Dapoxetine Hydrochloride Ntsiav Tshuaj Thiab Cinacalcet Hydrochloride Cov Ntsiav Tshuaj Yog Thawj Pom Zoo

Lub Plaub Hlis 15, raws li NMPA lub vev xaib tshuaj pom zoo siv yeeb tshuaj, Huabo Kaisheng thiab Jiayi Cov Tshuaj tau cia siab tias yuav ua thawj zaug tshuaj dapoxetine hydrochloride ntsiav tshuaj thiab cinacalcet hydrochloride ntsiav tshuaj, feem.

Txog Dapoxetine

Dapoxetine yog luv luv xaiv xaiv serotonin reuptake inhibitor thaum xub thawj siv rau kev ua kom loog thiab tiv thaiv kev tiv thaiv kab mob, thiab tom qab ntawd tau tsim kho los kho kho ntxov ntxov (PE).

PE yog tus txiv neej ib txwm muaj feem cuam tshuam sib deev. Raws li kev tshaj tawm txawv teb chaws, qhov muaj ntau ntawm PE hauv cov txiv neej hnub nyoog 18 txog rau 59 xyoo yog siab txog li 31%. Qhov tshwm sim ntawm FE hauv cov kws tshawb fawb hauv tsev yog 25. 8%. Txawm li cas los xij, qhov tshwm sim ntawm kev sab laj txog kev kho mob tsis siab. Tam sim no, kev siv tshuaj kho mob PE hauv tsev feem ntau suav nrog tadalafil, sildenafil, dapoxetine, apomorphine thiab vardenafil, ntawm uas tadalafil thiab sildenafil muaj cov khoom lag luam loj tshaj plaws, suav txog kwv yees 90% cov lag luam feem.

Txawm li cas los xij, txij li qhov kev tshawb nrhiav qub dapoxetine (kev ua lag luam lub npe Bilijin) tau muag nyob hauv Suav teb hauv 2013, nws cov muag khoom thiab cov lag luam tau loj hlob sai, thiab" PE Tus Kws Tshuaj Ntsuam Xyuas thiab Kho Suav Cov Kws Paub Zoo" pom zoo nws ua kev kho kab thawj zaug rau PE.

Hauv kev pom ntawm lub lag luam loj loj rau PE, ntau lub tuam txhab kev lag luam hauv tsev tau xa tawm hauv daim teb no. Hauv Dapoxetine kev ua lag luam, Kelun Cov Chaw Tsim Tshuaj yog thawj lub tuam txhab kev lag luam hauv tebchaws kom dhau qhov bioequivalence (BE) thiab tshaj tawm nws cov khoom lag luam raws li cov qauv zoo ntawm cov kev tshawb fawb thaum ntxov. Txawm li cas los xij, los ntawm cov kev tshuaj xyuas tam sim no thiab pom zoo rau kev nce qib, Huabo Kaisheng Tau ua tiav zoo tshaj Cologne thiab cia siab tias yuav los ua thawj lub tuam txhab los yeej Dapoxetine.

Tsis tas li ntawd, raws li kev nkag siab cov ntaub ntawv, ntxiv rau ob lub tuam txhab tau hais los saum toj no, peb lub tuam txhab tau xa cov ntawv thov npe. Nws tau tshaj tawm tias qhov taw qhia txog kev ua txhaum cai CN 1387432 Ib ntawm dapoxetine hauv Tuam Tshoj tau tso cai tas nyob rau hauv 2019, tab sis nws tau siv nyob rau hauv 2016, uas txhais tau hais tias ib zaug lub tuam txhab tau txais cov kev tsim nyog ntawm cov tsis tseem ceeb. tshuaj, nws tuaj yeem sau cia muag.

Tam sim no, tus nqi ntawm qhov kev tshawb fawb dapoxetine ib ntsiav tshuaj (30 mg) yog 65-75 yuan, thiab cov nqi tshuaj feem ntau yog qhov qis dua tus nqi tshawb fawb. Nws cia siab tias yav tom ntej ntawm dapoxetine cov tshuaj feem ntau yuav tsum tsim sildenafil cov tshuaj feem ntau nrog tus nqi zoo ci ntsa iab.

