Tag Nrho Ntawm 20 Kev Siv Hauv Tshuaj Hauv Tsev Thawj Zaug Hauv Lub Hauv Paus Pib Tam Sim No 2018.

Raws li kev txheeb cais, los ntawm 2001 txog rau 2017, nyob rau lub sijhawm txog 17 xyoos, NMPA pom zoo tag nrho ntawm 13 Chav kawm 1 tshuaj lom neeg thiab { {2}} khoom lag luam lom. Tus nab npawb ntawm cov tshuaj tshiab yog ib tug me ntsis ntxim hlub.

Lub Yim Hli 2015, Lub Xeev Pawg Saib Xyuas Kev Tshawb Fawb tau tshaj tawm cov ntawv hnyav," Cov lus pom zoo rau Kev Hloov Kho Cov Lus Rov Ntsuam Xyuas thiab Kev Pom Zoo rau Cov Tshuaj thiab Cov Cuab Yeej Siv Kho Mob" (Kev voj voog 44), txhawm rau kom sai li sai tau txoj cai hloov kho xws li kev tshuaj xyuas thiab kev pom zoo ntawm cov tshuaj tshiab, thiab pib tsim cov qauv tsav tsheb ua lub tsav tsheb. Qhov ua ntej tshaj mus rau Tuam Tshoj' s tshiab cov tshuaj.

Hauv 2018, kev hloov pauv tshuaj yeeb tshuaj thiab peev txheej hloov tau hloov pauv qhov teeb meem ntawm kev tsim cov tshuaj tshiab mus rau pej xeem. Nyob rau xyoo ntawd, NMPA pom zoo suav txog 9 cov tshuaj tshiab hauv tsev rau kev sau npe, thiab 2018 yog li hu ua" thawj xyoo ntawm Suav tshuaj tshiab" ;.

Txij li thaum 2018, tag nrho ntawm 20 chav kawm hauv tsev 1 tshuaj tshiab tau pib ua, uas koom nrog ntau thaj chaw xws li mob cancer, kab mob siab, thiab ntshav qab zib.

Yog li, dab tsi yog cov sib piv ntawm cov 20 tshuaj tshiab thiab cov tshuaj lom neeg? Qhov hais txog nyob hauv cov cheeb tsam yog dab tsi? Lub tsev lag luam tshuaj twg muaj tus lej loj tshaj? Nws ua dab tsi tom qab teev npe? Medicare them rau cov tshuaj twg? Lub neej tom ntej zoo li cas?

Dab tsi yog ib feem ntawm tshuaj lom neeg thiab tshuaj lom neeg?

Ntawm qhov 20 kev siv tshuaj tshiab hauv tsev, 15 yog cov tshuaj siv tshuaj thiab 5 yog cov tshuaj siv biologic. Qhov feem pua ​​tag nrho ntawm cov tshuaj siv tshuaj yog 75%.

Ntawm qhov saum toj kawg nkaus 10 kev muag tshuaj thoob ntiaj teb hauv 2019, 6 yog biopharmaceuticals thiab 4 tshuaj yeeb tshuaj. Ntawm lawv, tag nrho cov kev muag khoom ntawm biopharmaceuticals ntau ntau rau 58. 86 billion yuan, tag nrho cov muag tshuaj yog 37. 90 billion yuan, thiab biopharmaceuticals ntau dua {{{ 8}} nphom ntau dua li siv tshuaj ntau. Lub peev xwm ntawm biopharmaceuticals yav tom ntej tseem loj heev.

Hauv ob peb xyoos tom ntej no, tus neeg sau cia siab tias ntau Chav Kawm 1 cov khoom lag luam lom yuav tshaj tawm rau kev ua lag luam. Los ntawm tom qab ntawd, qhov kev faib ua feem ntawm cov tshuaj lom neeg yuav maj mam nce ntxiv.

Qhov hais txog nyob hauv cov cheeb tsam yog dab tsi?

Hauv kev hais txog ntawm kev qhia, ntawm 20 kev tsim tawm hauv tsev thawj cov tshuaj tshiab, 10 yog cov qog, uas suav txog ib nrab ntawm tag nrho, tom qab ntawd ua mob siab, 3. Ntxiv rau, Alzheimer' s kab mob, ntshav qab zib, tshuaj loog, mob psoriasis thiab mob vuv yog txhua tus.

