Zhejiang Hisun Pharmaceutical Co., Ltd. (tom qab no hu ua "Lub Tuam Txhab") tshaj tawm tias nws tag nrho -tus tswv lag luam, Hisun Pharmaceutical Nantong Co., Ltd. (tom qab no hu ua "Hisun Nantong"), tau txais lubDaim Ntawv Ceeb Toom Pom Zoo rau Kev Lag Luam Daim Ntawv Thov Kev Siv Tshuaj Siv Tshuaj Siv Tshuajrau oseltamivir phosphate API, raug pom zoo thiab muab los ntawm National Medical Products Administration (tom qab no hu ua "NMPA"), thaum Lub Ob Hlis 28, 2024. Peb tau tshaj tawm cov ntsiab lus tseem ceeb raws li hauv qab no:
I. Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Lub npe ntawm cov tshuaj API: Oseltamivir PhosphateRegistration Number: Y20220000102Notice Serial Number: 2024YS00159Registration Standard Number of the Chemical API: YBY61842024Packaging Specification: 3 kg/bagApplication Item: 5 marketing application for domestically Hisun Pharmaceutical Nantong Co., Ltd. Kev Pom Zoo Kev Pom Zoo: Raws li covTxoj Cai Tswj Tshuaj Txhaum Cai ntawm Cov Neeg Sawv Cev ntawm Tuam Tshoj, raws li kev tshuaj xyuas, cov khoom no ua raws li cov kev cai cuam tshuam rau kev pom zoo ntawm cov tshuaj generic, thiab kev tsim cov khoom no tau pom zoo los ntawm no.
II. Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Oseltamivir phosphate yog ib qho tshuaj tiv thaiv ntawm nws cov tshuaj metabolite (oseltamivir carboxylate), uas yog ib qho kev xaiv neuraminidase inhibitor tiv thaiv kab mob khaub thuas. Nws tau qhia rau kev kho mob khaub thuas A thiab B hauv cov neeg laus thiab cov menyuam yaus hnub nyoog 1 xyoos thiab siab dua, nrog rau kev tiv thaiv kab mob khaub thuas A thiab B hauv cov neeg laus thiab cov tub ntxhais hluas hnub nyoog 13 xyoos thiab siab dua. Nws thawj qhov chaw tsim tshuaj paus yog Roche Holding AG. Tam sim no, cov tuam txhab loj hauv tsev ntawm oseltamivir phosphate API suav nrog Hunan Eurasia Pharmaceutical Co., Ltd. thiab Hangzhou Firstir Pharmaceutical Co., Ltd., thiab lwm yam.
