Shaanxi BLOOM Tech Co., Ltd. yog ib tug ntawm cov uas paub txog manufacturers thiab lwm tus neeg ntawm lanreotide txhaj nyob rau hauv Suav teb. Txais tos rau kev lag luam wholesale bulk zoo lanreotide txhaj rau muag ntawm no los ntawm peb lub hoobkas. Kev pabcuam zoo thiab tus nqi tsim nyog muaj.
Kev txhaj tshuaj Lanreotideyog ib qho kev sib xyaw ua ke ntev ntev - ua yeeb yam somatostatin analog tsuas yog siv rau kev kho mob ntawm acromegaly thiab lwm yam mob tshwm sim los ntawm cov qog neuroendocrine. Nws cov ntsiab lus tseem ceeb, lanreotide, zoo inhibits qhov tso tawm ntawm kev loj hlob hormone (GH) thiab insulin-zoo li kev loj hlob yam-1 (IGF-1) los ntawm kev khi rau somatostatin receptors (tshwj xeeb tshaj yog SSTR2 thiab SSTR5 subtypes), yog li tswj kev nce qib ntawm acromegaly hauv cov neeg mob.
Cov tshuaj muaj ob daim ntawv tseem ceeb: sustained - tso tawm microsphere hmoov thiab ntev - ua yeeb yam hydrogel txhaj. Qhov tshwj xeeb ntawm sustained - tso tawm microsphere hmoov yog 30mg lossis 40mg; ntev -kev txhaj tshuaj hydrogel (xws li Somadulin) ® ATG txais kev txhaj tshuaj ua ntej tus cwj mem, nrog cov lus qhia tshwj xeeb suav nrog 60mg / 0.2ml, 90mg / 0.3ml, thiab 120mg / 0.5ml. Lub tom kawg siv tus kheej siab tshaj - sib dhos nanotube thev naus laus zis kom ua tiav cov tshuaj tso tawm, nrog lub sijhawm ntev tshaj plaws ntawm kev siv tshuaj txog li 56 hnub, txhim kho kev ua raws li cov neeg mob.
Peb Cov Khoom Muag Khoom
lanreotide COA
 |
||
| Certificate of Analysis | ||
| Compound npe | Lanreotide / Somatuline | |
| Qib | Pharmaceutical qib | |
| CAS Nr. | 108736-35-2 | |
| Ntau | Customize | |
| Ntim txheem | Customize | |
| Chaw tsim tshuaj paus | Shaanxi BLOOM TECH Co., Ltd | |
| Ntau No. | 202601090055 | |
| MFG | Peb 9, 2026 | |
| EXP | Peb 8, 2029 | |
| Qauv |
|
|
| Yam khoom | Enterprise txheem | Kev txheeb xyuas qhov tshwm sim |
| Qhov tshwm sim | Dawb los yog yuav luag dawb hmoov | Ua raws |
| Cov ntsiab lus dej | Tsawg dua lossis sib npaug li 5.0% | 0.48% |
| Poob rau ziab | Tsawg dua lossis sib npaug li 1.0% | 0.30% |
| Hnyav Hlau | Pb Tsawg dua lossis sib npaug li 0.5ppm | N.D. |
| Tsawg dua lossis sib npaug li 0.5ppm | N.D. | |
| Hg Tsawg dua lossis sib npaug li 0.5ppm | N.D. | |
| Cd Tsawg dua lossis sib npaug li 0.5ppm | N.D. | |
| Purity (HPLC) | Ntau dua lossis sib npaug li 99.0% | 99.90% |
| Ib leeg impurity | <0.8% | 0.56% |
| Tag nrho microbial suav | Tsawg dua lossis sib npaug li 750cfu / g | 170 |
| E. Coli | Tsawg dua lossis sib npaug li 2MPN / g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (los ntawm GC) | Tsawg dua lossis sib npaug li 5000ppm | 400ppm ua |
| Cia | Khaws rau hauv qhov chaw kaw, tsaus, thiab qhuav hauv qab -20 degree | |
|
|
||
|
|
||
| Chemical Formula: | C54H69N11O10S2 |
| Exact Mass: | 1095 |
| Molecular Luj: | 1096 |
| m/z: | 1095 (100.0%), 1096 (58.4%), 1097 (16.7%), 1097 (9.0%), 1098 (5.3%), 1096 (4.1%), 1098 (3.1%), 1097 (2.4%), 1097 (2.1%), 1096 (1.6%), 1099 (1.5%), 1098 (1.2%) |
| Elemental Analysis: | C, 59.16; H, 6.34; N, 14.05; O, 14.59; S, 5.85 |
Gastrointestinal pancreatic neuroendocrine hlav (GEP NETs) yog ib hom qog nqaij hlav tsis tshua muaj tshwm sim los ntawm kab mob plab lossis kab mob pancreas, suav txog kwv yees li 55% -70% ntawm tag nrho cov qog neuroendocrine. Hauv Suav teb, nws qhov xwm txheej yog 114/100000, thiab nws yuav siv sijhawm nruab nrab ntawm 4.8 xyoo rau cov neeg mob kuaj.Kev txhaj tshuaj Lanreotideraws li ntev - ua yeeb yam somatostatin analog, ua lub luag haujlwm tseem ceeb hauv kev kho GEP NETs.