Los ntawm cov phiaj xwm kev pom, PD-1 yog qhov nrov tshaj plaws, thiab muaj plaub qhov kev tawm tsam thawj cov tshuaj tshiab uas txhua yam yog PD-1 cov tshuaj tiv thaiv monoclonal, uas yog Junshi' s Triprelimumab, Cinda' s Sintilimab, Hengrui' s Carrizumab thiab BeiGene' s Tirelizumab. Ntxiv rau PD-1, PARP, GLP-1 thiab lwm lub hom phiaj nrov kuj tseem koom nrog.

Los ntawm lub tswv yim kev xav, ntau yam tshuaj no muaj qee lub npe. Treprinumab yog thawj qhov tshuaj tiv thaiv PD-1 monoclonal antibody, losenatide yog thawj qhov khoom ua haujlwm hauv GLP-1 agonist, thiab flumatinib yog" hloov kho version" ntawm Gleevec, Nila Pali yog qhov thib ob ntawm PARP inhibitor uas tau teev nyob hauv lub teb chaws, Danorevir sodium ntsiav tshuaj yog thawj qhov kev tshaj tawm hauv tsev muaj kab mob siab C DAA, thiab Abovite yog thawj qhov kev tawm tsam ua haujlwm ntev los tiv thaiv moxamol.

Lub tsev lag luam tshuaj twg muaj tus lej loj tshaj?

Ntawm cov 20 kev siv tshuaj tshiab hauv tsev tshiab, Hengrui thiab Hansen muaj cov lej loj tshaj plaws, ob qho uas yog 3, thiab seem yog txhua tus. Hengrui' s yog pirotinib, remazolam thiab carellizone, thaum Hansen' s yog losenatide, flumatinib thiab ametinib.

Muaj ib tug qauv nyob rau hauv kev lag luam tshuaj hauv tuam txhab uas tau dhau los ua qhov tseeb thiab pom tseeb. Rau cov kws tshaj lij kev lag luam xws li Hengrui, Hansen, thiab Zhengda Tianqing, tag nrho kev tiv thaiv ntawm ntau lub hom phiaj kub yog ib txoj hauv kev txhim kho. Piv txwv li, Hengrui muaj kub PD- 1 monoclonal antibody, thiab muaj remazolam los ntawm kev ua lag luam tshwj xeeb tshuaj loog. Rau cov tuam txhab lag luam tshuaj me me xws li Cinda, Geli thiab Hutchison Tshuaj, tsim cov lag luam tseem ceeb thiab nrhiav thaj chaw tshwj xeeb, xws li Geli, tsom mus rau thaj teb ntawm kab mob siab. Ntxiv rau thawj thawj cov neeg muaj kab mob siab C DAA, koob tshuaj tiv thaiv kab mob siab hom neeg thib ob hauv Lavida Wei tseem yuav teev npe sai sai no. Cinda tsom rau kev siv tshuaj lom neeg, thiab cov tshuaj molecule me me tsis tshua muaj feem.

Nws ua dab tsi tom qab teev npe?

Cov 20 chav kawm 1 tshuaj tshiab tam sim no ua tau zoo dua nrog anrotinib thiab PD-1 hauv tsev. Ntawm lawv, anlotinib muaj qhov muag tau ntau tshaj plaws hauv 2019, ntawm 2 5-3 billion yuan, thiab kev muag khoom tag nrho ntawm peb qhov PD-1s hauv 2019 yog ze li ntawm {{8} } billion yuan.

Ntxiv rau qhov ntim ntawm tillelizide thiab cov khoom lag luam uas tsis tau muab tso rau hauv kev ua lag luam txij thaum ntawd, cuaj ntawm cov 14 cov tshuaj yuav cia siab tias muaj muag ntau dua 100 lab yuan hauv {{2} }. Lawv yog anlotinib, danorevir sodium, pirotinib, thiab furfur. Quinitinib, teriprilumab, sentirimab, losenatide, carilizumab, thiab mannooligosaccharide diacid. Kev nthuav tawm ntawm kev muag khoom tshwj xeeb yog: danorevir sodium yog 124 lab yuan, fruquintinib yog 120 lab yuan, teripril monoclonal antibody yog 774 lab, thiab cindilimumab yog 1. {{7 }} billion.

