Catalogue of On-site Inspection Varieties for the Drug Clinical Trial Data

S.N

.

Pending

Number

Drug

NameApplication Unit

Responsi

ble

Person of

Applicati

on Unit

Clinical

Trial Group

Leader Unit

Princip

al

Investig

ator

Contract

Research

Organizatio

n

Responsible

Person of

Contract

Research

Organizatio

n

Institution of

Phase I/BE

Clinical

Trial

Princip

al

Investig

ator of

Phase

I/BE

Phase I

/BE

Analytical

Testing

Unit

Principal

Investigator

of Phase I

/BE

Analytical

Testing

Principal

Investigator

f Phase I

/BE

Phase

I /BE

Respons

ible

Person

of

Contrac

t

Researc

h

Organiz

ation

1CYHS14

90010

Gefitinib

Tablets

Qilu

Pharmaceutical

(hainan) Co., Ltd.

Liu

Wenmin/ / / /

The Third

Xiangya

Hospital of

Central South

University

Yang

Guopin

g

XBL-

ChinaWu Jingli / /

2 CXHS14

00157

Tenofovir

Disoproxi

l

Fumarate

Capsules

Fujian Cosunter

Pharmaceutical

Co., Ltd.

Li

Guoping

The Second

Affiliated

Hospital of

Chongqing

Medical

University

Ren

Hong

Guangzhou

Boji Medical

Biotechnolog

ical Co., Ltd.

Zhang

Xiangbiao

The First

Affiliated

Hospital of

The Fourth

Military

Medical

University of

Wen

Aidong

Departmen

t of

Pharmaceu

tical

Analysis,

China

Pharmaceu

Ding Li Guangzhou

Boji Medical

Biotechnolo

gical Co.,

Ltd.

Xiao

Huifeng

PLAtical

University

3JXHS140

0125

Azacitidi

ne

Injection

Celgene

Pharmaceuticals

Information

Consulting Co.,

Ltd (Shanghai)

Jonathan

Prim

Biller

Blood

Diseases

Hospital (and

Institute of

Hematology)

, Chinese

Academy of

Medical

Sciences;

Guangdong

Provincial

People’s

Hospital

Xiao

Zhijia

n， Du

Xin

Hangzhou

Tigermed

Consulting

Co., Ltd.

Li Jinlian

Blood

Diseases

Hospital (and

Institute of

Hematology),

Chinese

Academy of

Medical

Sciences;

Guangdong

Provincial

People’s

Hospital

Xiao

Zhijia

n， Du

Xin

Covance

Bioanalytic

al Services,

LLC

(Covance)

Melanie M.

McCort-

Tipton

Hangzhou

Tigermed

Consulting

Co., Ltd.

Li

Jinlian

4CXHS15

00143

Dronedar

one

Hydrochl

oride

Tablets

CSPC Ouyi

Pharmaceutical

Co., Ltd.; CSPC

Zhongqi

Pharmaceutical

Technology

(Shijiazhuang)

Co., Ltd.

Lu

Jianmin/ / / /

National

Drug Clinical

Trial

Institution,

Second

Hospital

Affiliated to

Suzhou

University

Zhang

Quanyi

ng

Nanjing

Kelitai

PharmaTec

h Co., Ltd.

Ding Li / /

5 JXHS150 Stivarga Bayer HealthCare Jiang Wei Fudan Li Jin PRA Health Peter / / / / / /

0103 AG

University

Shanghai

Cancer

Center

Science Winstanley

6JXHS150

0114

Ruxolitini

b

phosphate

tablets

Beijing Novartis

Pharma Ltd.

Lu

Siq

i（CHRIS

TOPHER

SNOOK)

None

(Internationa

l Multi-

center

Clinical

Trial)

/ PPD China Wang Jian

Peking

University

Third

Hospital

Li

Haiyan

Novartis

Pharmaceu

ticals

Corporatio

n

Wenkui Li

Quintiles

Enterprise

Management

(Shanghai)

Co., Ltd.

(former

Quintiles

Medical

Developmen

t (Shanghai)

Co., Ltd.)

Xu

Yuanjin

g

7 JXHS150

0115

Ruxolitini

b

phosphate

tablets

Beijing Novartis

Pharma Ltd.

Lu

Siq

i（CHRIS

TOPHER

SNOOK)

None

(Internationa

l Multi-

center

Clinical

Trial)

/ PPD China Wang Jian Peking

University

Third

Hospital

Li

Haiyan

Novartis

Pharmaceu

ticals

Corporatio

n

Wenkui Li Quintiles

Enterprise

Management

(Shanghai)

Co., Ltd.

