R&D: Life Line for pharmaceutical companies: A GM perspective 1/PLENARY SESSION/P 04... ·...
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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
13.0
0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0
石石・ガガ (16)タタタ (4)電電 (13)鉄鉄・金金 (10)通通 (12)メメメメ・写写 (9)エエエエメエエエ・機機 (44)家家家家 (15)パパパパパパメ (13)自自自・自自自自家 (44)化化 (50)航航・防防 (17)健健 (23)電電・電電 (45)ITハパハハハメ (115)パソソハハメ、ITサパサガ (59)医医家・タババ (61)対対対対対対 (600)
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
Increasing R&D cost ratio in pharma and Bio industry
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
formulations
Formulation patent
Substance
formulation
Drug Substance patent
Automobile, Automobile, Automobile, Automobile,
Electronics appliancesElectronics appliancesElectronics appliancesElectronics appliances
Pharmaceuticals
a product is composed of a product is composed of a product is composed of a product is composed of
hundreds and thousand of patenthundreds and thousand of patenthundreds and thousand of patenthundreds and thousand of patent、、、、
impact of a single patent limited.impact of a single patent limited.impact of a single patent limited.impact of a single patent limited.
Existence of a patent may not Existence of a patent may not Existence of a patent may not Existence of a patent may not
hinder the develop of other hinder the develop of other hinder the develop of other hinder the develop of other
patentspatentspatentspatents
One Basic patentOne Basic patentOne Basic patentOne Basic patent((((substancesubstancesubstancesubstance))))
High royalty feeHigh royalty feeHigh royalty feeHigh royalty fee
Giving up of new drug development Giving up of new drug development Giving up of new drug development Giving up of new drug development
due to patent infringementdue to patent infringementdue to patent infringementdue to patent infringement
Characteristics of patent for pharmaceuticals
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Pre-clinicalClinical
trialScreening
2~~~~3Y 3~~~~5Y 5~~~~10Y
No. of compounds
5555~~~~10101010
compundscompundscompundscompunds
10,00010,00010,00010,000
1111compocompocompocompo
undundundund
10,00010,00010,00010,000
5,0005,0005,0005,000~~~~
10,00010,00010,00010,000
compoundscompoundscompoundscompounds
Cost of JYCost of JYCost of JYCost of JY 80808080 BillionBillionBillionBillion////1111 NNNNCECECECE
Mode of action,
AMDE
pharmacokinetics,
Pharmaco dynamics
formulation
Clinical trialClinical trialClinical trialClinical trial
P1P1P1P1→→→→P2P2P2P2→→→→P3P3P3P3
Efficacy and safety Efficacy and safety Efficacy and safety Efficacy and safety
in humanin humanin humanin human
PK PDPK PDPK PDPK PD
Optimizing
Candidate
compounds
Investigation
RA
2~~~~3Y
totaltotaltotaltotal 10101010~~~~20202020YYYY
Ap
ply
ap
pro
val
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nc
h
regulatory
Drug discovery
development)
505050500,0000,0000,0000,000~~~~
1001001001000,0000,0000,0000,000
compoundscompoundscompoundscompounds
Library Synthesized Developed compounds Product
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Pre-clinical ClinicalDiscovery
screening
2~~~~3Y 3~~~~5Y 5~~~~10Y
Animal
studies
Formu
lation
Clinical Clinical Clinical Clinical
trialstrialstrialstrials
P1P1P1P1→→→→P2P2P2P2→→→→P3P3P3P3
CMCCMCCMCCMC
Optimizing
Invention
research
Basic
research review
2~~~~3Y
Ap
plic
atio
n
ap
pro
val
Review
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nt
ap
plic
atio
n
Lau
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ing
of N
CE
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en
