2001 4 2002 2 WWW.CEI.GOV.CN TEL 010 68558557 1 FAX 010 68558370
TEL 010 68558557 2 FAX 010 68558370 I...2...2...8 II...11...11...12...12...12...12 III...13...13...13...14 IV...15...15...15...15...15...16 V...16...16...16...16...17 VI...17...17...18...19
I 1972 30 15 proteins antibodies nucleic acids glucotherapeutics cell or tissue based therapeutics 1999 30 27 90% cytokines hormones clotting factors tissue plasminogen activators [antigens (vaccines)] (growth factors ) interfereons colony stimulating factors Amgen epogen (epogen, epoetin alfa, erythopoietin EPO) 1989 FDA 1991 HIV zidovudine Epogen 1999 17.6 1998 13.8 27 Ortho Biotech Procrit 1999 Epogen Amgen EPO Ortho Biotech Procrit HIV 1992 4.7 1998 13.6 EPO 1988 TEL 010 68558557 2 FAX 010 68558370
1991 Amgen Genetics Institute 1400 1995 Amgen Ortho Biotech Ortho Procrit 2000 4 Amgen US 5,955,422 Amgen Epogen - (novel erythopoesis-stimulating protein NESP) NESP 1-3 1999 12 Amgen (FDA) (EMEA) II Amgen -- G-CSF (Neupogen filgrastim) 1991 2 FDA 1996 HIV Amgen SD/01 1999 III (HBV) (HCV) HBV HCV Schering-Plough Intron A( - -2b) ICN Pharmaceuticals HBV HCV 1999 6.5 Schering-Plough Rebetron [Rebetol ribaviren Intron A ] 1998 6 1999 5 1999 5.3 Intron A Peg-Intron HCV - Schering -Plough Betaferon - -1a Berlex Laboratoris Betaseron 1993 FDA / MS 1995 Biogen Avonex - -1a 1996 1997 FDA / Serono Rebif( - -1a) TEL 010 68558557 3 FAX 010 68558370
10 insulin HGH follicle-stimulating hormone Humulin 1982 FDA Genentech Eli Lilly 1999 10 Lilly 80% Novo Nordisk Novolin NovoRapid Velosulin 65% Pharmacia Genotopin 1987 1995 3.88 1999 4.61 Eli Lilly Humatrope 1996 somatotropin 1997 1999 3.00 Genentech :Protropin (somatren), Nutropin (somatropin) Nutropin AQ somatropin 2 Novo Nordisk Norditropin 1988 1999 2.32 1995 FDA Genentech 1997 BioTechnology General Corporation BioTropin 1995 Genentech Serono Saizen 1996 FDA 1999 9100 Genentech HGH 1999 4 Genentech 5000 HGH Genentech California 1999 11 2 rfsh Serono Gonal-F (follitropin- ) 1995 1998 1999 3.487 1998 43% Serono FSH [Metrodin ( R )-HP] 41% 1.987 1.403 2000 6 Gonal-F FDA gonatropin 2000 10 Serono Ovidrel FDA 2001 DNA hcg TEL 010 68558557 4 FAX 010 68558370
TPA Genentech Activase (alteplase) 1987 FDA AMI 1990 1996 3 Activase IV III Genentech TPA TNKase (tenectaplase) 2000 5 FDA 5 MAbs 1998 260 700 8 FDA ReoPro (abciximab) Centocor 1995 1999 4.47 10 Centocor Remicade(infliximab) Crohn 1999 1.46 1999 11 FDA methotrexate 6.00 Genentech Herceptin (trastuzumab) IDEC Rituxan (rituximab) Herceptin 1998 FDA 1999 1.884 7.5-10 Rituxan 1997 FDA B- 1999 2.794 2000 50% 7800 38% 1.03 Synagis (palivizumab) MedImmune 1998 6 1999 9 FDA EMEA TEL 010 68558557 5 FAX 010 68558370
