An karɓi maganin baka na paclitaxel na farko a duniya a China

A ranar 13 ga Satumba, 2022, Shanghai Haihe Pharmaceutical Research and Development Co., Ltd. da Daehwa Pharmaceutical Co., Ltd. sun ba da sanarwar tare cewa, Cibiyar Kula da Magunguna ta Paclitaxel (RMX3001) tare da hadin gwiwar bangarorin biyu sun amince da su a hukumance. Evaluation (CDE) na Hukumar Kula da Magunguna ta Jiha.(Lambar karɓa: ƙasar JXHS2200082, ƙasar JXHS2200083, ƙasar JXHS2200084).

Gudanarwa

Majiyar hoto: Hukumar Kula da Magunguna ta Jiha

Paclitaxelana amfani da shi sosai wajen magance wasu munanan ciwace-ciwace irin su kansar huhu, sankarar nono, kansar kwai, kansa da wuyansa, da ciwon daji na ciki.Protein polymerization, microtubule taro, hana depolymerization, game da shi tabbatar da microtubules da kuma hana mitosis na ciwon daji Kwayoyin da kuma jawo apoptosis, game da yadda ya kamata hana yaduwa da ciwon daji Kwayoyin da kuma wasa da anti-cancer sakamako.

A halin yanzu, yawancin sassan duniya suna amfani da paclitaxel a cikin nau'i na allura, wanda ya kamata a yi shi da kuma gudanar da shi ta hanyar drip na ciki a asibiti.Marasa lafiya suna buƙatar komawa asibiti akai-akai, kuma za a sami sakamako mara kyau a wurin allurar.Sabili da haka, ci gaban shirye-shiryen paclitaxel na baka ya kasance koyaushe wuri mai zafi a cikin binciken masana'antu..

RMX3001 wani nau'i ne na baka na paclitaxel wanda Dahua Pharmaceutical ya ƙera dangane da sabuwar fasahar isar da magunguna ta lipid.Hukumar Abinci da Magunguna ta Koriya ta amince da ita a cikin Satumba 2016 (sunan ciniki Liporaxel), kuma alamar ta ci gaba ko kuma jiyya na layi na biyu na ciwon daji na ciki na metastatic ko ciwon daji na ciki na gida.A cewar sanarwar manema labarai daga Haihe Pharmaceuticals, Liporaxel shine samfurin paclitaxel na baka na farko wanda aka samu nasarar haɓakawa kuma aka amince dashi don tallatawa a duniya ya zuwa yanzu.A watan Satumba na 2017, Haihe Pharmaceutical ya sami R&D, samarwa da haƙƙin tallace-tallace na samfuran a babban yankin China, Hong Kong, Taiwan da Thailand daga Dahua Pharmaceuticals.

Aikace-aikacen jeri na RMX3001 a kasar Sin ya dogara ne akan bazuwar, lakabin buɗewa, daidaitacce-sarrafawa, ƙira mara ƙarancin ƙima, gwajin gwaji na asibiti da yawa na Phase 3, wanda ke nufin kwatanta jiyya na biyu na maganin baka na paclitaxel RMX3001 da allurar paclitaxel (Taxol) inganci da aminci a cikin marasa lafiya da ciwon daji na ciki.Farfesa Li Jin daga Asibitin Oriental na Shanghai da Farfesa Qin Shukui daga Asibitin Nanjing Jinling ne suka gudanar da binciken tare a matsayin manyan masu bincike.

Dokta Ruiping Dong, Babban Jami'in Harkokin Kasuwancin Haihe Pharmaceuticals, ya ce: "Karbar aikace-aikacen maganin maganin paclitaxel (RMX3001) wani muhimmin ci gaba ne ga Haihe Pharmaceuticals, kuma ina godiya ga masu bincike na asibiti da marasa lafiya da suka shiga cikin mu. gwaji.Ciwon kansar ciwon ciki har yanzu akwai wata babbar buƙatu na asibiti da ba a kai ba, kuma muna fatan za mu kawo sabbin dabaru da ingantattun jiyya ga marasa lafiya a China da ma duniya baki ɗaya da wuri-wuri."

Yunnan Hande Biotechnology Co., Ltd yana mai da hankali kan samar da paclitaxel tsawon shekaru 28.Ita ce masana'anta ta farko mai zaman kanta a duniya na paclitaxel na maganin ciwon daji da aka samo daga shuka wanda FDA ta Amurka, Turai EDQM, TGA ta Australiya, China CFDA, Indiya, Japan da sauran hukumomin kula da ƙasa suka amince.kamfani.Idan kana so ka sayaAPI ɗin Paclitaxel,don Allah a tuntube mu akan layi.


Lokacin aikawa: Satumba-14-2022