Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. ??????????????

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ACYW135?????????? ????????(??H1N1????) ??????????
Zhejiang Tianyuan Bio-Pharmaceutical Co.,
Ltd.??????????????
???? ??? 2009.8
2
??????
??????????? ???????? ????????A?C?????????? AC
YW135??????????
3
????????????
Preclinical ???
Phase 1 ????
Phase 2 ????
Phase 3 ????
Registration ??
Vaccine????
DTaP Vaccine ????????
Typhoid Vi PS Vaccine?? Vi ????
Men PS A Vaccine ??A?????
4
???????

• b???????????
• ???????(AC/ACYW)
• ????(23?/7???/??)
• HibDTaP????(??)
• Hib DTaP HBV????(??)
• ??Vi????
• ????(PATH?? ??.?????)

5
?????????
?????? ????? ?????72????????,?2(2/600)
??24????????????,??????????,?48??????
??? ?????72????????,?5(5/300)??24??????????
??,??????????,?48??????
6
?????????
??????
???? ???? ???? ???
??? 200 1/0.5 3/1.5 /
???? 200 1/0.5 4/2.0 /
??? 200 / / /
?? 600 2/0.33 7/1.17 0/0
7
?????????
??????????? ???????????????????????????????,??
??????????????? ????????4??,?????????????????????
????????
8
??????????
GMT
group A-specific SBA GMT
9
??????????
10
??????????
11
??????????
12
??????????
??????????(4???)
????? ?? A () C () Y() W135()
?? 99.39 93.33 98.18 93.79
??? 97.60 98.20 95.21 99.40
?? 99.40 97.59 96.39 100.00
?? 98.80 96.39 96.59 99.40
????????????
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????????????
1?Y?W135????????????C?????,
????????????,????????,?
????,???????????? 2????????????????????????
????????????????,Y?W135??
??????????????????????? ??W135?????Y?????????
????? 3???????,?????,?????????,
????Y?W135????,???????,?? ??????????????
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????????????
??WHO?????????,??????????,?????,???????????????
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• ??? ???????????
• ??????,?WHO??
• ???????,?WHO??
• ????????????SFDA????????????,???????FDA???

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???????????? (20092010)
????? ?? ?? ?? ?? ?? ????
A/Brisbane/59/2007 (IVR-148) H1N1 E7 29570 07/344 NIBSC/WHO 2008.3.19
A/Uruguay/716/2007 (NYMC X-175C) H3N2 E10 29730 07/360 NIBSC/WHO 2008.4.15
B/Brisbane/60/2008 (NIB-58) B E4 30880 08/364 NIBSC/WHO 2009.4.20
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??H1N1?????????
????? ?? ?? ?? ?? ?? ????
NYMC X-179A H1N1 E9 31280 09/124 NIBSC/WHO 2009.6.17
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?????????????????????

• ??????
• ????? A1 30ug/ml
• A3 30ug/ml
• B 30ug/ml
• ?????? 2000 ng/ml
• ????? 690ug/ml
• ????? 200 EU/ml
• ????? ???85115
• ?????? 200 ug /ml

??????? A1 30ug/ml A3 30ug/ml
B 30ug/ml 250ng/ml 300ug/ml 50
EU/ml ???85115 20 ug /ml
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Influenza Vaccine Production Process (1/2)
Seed virus ??
Inoculation and Propagation ????
Eggs ??
Quality Control ??
Harvest ??
Inactivation ??
Purification ??
Split ??
Purification ??
Monobulk H1N1 ??H1N1
Monobulk H3N2 ??H3N2
Monobulk B ??B
Quality Control ??
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Influenza Vaccine Production Process (2/2)
Monobulk H1N1 ??H1N1
Monobulk H3N2 ??H3N2
Monobulk B ??B
Quality Control ??
Blending tri-valent bulk ????
Quality Control ??
Quality Control ??
Filling, Labeling, Packaging ????????
Release ??
Distribution ??
Release ??
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Types of Influenza Vaccines ??????
????? WHOLE VIRUS
?????? SPLIT
????? SUBUNIT
Immunogenicity is comparable to sub-unit
?????????? Safety is better than whole virus
vaccine ??????????
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(No Transcript)
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(No Transcript)
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??????
2008???????????3?? ????1? ????1? ????1? 3????
??1?,????2??
25
????????????
????2006??????36.5????????????????7?? ?4???????
?,??????????? ?????????,????,????? ?????????????
??,??????????
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????????????

• ???2007??????42???????60????????,??????????
• ??2?????
• 1????????????,?????????????
• 1???????????,??????????

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• ??H1N1????????

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??H1N1????SFDA??

• ??????H1N1???????????????????2009?206?
• 2009.5.27WHO???????
• ??????????

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??H1N1????SFDA??

• ??H1N1??????????????????2009?316?
• ???????
• ???????????????
• 2009.10.1???1300???(2600???)
• 2009????6500???(1.3???)
• 2009.6.26???????????SFDA??

