Ma Sepatemaba 13, 2022, Shanghai Haihe Pharmaceutical Research and Development Co., Ltd. a me Daehwa Pharmaceutical Co., Ltd. i hoʻolaha pū ʻia ua ʻae ʻia ka paclitaxel oral solution (RMX3001) i hoʻomohala ʻia e nā ʻaoʻao ʻelua e ka Center for Drug. ʻO ka loiloi (CDE) o ka Moku'āina Hoʻokele Lapaʻau.(Helu ʻae: JXHS2200082 ʻāina, JXHS2200083 ʻāina, JXHS2200084 ʻāina).
Puna kiʻi: State Drug Administration
Paclitaxelhoʻohana nui ʻia i ka mālama ʻana i nā maʻi maʻi ʻino like ʻole e like me ka maʻi ʻaʻai māmā, ka maʻi maʻi umauma, ka maʻi maʻi ovarian, ka maʻi maʻi poʻo a me ka ʻāʻī, a me ka maʻi maʻi ʻōpū.ʻO ka polymerization protein, ka hui microtubule, ka pale ʻana i ka depolymerization, a laila e hoʻokūpaʻa i nā microtubules a me ka pale ʻana i ka mitosis o nā maʻi maʻi maʻi a me ka hoʻoulu ʻana i ka apoptosis, no laila e pale pono ai i ka hoʻonui ʻana o nā maʻi kanesa a me ka pāʻani ʻana i kahi hopena anti-cancer.
I kēia manawa, hoʻohana ka hapa nui o ka honua i ka paclitaxel ma ke ʻano o ka injection, pono e hana ʻia a lawelawe ʻia e ka intravenous drip i ka haukapila.Pono ka poʻe maʻi e hoʻi pinepine i ka haukapila, a loaʻa nā hopena ʻino ma ka wahi i hoʻopaʻa ʻia.No laila, ʻo ka hoʻomohala ʻana i ka hoʻomākaukau ʻana i ka paclitaxel waha he wahi wela i ka noiʻi ʻoihana..
ʻO RMX3001 kahi hoʻopuka waha o ka paclitaxel i hoʻomohala ʻia e Dahua Pharmaceutical e pili ana i kāna ʻenehana hoʻopuka lāʻau lipid self-emulsifying drug.Ua ʻae ʻia e ka Korean Food and Drug Administration i Kepakemapa 2016 (ka inoa kalepa ʻo Liporaxel), a ʻo ka hōʻailona he holomua a i ʻole ka lālani lua o ka mālama ʻana i ka maʻi maʻi ʻōpū metastatic a i ʻole ka maʻi maʻi ʻōpū o ka ʻāina.Wahi a kahi paʻi paʻi mai Haihe Pharmaceuticals, ʻo Liporaxel ka huahana paclitaxel waha mua i hoʻomohala maikaʻi ʻia a ʻae ʻia no ke kūʻai aku ma ka honua a hiki i kēia manawa.I Kepakemapa 2017, ua loaʻa iā Haihe Pharmaceutical ka R&D, hana a me nā kuleana kūʻai o ka huahana ma ka ʻāina nui o Kina, Hong Kong, Taiwan a me Thailand mai Dahua Pharmaceuticals.
Hoʻokumu ʻia ka palapala noi papa inoa o RMX3001 ma Kina ma kahi randomized, open-label, parallel-controlled, non-inferiority design, multi-center Phase 3 clinical trial, e manaʻo ana e hoʻohālikelike i ka lāʻau lua o ka paclitaxel oral solution RMX3001 a me paclitaxel injection (Taxol) ʻO ka pono a me ka palekana i nā maʻi me ka maʻi maʻi ʻōpū.Ua alakaʻi pū ʻia ke aʻo ʻana e Profesor Li Jin mai Shanghai Oriental Hospital a me Professor Qin Shukui mai ka Halemai ʻo Nanjing Jinling ma ke ʻano he mea noiʻi nui.
Ua ʻōlelo ʻo Kauka Ruiping Dong, Luna Nui o Haihe Pharmaceuticals: “ʻO ka ʻae ʻia ʻana o ka noi no ka paclitaxel oral solution (RMX3001) kekahi mea koʻikoʻi koʻikoʻi no Haihe Pharmaceuticals, a ke mahalo nui nei au i nā mea noiʻi lapaʻau a me nā maʻi i komo i kā mākou. hookolokolo.ʻO ka maʻi maʻi ʻōpū kiʻekiʻe Aia nō kahi pono lapaʻau nui ʻole i hoʻokō ʻia no ka mālama ʻana, a ke manaʻo nei mākou e lawe mai i nā lāʻau lapaʻau ʻoi loa o ka honua i nā maʻi ma Kina a a puni ka honua i ka hiki wawe.
Ke nānā nei ʻo Yunnan Hande Biotechnology Co., Ltd. i ka hana ʻana o ka paclitaxel no 28 mau makahiki.ʻO ia ka mea hana kūʻokoʻa mua o ka honua i ka paclitaxel lāʻau anticancer i loaʻa i ka mea kanu i ʻae ʻia e ka US FDA, European EDQM, Australian TGA, China CFDA, India, Iapana a me nā keʻena hoʻoponopono aupuni ʻē aʻe.ʻoihana.Inā makemake ʻoe e kūʻaiAPI Paclitaxel,e ʻoluʻolu e kelepona mai iā mākou ma ka pūnaewele.
Ka manawa hoʻouna: Sep-14-2022