I-JYMed Technology Co., Ltd. iyavuya ukwazisa ukuba imveliso yayo, iTirzepatide, igqibe ngempumelelo iDrug Master File (DMF) yobhaliso kunye ne-US FDA (iNombolo yeDMF: 040115) kwaye ifumene i-Acknowledgement ye-FDA ngo-Agasti 2, 2024.
Ukuveliswa kweMisa kunye noMgangatho oZinzileyo
Ngokutsho kwabaphathi abaphezulu be-JYMed Technology, imveliso eninzi ye-Tirzepatide Active Pharmaceutical Ingredient (API) inokufikelela kumanqanaba eekhilogram. Iibhetshi zemveliso zizinzile kwaye ziyaqhubeka, kunye nokuhluka okuncinci phakathi kweebhetshi, ukuqinisekisa umgangatho ohambelanayo.
Iimpembelelo ezibalulekileyo kwiGlucose kunye nokuNcitshiswa kweLipid
I-Tirzepatide yi-agonist yokuqala yehlabathi evunyiweyo kanye ngeveki ye-GIP/GLP-1. Njenge-agonist ye-receptor ezimbini, inokubopha ngaxeshanye kwaye isebenze zombini i-glucose exhomekeke kwi-insulinotropic polypeptide (GIP) receptor kunye ne-GLP-1 receptor emzimbeni womntu. Ukongeza ekunciphiseni amanqanaba e-glucose, kunciphisa ukutya, ubunzima bomzimba, kunye nomxholo wamafutha, kwaye ilawula ukusetyenziswa kwe-lipid. Ngaphandle kweziphumo zayo ezibalulekileyo zokwehliswa kweglucose kunye nokunciphisa ubunzima, uhlahlelo lweqela elingaphantsi kuluhlu lwe-SURPASS lwezifundo lubonise ukuba iTirzepatide ikwaphucula izikhombisi zemetabolism ezifana noxinzelelo lwegazi, i-lipids yegazi, i-BMI, kunye nomjikelezo wesinqe.
Ukuvunywa kwezizwe ngezizwe kunye neZibonelelo ezithembisayo
Ngokolwazi olufanelekileyo, i-glucose-ehlisa i-Mounjaro yamkelwa okokuqala yi-FDA yase-US ngoMeyi ka-2022 kunyango lwabantu abadala abanesifo seswekile se-2. Emva koko ifumene imvume kwi-EU, eJapan, nakweminye imimandla. NgoNovemba ka-2023, i-FDA iphinde yavuma isalathiso sokuncipha kobunzima phantsi kwegama lebrand Zepbound. NgoMeyi ka-2024, yangena ngempumelelo kwimarike yaseTshayina. Ngenxa yokusetyenziswa kwayo okubanzi kunye neenkcukacha zophando ezixhasayo, iTirzepatide iye yaba lelinye lamachiza epeptide abalaseleyo namhlanje. Ukuthengiswa kwayo kufikelele kwi-5.163 yeebhiliyoni zeedola ngo-2023, kwaye ikota yokuqala ye-2024 yodwa yabona intengiso ye-2.324 yeebhiliyoni zeedola, ebonisa izinga lokukhula elimangalisayo.
Malunga JYMed
I-Shenzhen JYMed Technology Co., Ltd. (emva koku ebizwa ngokuba yi-JYMed) yasekwa ngo-2009, igxile kuphando, uphuhliso, imveliso, kunye nokuthengiswa kweepeptides kunye neemveliso ezinxulumene ne-peptide. Ngeziko elinye lophando kunye neziseko ezintathu eziphambili zemveliso, i-JYMed yenye yabavelisi abakhulu bee-APIs ze-peptide ezenziwe ngamachiza e-China. Iqela eliphambili lenkampani le-R&D liqhayisa ngaphezulu kweminyaka engama-20 yamava kwishishini le-peptide kwaye liphumelele ngempumelelo uhlolo lwe-FDA kabini. Inkqubo yoshishino ye-peptide ebanzi kunye nesebenzayo ye-JYMed inikezela abathengi uluhlu olupheleleyo lweenkonzo, kubandakanywa uphuhliso kunye nokuveliswa kweepeptide zonyango, iipeptide zezilwanyana, i-antimicrobial peptides, kunye ne-cosmetic peptides, kunye nokubhaliswa kunye nenkxaso yokulawula.
Imisebenzi yoShishino oluPhambili
1.Ubhaliso lwasekhaya kunye nolwamazwe ngamazwe lwe-peptide APIs
2.Izilwanyana zezilwanyana kunye ne-cosmetic peptides
3.Custom peptides kunye CRO, CMO, OEM iinkonzo
Amachiza e-4.PDC (i-peptide-radionuclide, i-peptide-imolekyuli encinci, i-peptide-protein, i-peptide-RNA)
Ukongeza kwi-Tirzepatide, i-JYMed ingenise iifayili zobhaliso kunye ne-FDA kunye ne-CDE kwezinye iimveliso ze-API, kubandakanywa amachiza aziwayo eklasi ye-GLP-1RA njengeSemaglutide kunye neLiraglutide. Abathengi bexesha elizayo abasebenzisa iimveliso ze-JYMed baya kukwazi ukubhekisela ngokuthe ngqo kwinombolo yobhaliso ye-CDE okanye inombolo yefayile ye-DMF xa befaka izicelo zokubhalisa kwi-FDA okanye kwi-CDE. Oku kuya kunciphisa kakhulu ixesha elifunekayo ukulungiselela amaxwebhu ezicelo, kunye nexesha lokuvavanya kunye neendleko zokuphononongwa kwemveliso.
Qhagamshelana nathi
IShenzhen JYMed Technology Co., Ltd.
Idilesi:8th & 9th Floor, Building 1, Shenzhen Biomedical Innovation IndustrialIpaki, iNombolo ye-14 yeNdlela yeJinhui, kwiSithili saseKengzi, kwiSithili sasePingshan, eShenzhen
Ifowuni:+86 755-26612112
Iwebhusayithi: http://www.jymedtech.com/
Ixesha lokuposa: Aug-12-2024