新药申报信息简析

խ㧺ᄅ偆ઔ䦡䷶䳒䀀⇕䬖(CPM)·ᄅ偆亓㳪ߓ٨㦅ܫ࢖ڎଖቫᇳ(2014Q1-2014Q2)1ંৃ௦௏౨ೇྐ๞ރୣڳઝࢗ֟ᅱࣣ௦௏ၽཙྐ๞ރୣᆴဈݯᄥᄯڳ໭ྐཙ֟ԅᅖྑଶᄵד๥ᄯڳ໭ྐཙ֟ᆙ඘Վൟރ௔ಽᄯڳଛᅹڳСԅྐ๞ރୣޔ໸ᄯڳଛᅹࠩࣇԅྐ๞ރୣڳСெࣣᄯڳಃͱ೓सଛᅹெࣣŌᄯڳೇЦཙ֟ߙ࿐ڑᅟԤ*ᄯڳೇЦᄔԄᄷԤڑᅟԅஎॏଶᄵ*ContentsŌŌŌŌŌŌŌŌ2㙯㙴⾥⫼㥃ં஍ēسЫࢳဈྐ௦௏ྸ౨ೇԅྐ๞٫ပ40ّଶᄵ,࡮඘ఢຏġॳⷨॖଚѻક㣅᭛ৡѻકЁ᭛ৡ೑ݙᚙމAbbottpinaveriumbromideऍ㓈⒈䫉೑ѻॳ᭭ঞࠊࠖǃ䖯ষॳ᭭ঞࠊࠖAskaPharmaceuticalroxatidineacetateHCl᮴Astellasramosetron䳋㥿ৌ⨐䖯ষॳ᭭ঞࠊࠖAstellastacrolimusҪܟ㥿ৌ೑ѻॳ᭭ঞࠊࠖǃ䖯ষࠊࠖAstraZenecaadalimumab䰓䖒᳼ऩᡫ䖯ষࠊࠖAstraZenecaomeprazole༹㕢ᢝ૥೑ѻॳ᭭ঞࠊࠖǃ䖯ষॳ᭭ঞࠊࠖBiorexLabsbalsalazidedisodiumᏈ᷇∂䩴᮴BoehringerIngelheimcimetropiumbromide㽓ᠬ⒈䫉᮴DainipponSumitomoPharmamosapride㥿≭ᖙ߽೑ѻॳ᭭ঞࠊࠖǃ䖯ষॳ᭭ঞࠊࠖDong-Aeupatilin᮴Elannatalizumab䙷Ҫ⦴ऩᡫ᮴EliLillyalvimopan᮴Farnextiemoniummetilsulfate᮴ܼ⧗ϞᏖ㥃⠽ঞ݊೑ݙᓔথ⢊މॳⷨॖଚѻક㣅᭛ৡѻકЁ᭛ৡ೑ݙᚙމGlaxoSmithKlinealosetron䰓⋯ৌ⨐᮴GlaxoSmithKlineranitidine䳋ሐ᳓ϕ೑ѻॳ᭭ঞࠊࠖǃ䖯ষॳ᭭ঞࠊࠖHGParsHGP-25᮴IronwoodPharmaceuticalslinaclotideacetate᮴Johnson&Johnsoncisapride㽓≭ᖙ߽೑ѻॳ᭭ঞࠊࠖǃ䖯ষॳ᭭ঞࠊࠖJohnson&Johnsoninfliximab㣅໿߽ᯨऩᡫ䖯ষࠊࠖJohnson&Johnsonprucalopridesuccinate(IV)᱂शवᖙ߽᮴Kyorintroxipide᳆ᯨ⌒⡍೑ѻॳ᭭ঞࠊࠖMayoly-Spindleralverinecitrate+simeticone䰓ᇨ㓈ᵫ+㽓⬆⸙⊍ˈ໡ᮍ᮴Menariniotiloniumbromide༹᳓⒈䫉೑ѻॳ᭭ঞࠊࠖǃ䖯ষࠊࠖNovartistegaserodmaleate᳓ࡴ㡆㔫೑ѻॳ᭭ঞࠊࠖOtsukarebamipide⨲Ꮘ⌒⡍೑ѻॳ᭭ঞࠊࠖǃ䖯ষॳ᭭ঞࠊࠖPfizercelecoxibาᴹ㗗ᯨ೑ѻॳ᭭ǃ䖯ষॳ᭭ঞࠊࠖPfizerpiprozolinઠ᱂૥ᵫ᮴Pfizertixocortolpivalateenema᮴ReckittBenckisermebeverine