Transcript Slide 1

2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
R&D: Life Line for
pharmaceutical
companies:
A GM perspective
•
•
•
Joseph Cho
CEO, Astellas
Pharma China
Vice Chairman,
RDPAC
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Disclaimer
• This is not a thorough research report by a consultant.
• This is the personal perspective of a General managers with 33
years of working experience in the pharma industry
– 20 years in Taiwan (sales, marketing, drug registration, clinical trial,
business development)
– 13 years in Hong Kong and mainland China
– 20 years of working and engagement in industry groups in Taiwan
(IRPMA), Hong Kong (HKAPI) and China (RDPAC).
• Some thought exchanged with government officials and experts in
the industry and acadmics.
• Information supported by colleagues in the company, friends in IMS,
colleagues in RDPAC and lessons from top management and
colleagues in Astellas Pharma Group
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Protection of IPR:
Essential for financing drug R&D
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Increasing R&D cost ratio in pharma and Bio industry
対象企業合計　(600)
13.0
医薬品・バイオ (61)
ソフトウェア、ITサービス (59)
ITハードウェア (115)
電子・電気 (45)
健康 (23)
航空・防衛 (17)
化学 (50)
自動車・自動車部品 (44)
パーソナルケア (13)
家庭用品 (15)
エンジニアリング・機械 (44)
メディア・写真 (9)
通信 (12)
鉄鋼・金属 (10)
電力 (13)
タバコ (4)
石油・ガス (16)
0.0
2.0
4.0
6.0
8.0
10.0
12.0
出所：医薬産業政策研究所（2003）「財務データからみた製薬企業の10年」 リサーチペーパーシリーズ N０．１３
14.0
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Characteristics of patent
for pharmaceuticals
Pharmaceuticals
Automobile,
Electronics appliances
Substance
Formula
tion
patent
Drug
Substance
patent
formulat
ions
a product is composed of
hundreds and thousand of patent、
impact of a single patent limited.
Existence of a patent may not
hinder the develop of other
patents
formulat
ion
One Basic patent（substance）
High royalty fee
Giving up of new drug development
due to patent infringement
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Drug
discovery
Screening
Pre-clinical
2～3Y
develop
ment）Clinical
trial
5～10Y
3～5Y
2～3Y
RA
approval
Apply
Candidate
compounds
Mode of action,
Clinical trial
AMDE
P1→P2→P3
pharmacokinetics, Efficacy and safety
Pharmaco dynamics
in human
formulation
PK PD
regulatory
No. of compounds
500,000～
1000,000
compounds
Library
5,000～
10,000
compounds
Synthesized
5～10
compunds
1compo
und
10,000
10,000
Developed
compounds
Product
Cost of JY 80 Billion/１ NCE
launch
Investigation Optimizing
total 10～20Y
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
screening
2～3Y
Animal
studies
Formu
lation
Clinical
trials
P1→P2→P3
CMC
2～3Y
review
10～15years for R&D
approval
5～10Y
Application
Basic Optimizing
research Invention
research
3～5Y
10～
15Y
Launch of generics
Clinical Review
Exclusive period
Pre-clinical
Launching of NCE
Discovery
α
Patent
application
※α=
Patent 20Yr＋α（Max.5Yr）
=exclusivity（Max.25Yr）
extended
IPR
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Specific Challenges in China pharma market
for innovative drugs - market access
• In China, import or manufacture approval does not mean
market accessible.
–
–
–
–
–
Pricing approval in provinces/cities
Listing into formulary of target hospitals
Winning in hospital bidding/price negotiations
Reimbursement by health insurance
Distribution to retail outlets
• Reduction of 5-7 years of real patent life
• Generics may be launched prior to original products
• Ensuring sufficient market exclusive period vital for R&D
investment return
• Early entry to the market essential
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
How important is R&D?
•
Emergence of a company.
– If you have a break through new drugs.
•
Rapid Growth of the Company
– If you have a series of successful new product launch.
•
Can keeping the company alive
– When IPR of main products subsides.
