Tsis ntev los no, NMPA lub vev xaib tau qhia tias Zhejiang CDMO Pharmaceutical tau xa daim ntawv thov kev lag luam ntawm crisaborole ointment raws li cov tshuaj generic (Qeb 4) thiab nws tau txais los ntawm Lub Chaw rau Tshuaj Ntsuam Xyuas Tshuaj (CDE). Tam sim no, tsuas yog thawj lub tuam txhab tshuaj tshawb fawb Pfizer tau pom zoo rau kev lag luam ntawm crisaborole ointment hauv Suav teb, thiab tsis muaj lwm lub tuam txhab tau pom zoo los tsim cov tshuaj pleev crisaborole generics.
Kev Sib Tw rau Thawj Cov Tshuaj Siv Tshuaj Crisaborole
Crisaborole yog ib qho me me-molecule, non-steroidal, non-hormonal phosphodiesterase 4 (PDE-4) inhibitor Ameslikas tsim los ntawm Anacor. Xyoo 2016, Pfizer tau txais Anacor rau USD 5.2 billion, tau txais kev nkag mus rau crisaborole, thiab lwm yam. Nyob rau hauv tib lub xyoo, crisaborole tau pom zoo los ntawm FDA (hom npe: Eucrisa) rau kev kho mob ntawm cov neeg mob me me mus rau nruab nrab atopic dermatitis (AD) hnub nyoog. 2 xyoos thiab laus dua.
Hauv Suav teb, cov tshuaj pleev crisaborole tau suav nrog nyob rau hauv Thib Ob Batch of Overseas New Drug Xav Tau Ceev Xwm Ceev hauv Chaw Kho Mob hauv 2019. Thaum Lub Xya Hli 2020, crisaborole tau pom zoo los ntawm NMPA rau kev lag luam hauv Suav teb, thiab nws cov lus qhia yog rau kev kho mob me me mus rau nruab nrab AD. Hauv cov neeg mob hnub nyoog 2 xyoos thiab laus dua, dhau los ua thawj tus tsis yog-steroidal PDE-4 inhibitor pom zoo hauv Suav teb. Thaum Lub Yim Hli 2023, crisaborole ointment tau txais kev pom zoo rau qhov qhia tshiab, nthuav dav siv rau cov neeg mob hnub nyoog 3 hlis thiab siab dua.
Dhau li ntawm Pfizer tau pom zoocrisaboroletshuaj pleev, tsis muaj lwm lub tuam txhab domestic tau pom zoo rau kev lag luam. Txawm li cas los xij, cov ntaub ntawv tseem ceeb ntawm crisaborole yuav tas rau xyoo 2026. Tam sim no, ntau lub tuam txhab kws tshuaj hauv tsev tau xa daim ntawv thov kev lag luam rau kev lag luam ntawm crisaborole tshuaj pleev generics, suav nrog Nanjing Wanrong Jiancheng Pharmaceutical, Qilu Pharmaceutical, Hangzhou Solipharma, Zhejiang Gaozhi JiangxiangKharmaceutical, , Jiangsu Wangao Pharmaceutical. Nws tseem tsis tau paub meej tias leej twg yuav tau txais kev pom zoo thawj zaug tshuaj noj rau yav tom ntej.
PDE-4 Inhibitor R&D Toj roob hauv pes hauv Suav teb
Vim tias muaj peev xwm ua lag luam xav tau ntau rau AD kev kho mob, qhov "muaj txiaj ntsig zoo" tau txhawb nqa R&D rau PDE-4 inhibitors hauv Suav teb. Los ntawm inhibiting qhov degradation ntawm intracellular cyclic adenosine monophosphate (cAMP) thiab nce nws qib hauv cov hlwb, PDE-4 inhibitors tswj cov qib ntawm proinflammatory cytokines txhawm rau txhawm rau inflammatory teb. Lawv muaj qhov tseem ceeb hauv kev kho mob thiab muaj txiaj ntsig hauv kev kho mob tiv thaiv kab mob thiab kab mob, suav nrog AD thiab psoriasis.
Tam sim no, tsuas muaj ob lub PDE -4 inhibitors pom zoo rau kev lag luam hauv Suav teb: crisaborole los ntawm Pfizer thiab apremilast los ntawm Amgen (pom zoo los ntawm NMPA hauv 2021 rau kev kho mob ntawm cov kab mob plawv mus rau mob hnyav). Muaj kwv yees li ntau tshaj kaum PDE-4 inhibitors nyob rau hauv kev kho mob theem hauv Suav teb.
Thaum Lub Rau Hli 2021, Nuance Pharma tau pom zoo nrog Verona Pharma, nrog Nuance Pharma tau txais cov cai tshwj xeeb rau Verona Pharma cov tshuaj tshiab dual PDE3/4 inhibitor tshuaj, Ensifentrine (RPL554), uas tam sim no tab tom txhim kho.
Ensifentrine's dual inhibitory mechanism tso cai rau nws muaj ob qho tib si bronchodilatory thiab anti-inflammatory kev ua si los ntawm ib qho chaw. Tsis tas li ntawd, Ensifentrine tuaj yeem qhib lub cystic fibrosis transmembrane conductance regulator (CFTR), uas yuav pab txo cov hnoos qeev viscosity thiab txhim kho mucosal ciliary clearance, yog li muab cov kev siv hauv cystic fibrosis, hawb pob, thiab lwm yam kab mob ua pa.