+ispaghula᮴ܼ⧗ϞᏖ㥃⠽ঞ݊೑ݙᓔথ⢊މॳⷨॖଚѻક㣅᭛ৡѻકЁ᭛ৡ೑ݙᚙމSanofizolimidineԤ߽㉇ᅮ᮴SucampoPharmaceuticalslubiprostone᮴Takedalansoprazole݄㋶ᢝ૥೑ѻॳ᭭ঞࠊࠖǃ䖯ষॳ᭭ঞࠊࠖTakedapantoprazole⋂ᠬᢝ૥೑ѻॳ᭭ঞࠊࠖǃ䖯ষॳ᭭ঞࠊࠖTakedatrepibutone᳆ऍᏗ䗮೑ѻॳ᭭ঞࠊࠖTsumuraTJ-15᮴UCBcertolizumabpegol᮴UCBlafutidineᢝਟ᳓ϕ೑ѻॳ᭭ঞࠊࠖYuHanrevaprazan᮴ZeriaTP-01᮴Zeriapolaprezinc㘮᱂⨲䫠೑ѻॳ᭭ঞࠊࠖ3ܼ⧗ϞᏖ㥃⠽ঞ݊೑ݙᓔথ⢊މၽ௦௏ֳถઝē҉ဟII୙ংҕཙࡎރྻ܊ԅၽཙسЫࢳဈྐ٫ပ102ّଶᄵēఢຏġॳⷨॖଚѻક㣅᭛ৡⷨথ⢊ᗕAbbottbriakinumabIIᳳЈᑞActiveBiotechlaquinimodIIᳳЈᑞAjinomotoAJM-300IIIᳳЈᑞAlbaTherapeuticslarazotideacetateIIᳳЈᑞAlderBiopharmaceuticalsclazakizumabIIᳳЈᑞAlfaWassermannrifaximin⊼ݠࠡAllerganrezatomidineIIᳳЈᑞAlvinePharmaceuticalsALV-003IIᳳЈᑞAmgenAMG-139IIᳳЈᑞAmgenbrodalumabIIᳳЈᑞAstellasASP-015KIIᳳЈᑞAthersysMultiStemIIᳳЈᑞBioLineRxBL-7010IIᳳЈᑞܼ⧗೼ⷨ㥃⠽ॳⷨॖଚѻક㣅᭛ৡⷨথ⢊ᗕBiogenIdecbaminerceptIIᳳЈᑞBotanicCenturyMelokinexIIᳳЈᑞBraintreeLaboratoriesBLI-1300IIᳳЈᑞBristol-MyersSquibbNNC-114-0005IIᳳЈᑞBristol-MyersSquibbabataceptIIIᳳЈᑞBristol-MyersSquibbeldelumab(SC)IIᳳЈᑞBukwangAdipoPlusIIᳳЈᑞCJCorpCJ-20001IIᳳЈᑞCan-FiteBioPharmaCF-101IIᳳЈᑞCelgenecenplacel-LIIᳳЈᑞChemoCentryxvercirnonIIIᳳЈᑞChromosMolecularSystemsvatelizumabIIᳳЈᑞD-PharmDP-b99IIᳳЈᑞDong-ADA-6034IIIᳳЈᑞDong-ADA-9701IIIᳳЈᑞEliLillyBevenopranIIᳳЈᑞܼ⧗೼ⷨ㥃⠽ॳⷨॖଚѻક㣅᭛ৡⷨথ⢊ᗕEnzoBiochemAlequelIIᳳЈᑞGWPharmaceuticalsGWP-42003IIᳳЈᑞGalapagosGLPG-