•
Change of healthcare practice
– The case with H2 blockers for gastro-tectomy
•
If R&D flops :
–
–
–
–
•
Likely lay off,
change of company, jobs and positions for many people,
Loss of investment,
Death of patients and
Company no long exist: as shown next few slides
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Relationship between R&D investment and No. of new drugs launched
上
市
新
薬
数
■ Mega
30
◆
Major
●
Japan
2
RR=
0.8328
25
20
15
10
5
0
0
10,000
※新薬数は新規化合物
20,000
30,000
40,000
R&D expense (US $Million）
50,000
60,000
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
EU companies：Merger、scale up、restructure
COG reduction、R&D increase、S&M increase
1993年
38.4
2003年
18.4
0%
10%
売上原価
5.6
6.7
20%
32.2
36.4
30%
償却費
40%
11.6
15.4
50%
販売管理費
60%
70%
12.2
23.0
80%
研究開発費
90%
100%
営業利益
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00 01
Glaxo
Glaxo Wellcome
95合併
SK Beckman
89合併
Glaxo SmithKline
Wellcome
00 合併
SmithKline Beecham
Beecham
93 医薬品事業部門分離独立
ICI
Rhone-Poulenc
Rhone-Poulenc Rorer
90 買収
W.H.Rorer
Hoechst
68
Astra
Zeneca
acquisition of a
majority holding
Marion
Roussel-Uclaf
89
Merrell Dow
Ciba
Ciba-Geigy
95買収
Roche
Genentech
Aventis
04買収
Marion Merrell Dow
Sandoz
90 資本参加
99 合併
Hoechst
95 買収
Sanofi SI
Synthelabo
Ciba-Geigy
70合併
AstraZeneca
99 合併
Fisons
94 Sanofi
Prescription drug部門 Sterling
JR Geigy
02 03 04
94買収
Syntex
96 合併
Sanofiｰ
aventis
Sanofi-Synthelabo
99合併
Novartis
97 買収
Boehringer Mannheim
Novartis
02 買収
Chugai
Roche
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Key Acquisitions in 2008~2009 in the industry
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Key Acquisition cases in Jan.~Feb. 2010 in the industry
Time
acquiring Corp.
Target Corp.
( bil. USD
)
Strategy
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Leading MNC’s portfolio by development status
Most of leading MNCs have a big discover products base.
Source: Thomason Pharma
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Some thoughts about drug discovery
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
科
学
技
術
革
新
2nd golden period
First Golden Period
Pharmacology
Receptor
Ion Channel
Enzyme
Organic
Chemistry
Naturals
Aspirin
（Rheumatoid
Arthritis）
1800
1900
Epoch making
New drugs
Vaccines
Gene-chips
Insulin（DM）
Growth hormone
Β antagonist（Angina・Hypertension）
α Antagonist（Hypertension・BPH）
H2 Antagonist（Pepti-ucler）
Ｃa antagonsit（Hypertension・Angina）
ACE inhibitor（Hypertension・Cardiac Failure）
HMG-CoA reductase（Hyperlipidemia）
Patent Expiry
新
薬
誕
生
Pioneer
technology
Genomics
Biotechnology
Recombined
Genes
Cell fusion
Antibody
1950
1960
1970
1980
1990
2000
2010 （年）
－ 薬理学会公開講座「夢のくすり、今のくすり」1998年．京都市 －
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Key steps to new drug discovery
New treatment inspired by identified mechanism of
diseases
－information from papers, patients, healthcare
（Inspiration） professionals.
発想
Establishment of physical reactions and life syndromes
of target diseases.
Establishment of Methodology for screening
（Discovery ） － Papers and laboratory observations
発見
発明
Creation of new drugs via new technology (organic
chemistry, Bio-technology, Antibody, Vaccines）
（Invention） －Team works of multi-disciplines in life science
Innovation
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
•
New challenges for drug discovery:
The diseases, the causes and life styles
Why some diseases occurs
–
–
–
–
–
–
•
What are the causes
–
–
•
•
•
•
•
•
•
•
In some ethnics
In some ages
In a gender
In a geographic location
In some weather conditions
In some occupations
Extrinsic
Intrinsic
What is the prognosis for different types of patients? How long will the disease last and
how long does it takes to recover? The role of new drugs in the healing process.
How to diagnose
How to prevent from occurring?
How change of life styles affect the treatment
The recurrence and the causes.
Can we prevent it from occurring?
How to test anti-bodies, biologics for human use in animals?
Scaling up of new biologics and genomic product?
