Howerson cov tshuaj Almonertinib tshiab yuav raug pom zoo rau kev lag luam sai sai, kho EGFR hloov pauv tsis-me me ntawm cov ntsws mob ntsws (NSCLC)!

Jiangsu Haosen Pharmaceutical Group Co., Ltd. (txuas mus ntxiv" Hosen Pharmaceutical") tsis ntev los no tshaj tawm tias nws tau tshawb nrhiav thiab tsim Tuam Tshoj' s thawj peb-tiam EGFR-TKI tshiab yeeb tshuaj Amelol (Almonertinib Mesilatetablets, HS-10296)) Daim ntawv thov rau cov npe tshuaj tshiab tau lees paub los ntawm CDE lub Plaub Hlis 2019. Qhov kev soj ntsuam xyuas kev ua haujlwm tau tiav ob peb hnub dhau los thiab yog hauv" raws li kev pom zoo" xeev. Nws yuav tsum pom zoo kom tso npe nyob rau yav pem suab.

Ntawm cov neeg mob ntsws ntsws hauv Suav teb, ntau dua li 40% yog cov neeg mob uas tsis yog mob ntsws tsis muaj ntsws (NSCLC) uas muaj EGFR hloov pauv. Tom qab kho nrog EGFR-TKI tiam, ntau dua li ib nrab ntawm lawv yuav tsim kho T 790 M hloov pauv thiab ua rau tiv taus. Yog li, muaj kev kho mob maj nrawm xav tau los txhim kho lub tiam tshiab ntawm cov tshuaj muaj txiaj ntsig zoo thiab muaj tshuaj lom neeg tsawg uas tuaj yeem kov yeej cov tshuaj tiv thaiv.

Amelet® (Almonertinib Mesilate Tablets) yog Tuam Tshoj' s thawj peb-tiam EGFR-TKI kev tsim tshuaj tshiab ywj siab tsim los ntawm Howson Pharmaceutical. Raws li lub vev xaib ntawm Lub Xeev Tswj Xyuas Khoom Noj thiab Tshuaj, nws daim ntawv thov rau kev teev cov tshuaj tshiab tau lees paub los ntawm CDE thaum Lub Plaub Hlis 2019, thiab tau muab tso rau hauv kev txheeb xyuas qhov muaj feem thib tseem ceeb los ntawm CDE thaum Lub Tsib Hlis ntawm tib lub xyoo nrog" ; qhov tseem ceeb kev kho mob sib piv nrog cov kev kho mob uas twb muaj lawm." Cov kev ntsuas xyuas kev ua haujlwm tau ua tiav thiab yog nyob rau hauv" raws li kev soj ntsuam" lub xeev thiab cia siab tias yuav pom zoo rau cov npe nyob ze yav tom ntej.

Lub Cuaj Hlis 2019, ntawm lub sijhawm 20 th Lub Ntiaj Teb Kev Ntsuas Mob Hlwb (WCLC), xibfwb Lu Shun ntawm Lub Tsev Khomob Tsev Kawm Ntawv Koom Tes nrog Shanghai Jiaotong University tau tshaj tawm cov lus tshaj tawm txog cov txiaj ntsig kawg ntawm lub cim thib peb EGFR -TKI Ametinib Ntu II mus soj ntsuam chaw sim ntau qhov kev mloog thiab tham siab ntawm cov kws tshaj lij thiab kws tshawb fawb nyob hauv tsev thiab txawv teb chaws.