0974IIᳳЈᑞGiulianiGED-0507IIᳳЈᑞGlaxoSmithKlineGSK-1399686IIᳳЈᑞGlaxoSmithKlinesolabegronhydrochlorideIIᳳЈᑞHarborBioSciencesHE-3286IIᳳЈᑞHarborTherapeuticsHE-3286IIᳳЈᑞHutchisonChinaMediTechHMPL-004IIᳳЈᑞIl-YangilaprazoleIIIᳳЈᑞImmuronIMN-1002IIᳳЈᑞInDexPharmaceuticalsKappaproctIIᳳЈᑞInnatePharmaNN-8555IIᳳЈᑞInnovacellICEF-15IIᳳЈᑞIsisPharmaceuticalsalicaforsenIIIᳳЈᑞJohnson&JohnsoneluxadolineIIᳳЈᑞܼ⧗೼ⷨ㥃⠽ॳⷨॖଚѻક㣅᭛ৡⷨথ⢊ᗕJohnson&JohnsongolimumabIIIᳳЈᑞJohnson&JohnsonmethoxsalenIIᳳЈᑞJohnson&JohnsonustekinumabIIᳳЈᑞKurehaCorporationAST-120IIIᳳЈᑞKyorinKRP-203IIᳳЈᑞLGLifeSciencesLD02-GIFROIIᳳЈᑞLexiconPharmaceuticalsLX-1031IIᳳЈᑞLexiconPharmaceuticalstelotristatIIᳳЈᑞLuqaPharmaceuticalsLQ-006⊼ݠMarathonPharmaceuticalsMP-101IIIᳳЈᑞMarinaBiotechCEQ-508IIᳳЈᑞMeijiAM-3301IIᳳЈᑞMeijiRR-210IIᳳЈᑞMenariniibodutantIIᳳЈᑞMenarininepadutantIIᳳЈᑞMerckKGaAasimadolineIIIᳳЈᑞܼ⧗೼ⷨ㥃⠽ॳⷨॖଚѻક㣅᭛ৡⷨথ⢊ᗕMitsubishiTanabePharmaDDP-225IIᳳЈᑞNPSPharmaceuticalsteduglutide⊼ݠࠡNatrogenNatura-alphaIIᳳЈᑞNeovacsTNF-KIIᳳЈᑞNipponShinyakutamibaroteneIIᳳЈᑞNovartisESBA-105IIᳳЈᑞNovartisQAX-576IIᳳЈᑞNovartisbasiliximabIIᳳЈᑞNovartissecukinumabIIᳳЈᑞNovartissotrastaurinIIᳳЈᑞNovoNordiskipamorelinIIᳳЈᑞOsirisTherapeuticsremestemcel-lIIIᳳЈᑞOtsukatetomilastIIIᳳЈᑞOxagenODC-9101IIᳳЈᑞPalauPharmadersalazinesodiumIIᳳЈᑞPfizerPF-4236921IIᳳЈᑞܼ⧗೼ⷨ㥃⠽ॳⷨॖଚѻક㣅᭛ৡⷨথ⢊ᗕPfizerPF-547659IIᳳЈᑞPfizeranrukinzumabIIᳳЈᑞPfizertofacitinibIIIᳳЈᑞProgenicsPharmaceuticalsmethylnaltrexonebromideIIIᳳЈᑞPurGenesisPUR-0110IIᳳЈᑞQuBiologicsQBECOIIᳳЈᑞRottapharmMadausCR-3294IIᳳЈᑞRottapharmMadausdexloxiglumideIIIᳳЈᑞSKHoldingsHMP-304IIᳳЈᑞSKHoldingsSK-MS10IIᳳЈᑞSynergyPharmaceuticalsplecanatideIIᳳЈᑞSyntaPharmaceuticalsapilimodmesylateIIᳳЈᑞTakedaORE-1001IIᳳЈᑞTakedavedolizumabIIIᳳЈᑞTargaceptTC-6499IIᳳЈᑞTheravancevelusetragIIᳳЈᑞܼ⧗೼ⷨ㥃⠽ॳⷨॖଚѻક㣅᭛ৡⷨথ⢊ᗕTiGenixCX-601IIᳳЈᑞTibetPharmaceuticalsJiuzunpillIIᳳЈᑞTranzymeTZP-102IIᳳЈᑞTranzymeulimorelinIIᳳЈᑞTsumuraDaikenchutoIIᳳЈᑞTxCellOvaSaveIIᳳЈᑞUCBolokizumabIIᳳЈᑞVBLTherapeuticsCI-201IIᳳЈᑞVentriaBioscienceVen-105IIᳳЈᑞ4ܼ⧗೼ⷨ㥃⠽ၽᄯڳē࠼ڳޥಪଶྐଶ޳՜ڕसࡥďSFDAĐଛᅹಓСԅسЫࢳဈྐပ38ّēუ໔Сଶރୣອ࿫ޔ໸ெࣣఢຏġ㥃ક䗮⫼ৡࠖൟ5-⇼෎∈ᴼ䝌ॳ᭭㥃ǃ⠛ࠖҪܟ㥿ৌॳ᭭㥃ǃ㛊ಞࠖǃ䕃㝣݄ࠖ㋶ᢝ૥ॳ᭭㥃ǃ⊼ᇘࠖǃ⠛ࠖǃ㛊ಞ߽ࠖ⽣ᯨᯢॳ᭭㥃ǃᑆ⏋ ࠖǃ⠛ࠖǃ㛊ಞࠖǃ䕃㛊ಞࠖऍ㓈⒈䫉ॳ᭭㥃ǃ⠛ࠖਟୗ૥䝂+ਆમ㕢䕯,໡ᮍᷧࠖ˄Ⳉ㙴˅ਟୗ૥䝂+ਆમ㕢䕯ˈ໡ᮍᷧࠖ˄Ⳉ㙴˅ਟୗ૥䝂+㑶স䈚䝛䝃+ਆમ㕢䕯ˈ໡ᮍᷧࠖ˄Ⳉ㙴˅౏༜᱂∔⠛ࠖาᴹᯨᏗॳ᭭㥃༹᳓⒈䫉ॳ᭭㥃ǃ⠛༹ࠖ≭ᢝ⾺ॳ᭭㥃ǃ㛊ಞ༹ࠖ㕢ᢝ૥ࠊࠖЁ䯈ԧǃॳ᭭㥃ǃ⊼ᇘࠖǃ⠛ࠖǃ㛊ಞࠖЁ೑ᡍޚ೑ѻⱘ㥃⠽ঞ݊ࠖൟ㥃ક䗮⫼ৡࠖൟᇣ⺅ˈ໡ᮍ䕃㝣ࠖᏗ↨व಴+ᯢⷒˈ໡ᮍ⊼ᇘࠖᢝਟ᳓ϕॳ᭭㥃ǃ⠛ࠖǃ⠛ࠖ˄ߚᬷ⠛˅ǃ㛊ಞࠖǃ乫㉦ࠖ᳆ऍᏗ䗮ॳ᭭㥃ǃ⠛ࠖ᳆ᯨ⌒⡍ॳ᭭㥃ǃ⠛ࠖǃ㛊ಞࠖ᳓ࡴ㡆㔫ॳ᭭㥃ǃ⠛ࠖǃ㛊ಞࠖ᷇∂⻎৵୊ॳ᭭㥃ǃᷧࠖ˄Ⳉ㙴˅ǃ⠛ࠖǃ㛊ಞࠖ⃵≵亳ᄤ䝌䪟ॳ᭭㥃⃵≵亳ᄤ䝌䪟ˈ໡ᮍᷧࠖ˄Ⳉ㙴˅⇼⻋∔ॳ᭭㥃ǃ⊼ᇘࠖ∃Ꮕᅮॳ᭭㥃ǃষ㛊ࠖǃᬷࠖ˄໪⫼˅ǃᷧࠖ˄Ⳉ㙴˅ǃᷧࠖ˄䰈䘧˅ǃ⒊⎆ࠖ˄ষ㜨˅ǃ⒊⎆ࠖ˄໪⫼˅ǃ䌈ࠖǃ䕃㝣ࠖ⋂ᠬᢝ૥ॳ᭭㥃ǃ⊼ᇘࠖǃ⠛ࠖǃ㛊ಞࠖ⨲Ꮘ⌒⡍ॳ᭭㥃ǃ⠛ࠖǃ㛊ಞࠖ⬆⇻≭ᵫॳ᭭㥃ǃ⒊⎆ࠖ˄໪⫼˅ǃ⠛ࠖ⸱䝌⫬⊍ॳ᭭㥃ǃ⇨䳒ࠖǃ⊼ᇘࠖǃ⠛ࠖǃ