Txog Ntawm Sina Cov Ntaub Ntawv

Cinacalcet' s thawj cov tshuaj yog calcium uas zoo li tus neeg sawv cev thaum chiv thawj tsim los ntawm NPS Pharmaceuticals, uas tom qab tau tso cai rau Anjin thiab Xiehe Fermentation Kirin Pharmaceutical. Cov tshuaj txo cov theem ntawm parathyroid hormone, calcium, phosphorus, thiab calcium-phosphorus cov khoom los ntawm kev txhim kho qhov tsis paub txog cov calcium-rhiab receptors rau calcium qib hauv cov hlab ntshav. Cov kev pom zoo tam sim no suav nrog kev mob raum (CKD) kev saib xyuas lim ntshav Hypercalcemia hauv cov neeg mob hyperparathyroidism (SHPT), cov neeg mob parathyroid adenocarcinoma, thiab cov neeg mob uas muaj thawj hyperparathyroidism.

Lub npe lag luam thiab qhia txog cov tshuaj no txawv nyob txawv teb chaws lossis thaj chaw. Lub npe kev lag luam hauv Tebchaws Meskas yog Sensipar (2004. 03), cov npe lag luam hauv European Union yog Mimpara (2004. 12), thiab npe lag luam tawm. hauv Nyijpooj yog Regpara (2015. 06). Lub lag luam npe yog Gaiping (2014. 06). Txawm li cas los xij, cov tshuaj tsuas yog pom zoo rau kho SHPT hauv cov neeg mob CKD txij nkawm kev lim ntshav hauv Nyiv thiab Suav.

Txij li cov npe, Sina Kasai muag khoom tau nce xyoo los ntawm lub xyoo. Hauv 2015, kev muag khoom tau tshaj 1 lab lab daus las. Hauv 2018, kev muag khoom hauv Tebchaws Europe thiab Tebchaws Asmeskas tau nce txog ntau txog 1. 774 billion Asmeskas las. Hauv 2019, kev muag khoom ntawm qhov kev tshawb nrhiav qub Sinacaser qhia tias muaj pob zeb zoo li poob, feem ntau vim tias qhov tseem ceeb patent ntawm Sinacaser US 6011068 tas sijhawm rau lub Peb Hlis 8, 2018, thiab tom qab ntawd tus lej ntawm cov tshuaj tsis raug cai tau pom zoo rau cov npe.

Hauv Suav teb, Sina Kasai tau suav nrog hauv phau ntawv pov hwm kev kho mob hauv tebchaws xyoo ob tom qab kev pom zoo. Nrog rau kev nce nqi hauv kev tuav pov hwm kho mob, kev muag ntawm Gaiping hauv tsev kho mob pej xeem hauv cov xeev tseem ceeb thiab nroog hauv Suav tau loj hlob sai. Kev muag khoom hauv thawj ib nrab ntawm 2019 tau mus txog 21. 52 lab yuan, Tsawg tsawg dua cov muag tag nrho nyob rau xyoo 2018. Ntxiv mus, Gaiping tau ua tiav qhov kev tuav pov hwm kho mob rau 2019. Raws li kev nkag siab cov ntaub ntawv pov thawj, tus nqi ntawm txhua lub ntsiav tshuaj (25 mg) yog 34. rau tsev neeg mob rau cov neeg mob raum uas xav tau lim ntshav mus sij hawm ntev.

Hauv kev pom ntawm Gaiping qhov kev ua lag luam zoo tshaj plaws, ntau lub tuam txhab hauv tuam txhab xav kom muaj kev sib faib ntawm cov kua zaub. Tam sim no, tag nrho ntawm 5 cov tuam txhab tau xa cov ntawv thov rau 4 cov tshuaj feem ntau ntawm cinacalcet hydrochloride, ntawm uas Jiayi Pharmaceuticals tau xa cov ntawv thov ntawm qhov ntxov tshaj plaws kev kuaj xyuas cov txheej txheem.