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10~15years for R&D
Exclu
siv
e p
erio
d
10~~~~
15Y
α
Patent 20Yr+α(Max.5Yr)=exclusivity(Max.25Yr)
※※※※αααα=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
RRRR
2222
RRRR= = = = 0.83280.83280.83280.8328
0
5
10
15
20
25
30
0 10,000 20,000 30,000 40,000 50,000 60,000
■Mega Mega Mega Mega
◆MajorMajorMajorMajor
●Japan
※新薬数は新規化合物 R&D expense (US $Million))))
上市新
上市新
上市新
上市新薬数
薬数
薬数
薬数
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
18.418.418.418.438.438.438.438.46.76.76.76.7
5.65.65.65.636.436.436.436.4
32.232.232.232.215.415.415.415.4
11.611.611.611.623.023.023.023.0
12.212.212.212.2
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%2003200320032003年年年年1993199319931993年年年年
売上原価売上原価売上原価売上原価 償却費償却費償却費償却費 販売管理費販売管理費販売管理費販売管理費 研究開発費研究開発費研究開発費研究開発費 営業利益営業利益営業利益営業利益
EU companies::::Merger、、、、scale up、、、、restructure
COG reduction、、、、R&D increase、、、、S&M increase
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
0403020100999897969594939291908988878685
Roche
Genentech
JR Geigy
Ciba
Ciba-Geigy Ciba-Geigy
Sandoz
Novartis Novartis
Roche
Syntex Boehringer Mannheim
94949494買収買収買収買収 97 97 97 97 買収買収買収買収90 90 90 90 資本参加資本参加資本参加資本参加
Chugai
02 02 02 02 買収買収買収買収
96 96 96 96 合併合併合併合併
70707070合併合併合併合併
ICI
Astra
Zeneca
AstraZeneca99 99 99 99 合併合併合併合併
93939393 医薬品事業部医薬品事業部医薬品事業部医薬品事業部門門門門分離独立分離独立分離独立分離独立
Rhone-Poulenc Rhone-Poulenc Rorer
W.H.RorerFisons
Hoechst
Aventis
Roussel-Uclaf
Hoechst
Marion
Marion Merrell Dow
90909090 買収買収買収買収
95959595買収買収買収買収
99 99 99 99 合併合併合併合併
95959595 買収買収買収買収
89898989
acquisition of a acquisition of a acquisition of a acquisition of a
majority holdingmajority holdingmajority holdingmajority holding
68686868
Sanofi
Sterling
Sanofi SI
Synthelabo
Sanofi-Synthelabo94949494
99999999合併合併合併合併
Prescription drug部門部門部門部門
Sanofiーーーー
aventis04040404買収買収買収買収
Merrell Dow
Glaxo Glaxo Wellcome
Glaxo SmithKline
SmithKline Beecham
SK Beckman
Beecham
Wellcome
95959595合併合併合併合併
00000000 合併合併合併合併89898989合併合併合併合併
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
StrategyStrategyStrategyStrategy( ( ( ( bilbilbilbil. USD. USD. USD. USD
))))Target Corp.acquiring Corp.TimeTimeTimeTime
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
科学科学 科学科学 技術革新技術革新技術革新技術革新
新薬誕生新薬誕生新薬誕生新薬誕生
1800 1900 1950 1960 1970 1980 1990 2000 2010 ((((年年年年))))
Aspirin
(Rheumatoid
Arthritis)
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)
Insulin(DM)Growth hormone
Epoch making Epoch making Epoch making Epoch making Epoch making Epoch making Epoch making Epoch making
New drugs New drugs New drugs New drugs New drugs New drugs New drugs New drugs
VaccinesVaccinesVaccinesVaccinesVaccinesVaccinesVaccinesVaccines
GeneGeneGeneGeneGeneGeneGeneGene--------chipschipschipschipschipschipschipschips
Organic Organic Organic Organic ChemistryChemistryChemistryChemistryNaturalsNaturalsNaturalsNaturals
PharmacologyPharmacologyReceptor
Ion Channel
Enzyme
BiotechnologyBiotechnologyBiotechnologyBiotechnologyRecombined Recombined Recombined Recombined GenesGenesGenesGenesCell fusionCell fusionCell fusionCell fusionAntibodyAntibodyAntibodyAntibody
Pioneer Pioneer Pioneer Pioneer technologytechnologytechnologytechnology
GenomicsGenomicsGenomicsGenomicsGenomicsGenomicsGenomicsGenomics
First Golden Period 2nd golden period 2nd golden period 2nd golden period 2nd golden period
-薬理学会公開講座「夢のくすり、今のくすり」1998年.京都市-
Pate
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xpiry
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xpiry
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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 professionals.
