Everest Medicines, k'hamphani ea biopharmaceutical e tsepamisitseng maikutlo ho nts'etsopele le ho rekisa lihlahisoa tsa meriana tse fetohang ho sebetsana le litlhoko tsa bohlokoa tsa mebaraka ea Asia Pacific, e phatlalalitse kajeno hore Health Sciences Authority (HSA) ea Singapore e amohetse Trodelvy® (sacituzumab govitecan kapa SG) bakeng sa phekolo ea bakuli ba baholo ba nang le mofetše oa matsoele o tsoetseng pele kapa oa metastatic triple-negative (mTNBC) ba fumaneng liphekolo tsa pele tse peli kapa ho feta, bonyane e 'ngoe ea tsona bakeng sa lefu la metastatic. Sena se tšoaea tumello ea pele ea lithethefatsi ea Trodelvy e amoheloang ke Everest. Khampani e lebelletse letoto la tumello bakeng sa Trodelvy libakeng tsa eona tsa laesense selemong se tlang.
"E le karolo ea leano la rona le leholo la khoebo ho aha boteng bo matla ba khoebo mebarakeng ea Asia Pacific, re boemong bo botle ba ho potlaka ka potlako nakong ena e latelang ea kholo le sehlopha sa khoebo se thehiloeng, ho koala lekhalo lipakeng tsa bakuli ba nang le litlhoko tsa bongaka tse sa fihlelleheng le pele. -in-class biopharmaceutical innovation, "ho boletse Kerry Blanchard, MD, PhD, Mookameli ea ka Sehloohong oa Everest Medicines. "E le mohato o latelang re tla sebetsa 'moho le bohle ba amehang ho tlisa Trodelvy ho basali ba Singapore ba phelang le TNBC ea metastatic."
“TNBC e nka karolo ea 15-20 lekholong ea mafu a mofetše oa matsoele Singapore, ’me mofetše oa matsoele ke oona o bakang lefu la mofetše ho basali ka har’a naha. Mofuta ona oa lefu lena o mabifi le oo ho leng thata ho o phekola esale o na le likhetho tse fokolang haholo tsa kalafo, 'me bophelo ka kakaretso bo lutse bo sa fetohe har'a bakuli ka lilemo tse ka bang mashome a mabeli, "ho boletse Yang Shi, Ofisiri e ka Sehloohong ea Bongaka bakeng sa Oncology ho Everest Medicines. Mohato ona oa bohlokoa oa taolo o atametsa Trodelvy mohato o le mong ho bakuli ba Singapore ba nang le metastatic TNBC.
Ntle le Singapore, Everest e hokahana haufi-ufi le mekhatlo ea taolo ea Greater China le Korea Boroa ho lekola likopo tsa eona bakeng sa Trodelvy bakeng sa bakuli ba baholo ba nang le TNBC e tsoetseng pele ea lehae kapa metastatic TNBC ba fumaneng liphekolo tse peli kapa ho feta tsa pele tsa kalafo, bonyane e 'ngoe ea tsona lefu la metastatic.
• Ka Motsheanong 2021, Tsamaiso ya Naha ya Dihlahiswa tsa Bongaka ya China e amohetse Kopo ya yona ya Laesense ya Biologics bakeng sa Trodelvy ka tlhahlobo e tlang pele.
• Ka Tšitoe 2021, Lekala la Polokeho ea Lijo le Lithethefatsi (MFDS) la Korea Boroa le amohetse Kopo e Ncha ea Lithethefatsi (NDA) bakeng sa Trodelvy. Trodelvy o kile a fuoa Lebitso la Fast Track le Lebitso la Lithethefatsi la Likhutsana Korea Boroa.
• Ka Tšitoe 2021, Tsamaiso ea Lijo le Lithethefatsi ea Taiwan e amohetse NDA ea eona bakeng sa Trodelvy. Trodelvy o kile a fuoa Tlhokomelo ea Tlhahlobo ea Bohlokoa ba Bana le Mafu a Rare Severe naheng ea Taiwan.
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- Ntle le Singapore, Everest e hokahana haufi-ufi le mekhatlo ea taolo ea Greater China le Korea Boroa ho lekola likopo tsa eona bakeng sa Trodelvy bakeng sa bakuli ba baholo ba nang le TNBC e tsoetseng pele ea lehae kapa metastatic TNBC ba fumaneng liphekolo tse peli kapa ho feta tsa pele tsa kalafo, bonyane e 'ngoe ea tsona lefu la metastatic.
- Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that the Health Sciences Authority (HSA) of Singapore has approved Trodelvy®(sacituzumab govitecan or SG) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
- “As part of our larger business strategy to build a robust commercial presence in Asia Pacific markets, we are well-positioned to accelerate quickly during this next phase of growth with an established commercial team, bridging the gap between patients with unmet medical needs and first-in-class biopharmaceutical innovation,”.