Raws li thawj - tshuaj kho kab mob
Ntau qhov kev tshawb fawb soj ntsuam tau lees paub tias nws cov txiaj ntsig tseem ceeb hauv kev ncua ntev kev muaj sia nyob dawb (PFS) hauv cov neeg mob nrog GEP NETs. Piv txwv li, hauv kev sim CLARINET, 204 cov neeg mob uas tsis tuaj yeem kho tsis tau, muaj kev sib txawv heev lossis tsis sib xws, hauv zos qib siab, lossis metastatic GEP NETs tau suav nrog, ntawm 55% yog thawj tus neeg mob pancreatic. Cov neeg mob no tau muab faib ua pawg kho tshuaj thiab pab pawg tswj hwm cov placebo, nrog rau pawg no tau txais kev txhaj tshuaj subcutaneous ntawm 120mg ntawm lanreotide txhua 28 hnub. Cov txiaj ntsig tau pom tias qhov nruab nrab ntawm kev muaj sia nyob tsis muaj sia nyob ntawm cov neeg mob hauv pab pawg no tau tshaj 22 lub hlis, thaum pawg placebo tsuas muaj 16.6 lub hlis, nrog rau qhov phom sij (HR) ntawm 0.47 (95% CI 0.30-0.73, P.<0.001, log rank test), indicating that lanrelitide can significantly reduce the risk of disease progression. The research results were published in relevant medical journals, providing important evidence for its use as a first-line treatment for GEP NETs.
Hauv Suav teb, cov kev tshawb fawb soj ntsuam cuam tshuam kuj tau ua tiav ntawm Yipusheng qhov kev txhawb nqa - tso tawm acetate lanrelitide txhaj tshuaj (ua ntej sau). Cov txiaj ntsig ntawm nws txoj kev tshawb fawb Phase III tau pom tias cov khoom lag luam tuaj yeem ua kom ntev li kev loj hlob dawb ntawm cov neeg mob los ntawm 38.5 lub hlis thiab txo qhov kev pheej hmoo ntawm tus kab mob rov qab los ntawm 53%. Cov ntaub ntawv no qhia ntxiv txog nws txoj kev ua tau zoo thiab qhov zoo hauv Suav GEP NETs cov neeg mob, thiab vim li ntawd, cov khoom lag luam tau raug pom zoo ua ib qho tshuaj kho SSA los ntawm European Society of Neuroendocrine Oncology (ENETS) thiab cov lus qhia muaj cai hauv Suav teb.
Ntxiv nrog rau kev kho mob monotherapy, nws ua ke nrog lwm cov tshuaj kuj tau coj txoj kev cia siab tshiab rau cov neeg mob GEP NETs. JCOG1901 (STARTER-NET) txoj kev tshawb fawb, nthuav tawm ntawm American Society of Clinical Oncology Gastrointestinal Oncology Symposium 2025 (ASCO GI 2025), yog theem III txoj kev tshawb fawb txog kev sib xyaw ntawm everolimus thiab lenteride nrog everolimus monotherapy rau unresectable lossis recurrent}GEP. Txoj kev tshawb no suav nrog cov neeg mob uas muaj qhov sib txawv zoo (Qib 1/2), tsis ua haujlwm GEP-NET, thiab cov yam ntxwv tsis zoo (Ki-67 qhov ntsuas qhov ntsuas ntawm 5-20% lossis muaj lub siab diffuse metastasis). Cov neeg mob tau muab tso rau hauv qhov sib piv ntawm 1: 1 rau pawg everolimus monotherapy (EVE, 10 mg / hnub) lossis everolimus ua ke nrog lenvatinib pawg (EVE + LAN, 120 mg txhua 28 hnub).
