Daim ntawv thov rau kev sim tshuaj ntawm lorlatinib hauv kev kho mob ntawm ROS1-zoo tsis yog me me ntawm lub ntsws cancer tau txais

Tsis ntev los no, Cstone Pharmaceuticals tshaj tawm tias lub tuam txhab thiab Pfizer tau ua tiav tseem ceeb hauv kev sib koom ua ke ntawm kev tsim kho.lorlatinib. Daim ntawv thov kev soj ntsuam kuaj mob (IND) ntawm lorlatinib rau ROS1-zoo siab heev uas tsis yog-me me ntawm lub ntsws cancer (NSCLC) tau pom zoo los ntawm Tuam Tshoj National Drug Administration. Thawj Tswj Hwm lees txais.

Tsis ntev los no, Hong Kong lub tuam txhab tshuaj tshiab Cstone Pharmaceuticals (2616.HK) tshaj tawm tias lub tuam txhab thiab Pfizer koom ua ke tsim.lorlatinibtau ua kom muaj kev vam meej,lorlatinibrau ROS1-zoo siab heev uas tsis yog-me me cell ntsws cancer (NSCLC) kev soj ntsuam daim ntawv thov (IND) tau txais los ntawm National Medical Products Administration (NMPA) ntawm Tuam Tshoj. Nov yog lub ntiaj teb' thawj qhov kev tshawb fawb tseem ceeb ntawm lorlatinib hauv kev kho mob ntawm ROS1-zoo NSCLC. Txoj kev tshawb no yog tsom rau kev soj ntsuam cov qog nqaij hlav thiab kev nyab xeeb ntawm lorlatinib hauv cov neeg mob nrog ROS1-zoo tshaj NSCLC.

Hais txog qhov no, Dr. Yang Jianxin, Tus Thawj Saib Xyuas Kev Kho Mob ntawm Cstone Pharmaceuticals, tau hais tias: “Peb zoo siab heev uas pom tias lorlatinib tau txais los ntawm NMPA hauv Tuam Tshoj IND. Peb yuav sai sai ua ntej kev soj ntsuam kev tshawb fawb ntawmlorlatinibthiab siv zog ua kom tau raws li qhov xav tau ntawm cov neeg mob sai li sai tau. Tsis xav tau kev kho mob."

Ua ntejlorlatinib, Cstone Pharmaceuticals tau txais PD-L1 cov tshuaj tshiab sugarizumab thiab cov tshuaj kho qhov tseeb tshiab Pugeta® (pralsetinibCapsules) los ntawm kev tshawb fawb ywj pheej thiab kev txhim kho thiab kev qhia sab nraud ntawm" ob-pronged" mus kom ze. Kev vam meej ntawm Shuglizumab nyob rau theem III thiab IV kev tshawb fawb soj ntsuam ntawm mob ntsws cancer thiab thawj-kab kev kho mob ntawm cov qog nqaij hlav tsis me me los ntawm Pugeta® tau muab Cstone qhov txiaj ntsig zoo hauv kev kho mob ntsws cancer thiab kev tiv thaiv kab mob. Cstone Pharmaceuticals tau tsim ib lub moat nyob rau hauv qhov kub kub kho mob qog noj ntshav.

Sau qhov sib txawv hauv NSCLC kev kho mob

Thoob plaws ntiaj teb, qhov kev tuag ntawm cov qog nqaij hlav ntsws yog thawj zaug ntawm tag nrho cov qog nqaij hlav malignant. Raws li cov ntaub ntawv kuaj mob qog noj ntshav thoob ntiaj teb tshiab xyoo 2020, muaj kwv yees li 820,000 tus neeg mob qog noj ntshav tshiab hauv Suav teb, ntawm 85% yog NSCLC. Kwv yees li 2% -3% ntawm cov neeg mob NSCLC yog tshwm sim los ntawm ROS1 gene rearrangement. Tus naj npawb ntawm cov neeg mob nrog ROS1 gene rearrangement nyob rau hauv Suav teb yog kwv yees li 20,000 txhua xyoo, thiab nws muaj ntau dua nyob rau hauv cov tub ntxhais hluas, tsis haus luam yeeb los yog lub teeb-smoking nrog lub ntsws adenocarcinoma. Hauv kev ua haujlwm ntawm kev kho mob qog nqaij hlav cancer hauv lub ntsws, kev txhim kho ntawm lub hom phiaj ROS1 yog qhov kev tawg loj heev.

