Raws li tus kab mob COVID-19 kis mus ntxiv thiab muaj kev sib kis tshwm sim nyob rau ntau lub tebchaws thiab qhov chaw hauv tsev thiab txawv teb chaws; Txoj kev tsim tshuaj tshiab yeej tsis tso tseg!
Ceev ceev mus rau lub quarter kawg ntawm 2022. Raws li cov ntaub ntawv tsis tiav ntawm pej xeem cov ntaub ntawv, 15 cov tshuaj tshiab yuav yog thawj pawg ntawm FDA kev lag luam hauv lub quarter thib plaub ntawm 2022, suav nrog 5 monoclonal antibodies, 4 chemotherapies, 2 dual antibodies, 1 ADC therapy , 1 gene therapy, 1 microbiological therapy thiab 1 kev kho ua ke. Cov kev qhia muaj feem xyuam nrog ntau yam kev kho mob, xws li qog nqaij hlav, kab mob tsis tshua muaj thiab kab mob ntev.
Astrazeneca's tremelimumab, MiratiTherapeutics 'adagrasib thiab SpectrumPharmaceuticals 'poziotinib yuav tsum ua txhaum kev lag luam kev lag luam ntawm cov tshuaj lag luam yav dhau los ntawm cov hom phiaj thiab hom tshuaj, raws li. Qhia qhov chaw kho mob ntawm lub khw ncuav mog qab zib.
Astrazeneca's tremelimumab xav tias yuav dhau los ua CTLA thib ob -4 tshuaj tiv thaiv kom pom zoo thoob ntiaj teb, tom qab Yervoy (BMS). tremelimumab, tom qab 18 xyoo nyob rau hauv txoj kev loj hlob, muaj ntau twists thiab lem nyob rau hauv nws cov hmoov zoo; Tom qab mus dhau ntawm Pfizer thiab Astrazeneca, nws tau sim ntau qhov qhia txog kev mob qog noj ntshav sib txawv, thiab thaum kawg tuaj txog kaj ntug ntawm yeej.
Yervoy tau yog ib lub ntiaj teb muag tshuaj tiv thaiv qog noj ntshav zoo tshaj plaws txij li nws tau pom zoo los ntawm FDA, nrog kev muag khoom ntawm $ 2.02 nphom hauv 2021, nce 20 feem pua ntawm xyoo dhau los. Tab sis tremelimumab qhov kev pom zoo tuaj yeem ntxiv rau qhov kev loj hlob qeeb ntawm Yervoy nyob rau xyoo tas los no, uas tau txhawb nqa los ntawm ntau cov tshuaj tiv thaiv kab mob.
MiratiTherapeutics 'adagrasib yuav tsum dhau los ua tus thib ob KRASG12C inhibitor pom zoo tom qab Sotorasib (Amgen). Raws li peb txhua tus paub, KRAS tau raug suav tias yog lub hom phiaj "tsis tsim nyog". Tam sim no, tsuas yog Amgen's Sotorasib tau ua lag luam thoob ntiaj teb, thiab lub sijhawm ua lag luam tsawg dua ib xyoos. Yog tias Miratitics 'adagrasib tau pom zoo los ntawm Lub Kaum Ob Hlis 14, 2022, nws yuav ncaj qha rau Sotorasib, thiab nws tseem yuav pom leej twg yuav ua tiav hauv KRASG12C inhibitor kev ua lag luam.
Tam sim no, thoob ntiaj teb kev faib tawm ntawm KRAS lub hom phiaj kev tshawb fawb lag luam suav nrog Jinfang Pharmaceutical, Bayda Pharmaceutical, Maya Li Pharmaceutical, Amgen, Yifang Biological, MiratiTherapeutics, Jansen, Genex, Novartis, Boehringer Ingelheim, Eli Lilly thiab lwm yam lag luam.
poziotinib yuav tsum yog thib ob HER2-mutated NSCLC tshuaj pom zoo tom qab T-DXd (Daiichi Sankyo). Thaum Lub Yim Hli 11, FDA tau pom zoo Enhertu raws li kev kho mob thib ob rau HER2-mob qog nqaij hlav tsis me me hauv lub ntsws, dhau los ua lub ntiaj teb thawj cov tshuaj pom zoo rau HER2-mutated NSCLC. Qhov kev sib tw tam sim no thiab kev txhim kho yav tom ntej ntawm cov phiaj xwm kho rau HER2 gene variant NSCLC. poziotinib, yog tias pom zoo, yuav yog qhov tseem ceeb ntawm kev kho mob los tiv thaiv NSCLC.
