Hubei JXBio Pharmaceutical Co., Ltd., sebaka sa tlhahiso ea peptide se inehetseng sa JYMed, se phethetse ka katleho tlhahlobo e 'ngoe ea sebakeng seo ke US Food and Drug Administration (FDA) ho tloha ka la 10-14 Hlakubele. Tlhahlobo ena, e leng karolo ea tlhahlobo ea Tiisetso ea Boleng ba Lithethefatsi, e hlahlobile litsamaiso tsa bohlokoa tse kenyeletsang boleng, tlhahiso, lisebelisoa le lisebelisoa, taolo ea lab, le tsamaiso ea thepa. Li-API tse hlahlobiloeng li kenyelelitse Liraglutide, Semaglutide, Tirzepatide, le Oxytocin.

Ka mor'a tlhahlobo eo, FDA e ile ea fana ka tlaleho ea molao ea Establishment Inspection Report (EIR), e tiisang hore ts'ebetso ea Hubei JXBio e finyella litekanyetso tse phahameng tsa setsi sa boleng le ho latela melao.

Sena se tšoaea tlhahlobo ea bobeli e latellanang ea FDA e fetisitsoeng ke setsi sa rona sa Hubei, e tiisang boitlamo ba rona ho litsamaiso tsa maemo a lefatše tsa tlhahiso le boleng. E boetse e bula tsela bakeng sa ngodiso e bonolo ya dihlahiswa tsa lefatshe mme e matlafatsa maemo a rona mmarakeng wa matjhaba wa peptide.

Mabapi le JYMed

JYMed ke k'hamphani ea theknoloji e phahameng e sebetsanang le lipatlisiso, nts'etsopele, tlhahiso le khoebo ea lihlahisoa tse thehiloeng ho peptide. Re boetse re fana ka lits'ebeletso tsa CDMO tsa ho qetela, tse fanang ka tharollo ea peptide ho bareki ba meriana, ba litlolo le ba bongaka ba liphoofolo lefatšeng ka bophara.

Sehlahisoa sa rona se kenyelletsa li-API tse ngata tsa peptide. Lihlahisoa tsa li-Flagship tse kang Semaglutide le Terlipressin li phethile ka katleho US FDA DMF filing.

Tšehetso ea rona e felletseng, Hubei JXBio, e sebelisa mekhoa ea tlhahiso ea peptide API e hahelletsoeng ho fihlela litekanyetso tsa cGMP tse behiloeng ke US FDA le NMPA ea China. Setsi sena se kenyelletsa mela e 10 ea tlhahiso e kholo le ea liteko, e tšehelitsoeng ke sistimi e thata ea taolo ea boleng ba meriana (QMS) le lenaneo le matla la bophelo bo botle le polokeho ea tikoloho (EHS).

JXBio e fetile tlhahlobo ea GMP ke US FDA le NMPA ea Chaena 'me e amoheloa ke lik'hamphani tse etellang pele tsa meriana lefatšeng ka bophara bakeng sa bokhabane tsamaisong ea EHS, e bonts'ang boitlamo ba rona bo sa thekeseleng ba boleng, polokeho le tlhokomelo ea tikoloho.

Libaka tse kholo tsa Khoebo

• Ngoliso ea lefats'e le ho lumellana le taolo bakeng sa li-API tsa peptide

• Lihlahisoa tsa peptide tsa bongaka ba liphoofolo le litlolo

• Nts'etsopele le tlhahiso ea peptide e ikhethileng (CRO, CMO, OEM)

• Li-conjugates tsa lithethefatsi tsa Peptide (PDCs), ho kenyeletsa:

• Peptide–radionuclide conjugates

• Peptide–makopanyi a molecule e nyane

• Peptide-protein conjugates

• Meriana ea phekolo ea Peptide-RNA

LIHLAHISO TSE KHOLO

Ho tseba haholoanyane ka lihlahisoa tsa rona, ka kopo ikopanye le rona:

Lipotso tsa Global API le Cosmetic: +86-150-1352-9272

Ngoliso ea API & Litšebeletso tsa CDMO (limmaraka tsa US le EU): +86-158-1868-2250

Lengolo-tsoibila:jymed@jymedtech.com

Aterese: Floors 8 & 9, Building 1, Shenzhen Biomedical Innovation Industrial Park,

14 Jinhui Road, Setereke sa Kengzi, Setereke sa Pingshan, Shenzhen, Chaena