Isiguli Sokuqala Sithathelwe Ukwelashwa Kwe-Osteoporosis

I-Transcenta Holding Limited imemezele ukufakwa ngempumelelo kwesiguli sokuqala e-China Phase I Study ye-TST002 yokwelashwa kwe-osteoporosis.

Lolu cwaningo lomtholampilo lweSigaba I luwucwaningo olungahleliwe futhi oluyimpumputhe kabili, olulawulwa yi-placebo, umthamo owodwa okhuphukayo, olumaphakathi olwenzelwe ukuhlola ukuphepha, ukubekezelelana, kanye nephrofayili ye-pharmacokinetics ye-TST002 njengokwelashwa ezigulini ezine-osteoporosis.

I-TST002 (i-Blosozumab) iyi-anti-sclerostin monoclonal antibody eyenziwe ngumuntu njengekhandidethi yezidakamizwa ze-osteoporosis nezinye izifo zokulahlekelwa kwamathambo. Inomphumela ombaxambili onakho kokubili i-anabolic ne-anti-resorptive effects, evuselela ukwakheka kwamathambo futhi ivimbele ukumuncwa kwamathambo, okuholela ekwandeni okusheshayo kokuqina kwamaminerali amathambo namandla amathambo. Ukuvimbela umsebenzi we-sclerostin ekulashweni komuntu nge-anti-sclerostin antibody noma ngokususwa kofuzo okwenzeka ngokwemvelo kuboniswe njengendlela ephumelelayo ekwandiseni ukuminyana kwamaminerali amathambo (BMD) nokunciphisa ukuphuka kwethambo. Okwamanje alukho ukwelapha okugunyaziwe kwe-anti-sclerostin antibody e-China okwamanje nakuba i-Romosozumab yase-Amgen ivunyelwe e-United States, Europe nase-Japan.

I-Transcenta enelayisense ye-Blosozumab (TST002) evela kwa-Eli Lilly and Company (“Eli Lilly”) ukuze ithuthukiswe futhi idayiswe e-Greater China ngo-2019. U-Eli Lilly uqedele izifundo zomtholampilo zesigaba II se-Blosozumab e-United States nase-Japan futhi uthole iphrofayela yokuphepha ethembisayo. kanye nedatha yokusebenza kahle. I-Transcenta iqede ngempumelelo ukudluliswa kobuchwepheshe, yasungula inqubo yokukhiqiza endaweni yayo ye-Hangzhou HJB, futhi yaqeda ukukhiqizwa kwe-GMP ukuze isetshenziswe emtholampilo kanye nolunye ucwaningo lwangaphambi komtholampilo njengoba kudingwa i-CDE yesicelo se-TST002 IND e-China. I-IND yocwaningo lwase-China lwe-TST002 yasulwa ku-NMPA ngoSepthemba 22, 2021 ukuze kuhlolwe i-TST002 ngokuqondile ezigulini ezine-osteopenia.

"I-TST002 ingase ibe i-anti-sclerostin monoclonal antibody yesibili emhlabeni." kusho uDkt. Michael Shi, i-EVP, iNhloko ye-Global R&D kanye ne-CMO yaseTranscenta. "Sibheke ngabomvu ukwenza ucwaningo olunzulu ukuze siqhubeke nokuhlola ukuphepha nokubekezelelana kwe-TST002 futhi silethe izindlela zokwelapha ezisebenza kahle nezihlukene ezigulini zaseShayina ezine-osteoporosis."

Njengamanje kunabantu abangaphezu kwezigidi eziyi-100 abane-osteoporosis ehlukahlukene e-China futhi abangaphezu kwezigidi ezingu-4 babo bahlushwa ukuphuka kwamathambo. Lezi zinombolo zikhula ngenxa yethonya lendlela yokuphila, ukudla kanye nokuguga kwabantu, okuholela emithwalweni ebalulekile yezempilo, yezomnotho nezenhlalakahle ehambisana nokuphuka okuhlobene ne-osteoporosis. Kunezidingo ezibalulekile ezingafinyeleleki kule ndawo yesifo ikakhulukazi ezigulini ezine-osteoporosis enzima naphezu kokutholakala kwenani lama-agent anti-resorptive njenge-bisphosphonate ne-anti-RANKL inhibitor kanye ne-anabolic agent eqondiswe ku-PTH.