Txawm li cas los xij, nws muaj kev txhawj xeeb tias kev tso tawm ntau yam tshuaj, uas yuav tsum tau pom zoo thaum ntxov xyoo no, tau ncua qeeb vim yog COVID-19 kev sib kis thiab lwm yam. Nws cia siab tias lawv yuav raug pom zoo hauv lub quarter thib plaub raws li tau teem tseg.
Tririplimumab, PD-1 mab, tau xa mus rau FDA raws li lub hauv paus dov thaum ntxov Lub Peb Hlis 2021 rau BLA rau kev kho mob ntawm cov kab mob qog noj ntshav los yog metastatic nasopharyngeal carcinoma. Txawm li cas los xij, COVID-19 cuam tshuam txog kev mus ncig txwv tsis pub FDA ua kom tiav cov ntawv pov thawj tsim nyog. Thaum Lub Xya Hli 6 ntawm lub xyoo no, Junshibio tau xa nws daim ntawv tso cai biologics License (BLA) rau FDA rau kev siv tririplimumab ntxiv rau gemcitabine / cisplatin ua thawj kab kev kho mob rau cov neeg mob uas muaj mob hnyav lossis metastatic nasopharyngeal carcinoma (NPC) thiab ua ib tus neeg sawv cev. rau kev kho thib ob lossis siab dua tom qab kev kho mob platinum rau cov neeg mob uas rov muaj dua lossis metastatic nasopharyngeal carcinoma (NPC). PDUFA tau teem sijhawm rau Lub Kaum Ob Hlis 23, 2022.
Qhov tseeb, kev txhaj tshuaj tririplizumab yog thawj zaug hauv tsev PD -1 tsom mab pom zoo rau kev lag luam hauv Suav teb. Nws tau raug pom zoo rau 5 qhov taw qhia hauv Suav teb; Thaum Lub Kaum Ob Hlis 2020, tririplimumab tau dhau los ntawm kev sib tham txog kev pov hwm kho mob hauv tebchaws thawj zaug. Tam sim no, peb qhov kev qhia tau suav nrog hauv 2021 Cov Ntawv Tshuaj, uas yog tib qho tshuaj tiv thaiv PD-1 mab siv hauv kev kho mob melanoma thiab nasopharyngeal carcinoma hauv daim ntawv pov hwm kho mob hauv tebchaws. Yog tias ua tiav kev pom zoo, nws kuj yog lub cim ntawm kev ua tiav ntawm cov tshuaj biosimilar hauv hiav txwv.
AT-GAA yog ob qho kev kho mob uas muaj cipaglucosidasealfa thiab megalstat. Hauv kev tshawb fawb preclinical, AT-GAA tau cuam tshuam nrog nce qib ntawm daim ntawv lysosomal paub tab ntawm GAA thiab txo qis glycogen hauv cov leeg, tshem tawm qhov tsis xws luag autophagy, thiab txhim kho cov leeg nqaij. Nyob rau lub Tsib Hlis xyoo no, Lub Tuam Txhab tshaj tawm tias FDA txuas ntxiv hnub PDUFA rau AT-GAA rau 2022.
ublituximab yog ib qho tshiab glycoengineered anti-CD20 monoclonal antibody tsom lub cim epitope ntawm CD20 antigen ntawm mature B lymphocytes uas txawv ntawm CD20 monoclonal antibody pom zoo. Xws li ofatumumab, ocrelizumab/rituximab, obinutuzumab (GA101). ublituximab paub tias muaj txiaj ntsig zoo dua li cov tshuaj blockbuster ntau yam sclerosis Aubagio (teriflunomide) hauv kev rov qab ntau yam sclerosis (RMS). Thaum Lub Tsib Hlis 31, TGTherapeutics tshaj tawm tias FDA tau txuas ntxiv hnub PDUFA rau BLA ntawm ublituximab therapy complex RMS rau lub Kaum Ob Hlis 28, 2022.
teplizumab yog ib qho tshuaj tiv thaiv-CD3 monoclonal antibody tsim los tiv thaiv lossis ncua T1D hauv cov tib neeg uas muaj kev pheej hmoo siab muaj ob lossis ntau dua autoantibodies cuam tshuam nrog hom 1 mob ntshav qab zib. Thaum Lub Rau Hli 30, ProventionBio tshaj tawm tias FDA tau txuas ntxiv PDUFA rau teplizumab rau Kaum Ib Hlis 17, 2022.