(former

Quintiles

Medical

Developmen

t (Shanghai)

Xu

Yuanjin

g

Co., Ltd.)

8JXHS150

0116

Ruxolitini

b

phosphate

tablets

Beijing Novartis

Pharma Ltd.

Lu

Siq

i（CHRIS

TOPHER

SNOOK)

None

(Internationa

l Multi-

center

Clinical

Trial)

/ PPD China Wang Jian

Peking

University

Third

Hospital

Li

Haiyan

Novartis

Pharmaceu

ticals

Corporatio

n

Wenkui Li

Quintiles

Enterprise

Management

(Shanghai)

Co., Ltd.

(former

Quintiles

Medical

Developmen

t (Shanghai)

Co., Ltd.)

Xu

Yuanjin

g

9JXHS150

0117

Ruxolitini

b

phosphate

tablets

Beijing Novartis

Pharma Ltd.

Lu

Siq

i（CHRIS

TOPHER

SNOOK)

None

(Internationa

l Multi-

center

Clinical

Trial)

/ PPD China Wang Jian

Peking

University

Third

Hospital

Li

Haiyan

Novartis

Pharmaceu

ticals

Corporatio

n

Wenkui Li

Quintiles

Enterprise

Management

(Shanghai)

Co., Ltd.

(former

Quintiles

Medical

Developmen

t (Shanghai)

Co., Ltd.)

Xu

Yuanjin

g

10 JXHS150

0118

Ruxolitini

b

Beijing Novartis

Pharma Ltd.

Lu Siqi

(CHRIST

None

(Internationa

/ PPD China Wang Jian Peking

University

Li

Haiyan

Novartis

Pharmaceu

Wenkui Li Quintiles

Enterprise

Xu

Yuanjin

phosphate

tablets

OPHER

SNOOK)

l Multi-

center

Clinical

Trial)

Third

Hospital

ticals

Corporatio

n

Management

(Shanghai)

Co., Ltd.

(former

Quintiles

Medical

Developmen

t (Shanghai)

Co., Ltd.)

g

11JXHS150

0119

Ruxolitini

b

phosphate

tablets

Beijing Novartis

Pharma Ltd.

Lu

Siq

i（CHRIS

TOPHER

SNOOK)

None

(Internationa

l Multi-

center

Clinical

Trial)

/ PPD China Wang Jian

Peking

University

Third

Hospital

Li

Haiyan

Novartis

Pharmaceu

ticals

Corporatio

n

Wenkui Li

Quintiles

Enterprise

Management

(Shanghai)

Co., Ltd.

(former

Quintiles

Medical

Developmen

t (Shanghai)

Co., Ltd.)

Xu

Yuanjin

g

12 JXHS150

0126

Tofacitini

b citrate

tablets

Pfizer

Pharmaceutical

Co., Ltd.

Wu

Xiaobin

Peking

University

People’s

Hospital

Li

Zhangu

o

/ / Clinical

Pharmacolog

y Research

Center at

Peking Union

Hu Bei Bioanalytic

al Systems,

Inc.

Rebecca

Hadar

/ /

Medical

College

Hospital of

Chinese

Academy of

Medical

Sciences

13CXHR08

00039

Compoun

d bismuth

potassium

citrate

capsules

Hainan Hailing

Pharmaceutical

Corporation Ltd.;

Hainan Hailing

Pharmaceutical

Corporation Ltd.

Zhao Xu

The First

Affiliated

Hospital of

Nanjing

Medical

University

Shi

Ruihua/ /

National

Drug Clinical

Trial

Institution,

the First

Affiliated

Hospital to

Nanjing

Medical

University

Zhang

Yindi， Zhang

Jinsong

China

Pharmaceu

tical

University

Ding Li / /

14 CXZS09

00009

Niantong

Qufeng

Granules

Chengdu Huaxi

Natural Medicine

Co., Ltd.

Feng

Sigang

National

Medicine

Clinical

Research

Base at

Affiliated

Hospital of

Nanjing

Li

Yua

n，Qia

nxian

Beijing

Qihuang

Drug

Clinical

Research

Center

Huang

Weiping

/ / / / / /

University of

Chinese

Medicine,

National

Drug

Clinical Trial

Institution at

Affiliated

Hospital of

Chengdu

University of

Traditional

Chinese

Medicine

15CXSS13

00013

Recombin

ant super

potent

anti-

tumor and

anti-virus

protein

for

injection

GENOVA

BIOTECH

(Qingdao)

COMPANY,

LTD.