Hmoov tsis zoo, tam sim no kev kho mob rau cov neeg mob ROS1-zoo NSCLC tseem txwv thoob ntiaj teb. Raws li kev lag luam hauv Suav teb muaj kev txhawj xeeb, tam sim no kev pom zoo tshuaj kho mob hauv tsev rau ROS1 gene rearrangement tsuas yogcrizotinibhauv qab Pfizer. , Muaj qhov xav tau loj heev hauv kev ua lag luam.

Raws li peb tiam ALK/ROS1 tyrosine kinase inhibitor (TKI), lorlatinib tuaj yeem muab kev kho mob tshiab rau cov neeg mob uas muaj ROS1-zoo siab heev NSCLC.

Raws li kev tshawb fawb CROWN yav dhau los, cov ntaub ntawv taub hau-rau-lub taub hau sib piv cov txiaj ntsig thiab kev nyab xeeb ntawm lorlatinib thiabcrizotinibnyob rau hauv thawj-kab kev kho mob ntawm untreated ALK-zoo NSCLC tau pom tias lorlatinib nyob rau hauv thawj zaug kev kho mob los yog crizoline kev kho mob. Lub hom phiaj teb tus nqi (ORR) thiab intracranial ORR ntawm cov neeg mob nrog ROS1-zoo siab NSCLC uas tsis kho nrog tinib tau txhim kho. Innovatively, rau cov neeg mob uas muaj lub paj hlwb zoo metastases, lorlatinib tau ua tiav qhov kev tshem tawm ntau dua thiab lub sijhawm tshem tawm mus ntev.

Nrog nws cov ntaub ntawv zoo nkauj hauv CROWN txoj kev tshawb fawb,lorlatinibtau pom zoo los ntawm US Food and Drug Administration (FDA) rau thawj kab kev kho mob ntawm cov neeg laus cov neeg laus nrog ALK-positive metastatic NSCLC tau lees paub los ntawm FDA-pom zoo xeem txoj kev. Pfizer kuj tau ua tiav ntau qhov kev tshawb fawb soj ntsuam ntawm lorlatinib rau ALK-positive ntsws cancer hauv Suav teb, thiab xa daim ntawv thov tshuaj tshiab rau ALK-zoo siab NSCLC hauv lub Peb Hlis 2021.

Txoj kev tshawb fawb soj ntsuam ntawm lorlatinib tau txais, coj lorlatinib los ze zog rau lub sijhawm ntawm kev pab cov neeg mob Suav.

Cstone' qhov muaj zog nyob hauv thaj tsam ntawm mob ntsws cancer

Kev taw qhia ntawmlorlatinibyog ib qho kev ntsuas tsaws ntawm Cstone' ob lub log tsav tsheb tshiab kev txhim kho tshuaj, thiab nws tseem yog ib feem tseem ceeb ntawm lub tuam txhab' kev koom tes tob nrog Pfizer. Thaum lub Cuaj Hlis 2020, Cstone Pharmaceuticals thiab Pfizer tau mus txog kev sib koom tes zoo, suav nrog Pfizer US $ 200 lab kev nqis peev hauv CStone Pharmaceuticals, thiab Cstone Pharmaceuticals los tsim thiab ua lag luam nws tus kheej tsim suglizumab hauv Suav teb av loj. Tso cai rau Pfizer, thiab lub hauv paus kev koom tes ntawm Cstone Pharmaceuticals thiab Pfizer los qhia ntau cov khoom lag luam oncology rau hauv cheeb tsam Greater Tuam Tshoj. Nyob rau lub Rau Hli ntawm lub xyoo no, kev koom tes ntawm ob tog tau nkag siab ntxiv. Cstone Pharmaceuticals xaiv ntawm nws tus kheejlorlatinib, uas tau koom ua ke tsim nrog Pfizer.