Cov txiaj ntsig kev tshawb fawb tau pom tias qhov nruab nrab PFS ntawm pawg everolimus monotherapy yog 11.5 lub hlis, thaum qhov nruab nrab PFS ntawm pab pawg kho mob ua ke tau ntev mus rau 29.7 lub hlis (HR=0.38; 99.91% CI: 0.15-0.96, P{5}}, 4,0,0,0,0,0,0,0 stratified log rank test). Nyob rau hauv cov nqe lus ntawm lub hom phiaj teb tus nqi (ORR), pawg everolimus monotherapy muaj ORR ntawm 8.7% (6/69), thaum pab pawg kho mob ua ke muaj ORR ntawm 26.8% (19/71); Nyob rau hauv cov nqe lus ntawm tus kab mob tswj tus nqi (DCR), pawg monotherapy nrog everolimus muaj tus nqi ntawm 87.0% (60/69), thaum pab pawg kho mob ua ke muaj tus nqi ntawm 91.5% (65/71). Txawm hais tias pawg kho mob sib xyaw ua ke muaj qhov tshwm sim ntau dua ntawm hematological thiab tsis muaj hematological toxicity dua li pawg kws kho mob monotherapy, tsis muaj kev kho mob ntsig txog kev tuag, thiab kev nyab xeeb tag nrho yog tswj tau.
Raws li cov txiaj ntsig tau txais txiaj ntsig saum toj no, Pawg Saib Xyuas Kev Nyab Xeeb thiab Kev Nyab Xeeb (DSMC) pom zoo kom txiav tawm qhov kev tshawb fawb no thaum ntxov, qhia tias kev sib xyaw ntawm everolimus thiab lenteride tuaj yeem dhau los ua thawj zaug tshiab - kab kev kho tus qauv rau kev sib txawv GEP zoo - NET cov neeg mob uas muaj qhov cuam tshuam tsis zoo.
Siv rau kev kho mob tshwj xeeb ntawm GEP NETs
Rau cov neeg mob uas tsis tuaj yeem kho lossis metastatic GEP NETs,kev txhaj tshuaj lanreotideyog ib txoj kev kho mob tseem ceeb. Vim tias cov qog nqaij hlav hauv cov neeg mob no tsis tuaj yeem raug phais tshem tawm thiab tej zaum yuav kis mus rau lwm qhov chaw, cov kev kho ib txwm siv feem ntau tsis muaj txiaj ntsig. Los ntawm kev sib tw thaiv cov somatostatin receptors, kev loj hlob thiab kev loj hlob ntawm cov qog hlwb raug cuam tshuam, yog li tswj kev loj hlob ntawm tus kab mob. Piv txwv li, nyob rau hauv ob qho tib si CLARINET sim hais los saum toj no thiab theem III kev soj ntsuam kev tshawb fawb nyob rau hauv Tuam Tshoj, ib tug loj tus naj npawb ntawm unresectable los yog metastatic GEP NETs cov neeg mob tau suav nrog, thiab cov kev tshawb fawb tau pom tau hais tias lawv muaj peev xwm ua tau kom ncua kev vam meej ntawm cov neeg mob thiab txhim kho lawv prognosis.
2. Cov qog nqaij hlav nrog cov qib sib txawv ntawm qhov sib txawv
Tsim nyog rau GEP NETs cov neeg mob uas muaj qib sib txawv ntawm qhov sib txawv. Ob qho tib si sib txawv thiab sib txawv nruab nrab GEP NETs tuaj yeem siv qee yam kev kho mob. Hauv kev sib txawv ntawm GEP NETs, cov qog hlwb loj hlob kuj qeeb tab sis tseem muaj peev xwm los cuam tshuam thiab metastasize. Los ntawm inhibiting lub secretion muaj nuj nqi ntawm cov qog hlwb, qhov tshwm sim ntawm cov tsos mob ntawm cov tsos mob yuav txo tau, thiab proliferation ntawm cov qog hlwb yuav inhibited kom ntev lub ciaj sia taus ntawm cov neeg mob. Rau qhov sib txawv nruab nrab ntawm GEP NETs, txawm hais tias qhov malignancy ntawm qog hlwb yog qhov siab, lawv tuaj yeem tswj tau qhov kev loj hlob ntawm tus kab mob mus rau qee qhov thiab txhim kho lub neej zoo ntawm cov neeg mob.
