NtawmKaum Ib Hlis 5, Novartistshaj tawm tias nwsRadioligand therapy (RLT) tshuaj Pluvicto (lutetium [177Lu] vipivotide tetraxetan)tau txaisKev pom zoo ib txhij los ntawm Tuam Tshoj National Medical Products Administration (NMPA)rauob qhov qhia:
Cov neeg laus uas muaj PSMA-zoo metastatic castration-cov qog nqaij hlav prostate resistant (mCRPC) uas tau ua tiav tom qab androgen receptor pathway inhibitors (ARPIs) thiab tsim nyog rau kev kho mob qeeb.
2.Cov neeg laus nrog PSMA-mCRPC zooleej twg muajnce tom qab ARPIs thiab taxane-raws li kev kho mob.
Cov ntsiab lus tseem ceeb:
•Pluvicto tau pom zoo thawj zaug los ntawm FDA hauv 2022rauthib peb- kab kev kho ntawm PSMA-mCRPC zoo.
•Hauv thawj peb lub hlis twg ntawm 2025, nws ua tiav kev muag khoom ntawm $ 1.389 billion (≈ 9.9 billion), ua ablockbuster nuclear tshuaj tshuajnyob rau hauv Novartis 'portfolio.
Kev pom zoo raws li Kev Tshawb Fawb Ntiaj Teb & Suav Kev Tshawb Fawb:
Cov kev pom zoo tau txais kev txhawb los ntawm:
•Kev kawm thoob ntiaj teb Phase III VISION
•PSMAfore kawm
•Cov kev tshawb fawb suav nrog kev sib txuas
1. Txoj Kev Kawm VISION (Lub Ntiaj Teb Phaj III, Randomized, Qhib-Label)
•Cov pejxeem: PSMA-cov neeg mob mCRPC zoo uas tau txaisARPIs thiab taxane chemotherapy.
•Kev tshawb pom:Piv rautus qauv zoo tshaj plaws ntawm kev saib xyuas (bSOC) ib leeg, lutetium [177Lu] vipivotide tetraxetan + bSOCkho tau zoo heev:
•Radiographic progression-dawb ciaj sia taus (rPFS)
•Overall survival (OS)
2. PSMAfore Study (Ntiaj teb Phase III, Randomized, Qhib-Label)
•Cov pejxeem:mCRPC cov neeg mob uas tau txaisib qho ARPI tab sis tsis muaj tshuaj kho mob.
•Kev tshawb pom: Lutetium [177Lu] vipivotide tetraxetanqhia:
•6-hli ntev rPFS (11.60 hli vs . 5.59 hli, HR 0.49, P<0.001)vs. hloov mus rau lwm qhov ARPI.
Ntau lub hom phiaj teb tus nqi (ORR 50% vs. 15%) (ntawm cov neeg mob uas ntsuas tau qhov txhab).
Cov lus teb siab dua (CR 21% vs. 4%) & PSA50 tus nqi teb (51% vs. 17%).
Yav Tom Ntej Muaj Peev Xwm:
Novartis tab tom tshawb nrhiav ua ntej - kab mob qog noj ntshav prostate nrog cov tshuaj no.
PSMAaddition (Phase III rau metastatic hormone- mob qog nqaij hlav prostate rhiab heev, mHSPC) tau nthuav tawm ntawm ESMO 2025 tau ntsib nws thawj qhov kawg, txo qis kev mob radiographic lossis kev pheej hmoo tuag los ntawm 28% (HR 0.72, p=0.002).
Kev cuam tshuam kev lag luam: Prostate Cancer Dominates Txiv neej Tshuaj Muag
•Los ntawm 2016 mus rau H1 2025, 7 tawm ntawm 10 qhov zoo tshaj plaws - muag txiv neej tshuaj nyob rau hauv Tuam Tshoj txoj kev kho mob pej xeemua rauKev kho mob qog noj ntshav prostate, highlighting lubmob hnyav hnyav.
•Novartis 'Pluvicto pom zoo hauv Suav tebyuavua ntej precision kho mob qog noj ntshav prostate, muabkev cia siab tshiab rau cov neeg mob.
Cov ntaub ntawv Source: Yaozhi Data
|
Serial Number
|
Tshuaj
|
Kev Muag Khoom Loj (hauv billions ntawm yuan)
|
Cov Kab Mob Txiv Neej
|
|---|---|---|---|
|
1
|
Goserelin Acetate Sustained -Tshuaj Tsom Tshuaj
|
248.51
|
Hormone-sensitive prostate cancer
|
|
2
|
Docetaxel Txhaj
|
231.27
|
Hormone-refractory metastatic prostate cancer
|
|
3
|
Leuprorelin Acetate Microspheres rau Txhaj
|
217
|
Prostate mob cancer
|
|
4
|
Paclitaxel Txhaj
|
112.5
|
Seminoma
|
|
5
|
Leuprorelin Acetate Sustained -Tshuaj Microspheres rau Txhaj
|
87.57
|
Prostate mob cancer
|
|
6
|
Finasteride ntsiav tshuaj
|
80.33
|
Benign prostatic hyperplasia; Androgenetic alopecia hauv cov txiv neej nrog loj prostate
|
|
7
|
Bicalutamide ntsiav tshuaj
|
78.13
|
Prostate mob cancer
|
|
8
|
Tamsulosin Hydrochloride Sustained -Tshuaj Capsules
|
74.02
|
Benign prostatic hyperplasia
|
|
9
|
Abiraterone Acetate ntsiav tshuaj
|
67.32
|
Castration{0}} tiv thaiv qog noj ntshav prostate
|
|
10
|
Triptorelin Acetate rau txhaj tshuaj
|
61.48
|
Prostate mob cancer
|
Cov ntaub ntawv Source: Yaozhi Data