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??H1N1????SFDA??

• ??H1N1???????????? ??????2009?322?
• ??????????????????????????
• ????
• ??
• ?????
• ??
• ??

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??H1N1????SFDA??

• ??????H1N1?????????????????????2009?32
  9?
• ??????????????

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??H1N1?????????????????

• ??????????
• ???????????????

33
??H1N1??????????????

• ????????H1N1?????????????????
  ??????2009?316?
• ??????????

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??H1N1????????

• ????
• ?????
• ?????????H1N1????????
• ???????????,??????
• ??CDC????????
• ?????(??????),??????????
• ???????????
• SFDA??????????????
• ????(9??)
• ??????,GMP??(9??)
• ???(9??)

35
? ? ???? ACYW135??????????
???????? (??H1N1????) ??????????
36
????????
??????5? (1)???? (2)???? (3)??? (4)????(?????
) (5)????
37
????????????
??????(37.137.5?)???(37.638.5?)???(38.6?)???
?????????56???24????????,????12?,????3?????????
???????????? ??????,??????????????????,????12???
??????????????????????,?????????,?????23???
38
??????
?????????,????????,???????,????,????,????????? ??
??????????? ?????????????,???????,???????????
39
????????????
????????,?????????????(2.5cm)????(2.65.0cm)????(
gt5.0cm)????????/????????????? ??????????????????2
4?????,????????,????,????????,????????gt5.0cm??????
?????????????????????2448???????
40
??????
??????????????? ????????????????,????,??1015???
????????????????????????????????,????23?,??12??
??
41
??????
1?????? 2?????????????,??????????????,???? 3?
???????????????? 4??????????????????,???????
5? ????
42
???????
??2-7????,?????????????????,??????????????????????
????????????? ????????,?????38C??,?????2-7?,???
???????????,?????,????????????,????????????,??????
?????????
43
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1????????????,????????????????????????????????????
??????????????????? 2???????????????????????????
3???????????????????????????????????????? 4??????
,??????????,??????????????? 5??????????,???? 6??
???????????????,??VC ???????????????,????????,????
???
44
????????
??712??????????????????,??????????,??????????
????????????,?????????? ???????? 1????712????,?
?????,??????????,???? 2????????????????????????
???????????,?????????????????????????????????? 3
??????,?????????????? 4?????
45
??????????
1????????????? 2?????????????????? 3????????????
?????,???????? 4???????????????(??)0.1-0.2ng/kg??
5?????????,???????
46
????????
??????????????????????? ?????????????????,????? ??
????????? ????????? 1????????????,????????(?????
???) 2????????????????? 3?????????,?????????
47
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1?????????????????? 2?????????????????? 3???????
????????????????????????????????????? 4??????????
??????????????,??????? 5?????????????????,???????
???????????????????????????,????????????????????
6??????????????????????
48
?????
???????,????????????????? ????????(???)??????????
??????,????????????????,???????,??????,???????????
??????? ?????????????????
49
?????
???? ?????? ???? ?????????????????
???????,????????????????????????,????????????????
????,??????,????????,????,???????????????,????,???
?,???????????????,???? ???????????????37?
????????????????????,?????????????,????,??????????
? ????????????68???24????????????????????,
????,35?????????,????????????????????????????????
?,????? ?? ?????????????????????????,????2
550mg,????0.51mg/kg ,??23??????(???),????4mg,??
??0.10.2mg/kg,??23?????,????12.525mg????1mg/kg
,??23?????????(???)?????(???)???
50
?????
???? ?????? ???? (1)???????????12????? (2)
?????????????,????,??,????????????????????????????
????? (3)?????????????,??????????????????????,????
?????,?????????,????????????????????????????????
????????????????????????????????????? (4)??????,
???????????????,???????? ?? (1)???????? (2)???
??,??????,??2550mg/?,??23?????1mg/kg,??34?????
?,?????
51
?????
??????????????????,???????,???????(???)?????1?????
,?????????????????,??????,????????????????????????
???,????,????,?????,????,?????
52
???????
????????,????,????,???????? ????,???????? ??????
??? ??????????????????????????????,??????????? ?
??????????????????? ????????,?????,????? ??????,
?????????,??????
53
????????
1/1000????????0.01??/???? ????(??????) ??????????
???? 2??? 0.0625?? 25?
0.125?? 611? 0.25?? 11???
0.5?? ?? 0.51??
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?????????????
????????,?????? ???????????,????????????????? ????
,????????????? ???????????????10???????? ?????????
???2030??? ?????????????,???????? ???????????????
????????????,???????? ????????????,????????,?????
????812?????????,????? ???? ????? ???
?? ?????
55
???????
?????????? ?????????,????????(????
)30mg?????250mg, ????????????????????,????????????
?????1.0mg,??lt1?0.25mg,14?0.5mg,58?0.75mg,9????
????????????,???????
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• Lets built up together the health greatwall to
  prevent diseases!
• ?????????!

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????
???????????? 8008011200