Tsis ntev los no, Jinyao Pharmaceutical Co., Ltd. (tom qab no hu ua "Lub Tuam Txhab") tau txais "Daim Ntawv Pom Zoo rau Kev Lag Luam Daim Ntawv Thov Kev Siv Tshuaj Siv Tshuaj Siv Tshuaj (API)" rau Formoterol Fumarate, uas tau txheeb xyuas thiab muab los ntawm National Medical Products Administration (tom qab no hu ua "NMPA").
I. Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Tshuaj API Lub Npe: Formoterol Fumarate
Tus lej naj npawb: Y20230000656
Txais Tos Txais: CYHS2360607
Kev Sau Npe Tus Qauv Qauv ntawm Tshuaj API: YBY75362024
Chaw tsim tshuaj paus: Jinyao Pharmaceutical Co., Ltd.
Chaw Nyob Chaw Tsim Khoom: Tsis yog . 19 Xinyao 9th Street, West District, Tianjin Development Zone
Ntim Cov Lus Qhia: 100g / hnab, 50g / hnab, 20g / hnab, 10g / hnab
Daim ntawv thov khoom: Daim ntawv thov kev lag luam rau kev tsim khoom siv tshuaj API
Kev Pom Zoo Pom Zoo: Tom qab kev tshuaj xyuas, cov khoom no ua tau raws li cov kev cai rau kev sau npe tshuaj thiab raug pom zoo rau kev sau npe.
II. Tshuaj-Cov ntaub ntawv ntsig txog
Formoterol Fumarate yog 2 receptor agonist. Nws muaj cov teebmeem ntawm kev so ntawm cov leeg nqaij bronchial, txo cov nqaij ntshiv nqaij ntshiv nqaij ntshiv thiab tiv thaiv - kev ua xua, nrog rau lub sijhawm ntev ntawm kev ua haujlwm thiab kev xaiv siab rau txoj kev ua pa. Tam sim no, cov ntaub ntawv kev lag luam uas muaj ntau tshaj plaws suav nrog cov ntsiav tshuaj, tshuaj nqus pa, nqus cov hmoov qhuav, thiab lwm yam. Nws tau qhia rau kev saib xyuas kev kho mob ntawm cov neeg mob uas muaj kab mob obstructive pulmonary disease (COPD), feem ntau yog rau cov mob ntsws ntev thiab mob ntsws, thiab tuaj yeem ua rau muaj zog thiab ntev - tiv thaiv kab mob ntev - mob hawb pob.
Raws li cov ntaub ntawv nthuav dav hauv tsev kho mob hauv tebchaws los ntawm MiNet (xws li cov tsev kho mob pej xeem hauv nroog, county- cov tsev kho mob pej xeem, cov tsev kho mob hauv nroog, thiab cov chaw noj qab haus huv hauv nroog), kev muag khoom hauv tsev ntawm formoterol ib leeg - cov khoom npaj rau xyoo 2022 thiab 2023 yog RMB 7.56 lab thiab RMB 80.49 lab raws li.
Lub Tuam Txhab xa daim ntawv thov rau npe Formoterol Fumarate API rau NMPA thaum Lub Xya Hli 2023 thiab tau txais kev lees paub. Thaum Lub Rau Hli 2024, cov ntaub ntawv ntxiv tau raug xa mus raws li kev ceeb toom yuav tsum tau ua, thiab "Daim Ntawv Ceeb Toom Pom Zoo rau Kev Lag Luam Kev Siv Tshuaj Siv Tshuaj (API)" rau Formoterol Fumarate tau txheeb xyuas thiab muab los ntawm NMPA tau txais tsis ntev los no. Cov xwm txheej ntawm API no ntawm Cov Khoom Siv Pabcuam, Cov Khoom Siv thiab Cov Khoom Siv Ntim Cov Ntawv Sau Npe Cov Ntaub Ntawv ntawm Lub Chaw rau Kev Ntsuas Tshuaj (CDE) ntawm NMPA yog "A" (cov ntaub ntawv raw tau pom zoo siv hauv kev npaj ua lag luam).
Txog rau tam sim no, Lub Tuam Txhab tau sau peev ntawm kwv yees li RMB 3.52 lab hauv R & D project ntawm Formoterol Fumarate API.
