ʻO Everest Medicines, kahi hui biopharmaceutical e kālele ana i ka hoʻomohala ʻana a me ka hoʻolaha ʻana i nā huahana lāʻau transformative e hoʻoponopono i nā pono koʻikoʻi i kūpono ʻole i nā mākeke ʻo Asia Pacific, ua hoʻolaha i kēia lā ua ʻae ka Health Science Authority (HSA) o Singapore iā Trodelvy®(sacituzumab govitecan a i ʻole SG) no ka mālama ʻana ʻO nā poʻe maʻi me nā maʻi maʻi maʻi maʻi hiki ʻole ke hoʻoponopono ʻia a i ʻole ka metastatic triple-negative breast cancer (mTNBC) i loaʻa i ʻelua a ʻoi aʻe paha nā lāʻau lapaʻau ma mua, ma ka liʻiliʻi hoʻokahi o lākou no ka maʻi metastatic. Hōʻailona kēia i ka ʻae ʻana o ka lāʻau lapaʻau mua o Trodelvy i loaʻa e Everest. Manaʻo ka Hui i nā ʻae ʻia no Trodelvy ma kāna mau wahi laikini i ka makahiki e hiki mai ana.
"Ma ke ʻano o kā mākou hoʻolālā ʻoihana nui e kūkulu i kahi ʻoihana kūʻai ikaika ma nā mākeke ʻo Asia Pākīpika, ua kūpono mākou i ka wikiwiki i ka wā o kēia kaʻina o ka ulu ʻana me kahi hui pāʻoihana paʻa, e hoʻopaʻa ana i ka ʻokoʻa ma waena o nā maʻi me nā pono lapaʻau pono ʻole. -in-class biopharmaceutical innovation, "wahi a Kerry Blanchard, MD, PhD, Luna Nui o Everest Medicines. "Ma kahi hana aʻe e hana pū mākou me nā mea kuleana āpau e lawe mai iā Trodelvy i nā wahine ma Singapore e noho ana me ka metastatic TNBC."
"ʻO TNBC ka 15-20% o nā maʻi maʻi maʻi maʻi āpau ma Singapore, a ʻo ka maʻi kanesa o ka umauma ke kumu nui o ka make ʻana o ka maʻi kanesa i nā wahine. ʻO kēia ʻano koʻikoʻi a paʻakikī i ka mālama ʻana o ka maʻi i ka wā kahiko he mau koho lapaʻau liʻiliʻi loa, me ke ola holoʻokoʻa i hoʻololi ʻole ʻia i waena o nā mea maʻi no kahi kokoke i ʻelua mau makahiki, "wahi a Yang Shi, Luna Nui o ka Oncology ma Everest Medicines. ʻO kēia kaʻina hana hoʻoponopono e lawe iā Trodelvy i kahi ʻanuʻu kokoke i nā mea maʻi Singaporean me ka metastatic TNBC.
Ma waho aʻe o Singapore, ke hui pū nei ʻo Everest me nā kino hoʻoponopono ma Greater China a me South Korea e nānā i kāna mau noi no Trodelvy no nā poʻe maʻi makua me ka TNBC kūloko kūloko a i ʻole metastatic i loaʻa i ʻelua a ʻoi aʻe nā lāʻau lapaʻau ma mua, ma ka liʻiliʻi hoʻokahi o lākou. maʻi metastatic.
• Ma Mei 2021, ua ʻae ka China National Medical Products Administration i kāna palapala noi Biologic License no Trodelvy me ka loiloi mua.
• I Kekemapa 2021, ua ʻae ke Kuhina o ka Meaʻai a me ka Palekana Lapaʻau (MFDS) o South Korea i kahi noi lāʻau hou (NDA) no Trodelvy. Ua hāʻawi mua ʻia ʻo Trodelvy i ka Hoʻohanohano ʻo Fast Track a me Orphan Drug Designation ma South Korea.
• I Dekemaba 2021, ua ʻae ka Taiwan Food and Drug Administration i kāna NDA no Trodelvy. Ua hāʻawi mua ʻia ʻo Trodelvy i ka Pediatric and Rare Severe Severe Priority Review Designation ma Taiwan.
He aha e lawe ʻia mai kēia ʻatikala:
- Ma waho aʻe o Singapore, ke hui pū nei ʻo Everest me nā kino hoʻoponopono ma Greater China a me South Korea e nānā i kāna mau noi no Trodelvy no nā poʻe maʻi makua me ka TNBC kūloko kūloko a i ʻole metastatic i loaʻa i ʻelua a ʻoi aʻe nā lāʻau lapaʻau ma mua, ma ka liʻiliʻi hoʻokahi o lākou. maʻi 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,”.