Qhov kev sim zaum II no suav txog 244 cov kev kawm los ntawm Suav teb suav thiab Taiwan, nrog lub sijhawm kho mob nruab nrab ntawm 9. 5 lub hlis (txij li Lub Tsib Hlis 25, {{{{6 }}}})). Cov ntaub ntawv tau raug tshoov siab tom qab raug soj ntsuam los ntawm pawg neeg saib xyuas kev ywj pheej: Ogilvy Lub hom phiaj tau teb (ORR) ntawm kev kho nitinol yog {{5}}. 4%, thiab tus nqi tswj kab mob (DCR) yog 9 3. 4%, qhia kev hloov pauv tshuaj zoo-tiv thaiv kev cuam tshuam; ORR pab pawg qhia tau pom tias ometinib yog nyob hauv cov neeg mob hauv txhua pawg me Txhua tus ua tau zoo, ntawm cov kev kho kom zoo tau ua tiav rau cov neeg mob hlwb metastasis (ORR= 61. 5%); cov kev phiv tshuaj nyob rau hauv txoj kev tshawb no muaj peev xwm tiv taus thiab muaj kev tswj hwm hauv qib 1 lossis qib 2, qib 3 thiab siab dua qhov xwm txheej thiab txo qhov tshwm sim tsis zoo thiab tus nqi tshuaj thim rov qab muaj tsawg. Tsis muaj tus kab mob ntsws interstitial tshwm sim hauv cov neeg mob thaum lub sijhawm kawm.

Hauv kev sib tham ntawm kev sib tham tom qab, Paul, tus tsim ntawm World Lung Cancer Conference, tus thawj tswj hwm ntawm WCLC rau ntau qhov kev sib tham ua ntu zus, thiab cov kws paub zoo thoob ntiaj teb xws li tus kws tshaj lij Spanish muaj npe nrov Robust, tau qhuas cov kev tshawb fawb tau los ntawm Ametinib thiab nws lub peev xwm kev ua tau zoo nrog zoo sib xws thoob ntiaj teb cov tshuaj ua ntej Analogy. Professor Lu Shun tau hais tias Ametinib tsis yog tsuas yog ua haujlwm zoo thiab muaj kev nyab xeeb xwb, tabsis tseem muaj peev xwm dhau qhov teebmeem ntawm kev siv tshuaj, uas yuav coj ntau txoj kev kho mob rau kev tiv thaiv qog mob ntsws.

Almonertinibcov qauv tshuaj lom neeg (Source: medchemexpress.cn)

Raws li lub cim thib peb EGFR-TKI, Amerol® (Almonertinib Mesilate) tuaj yeem hloov pauv tau thiab xaiv tau qhov cuam tshuam kev hloov pauv ntawm EGFR-kev hloov pauv thiab T 790 M-resistant kev hloov pauv, tsis tsuas yog qhia qhov ua tau zoo thiab kev nyab xeeb, tab sis kuj rau lub hlwb Cov neeg mob nrog metastases muaj cov kev kho mob pom tseeb." Txawm hais tias kev ua kom zoo lossis kev nyab xeeb kev nyab xeeb, Almonertinib tuaj yeem siv los ua qhov kev xav tau zoo tshaj plaws rau cov neeg mob uas tsis yog mob ntsws hauv hlwb me me," hais tias xibfwb Yang Zhixin ntawm lub koom haum ntawm Oncology, Taiwan University. Kev pom zoo ntawm Almonertinibcan tsis yog tsuas nqa cov neeg mob Cov kev pabcuam hauv tsev kho mob ncaj qha tseem yuav txo cov neeg tos cov neeg mob hauv tsev hauv cov neeg yuav tshuaj.

Raws li Tuam Tshoj' s lub tuam txhab kev lag luam ua tshuaj tshiab, Howson Pharmaceutical tau ua haujlwm ntawm kev tiv thaiv qog ntau xyoo. Hauv 2019, nws tau ua tiav cov kev tsim cov tshuaj tshiab tshiab Howson Xinfu® (kev tshawb nrhiav ywj siab thiab kev txhim kho rau kev kho tus mob myeloid leukemia (CML. Flufatinib mesylate ntsiav tshuaj). Amerol® (Almonertinib Mesilate) tau pom zoo rau cov npe, uas yuav ua rau qhov kev lag luam hauv tsev nruab nrab ntawm kev tshawb fawb ywj pheej thiab kev txhim kho ntawm peb-tiam EGFR-TKI thiab qhib lub sijhawm tshiab ntawm kev tsim tshuaj tshiab kho mob. Tshwj xeeb rau cov neeg mob hauv tsev, raws li kev tsim tshuaj tshiab hauv tsev, nws txhim kho txoj kev siv tshuaj thiab ua rau muaj kev cia siab kom muaj txoj sia nyob ntev rau cov neeg mob coob uas tsis yog mob ntsws me me hauv lub ntsws.