Hauv Phase III txoj kev tshawb fawb, cov txiaj ntsig tau pom tias qhov kev hloov pauv ntawm qhov nruab nrab FEV1 cheeb tsam hauv qab qhov nkhaus (qhov ntsuas lub ntsws ua haujlwm) los ntawm lub hauv paus mus rau Lub Limtiam 12 hauv pawg Ensifentrine yog 94mL (P.<0.0001), indicating that the study had reached its primary endpoint.
Thaum lub Cuaj Hlis 2021, Innovent Biologics thiab UNION Therapeutics koom ua ke tshaj tawm tias lawv tau ua tiav qhov kev pom zoo hais txog orismilast, UNION tus thawj coj siv tshuaj rau kev kho mob ntawm daim tawv nqaij kab mob, PDE-4 inhibitor tam sim no nyob rau hauv kev kho mob Phase II. Raws li kev pom zoo, Innovent yuav tau txais cov cai tshwj xeeb rau kev tshawb fawb, kev tsim kho, thiab kev lag luam ntawm orismilast hauv Suav teb. UNION yuav tau txais kev them nyiaj ua ntej ntawm USD 20 lab thiab muaj cai tau txais kev them nyiaj tseem ceeb suav nrog tag nrho txog $ 247 lab.
Hauv Phase IIa kev tshawb fawb soj ntsuam tsom rau atopic dermatitis, orismilast pom tau tias muaj peev xwm zoo tshaj plaws hauv chav kawm (BIC) zoo, uas qhia cov kev tiv thaiv zoo tshaj plaws thiab kev zam zoo dua los ntawm kev tsim tawm tshiab. Nws yuav tsum tau hais txog qhov tsis xav tau ntawm cov neeg mob uas muaj kab mob ntawm daim tawv nqaij.
Thaum Lub Kaum Ib Hlis 2022, Jumpcan Pharmaceutical thiab Newsoara tau tshaj tawm tias lawv tau pom zoo los koom tes nrog cov lus pom zoo xws liPDE -4 inhibitorthiab cov khoom sib xyaw ua ke los ntawm Newsoara hauv Suav teb av loj. Raws li kev pom zoo, Jumpcan Pharmaceutical yuav them nyiaj ua ntej tsis pub ntau tshaj RMB 180 lab thiab kev loj hlob tseem ceeb ntawm kev them nyiaj tsis pub tshaj USD 12.125 lab, thiab lwm yam.
Thaum Lub Kaum Hli 2023, Livzon thiab Lansson koom ua ke tshaj tawm kos npe rau daim ntawv cog lus patent thiab thev naus laus zis hloov pauv hauv Tuam Tshoj rau LS21031 tsim los ntawm Lansson. LS21031 yog ib qho tshiab thiab xaiv PDE-4 allosteric modulator R&D los ntawm Lansson, uas tau pom zoo rau kev kho mob hauv Suav teb thaum Lub Peb Hlis 2023, nrog rau nws qhov qhia tau tias muaj kev nyuaj siab.
Raws li daim ntawv cog lus, Livzon yuav tau txais cov thev naus laus zis uas cuam tshuam, thaum Lansson yuav tau txais kev them nyiaj ua ntej ntawm RMB 15 lab, thiab tseem tuaj yeem tau txais tus nqi tseem ceeb ntawm kev loj hlob tsis pub ntau tshaj RMB 70 lab thiab tus nqi muag ntawm RMB 80 lab yav tom ntej. .
PDE-4 inhibitor, raws li cov tiam tom ntej ntawm cov tshuaj rau kev kho cov kab mob inflammatory, tau ua tiav cov txiaj ntsig zoo heev. Kev tshawb fawb thiab kev nqis peev boom hauv daim teb no txuas ntxiv, ob qho tib si hauv tsev thiab txawv teb chaws. Tsis tas li ntawd, nrog qee cov tshuaj patents tas sij hawm, kev sib tw hauv kev lag luam generics tau dhau los ua nruj heev. Yav tom ntej, ntsib PDE -4 txoj kev yuav yog kev sib ntaus sib tua hnyav.
Cov ntaub ntawv tseem ceeb:
1, https://www.prnasia.com/story/321878-1.shtml.
2, Luelmo J, Gratacós J, Martínez-Losa MM, et al. Ib daim ntawv tshaj tawm ntawm 4 xyoo ntawm kev paub ntawm ntau qhov kev qhuab qhia ntawm psoriasis thiab psoriatic mob caj dab [J]. Reumatología Clínica (English Edition), 2014, 10(3): 141-146.
3, Torre Alonso JC, et al. Cov kws tshaj lij pom zoo rau kev siv apremilast hauv psoriatic mob caj dab. Reumatol Clin (Engl Ed). 2022 May 7:S2173-5743(22)00092-2.
Hais Txog Tus Sau:
Xiaobin
Xiaobin tau kawm tiav Master's degree hauv Pharmacy thiab tam sim no ua haujlwm ua haujlwm tswj hwm kev noj qab haus huv rau pej xeem. Kev taug kev los ntawm cov ntaub ntawv sib txawv thiab nyuaj txhua hnub thiab hnov qhov kev nkag siab ntawm nws tus kheej tsis tseem ceeb. Thaum zoo siab los ua tim khawv rau lub sij hawm golden ntawm txoj kev loj hlob ntawm Tuam Tshoj bio-pharmaceutical kev lag luam. Cia siab tias yuav kawm thiab txhim kho ua ke nrog txhua tus.