Muaj peb nrog ntau dua ntawm 1 billion yuan, namely anrotinib, sentirimab thiab carilizumab. Ntawm cov tshuaj tshiab no, nws xav pom tias anrotinib thiab anrotinib yuav ua tau zoo heev hauv 2-3 xyoos tom ntej no. Raug PD-1.

Medicare them rau cov tshuaj twg?

Lub Kaum Ib Hlis 28, 2019, qhov txiaj ntsig ntawm kev sib tham txog kev tuav pov hwm kev kho mob tau tshaj tawm (tag nrho cov tshuaj lag luam pom zoo ua ntej Lub Kaum Ob Hlis 31, 2018 muaj cai los koom rau hauv kev xaiv) Cov. Ua ntej no, Daim Ntawv Pov Hwm Kev Pov Hwm Kho Mob hauv Tebchaws Meskas tau hloov kho plaub zaug txij thaum 2000. Hauv 2004, 2009, 2017 thiab 2018, phau ntawv pov hwm kev tuav pov hwm kev noj qab haus huv tau hloov tshiab ntau dua, uas zoo rau kev sib txuas sai ntawm cov tshuaj tshiab los ntawm kev lag luam mus rau kev tuav pov hwm kho mob nkag mus. Tam sim no, ntawm 20 chav kawm tshiab 1 tshuaj tshiab, 6 cov tshuaj tshiab tau suav nrog kev pov hwm kev kho mob, hu ua, rov ua cytokine gene-derived protein txhaj, tshuaj anrotinib tsiav tshuaj, pirotinib ntsiav tshuaj , fruquintinib tsiav tshuaj, roxastat Capsules thiab Sintilimab. Yav tom ntej, Ntau Chav Kawm 1 tshuaj tshiab hauv tsev yuav suav nrog kev pov hwm kho mob.

Lub neej tom ntej zoo li cas?

Nyob rau hauv lub neej yav tom ntej, qhov sib txawv nruab nrab ntawm lub sijhawm mus rau kev ua lag luam ntawm domestic thiab tshuaj yeeb yaj kiab yuav dhau los ua me dua.

Coj PD-1 ua piv txwv. Hauv 2014, lub ntiaj teb' s thawj PD-1 monoclonal antibody K tshuaj tau tsim. Hauv 2018, thawj qhov kev tsim tawm ntawm PD-1 monoclonal antibody Trepride tau teev npe nyob hauv, tsuas yog 4 xyoo sib nrug, piv nrog cov dhau los. Cov kis tau nqaim ntau, thiab qhov kev sib txawv yuav ua rau me me yav tom ntej.

Nyob rau yav tom ntej, cov tshuaj hauv tsev yuav teev nyob rau txawv teb chaws thiab tom qab ntawd.

Zebutinib ntawm BeiGene tau pom zoo rau kev lag luam hauv Tebchaws Asmeskas thaum Lub Kaum Ob Hlis xyoo dhau los thiab tau dhau los ua thawj cov tshuaj tshiab hauv tebchaws tau pom zoo los ntawm FDA. Nws xav tias nws yuav muaj kev lag luam li ntawm thawj ib nrab ntawm lub xyoo. Nyob rau hauv lub neej yav tom ntej, yuav muaj ntau thiab ntau dua ntawm cov tshuaj nyob rau hauv tsev lag luam tawm txawv teb chaws ua ntej thiab tom qab ntawd.

Nyob rau hauv lub neej yav tom ntej, cov tuam txhab tshuaj yuav yuav tawg, thiab cov tshuaj tshiab yuav tsis muaj qhov tshwj xeeb ntawm cov kws tshaj lij.

Ib hom tshuaj tshiab zoo txaus kom txhawb nqa cov tuam txhab tshuaj, xws li Xindili rau Xinda, thiab Tripreg rau Junshi. Nyob rau hauv lub neej yav tom ntej, kev tshaj tawm txog tshuaj tshiab hauv tsev yuav nyob rau hauv tag nrho cov paj ntoo, ntxiv nrog rau cov kws tshaj lij kev lag luam kws tshaj lij, cov tuam txhab lag luam tseem yuav ci.