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
The relationship between the level of satisfaction with medical treatment and
the level of contribution that medication makes to treatment (Japan)
100
Contribution of
medication
to treatment
（％）
90
80
70
60
Hypertension Peptic ulcer
Angina Pectoris
Gout
Diabetes mellitus
Hyperlipidemia
Tuberculosis
Asthma
Arrhythmia
Chlamydia infection
Allergic rhinitis
Candidiasis
Herpes virus infection
Epilepsy Myocardial Dermatophytosis
Anxiety
Leukemia
infarction
MRSA infection
Depression
Prostate hyperplasia
Schizophrenia
Prostate cancer
Parkinson’s disease
SLE
Glaucoma
Low back pain
Atopic dermatitis
Irritable bowel syndrome
Pressure sores
Chronic obstructive pulmonary disease
Rheumatoid arthritisAutonomic
40
Endometriosis
Transplantation AIDS
ataxiaOsteoporosis Nephrosis syndrome
Occlusive peripheral arterial disease
Cerebral infarction
Hemorrhagic stroke Stress urinary incontinence
Hepatitis C
30
Urinary
Breast cancer
Diabetic neuropathy
Fibroid
Chronic glomerulonephritis
Osteoarthritis incontinence
Spondylosis
Cataracts
Diabetic nephropathy
Uterine cancer
Hepatitis B
20
Cirrhosis Diabetic retinopathy Chronic pelvic pain
Neuromuscular disturbance and
Chronic
renal
failure
Stomach cancer
myopathy
Lung cancer
Liver cancer
Colon cancer
Multiple sclerosis
10
Alzheimer’s
disease
Senile
dementia
0
0
10
20
30
40
50
60
70
80
50
90
Satisfaction is relatively high for diseases in the PCP market
Diseases mainly taken care of by PCPs
Note: Questionnaire for Japanese doctors ( :15/10/1999-22/12/1999; postal survey; 128 responses;)
Source: Japan Human Science Foundation: 2000 report on survey into basic technology in Japan, “Outlook on
medical needs in 2010”; internal Astellas data; BCG analysis;
Level of satisfaction
with medical
100
treatment
（％）
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
New challenges of clinical research for
unmet needs
• More aging population with many underlying diseases
who use many drugs.
• Difficulty in conduct clinical trials for infants.
• Diagnostic method and parameters not established.
• Need to provide long term efficacy and safety.
• Not just for efficacy and safety, need to justify the value
with health-economic models, accepted by the payers
and, healthcare professionals and patients.
• How to justify value to quality of life and extension of life
expectancy not in years.
• Early engagement in clinical trial design of marketing for
proper positioning of the new drug
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
6 phases of failed clinical
development project
•
•
•
•
•
•
Enthusiasm
Disillusionment
Panic
Search for guilty
Punishment for the innocent
Praise and honors fir non-participants
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
The Global Scenario Envisioned by Astellas
 Progress of policies to control health expenditure
 New healthcare reforms in EU, USA and Japan all
focusing in cost containment.
 Who should pay for the drug and technology innovation?
Government? Insurance? Patient?
 Decrease in market growth rate
 Market growth in EU, Japan and USA decreased to 5% of
below, except pharmerging markets led by China.
 Increased complexity of the market
 Many diseases cared by primary care professionals are
getting satisfactory treatment by medicines while good
remedies for chronic diseases, CNS, DM, RA and
diseases related to auto-immune system remains few.
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
The total number of blockbusters produced by the top 10 drug companies,
the number of blockbusters being delivered to the market and
the number of blockbusters with expiring patents
Number of
blockbusters
launched,
25
120
Result
20
Number of
blockbusters with
expiring patents
Forecast
Total number of
blockbusters sold
on the market
Number of
blockbusters
100
80
15
Number of blockbusters
delivered to the market annually
(average over 3 years*)
60
10
40
5
Number of blockbusters expiring
annually after average patent term
(average over 3 years)
0
1986
20
0
1988
1990
1992
1994
1996
1998
2000
2002
2004
2006
2008
2010 （Launch Year ）
Stagnation of new deliveries and the expiration of
patents will simultaneously brake market growth.
* The number of products delivered to the market for 2001-2010 is based on risk-adjusted estimates
Note: Blockbusters are those drug products with peak sales of US$500 million or more based on 2001 prices. The ranking of the top 10 drug
companies was based on the 2001 market; since that time some of those companies have been amalgamated through the M&A
process.
Source: FDA, Lehman Brothers, Paine Webber, Scrip, BCG analysis
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
■ There will be four basic types of players in the future market
a. Super-scale players: 2-3 companies
– Focusing on the conventional market, they compete with size as their advantage.
– In order to resist the pressure of falling earnings brought about by decreasing market growth
rates, they buy out their competitors (achieving cost synergies) and advance the process of
consolidation between superior companies.
– Global market share of the top player is 20-30%.
b. Specialized players: many
– As the market becomes increasingly complex, they capitalize on a single strength unrivaled by
others.
– A diverse range of specialized players exists and new players will continue to enter the market.
c. Global category players: 5-10 companies
– They have global reach, and construct top-level franchises in multiple highly specialized
therapeutic areas/diseases.
