Ukuhlolwa Okusha Komtholampilo Komuthi Omusha Wophenyo Wokwelapha I-Alopecia

A BAMBA MahhalaRelease 3 | eTurboNews | eTN
Ibhalwe ngu Linda Hohnholz

I-Hope Medicine Inc., okuyinkampani emisha ye-biopharmaceutical esiteji somtholampilo, isanda kumemezela ukuthi i-US Food and Drug Administration (FDA) isivumile isicelo sayo se-Investigational New Drug (IND) socwaningo lwesigaba II ukuze ihlole i-HMI-115, esezingeni lokuqala. isidakamizwa se-monoclonal antibody ekwelapheni i-androgen alopecia. Ngo-2021, i-HMI-115 isivele ithole I-US FDA Clearance of IND Application yeSigaba II sokuhlolwa komtholampilo kokwelashwa kwe-endometriosis.

Ngo-April 2019, i-HopeMed yenza isivumelwano selayisense esikhethekile somhlaba wonke ne-Bayer AG mayelana nokuthuthukiswa nokudayiswa kwe-anti-monoclonal antibody eqondise i-PRL receptor yokwelapha ukuqothuka kwezinwele zephethini yabesilisa nabesifazane, i-endometriosis, nezinye izifo ezingamahlalakhona nge-dysregulated prolactin. (PRL) ukusayina. Le antibody ibonise izici ezinhle kakhulu kumamodeli ezilwane okuhlanganisa amamodeli e-NHP nocwaningo lokuphepha kwabantu. Ukwelashwa kwayo kwezinkomba ezimbili eziyinhloko, i-endometriosis kanye ne-androgenetic alopecia, kokubili kuvunywe yi-US FDA ezinhlolweni zomtholampilo zeSigaba II. Uhlolo lomtholampilo lwesigaba II se-HMI-115 ku-endometriosis seluvele luqalile ukubhaliswa kwesiguli e-US ekupheleni kuka-2021. Uhlolo lwaso lomtholampilo lweSigaba II sokwelashwa kwe-androgenetic alopecia luyisizinda esiningi samazwe ngamazwe, olungahleliwe, olungaboni kabili, lwe-placebo- ucwaningo olulawulwayo, okuhlelwe ukuthi lwenziwe e-United States, e-Australia nakwamanye amazwe.

UDkt. Henri Doods, oyi-CEO ye-HopeMed, uthe “Ngiyaziqhenya kakhulu ngokuthi i-FDA iphinde yagunyaza i-IND yethu yesibili okuyigxathu elibalulekile enkampanini yethu encane. Kuyisinyathelo esibalulekile esiya kunjongo yethu yokuletha i-First-in-Class kanye nemikhiqizo ehluke kakhulu ezigulini. Kokubili i-endometriosis kanye ne-alopecia kuyizinkomba lapho iziguli zilindele ngabomvu izinketho ezintsha zokwelapha ezisebenza ngempumelelo nokuphepha. Impumelelo yokuba nezimvume ezimbili ze-IND ngesikhathi esifushane kangaka iyisikhuthazo kulo lonke iqembu. Sizibophezele kakhulu ekuqhubekeni nokuqinisa nokwandisa imisebenzi yethu ye-R&D ukuze ilethe izindlela zokwelapha ezintsha ezigulini emhlabeni jikelele.”

 

LOKHO ONGAKUTHATHE KULESI SIHLOKO:

  • Isivivinyo saso somtholampilo seSigaba sesi-II sokwelashwa kwe-androgenetic alopecia siwucwaningo lwamazwe ngamazwe olugxile ezintweni eziningi, olungahleliwe, olungaboni kabili, olulawulwa yi-placebo, oluhlelelwe ukuthi lwenziwe e-United States, e-Australia nakwamanye amazwe.
  • Ngo-Ephreli 2019, i-HopeMed yangena esivumelwaneni selayisense esikhethekile somhlaba wonke ne-Bayer AG mayelana nokuthuthukiswa nokudayiswa kwe-anti-monoclonal antibody eqondise i-PRL receptor yokwelapha ukuqothuka kwezinwele zephethini yabesilisa nabesifazane, i-endometriosis, nezinye izifo ezingamahlalakhona nge-dysregulated prolactin. (PRL) ukusayina.
  • Impumelelo yokuba nezimvume ezimbili ze-IND ngesikhathi esifushane kangaka isikhuthazo kulo lonke iqembu.

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Linda Hohnholz

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