I 国外生物药品产业发展概况

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涯倍文
7 years ago
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1 TEL FAX

2 TEL FAX I II III IV V VI

..15...15...15...15...15...16 V...16...16...16...16...17 VI.

4 I proteins antibodies nucleic acids glucotherapeutics cell or tissue based therapeutics % 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 Ortho Biotech Procrit 1999 Epogen Amgen EPO Ortho Biotech Procrit HIV EPO 1988 TEL FAX

stimulating factors Amgen epogen (epogen, epoetin alfa, erythopoietin EPO) 1989 FDA 1991 HIV zidovudine Epogen 1999 17.

5 1991 Amgen Genetics Institute Amgen Ortho Biotech Ortho Procrit Amgen US 5,955,422 Amgen Epogen - (novel erythopoesis-stimulating protein NESP) NESP Amgen (FDA) (EMEA) II Amgen -- G-CSF (Neupogen filgrastim) FDA 1996 HIV Amgen SD/ III (HBV) (HCV) HBV HCV Schering-Plough Intron A( - -2b) ICN Pharmaceuticals HBV HCV Schering-Plough Rebetron [Rebetol ribaviren Intron A ] Intron A Peg-Intron HCV - Schering -Plough Betaferon - -1a Berlex Laboratoris Betaseron 1993 FDA / MS 1995 Biogen Avonex - -1a FDA / Serono Rebif( - -1a) TEL FAX

A( - -2b) ICN Pharmaceuticals HBV HCV 1999 6.5 Schering-Plough Rebetron [Rebetol ribaviren Intron A ] 1998 6 1999 5 1999 5.

6 10 insulin HGH follicle-stimulating hormone Humulin 1982 FDA Genentech Eli Lilly Lilly 80% Novo Nordisk Novolin NovoRapid Velosulin 65% Pharmacia Genotopin Eli Lilly Humatrope 1996 somatotropin Genentech :Protropin (somatren), Nutropin (somatropin) Nutropin AQ somatropin 2 Novo Nordisk Norditropin FDA Genentech 1997 BioTechnology General Corporation BioTropin 1995 Genentech Serono Saizen 1996 FDA Genentech HGH Genentech 5000 HGH Genentech California rfsh Serono Gonal-F (follitropin- ) % Serono FSH [Metrodin ( R )-HP] 41% Gonal-F FDA gonatropin Serono Ovidrel FDA 2001 DNA hcg TEL FAX

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

7 TPA Genentech Activase (alteplase) 1987 FDA AMI Activase IV III Genentech TPA TNKase (tenectaplase) FDA 5 MAbs FDA ReoPro (abciximab) Centocor Centocor Remicade(infliximab) Crohn FDA methotrexate 6.00 Genentech Herceptin (trastuzumab) IDEC Rituxan (rituximab) Herceptin 1998 FDA Rituxan 1997 FDA B % % 1.03 Synagis (palivizumab) MedImmune FDA EMEA TEL FAX

46 1999 11 FDA methotrexate 6.00 Genentech Herceptin (trastuzumab) IDEC Rituxan (rituximab) Herceptin 1998 FDA 1999 1.884 7.

8 (RSV) Johnson & Johnson Orthoclone OKT3, Ligand Pharmaceuticals Simulect Roche Zenapax 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 NCEs Actelion 2001 bosentan, tracleer Scios B Nesiritide (Natrecor) Lylly Xigris (drotrecogin ) TEL FAX

Aldurazyme -L-iduronidase BioMarin Genzyme (mucopolysaccaridosis-i) Celltech Group Connetics ConXn ( rh-relaxin) II

9 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 FAX

fab) Glaxo SmithKline Twinrix (hepatitis A + hepatitis B vaccine) 2002 Abbott D2E7 (adalimumab) Genentech Xanelim (efalizumab) Amgen Aranesp

10 Genzyme Fabrazyme - Fabry - Fabrazyme TKA Replagal Fabry - A agalsidase alfa Elly Lilly % % 6 18% Lahman brather Commerzbank Lahman brather Amgen, Genentech, Imclone Gilead Sciences Medarex Abgenix CAT Commerzbank TEL FAX

Lahman brather Commerzbank Lahman brather Amgen, Genentech, Imclone Gilead

11 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 Enbrel 30 Immunex Amgen Genentech % 36% rituximab(rituxan) 84% 8.19 trastuzumab(herceptin) % IND 4 BLA CAT 5500 Drug Royalty (DRC) CAT 1990 CAT 6 TEL FAX

5 8 2005 Enbrel 30 Immunex Amgen Genentech 2001 22 2000 27% 36% 17.43 rituximab(rituxan) 84% 8.

12 12 4 adalimumab(d2e7) Abbott III - Merlin Biociences Chistopher Evans % (NDA) Orphan Drugs % 1983 Orphan Drug Act Genezyme I cerezyme Amgen TEL FAX