Liu

Longbin

Xiangya

Hospital of

Centre-south

University

Tan

Deming/ / / / / / / /

16 CXSS13

00014

Recombin

ant super

GENOVA

BIOTECH

Liu

Longbin

/ / / / Beijing

Youan

Li

Ning， PLA Unit

62035

Chen Zhihang Beijing

Huatai

Liu

Qiguang

potent

anti-

tumor and

anti-virus

protein

for

injection

(Qingdao)

COMPANY,

LTD.

Hospital

Affiliated to

Capital

Medical

University

Wang

Meixia

Runfeng

Consulting

Co., Ltd.

17JXSS130

0004

Methoxy

Polyglyco

l

Recombin

ant

Human

Erythropo

ietin

Injection

Shanghai Roche

Pharmaceutical Co

Limited

Lou

Dingbo

Renji

Hospital,

Shanghai

Jiao Tong

University

School of

Medicine

Qian

Jialin

EPS China

CO., LtdXiaoyan Tian

Renji

Hospital,

Shanghai Jiao

Tong

University

School of

Medicine， Ruijin

Hospital,

Shanghai

Jiaotong

University

School of

Medicine,

China-Japan

Friendship

Hospital

Qian

JialinQPS,L.L.C T.Ben.Hsu

EPS China

CO., Ltd

Xiaoyan

Tian

18 JXSS130 Methoxy Shanghai Roche Lou Renji Qian EPS China Xiaoyan Tian Renji Qian QPS,L.L.C T.Ben.Hsu EPS China Xiaoyan

0005

Polyglyco

l

Recombin

ant

Human

Erythropo

ietin

Injection

Pharmaceutical Co

LimitedDingbo

Hospital,

Shanghai

Jiao Tong

University

School of

Medicine

Jialin CO., Ltd

Hospital,

Shanghai Jiao

Tong

University

School of

Medicine， Ruijin

Hospital,

Shanghai

Jiaotong

University

School of

Medicine,

China-Japan

Friendship

Hospital

Jialin CO., Ltd Tian

19 JXSS130

0006

Methoxy

Polyglyco

l

Recombin

ant

Human

Erythropo

ietin

Injection

Shanghai Roche

Pharmaceutical Co

Limited

Lou

Dingbo

Renji

Hospital,

Shanghai

Jiao Tong

University

School of

Medicine

Qian

Jialin

EPS China

CO., Ltd

Xiaoyan Tian Renji

Hospital,

Shanghai Jiao

Tong

University

School of

Medicine， Ruijin

Hospital,

Qian

Jialin

QPS,L.L.C T.Ben.Hsu EPS China

CO., Ltd

Xiaoyan

Tian

Shanghai

Jiaotong

University

School of

Medicine,

China-Japan

Friendship

Hospital

20JXSS130

0007

Methoxy

Polyglyco

l

Recombin

ant

Human

Erythropo

ietin

Injection

Shanghai Roche

Pharmaceutical Co

Limited

Lou

Dingbo

Renji

Hospital,

Shanghai

Jiao Tong

University

School of

Medicine

Qian

Jialin

EPS China

CO., LtdXiaoyan Tian

Renji

Hospital,

Shanghai Jiao

Tong

University

School of

Medicine， Ruijin

Hospital,

Shanghai

Jiaotong

University

School of

Medicine,

China-Japan

Friendship

Hospital

Qian

JialinQPS,L.L.C T.Ben.Hsu

EPS China

CO., Ltd

Xiaoyan

Tian

21JXSS130

0008

Methoxy

Polyglyco

l

Recombin

ant

Human

Erythropo

ietin

Injection

Shanghai Roche

Pharmaceutical Co

Limited

Lou

Dingbo

Renji

Hospital,

Shanghai

Jiao Tong

University

School of

Medicine

Qian

Jialin

EPS China

CO., LtdXiaoyan Tian

Renji

Hospital,

Shanghai Jiao

Tong

University

School of

Medicine， Ruijin

Hospital,

Shanghai

Jiaotong

University

School of

Medicine,

China-Japan

Friendship

Hospital

Qian

JialinQPS,L.L.C T.Ben.Hsu

EPS China

CO., Ltd

Xiaoyan

Tian

22 JXHS130

0072

Blonanser

in tablets

Sumitomo

Dainippon

Pharma Co., Ltd.