– While not greatly affected by the declining growth of conventional markets, they can sustain their
level of growth by taking advantage of the increasing market complexity.
d. Local players
– Develop business in local markets by focusing on generics.
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Brief on China Pharma market
• About 400M covered by urban worker’s and
resident insurance.
• About 800M covered by New Rural Cooperative
health program for primary care
• Market size reached RMB 210 Billion with
growth of 27% in 2009.
• Progress of new healthcare reform has profound
impact on the industry.
• Healthcare technology assessment to be used
for price negotiation for expensive drugs
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Total China hospital market Reached 243.9 billion
RMB in 2009
300,000
243,894.2
250,000
191,981.2
64,947.2
MAT RMB (mio)
200,000
151,500.9
52,083.9
150,000
107,150.8
100,000
120,699.8
43,192.1
35,987.1
31,482.4
178,947.0
139,897.3
108,308.8
50,000
75,668.4
84,712.7
MAT4Q05
MAT4Q06
JV + IMPORT
31,482.4
35,987.1
43,192.1
52,083.9
64,947.2
LOCAL
75,668.4
84,712.7
108,308.8
139,897.3
178,947.0
CHPA
107,150.8
120,699.8
151,500.9
191,981.2
243,894.2
0
MAT4Q07
MAT4Q08
MAT4Q09
Local companies were driving the increase of china pharma
MKT.
Source: IMS 4Q09
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Leading MNCs Ranking in past decade
Besides company merging, new product launching is another engine for MNCs
to improve ranking in China market.
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
New products play an important role to China
business
New product share in China business
25%
20%
PFIZER GROUP
ASTRAZENECA GROUP
BHC GROUP
SANOFI-AVENTIS GP.
15%
ROCHE GROUP
NOVARTIS GROUP
GLAXOSMITHKL GROUP
10%
NOVO NORDISK GROUP
M.S.D. GROUP
ELI LILLY GROUP
ASTELLAS GROUP
5%
0%
2005
2006
2007
2008
2009
New product= launched within 5 years
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Leading therapy class by Country
in past years
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Affluence is changing lifestyle and prevalence of chronic condition such as
diabetes,
hypertension and cerebro-vascular is rising rapidly.
CAGR93-03
12.5%
Hypertension
4.8%
Heart Diseases
16.7%
Diabetes
8.6%
Cerebrovascular Diseases
2.4%
Genitourinary Diseases
-0.5%
Acute Gastritis
0.5%
Gallbladder Disorders
0.9%
1998
1993
Arthritis
-1.0%
-2.2%
2003
Geriatric Chronic Bronchitis
Eye Diseases
1.4%
Neurological Diseases
7.0%
Malignant tumors
-3.3%
Infectious Diseases
6.9%
Psychotic disorders
7.4%
Injury and poisoning
0
5
10
15
Urban Patient Number (Mil)
Source: MOH statistics yearbook 2008
20
25
30
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
The elderly is taking a growing share of the China Total population giving
another evidence to the increase of the chronic disease.
Population composition by age
Share of Total population %
120
100
80
60
40
20
0
1990
2000
2007
5.58
7.09
9.35
15~64
66.81
69.99
72.78
0~14
27.7
22.9
17.88
>65
Source: National Bureau of Statistics
Chronic diseaes
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Antibiotics lost its share in the last decade while share of TCM and Oncology's
are increasing drastically
Top 10 TCs in 2008
35%
18%
1999 Value Share
2008 Value Share
CAGR99-08
16%
12%
20%
10%
15%
8%
6%
10%
4%
5%
Source: IMS 4Q08
DRUGS USED IN DIABETES
IMMUNOSTIMULATING AGENTS
CARDIAC THERAPY
ANTI-HYPERTENSION
ANTI-ULCERANTS
CEREB.+PERIPHE.VASOTHERAP
INTRAVENOUS SOLUTIONS
ONCOLOGICS
TCM
0%
2%
0%
CAGR (%)
14%
25%
SYS. ANTIBACTERIALS
Market share (%)
30%
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
In 6 of top 10 TCIII in China market, the sales of generic
product is even bigger than the origin product (red line)
Source: IMS
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Comparison of Pharma Industry of China and India
• Similarity
– Production of low cost, low concentration of industry
– Mainly produce Generics
– Small share of independent innovation research and the
proportion of drugs
• Difference
– The manufactures in china always copy low-tech product and
compete in the market with low price but seldom choose hightech product
– The India manufactures choose a better way– innovative copy
and get their own patent so that get more profit.
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Pharma R&D in China
• Majority of pharma industry have been focusing on
copying in past few decades.
• China has decided to become an innovative state in
2007.
