I-Hubei JXBio Pharmaceutical Co., Ltd., indawo yokuvelisa i-peptide ezinikeleyo ye-JYMed, igqibe ngempumelelo olunye uhlolo lwendawo yi-US Food and Drug Administration (FDA) ukususela ngoMatshi 10-14. Uhlolo, oluyinxalenye yoPhicotho loQinisekiso loMgangatho weChiza, luvavanye iinkqubo eziphambili ezibandakanya umgangatho, imveliso, izixhobo kunye nezibonelelo, ulawulo lwelebhu, kunye nolawulo lwemathiriyeli. I-APIs ehlaziyiweyo ibandakanya i-Liraglutide, i-Semaglutide, i-Tirzepatide, kunye ne-Oxytocin.

Emva kokuhlolwa, i-FDA ikhuphe iNgxelo yoHlolo olusemthethweni (EIR), eqinisekisa ukuba imisebenzi ye-Hubei JXBio ihlangabezana nemigangatho ephezulu ye-arhente yomgangatho kunye nokuthotyelwa.

Oku kuphawula uhlolo lwesibini olulandelelanayo lwe-FDA olupasiswe liziko lethu laseHubei, liqinisekisa ukuzinikela kwethu kwimveliso ekumgangatho wehlabathi kunye neenkqubo ezisemgangathweni. Ikwavula indlela yobhaliso lwemveliso yehlabathi kwaye yomeleza indawo yethu kurhwebo lwehlabathi lwepeptide.

Malunga JYMed

I-JYMed yinkampani yoxubo lobuchwephesha obuphezulu obugxile kuphando, uphuhliso, imveliso, kunye norhwebo lweemveliso ezisekwe kwipeptide. Sikwabonelela ngeenkonzo zeCDMO zokugqibela, ezibonelela ngezisombululo zepeptide ezilungiselelwe amayeza, ezozithambiso, kunye nabathengi bezilwanyana kwihlabathi liphela.

Ipotfoliyo yethu yemveliso ibandakanya uninzi lwe-peptide APIs. Iimveliso ze-Flagship ezifana ne-Semaglutide kunye ne-Terlipressin ziye zagqiba ngempumelelo ukufayila kwe-US FDA DMF.

I-subsidiary yethu epheleleyo, i-Hubei JXBio, isebenza ngemigca yemveliso ye-peptide ye-API eyilelwe ukuhlangabezana nemigangatho ye-cGMP esekwe yi-US FDA kunye ne-NMPA yase-China. Eli ziko libandakanya i-10 enkulu kunye ne-pilot-scale-scale imigca yokuvelisa, exhaswa yinkqubo engqongqo yolawulo lomgangatho wamachiza (QMS) kunye nenkqubo eqinile yempilo kunye nokhuseleko lwendalo (EHS).

I-JXBio iphumelele ukuhlolwa kwe-GMP yi-FDA yase-US kunye ne-NMPA yase-China kwaye yamkelwa ziinkampani ezikhokela amayeza zehlabathi ngokugqwesa kulawulo lwe-EHS, ebonisa ukuzibophelela kwethu okungagungqiyo kumgangatho, ukhuseleko, kunye nolawulo lokusingqongileyo.

IiNdawo zoShishino ezingundoqo

• Ubhaliso lwehlabathi kunye nokuthotyelwa kwemithetho yeepeptide APIs

• Iimveliso zepeptide zonyango lwezilwanyana kunye nezithambiso

• Uphuhliso kunye nokuveliswa kwepeptide yesiko (CRO, CMO, OEM)

• Ii-Peptide-drug conjugates (PDCs), kuquka:

• Iiconjugates zePeptide–radionuclide

• I-Peptide-imolekyuli encinci edibanisayo

• Ii-Peptide-protein conjugates

• Unyango lwePeptide–RNA

IIMVELISO EZIPHAMBILI

Ukuze ufumane inkcazelo engakumbi malunga neemveliso zethu, nceda uqhagamshelane nathi:

I-Global API kunye nemibuzo yeCosmetic: +86-150-1352-9272

Ubhaliso lwe-API kunye neeNkonzo ze-CDMO (iimarike zase-US kunye ne-EU): +86-158-1868-2250

I-imeyile:jymed@jymedtech.com

Idilesi: Umgangatho 8 & 9, Isakhiwo 1, Shenzhen Biomedical Innovation Industrial Park,

14 Jinhui Road, kwiSithili saseKengzi, kwiSithili sasePingshan, eShenzhen, eTshayina