Loaʻa ka Laikini Hana Hana Hou i kūkulu ʻia ma Kina

PALAPALA 1 | eTurboNews | eTN
i kakauia ma Linda Hohnholz

ʻO Jiangsu Recbio Technology Co., Ltd., kahi hui biopharmaceutical e kālele ana i ka noiʻi, hoʻomohala ʻana a me ka hoʻolaha ʻana i nā lāʻau lapaʻau hou e hiki ai ke hoʻoponopono i nā maʻi maʻamau me nā kaumaha koʻikoʻi, ua hoʻolaha koke nei ua loaʻa i ka hui ka Laikini Hana Hana Lapaʻau (ke kiko: recombinant two-component ʻO ka maʻi maʻi COVID-19 [CHO cell]) i hoʻopuka ʻia e ka Jiangsu Medical Products Administration (JSMPA).

Hōʻike ia ua kūpono ka hale hana Recbio ma Taizhou, ka moku ʻo Jiangsu, Kina (Taizhou hale) e hana i ka maʻi maʻi COVID-19 recombinant ʻelua [CHO cell] (ReCOV), e hōʻike ana ua hana ʻo Recbio i kahi hana koʻikoʻi i kahi ʻoihana kano me kahi kaulahao ʻoihana holoʻokoʻa e uhi ana i ka noiʻi, hana a me ke kūʻai aku.         

Ua hoʻolālā ʻia ka hale hana hou i kūkulu ʻia ma muli o nā maʻamau ʻo Good Manufacturing Practices (cGMP) i kēia manawa. Me ka nui o ka GFA ma luna o 17,000 sq.m., ua loaʻa i ka hale ʻo Taizhou kahi mana hana makahiki ma mua o 100 miliona mau doses, hiki ke hoʻonui koke ʻia i 300 miliona doses i kēlā me kēia makahiki.

I nā makahiki he 10 i hala iho nei, ua hoʻohana mālie ʻia nā adjuvants hou i ka ʻoihana kano a lawe mai i nā loli hohonu i ka ʻoihana. ʻO Recbio kekahi o nā hui liʻiliʻi me ka hiki ke hana ʻoihana no nā adjuvants hou i ʻae ʻia e FDA no ka hoʻohana kanaka. Mahalo i kēlā, ʻo nā kano i hoʻomohala ʻia e ka ʻoihana ʻaʻole wale ka hana kiʻekiʻe, akā ʻaʻole hilinaʻi i kekahi mea hoʻolako adjuvant. Hoʻolako ʻia me kahi moʻolelo i kūkulu ʻia i loko o ka hale i kūkulu ʻia BFA03 benchmarking AS03, ua hōʻike ʻo ReCOV i ka immunogenicity maikaʻi loa, palekana, a me ka hoʻomanawanui ʻana i ka Phase I clinical study ma New Zealand. ʻO ka mea nui, ʻaʻole i liʻiliʻi ka helu o ka neutralizing antibodies i hoʻoiho ʻia e ReCOV ma mua o ka mea i hoʻoiho ʻia e nā kano mRNA mainstream honua. Manaʻo ʻia ʻo ReCOV e noi no kahi EU (Emergency Use Authorization) ma mua o ka hapa mua o 2022.

E pili ana i ka ma'i ma'i COVID-19 (ReCOV)

I Mei 2020, ʻo Recbio, me Jiangsu Provincial Center for Disease Control and Prevention (“Jiangsu CDC”) a me Taizhou Medical New & High-tech Industrial Development Zone, i hoʻomohala pū i kahi kano COVID-19 (ReCOV). Ma lalo o ke alakaʻi ʻana a Profesor Fengcai Zhu mai ka Jiangsu CDC, ua hoʻopaʻa maikaʻi ka hui R&D i ke kano me ka hoʻohana ʻana i ka ʻenekinia protein a me nā ʻenehana adjuvant hou i hiki ai iā ReCOV ke hoʻohiki i ka palekana a me ka immunogenicity ikaika e kūʻē iā SARS-CoV-2 a me nā ʻano hopohopo e like me Delta. ʻO kahi pūʻulu o nā pōmaikaʻi piha e like me ka pale ʻoi aku ka maikaʻi o ka pale ʻana i nā ʻano like ʻole e kū mai ana, ka hoʻonui ʻana i ka hana maʻalahi, nā uku kumukūʻai, hiki ke komo i ka honua holoʻokoʻa, kūpaʻa hoʻomākaukau maikaʻi, a me ka mālama ʻana a me ka lawe ʻana i ka lumi lumi i lilo i mea hoʻokūkū hou i ka lua o ka hanauna hou COVID-19 kano. .

He aha e lawe ʻia mai kēia ʻatikala:

  • Under the guidance of Professor Fengcai Zhu from the Jiangsu CDC, the R&D team thoroughly optimized the vaccine using protein engineering and new adjuvant technologies so that ReCOV has promising safety and strong immunogenicity against SARS-CoV-2 and variants of concern such as Delta.
  • Hōʻike ia ua kūpono ka hale hana Recbio ma Taizhou, ka moku ʻo Jiangsu, Kina (Taizhou hale) e hana i ka maʻi maʻi COVID-19 recombinant ʻelua [CHO cell] (ReCOV), e hōʻike ana ua hana ʻo Recbio i kahi hana koʻikoʻi i kahi ʻoihana kano me kahi kaulahao ʻoihana holoʻokoʻa e uhi ana i ka noiʻi, hana a me ke kūʻai aku.
  • A series of comprehensive advantages such as better cross-protection against emerging variants, easy production scale-up, cost advantages, worldwide accessibility, good preparation stability, and storage and transportation at room temperature become a very competitive second-generation new COVID-19 vaccine.

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Linda Hohnholz

Lunahooponopono no eTurboNews ma ka eTN HQ.

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