Gaotian

Hehao

Shanghai

Mental

Health

Center

Li

Huafan

g

/ / Clinical

Pharmacolog

y Research

Center at

Peking Union

Medical

College

Hospital

Hu Bei Clinical

Pharmacol

ogy

Research

Center at

Peking

Union

Medical

Wang

Hongyun

/ /

College

Hospital

23CXSS14

00005

23-valent

pneumoc

occal

polysacch

aride

vaccine

Yuxi Walvax

Biotechnology

Co., Ltd.

Li

Yunchun

Guangxi

Center for

Disease

Prevention

and Control

Li

Yanpin

g

Beijing Simu

Ruike

Technology

Co., Ltd.

Huang

Linxiong/ / / / / /

24CXSS14

00023

Haemoph

ilus

Influenza

e Type b

Conjugate

Vaccine

Chengdu Olymvax

Biopharmaceutical

s Inc.

Fan

Shaowen

Jiangsu

Provincial

Center for

Disease

Control and

Prevention

Zhu

Fengcai

Shenzhen

Ying He

Yuan

Medical

Technology

Development

Co., Ltd.

Yong Yuan / / / / / /

25CYHB15

90005

Bupropio

n

Hydrochl

oride

Sustained

-Release

Tablets

Zhejiang Jingxin

Pharmaceutical

Co., Ltd.

Lv Gang / / / /

Drug Clinical

Trial

Institution at

General

Hospital of

Ningxia

Medical

University

Dang

Hongwa

n

Frontage

Laboratorie

s

(Shanghai)

Co., Ltd.

Zuo Ming / /

26 JXHS150

0046

Pazopani

b Tablets

Glaxo Group

Limited

Zhang Ye Beijing

Tumor

Guo Jun / / / / / / / /

Hospital

27JXHS150

0047

Pazopani

b Tablets

Glaxo Group

LimitedZhang Ye

Beijing

Tumor

Hospital

Guo Jun / / / / / / / /

28CXSS15

00014

Conberce

pt

Ophthalm

ic

Injection

Chengdu

Kanghong

Biotechnologies

Co., Ltd.

Ke

Zunhong

Beijing

Tongren

Hospital

Affiliated to

Capital

Medical

University

Zhang

Feng/ / / / / / / /

29JXHS150

0104

Gadobutr

ol

Injection

Bayer HealthCare

AGJiang Wei

Zhongshan

Hospital,

Fudan

University

Zeng

Mengsu/ / / / / / / /

30JXHS150

0105

Gadobutr

ol

Injection

Bayer HealthCare

AGJiang Wei

Zhongshan

Hospital,

Fudan

University

Zeng

Mengsu/ / / / / / / /

31JXHS150

0106

Gadobutr

ol

Injection

Bayer HealthCare

AGJiang Wei

Zhongshan

Hospital,

Fudan

University

Zeng

Mengsu/ / / / / / / /

32 JXHS150

0107

Gadobutr

ol

Bayer HealthCare

AG

Jiang Wei Zhongshan

Hospital,

Zeng

Mengsu

/ / / / / / / /

InjectionFudan

University

33JXHS150

0109

Erlotinib

Hydrochl

oride

Tablets

Roche

Registration Ltd.

Lou

Dingbo

Guangdong

General

Hospital

Wu

Yilong/ / / / / / / /

34JXHS150

0110

Erlotinib

Hydrochl

oride

Tablets

Roche

Registration Ltd.

Lou

Dingbo

Guangdong

General

Hospital

Wu

Yilong/ / / / / / / /

35JXHS150

0112

Dapaglifl

ozin

tablets

AstraZeneca

ChinaWang Lei

Peking

University

People’s

Hospital

Ji

Linong/ /

Peking

University

Third

Hospital

Li

Haiyan

Bioanalytic

al Service

Departmen

t, Wuxi

Apptec

New Drug

Developme

nt Co., Ltd.

Shanghai

Chen Weikao

ICON

CLINICAL

RESEARCH

LIMITED

Bryan

Ridgell

36 JXHS150

0113

Dapaglifl

ozin

tablets

AstraZeneca

China

Wang Lei Peking

University

People’s

Hospital

Ji

Linong

/ / Peking

University

Third

Hospital

Li

Haiyan

Bioanalytic

al Service

Departmen

t, Wuxi

Apptec

New Drug

Chen Weikao ICON

CLINICAL

RESEARCH

LIMITED

Bryan

Ridgell

Developme

nt Co., Ltd.

Shanghai