Los ntawm qhov kev xav ntawm kev lag luam, kev koom tes nrog Pfizer tau ua rau Cstone Pharmaceuticals tau txais ib qho accelerator rau nws txoj kev lag luam kev loj hlob hauv kev mob qog noj ntshav. Pfizer tau koom nrog hauv kev lag luam mob qog noj ntshav hauv tsev tau ntau xyoo. Hauv thaj chaw mob qog noj ntshav, nws twb muaj ntau cov tshuaj kho mob rau cov noob hloov pauv, thiab muaj kev nkag siab tob txog kev lag luam ntawm ALK thiab ROS1 lub hom phiaj. Kev koom tes ntawm Cstone Pharmaceuticals thiab Pfizer tuaj yeem ua rau luv luv ntawm cov khoom tsim thiab kev lag luam.

Dr. Yang Jianxin tau hais tias yav tom ntej, Cstone Pharmaceuticals yuav txuas ntxiv ua haujlwm nrog Pfizer kom coj ntau txoj kev kho mob rau cov neeg mob hauv thaj chaw mob qog noj ntshav.

Nws tau nkag siab tias Lolatinib yog Cstone' qhov thib peb blockbuster khoom hauv thaj teb ntawm NSCLC. Nyob rau hauv keeb kwm yav dhau ntawm" centralized procurement thiab txo nqi" thiab" lub tswv yim tshuaj kho mob tus nqi taw qhia" hauv kev lag luam tshuaj hauv tsev, cov tuam txhab tshuaj yuav tsum muaj ntau yam tshuaj tshiab nrog kev ua lag luam muaj peev xwm los tsim kom muaj kev sib tw tshwj xeeb yog tias lawv xav txuas ntxiv kom lees paub los ntawm cov tub ua lag luam. . Tshwj xeeb rau kev lag luam qhia, nws yog ib qho ntawm cov tswv yim kom ua tiav, nrog ntau yam tshuaj tsom rau ntau hom neeg mob. Nws kuj yog vim li no uas Cstone Pharmaceuticals tau xaiv los txuas ntxiv siv nws lub zog hauv kev lag luam mob qog noj ntshav.

Cstone Pharmaceuticals tsim kho matrix hauv kev kho mob ntsws cancer raws li kev tshawb fawb tus kheej. Tshwj xeeb tshaj yog tsim nyog hais txog yog cov qab zib, uas yog tus kheej tsim los ntawm Cstone Pharmaceuticals. Nws ntau qhov ntsuas yog qhov zoo tshaj plaws hauv nws chav kawm. Cstone lub rooj sib tham dhau los hauv Ntiaj Teb ntawm Mob ntsws cancer (WCLC) thiab European Society of Medical Oncology (ESMO lub rooj sib tham txhua xyoo kuj tau tshaj tawm cov ntaub ntawv kawm blockbuster ntawm suglimumab theem III NSCLC thiab theem IV NSCLC. Thaum Lub Kaum Ib Hlis 2020, National Medical Products Administration ntawm Tuam Tshoj lees txais ib daim ntawv thov tshuaj tshiab rau qab zibizumab rau thawj kab kev kho mob ntawm cov neeg mob uas muaj cov kab mob squamous thiab non-squamous non-small cell lung cancer (NSCLC) ua ke nrog kev kho mob; nyob rau lub Cuaj Hli xyoo no, Lub Xeev Tuam Txhab Tshuaj tau lees txais Daim ntawv teev npe tshuaj tshiab rau kev siv tshuaj qab zib rau kev sib koom ua ke hauv kev kho tsis tau zoo hauv theem III NSCLC cov neeg mob uas tsis tau nce qib tom qab sib txuas lossis sib txuas lus xov tooj cua thiab tshuaj khomob, uas txhais tau hais tias qabzib yuav tsum dhau los ua lub ntiaj teb thawj PD-L1 monoclonal antibody ib txhij npog tag nrho cov pejxeem. Hauv zos advanced / unresectable (theem III) thiab metastatic (theem IV) NSCLC.