zosiyanasiyana zothandizira odwala ku China omwe ali ndi matenda osteoporosis."

Pakadali pano pali anthu opitilira 100 miliyoni omwe ali ndi matenda osiyanasiyana osteoporosis ku China ndipo opitilira 4 miliyoni aiwo akudwala matenda osweka osteoporotic. Ziwerengerozi zikuchulukirachulukira chifukwa cha chikoka cha moyo, zakudya komanso ukalamba, zomwe zimapangitsa kuti pakhale zovuta zathanzi, zachuma komanso zachikhalidwe zomwe zimagwirizanitsidwa ndi kusweka kwa mafupa osteoporosis. Pali zofunikira zosakwanira m'derali la matendawa makamaka kwa odwala omwe ali ndi matenda otupa mafupa aakulu ngakhale kuti alipo angapo othandizira anti-resorptive monga bisphosphonate ndi anti-RANKL inhibitor ndi anabolic agent akuyang'ana PTH.

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Avatar ya Linda Hohnholz

Linda Hohnholz

Mkonzi wamkulu kwa eTurboNews zochokera ku eTN HQ.

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