Hloov tshiab ntawm Hande qhov chaw tshiab

1. Cov kev ua haujlwm tshiab kawg:
Regulatory tshaj tawm ntawm natural paclitaxel:
● Tuam Tshoj CDE:
Thaum Lub Kaum Ob Hlis 13, 2021, CDE daim ntawv thov ntxiv tau ua tiav (qhov tseeb CDE xwm txheej tau pom hauv daim duab).thiab Hande tau lees txais GMP ntawm qhov chaw ua raws li kev soj ntsuam ntawm Yunnan Provincial Food and Drug Administration thaum Lub Ib Hlis 18-20, 2022. Txij li thaum CDE yuav tsis muab cov ntaub ntawv pom zoo rau API rau npe thiab hloov tshuaj xyuas, nws yuav tsis muab cov ntaub ntawv txhawb nqa rau lub lub sijhawm, tab sis nws tuaj yeem raug xa mus los ntawm kev npaj thiab khoom siv.Raws li CDE qhov kev pom zoo, thov xa mus rau email ceeb toom hloov pauv rau cov txheej txheem cuam tshuam thiab cov qauv hloov pauv..
Tom qab kev tshuaj xyuas ntawm qhov chaw, Yunnan Hande yuav rov pib ua lag luam muag hauv Suav lag luam.Koj lub tuam txhab tuaj yeem siv Hande cov khoom siv rau kev tshawb fawb thiab kev tsim kho, kev sim me me, kev sim tsav thiab kev siv tshuaj kho mob raws li koj xav tau.Cov ntaub ntawv thov tuaj yeem hais ncaj qha rau Hande CDE cov ntaub ntawv.

1
● EU EDQM:
Hande tau txais daim ntawv pov thawj CEP thiab "Certificate Document for Export of APIs to the EU" ("WC"), thiab EU ua lag luam tau rov pib ua lag luam muag khoom.Yog tias koj lub tuam txhab xav tau CEP daim ntawv pov thawj thiab daim ntawv tso cai lossis cov khoom, thov hu rau peb raws sijhawm.

● US FDA:
Cov ntaub ntawv hloov pauv DMF tau xa tuaj.

● Lwm lub teb chaws lossis cheeb tsam:
Russia: Cov neeg siv khoom uas twb muaj lawm tau pib qhib kev sau npe;
Is Nrias teb: DMF cov ntaub ntawv xa tuaj;
Brazil: DMF cov ntaub ntawv npaj;
Nyiv: Cov ntaub ntawv sau npe tau xa tuaj;
Australian TGA: Hauv kev npaj;
EU GMP: hauv kev npaj;
Lwm lub teb chaws yuav siv ib txhij.Yav tom ntej, Hande yuav pab koj lub tuam txhab kom nthuav dav thoob ntiaj teb kev lag luam kev lag luam.

2. 10-DAB semi-synthetic paclitaxel ntau lawm kab:
Pilot ntau lawm thiab kev sim ua tiav.Tam sim no ua cov kev tshawb fawb zoo thiab kev soj ntsuam kev ruaj ntseg.3 batch pov thawj batch tsim cov phiaj xwm yuav pib thaum Lub Ib Hlis 2022 tom qab kev teeb tsa thiab kev ua haujlwm ntawm cov cuab yeej ua tiav.
10-DAB semi-synthetic paclitaxel regulatory register plan:
● Tuam Tshoj CDE: Cov Ntaub Ntawv No.: Y20210000685, nws tau npaj yuav pib daim ntawv thov nyob rau lub quarter thib ob ntawm 2022;
● EDQM thiab FDA: Npaj ua ntaub ntawv hauv lub quarter thib plaub ntawm 2022.

3. Cov kab ua haujlwm tseem ceeb:
Los ntawm cov kev txheeb cais ntawm qhov chaw thiab kev sim ua piv txwv ntawm ntau lub hauv paus cog yew, lub phiaj xwm kev yuav khoom txhua xyoo tau ua tiav nrog 3 lub hauv paus cog qoob loo loj kom ntseeg tau tias cov khoom siv raw txaus ntawm cov txiaj ntsig zoo ntawm paclitaxel.Cov zis txhua xyoo ntawm 10-DAB yog 2000kg / xyoo, nrog cov khoom ruaj khov thiab khoom siv ntev.
● 10-DAB III regulatory filing:
DMF: Tus lej DMF tau txais.
2. Lwm cov ntaub ntawv
1. Kev cuam tshuam los ntawm kev sib kis, Hande yuav tsis koom nrog CPHI exhibition.Txhawm rau ua haujlwm zoo dua rau koj lub tuam txhab, peb yuav txuas ntxiv ua cov neeg tuaj xyuas thiab koom tes nrog koj lub tuam txhab kev lag luam kev lag luam ua haujlwm nrog cov kev pabcuam zoo dua.


Post lub sij hawm: Feb-18-2022