Daim ntawv thov ntawmkev txhaj tshuaj lanreotideHauv kev kho mob plab hnyuv pancreatic neuroendocrine hlav (GEP NETs) feem ntau yog ua raws li ntau yam thoob ntiaj teb multicenter randomized tswj kev sim (RCTs) thiab kev tshawb fawb soj ntsuam, uas muab kev tshawb fawb hauv paus rau nws cov txiaj ntsig thiab kev nyab xeeb.
Kev tshawb fawb tseem ceeb: CLARINET mus sib hais yog thawj qhov loj - theem III txoj kev tshawb fawb kom paub meej tias nws lub peev xwm tseem ceeb los ncua PFS hauv cov neeg mob GEP NETs, muab cov pov thawj tseem ceeb rau lanrelitide ua thawj - kab kev kho mob rau GEP NETs. Cov txiaj ntsig kev tshawb fawb tau luam tawm hauv New England Journal of Medicine (N Engl J Med, 2014).
Kev tshawb fawb tseem ceeb: Txoj kev tshawb fawb no tau lees paub thawj zaug tias kev sib xyaw ua ke ntawm everolimus thiab lanreotide tuaj yeem ua kom ntev ntev ntawm kev muaj sia nyob tsis muaj sia nyob (PFS) ntawm cov neeg mob sib txawv GEP NETs uas muaj qhov tsis zoo, thiab kev nyab xeeb yog tswj tau, muab lub tswv yim tshiab rau kev kho ua ke. Cov txiaj ntsig kev tshawb fawb yuav raug tshaj tawm ntawm American Society of Clinical Oncology Gastrointestinal Oncology Symposium 2025 (ASCO GI 2025).
Kev tshawb fawb tseem ceeb: Txoj kev tshawb fawb no tau lees paub tias kev kho tshuaj khomob lossis cov phiaj xwm kho mob nrog cov tshuaj toxicity siab, kev kho mob nrog lanreotide tom qab kev ua haujlwm ruaj khov tuaj yeem ua rau tus neeg mob PFS ntev thiab txo cov tshuaj tsis zoo. Cov txiaj ntsig kev tshawb fawb tau tshaj tawm ntawm 2021 European Neuroendocrine Lub Rooj Sib Tham Txhua Xyoo (ENETS).
Kev tshawb fawb tseem ceeb: Txoj kev tshawb no muab ib qho kev xaiv tshiab rau cov tswv yim kho mob ntawm cov neeg mob pancreatic thiab midgut NET tom qab kev kho cov tshuaj noj. Cov txiaj ntsig kev tshawb fawb tau tshaj tawm ntawm 2021 European Neuroendocrine Lub Rooj Sib Tham Txhua Xyoo (ENETS).
FAQ
Cov tshuaj lanreotide ua dab tsi?
Ipstyl yog siv rau lub sijhawm ntev - kev kho mob ntawm acromegaly (kev loj hlob hormone tsis meej) hauv cov neeg mob uas tsis tuaj yeem kho nrog kev phais lossis hluav taws xob. Cov tshuaj no ua haujlwm los ntawm kev txo qis cov tshuaj hormones uas lub cev tsim tawm.
lanreotide puas tuaj yeem txo cov qog?
PRIMARYS tau pom tias kev kho thawj zaug nrog Ipstyl 120 mg txhua 28 hnub muab kev txo qis hauv kev kho mob (Ntau dua lossis sib npaug li 20%) hauv cov qog nqaij hlav hauv 62.9% ntawm cov neeg mob ntawm 1 xyoos.
Puas yog octreotide thiab lanreotide tib yam?
Muaj qhov sib txawv me ntsis hauv FDA pom zoo: octreotide (Sandostatin) tau pom zoo rau cov tsos mob ntawm carcinoid/VIPoma syndrome thiab Ipstyl tau pom zoo rau kev tswj cov qog. Hauv kuv lub tswv yim, nws yog qhov zoo tshaj kom muaj kev xaiv. Yog tias koj tau nyob hauv Sandostatin thiab nws ua haujlwm, tsis tas yuav pob zeb lub nkoj.
Puas yog lanreotide cuam tshuam rau daim siab?
Txoj kev tshawb no qhia tau hais tias 120 lub lis piam ntawm kev kho mob nrog ipstyl hauv ADPKD cov neeg mob uas muaj lub siab loj ua rau muaj qhov txo qis hauv daim siab loj hlob piv nrog cov qauv kev saib xyuas. Cov txiaj ntsig zoo tseem muaj nyob rau 4 lub hlis tom qab kev kho mob.
Cim npe nrov: lanreotide txhaj tshuaj, lwm tus neeg, manufacturers, hoobkas, lag luam wholesale, yuav, nqe, tej, kev muag khoom