(RSV) 1999 2.93 2000 3.48 Johnson & Johnson Orthoclone OKT3, Ligand Pharmaceuticals Simulect Roche Zenapax 1999 1 Novo Nordisk NovoMix30 Aldurazyme -L-iduronidase BioMarin Genzyme (mucopolysaccaridosis-i) Celltech Group Connetics ConXn ( rh-relaxin) II III II I/II III antithrombin III Genzyme III (heparin) III 2001 31 NCEs 7 2001 2001 Actelion 2001 bosentan, tracleer Scios B Nesiritide (Natrecor) 10 2001 Lylly Xigris (drotrecogin ) TEL 010 68558557 6 FAX 010 68558370
FDA C 20% Amgen 2001 Immunex anakinra(kineret) -1 darbepotin (aranesp) Amgen Aranesp 2001 Schering-Plough PEG-Intron PEG- Intron PEG -2b PEG Schering-Plough Roche PEG -2a peginterferon -2a, Pegasys 2002 Berlex/Ilex Campath (alemtuzumab) B T CD52 B Protheric DigiFab (digoxin immune fab) Glaxo SmithKline Twinrix (hepatitis A + hepatitis B vaccine) 2002 Abbott D2E7 (adalimumab) Genentech Xanelim (efalizumab) Amgen Aranesp Kineret 2002 GSK Corixa Bexxar (tositumomab) 131 I CD20 B CD20 B B II I Idec Zivalin (ibritumomab tiuxetan) CD20-90 TEL 010 68558557 7 FAX 010 68558370
Genzyme Fabrazyme - Fabry - Fabrazyme TKA Replagal Fabry - A agalsidase alfa Elly Lilly 1982 1999 20% 4 10 100 200 2000 369 500 46 11% 6 18% Lahman brather Commerzbank Lahman brather Amgen, Genentech, Imclone Gilead Sciences Medarex Abgenix CAT Commerzbank 2001 9 TEL 010 68558557 8 FAX 010 68558370
2001 2001 Amgen 160 Immunex Amgen 730 Genentex 280 Amgen AstraZeneca 784 Pharmacia 552 Schering-Plough 550 Aventis 531 Amgen Immunex Enbrel(etancercept) Enbrel Immunex 1999 Enbrel 2001 Enbrel 7.5 8 2005 Enbrel 30 Immunex Amgen Genentech 2001 22 2000 27% 36% 17.43 rituximab(rituxan) 84% 8.19 trastuzumab(herceptin) 3.47 26% 2005 5 IND 4 BLA 4 6 2003 2002 CAT 5500 Drug Royalty (DRC) CAT 1990 CAT 6 TEL 010 68558557 9 FAX 010 68558370
12 4 adalimumab(d2e7) Abbott III - Merlin Biociences Chistopher Evans 2000 65% (NDA) 2001 12 100 7 Orphan Drugs 20 1982 2000 56% 1983 Orphan Drug Act 7 6000 200 900 1993 1999 Genezyme I cerezyme 1999 5 Amgen TEL 010 68558557 10 FAX 010 68558370
1990 vitravene. II 100 80 18 1996 (TPO) TEL 010 68558557 11 FAX 010 68558370
TEL 010 68558557 12 FAX 010 68558370 r-sk 1998,
III 200 2001 20 ( ) ( ) ( ) ( N) 20 (rhgh) 5 EPO - (GM-CSF) 8-2(rhulL-2) 9 1993 TEL 010 68558557 13 FAX 010 68558370
1992 1993 1 1 4 10 500 600 a-1b (rhu IFNQ-lb) (r-bfgf) (r-sk) 2% 20% TEL 010 68558557 14 FAX 010 68558370
TEL 010 68558557 15 FAX 010 68558370 IV " " WTO 100 20% 10 6.5% " " 40 WTO WTO
V 1990 2000 2001 2001 FDA Gleevec TEL 010 68558557 16 FAX 010 68558370
TEL 010 68558557 17 FAX 010 68558370 FDA VI
863 15 50 WTO 8 12 6 4 8 3 6 6 3 3 TEL 010 68558557 18 FAX 010 68558370
TEL 010 68558557 19 FAX 010 68558370