2009 10 51 () 21 13 5 III 12 25 20 15 10 5 0 2008.10 2008.11 2008.12 2009.01 2009.02 2009.03 2009.04 2009.05 2009.06 2009.07 2009.08 2009.09 2009.10 III 13 14 () 16 () 1
1 21 12 ( 6) 4 Me-too ( 5) 2 ( 3) 8 ( 2) 6 4 (100 ) Johnson & Johnson Simponi(golimumab)Novartis Muckle-Wells Ilaris(canakinumab) Imprida HCT(++) Palau Pharma IRIST 4 3 SaphrisQLT Onsolis Nycomed Instanyl 1 2009 10 / () pralatrexate Folotyn Allos Therapeu tics T ( ) golimumab Simponi Johnson & Johnson alpha ( ) Muckle-W canakinuma b Ilaris Novartis ells 1b ( ) 2
/ () mecobalami n, Eisai Methycob al Eisai Vitamin B12 ( ) uliprisnil acetate me-too Ella ellaone Myonova HRA Pharma () 4 saxagliptin me-too Onglyza Bristol-My ers Squibb 2 (DPP IV) ( ) asenapine maleate / Saphris Sycrest Merck Co & 5- ( ) fentanyl, Meda / Onsolis QLT mu kappa () lamotrigine, once-daily / Lamictal XR GlaxoSmi thkline ( ) fentanyl, nasal / Instanyl Nycomed Pharma mu kappa () taltirelin hydrate ODT / Ceredist Mitsubishi Tanabe Pharma () vaccine (egg-based), MedIm / monovale nt seasonal infl AstraZen eca ( ) amlodipine+ HCTZ+vals artan, Nov / Imprida HCT Novartis ( ) 3
/ () HMGCoA simvastatin stent, Palau / IRIST Palau Pharma alpha ( ) 6 Erelib eslicarbaze pine acetate Exalief Pazzul Stedesa Bial ( ) Zebinix vaccine Influvac Zilbrix Zilbrix Hib Solvay ( ) vaccine, Arepanrix GlaxoSmi thkline ( ) vaccine, Celvapan, Baxter Internatio nal ( ) vaccine, Sanofi-Av entis ( ) vaccine, Fluvirin Novartis ( ) /colchicine Colcrys URL Pharma ( ) 2 13 2 4 ( 6) 3 ( 4
3) 4 ( 2) 2 4( 50 100 ) 2 Boehringer Ingelheim Twynsta(+) TiGenix ChondroCelectGenmab ofatumumab Addrenex Jenloga XR 3( 20 50 )(miriplatin) 2( 5 20 ) 2 2009 10 / () prucalopride Resolor Movetis 5 () VEGFR pazopanib hydrochlorid e Armala Patorma Votrient GlaxoSmit hkline C-kit () (VEGF) ofatumumab Arzerra (IV) Azerra Genmab CD20 ( ) /clonidine / Jenloga XR/Symp res XR Addrenex Pharmace uticals Alpha 2 Alpha ( ) pramipexole- ER Mirapex ER Boehringer Ingelheim D3 ( ) 5
/ () telmisartan + amlodipine, BI Twynsta Boehringer Ingelheim 1 ( ) triptorelin, sustained-rel ease Pamoreli n, 6mth Trelstar, 6mth Debiophar m LHRH () miriplatin hydrate Miripla Dainippon Sumitomo Pharma DNA () ChondroCele ct TGX-001 TiGenix ( ) vaccine, Celvapan, Baxter Internation al () vaccine, Green Flu-S Green Cross () vaccine Influvir Microgen () vaccine, Pandeflu Microgen () 3 5 2 me-too ( 5) 1 ( 4) 1 ( 3) 2 ( 2) 1 4( 50 100 ) 2 AstraZeneca Brilinta(ticagrelor) 6
Hoffmann-La Roche eldecalcitol 3( 20 50 )Protalix Gaucher`s taliglucerase alfa 1( 0 5 ) 12 1 ( 6) 3 me-too ( 5) 1 ( 4) 2 ( 3) 2 ( 2) 3 1 5 2 POZEN CureMark CM-AT 4 2 3 4 2 3 1 1 3 2009 10 () Me-too taliglucerase alfa Protalix () Gaucher`s ( ) ticagrelor AstraZene ca P2Y12 ( ) olmesartan+ amlodipine+ HCTZ,Dai Daiichi Sankyo 1 ( ) / lercanidipine Recordati L-type ( ) 7
() eldecalcitol Hoffmann- La Roche D ( ) nicotine conjugate, Nabi Nabi Biopharm aceuticals ( ) favipiravir Toyama DNA RNA ( ) HPN-100 Medicis Ammonia scavenger ( ) Me-too omadacyclin e Paratek 30S () 4 (DPP IV) LC-15-0444 LG Life Sciences ( ) 4 teneligliptin Mitsubishi Tanabe Pharma (DPP IV) ( ) 8
() H+ K+ ATP ASA + POZEN ( omeprazole ) fluticasone furoate + vilanterol GlaxoSmit hkline 2 (LABA) (COPD ) ETEC vaccine Intercell () vilanterol GlaxoSmit hkline 2 (LABA) (COPD ) anthrax immune globulin Emergent BioSolutio ns () CM-AT CureMark ( ) 9
1 3 1 2 () 4 2009 10 SFDA 2 23 ( 16 ) 5 2009 10 SFDA ( () () /) Moxifloxacin Hydrochloride and Bayer Schering Pharma Sodium Chloride Avelox AG Injection Cefprozil Bristol Myers Squibb S.R.L. Fluticasone Glaxo Wellcome Propionate Operations Recombinant R Human Insulin BIOTON S.A. SciLin R Injection 10
() () ( /) Nicorandil Tablets Sigmart Nicardipine Hydrochloride SR Microgranules Indapamide Capsules Mosapride Citrate MILLIBAR Bleomycin Hydrochloride for BLEOCIN Injection Flurbiprofen Cataplasms Budesonide Suspension Inhalation Gadobutrol Injection for Pulmicort Respules Gadovist Multiple Vitamins Pharmaton and Lysine Syrup Kiddi Finasteride Tablets Tohoku Nipro Pharmaceutical Corporation Astellas Tokai Co.,Ltd.Nishine Plant Laboratorio Italiano Biochimico Farmaceutico LISAPHARMA S.p.A. The Suzuka Plant of Dainippon Sumitomo Pharma Co., Ltd. TAIKO PHARMACEUTICAL CO., LTD. Takasaki plant,nippon KAYAKU COLTD MIKASA SEIYAKU CO.,LTD KAKEGAWA FACTORY AstraZeneca Pty Ltd Bayer Schering Pharma AG Ginsana SA Merck Sharp & Dohme Quimica de Puerto Rico Ltd. 11
3 75 39 36 31 24 7 3 3 6 2009 10 3 3 1.1 1.1 1.1 3.1 3.1 3.1 3.1 3.1 3.1 3.1 39 33 5 1 3 3 7 2009 10 3 3 3.1 3.3 3.4 3.1 3.2 12
3.1 3.2 3.1 3.1 3.1 3.1 3.1 3.2 3.1 3.1 3.1 4 28 26 2 2 ( 2 ) 8 2009 10 26 (21 ) 24 1 1 9 2009 10 13
14