• Many budget allocated for life science, RMB 6.6Billion
allocated to various projects since late 2008.
– Projects included all types of collaboration of industry and
research institutions and healthcare institutions.
– Grant amount usually less than 200M per institute.
• R&D is encouraged by the government but not sufficient
for return to investment for pharma R&D due to
regulatory and risk sharing system in China.
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Marketing Authorization System
Key barriers for Pharma R&D in China under current registration
system
• Requesting Pharma R&D may not be equipped with the production
facilities
• Pharma R&D have to transfer the technology to drug manufacturer, the
right and benefits are not well protected
Key benefits of market authorization system for Pharma R&D in
China
• Pharma R&D can be the Marketing Authorization Holder without
production facilities
• Pharma R&D can collaborate with drug manufacturer for toll
manufacturing with/without mandatory technology transfer
• Reasonable amount of return back to R&D as incentive for stimulating
sustainable R&D
38
• Pharma R&D can focus on R&D with their key competence
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
About clinical trial in China
China
Is China
Underrepresented
Other
Countries
2nd DIA
Annual Meeting | Relative
May 16-19,To
2010
| Beijing,
China
Based On Its Population And Market Size
Phase III trials sponsored by industry
Number of trials
(2007)
China
India
Czech
58
106
11
54
963
144
128
CAGR* of trials
(2003-2007)
32
9
100
Russia
Number of trials per
$1bn drug sales (2007)
3
4
Poland
Argentina
Number of trials per 100
million population (2007)
44
378
23
90
99
Brazil
92
48
Mexico
89
85
Source: Clinicaltrials.gov; Global Insight; IMS; team analysis
*CAGR Cumulative Annual Growth Rate
26
17
250
25
26
34
6
8
36
28
25
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Global Clinical Trial in China
• According to SFDA record during Jan 2004 and Apr 2008, the
average evaluate time of global clinical trial is 7 month.
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Simultaneous Global Development
Benefits
• Submission to and review by relevant regulatory authorities at the
same time
• Broader regulatory oversight and experiences
• Earlier availability of innovative drug therapy to emerging market
population; ultimately leads to reduction in “drug lag”
• Enables science-based approach to better define intrinsic and
extrinsic factors (risk-based)
• Identify clinically meaningful ethnic differences & discuss next
steps
• Registration dossiers to include higher percentage of Asian data
• Advance knowledge, experience and competence of drug clinical
development of investigators / medical community
42
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Simultaneous Global Development-2
Challenges
• Longer CTA approval times (agency & ethics committee)
& start-up times
• Other general barriers (not inclusive of all countries)
• Lack of harmonization – requirements, processes
• Unique requirements, outside international standards (e.g.,
country-specific Quality data)
• Lack of formal mechanism for agency consultation
• Inflexibility to CTA amendments (protocol & quality changes)
• Uncertainty of ICH/WHO GCP enforcement
• Inefficient/outdated review processes, lack of transparency
• Unpredictable requests
• Intellectual property concerns
• Insufficient resources within regulatory agencies
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Global development could speed up product
launch in China.
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
RDPAC’s suggestion on SGD
•
•
•
•
Separation administration of CTA and NDA
Implementation of Special Review Procedures
Speed up the approval process for clinical trial of innovative products
Enhancement of clinical trial administration by allocating the
responsibilities to all stakeholders
• Introduction of Marketing Authorization System
• Communication and interaction among stakeholders
• Harmonization, the principle of “ sameness” will direct the development
path
For SGD, it is a race to change!
Who will be left behind ?
45
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Trend – Increasing IMCT in China
# of IMCT Application and Approval
60
55
51
50
42
40
30
26
23
20
10
13
0
2006
2007
# of IMCT Application
Source: RDPAC Drug Registration Timeline Survey
2008
# of IMCT Approval
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Drug Development Model in China
Yesterday
A Linear Development Model Following International Approval
≥4 years drug lag
Global Development
CPP R-CTA Review
Approval
Outside China
Clinical Trial
IDL Review
4 Years
Approval
In China
A Parallel Development Model ≥2 years drug lag
Today
Global Development
GCTA Review
CPP R-CTA Review
Clinical Trial
CPP
Clinical Trial
IDL Review
IDL Review
2 Years
CPP = Certificate of Pharmaceutical Product
R-CTA = Regional Clinical Trial Application
IDL = Import Drug License
GCTA = Global Clinical Trial Application
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2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
The Road To Enlightenment…Follow The Lights
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2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Many thanks for your kind attention!
[email protected]
www.astellas.com.cn
www.rdpac.org
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