Establishment of physical reactions and life syndromes of target diseases.Establishment of Methodology for screening
- Papers and laboratory observations
Creation of new drugs via new technology (organic chemistry, Bio-technology, Antibody, Vaccines)
-Team works of multi-disciplines in life science
発 想発 想
発 見発 見
発 明発 明
Innovation
(Inspiration)
(Discovery )
(Invention)
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 – In some ethnics– In some ages– In a gender– In a geographic location– In some weather conditions– In some occupations
• What are the causes– 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)
Contribution of medication to treatment(%)(%)(%)(%)
Diseases mainly taken care of by PCPsNote: 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;
Herpes virus infectionTuberculosisDermatophytosisMRSA infection Chlamydia infectionCandidiasisStomach cancerAIDS Colon cancerLiver cancerLung cancer Breast cancerUterine cancer
Prostate cancerLeukemiaFibroid
Diabetes mellitusDiabetic neuropathy Diabetic retinopathyDiabetic nephropathy
HyperlipidemiaSchizophrenia DepressionAnxietyParkinson’s disease
Alzheimer’s diseaseSenile dementiaMultiple sclerosisEpilepsy
Autonomic ataxiaNeuromuscular disturbance and myopathyMyocardialinfarction Arrhythmia
Hemorrhagic strokeCerebral infarctionAsthma
Atopic dermatitis Pressure soresRheumatoid arthritisOsteoarthritis SLESpondylosis Low back painOsteoporosisGout Peptic ulcer
Cirrhosis Hepatitis BHepatitis C Nephrosis syndromeChronic glomerulonephritisChronic renal failureProstate hyperplasiaEndometriosisGlaucoma
Cataracts0102030405060708090100
0 10 20 30 40 50 60 70 80 90 100Level of satisfaction with medical
treatment(%)(%)(%)(%)Chronic pelvic painStress urinary incontinenceTransplantation Chronic obstructive pulmonary diseaseIrritable bowel syndromeOcclusive peripheral arterial disease
Satisfaction is relatively high for diseases in the PCP market
HypertensionAngina PectorisAllergic rhinitisUrinaryincontinence
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
* 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&Aprocess.
Source: FDA, Lehman Brothers, Paine Webber, Scrip, BCG analysis
Stagnation of new deliveries and the expiration of patents will simultaneously brake market growth.
Number of blockbusters
launched,
Number of blockbusters with expiring patents
Number of blockbusters
0000
5555
10101010
15151515
20202020
25252525
1986198619861986 1988198819881988 1990199019901990 1992199219921992 1994199419941994 1996199619961996 1998199819981998 2000200020002000 2002200220022002 2004200420042004 2006200620062006 2008200820082008 2010201020102010
0000
20202020
40404040
60606060
80808080
100100100100
120120120120
((((Launch Year ))))
Result Result Result Result Forecast Forecast Forecast Forecast
Total number of blockbusters sold
on the market
Number of blockbusters delivered to the market annually
(average over 3 years*)
Number of blockbusters expiring annually after average patent term
(average over 3 years)
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
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.
■■■■ There will be four basic types of players in the future market
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
Local companies were driving the increase of china pharma MKT.
Source: IMS 4Q09
75,668.4 84,712.7108,308.8
139,897.3
178,947.031,482.435,987.1
43,192.1
52,083.9
64,947.2
243,894.2
191,981.2
151,500.9
120,699.8107,150.8
0
50,000
100,000
150,000
200,000
250,000
300,000
MA
T R
MB
(m
io)
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
MAT4Q05 MAT4Q06 MAT4Q07 MAT4Q08 MAT4Q09
5 yr CAGR=22.8%
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
0%
5%
10%
15%
20%
25%
2005 2006 2007 2008 2009
Ne
w p
rod
uc
t s
ha
re in
Ch
ina
bu
sin
es
s
PFIZER GROUP
ASTRAZENECA GROUP
BHC GROUP
SANOFI-AVENTIS GP.
ROCHE GROUP
NOVARTIS GROUP
GLAXOSMITHKL GROUP
NOVO NORDISK GROUP
M.S.D. GROUP
ELI LILLY GROUP
ASTELLAS GROUP
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.
0 5 10 15 20 25 30
Injury and poisoning
Psychotic disorders
Infectious Diseases
Malignant tumors
Neurological Diseases
Eye Diseases
Geriatric Chronic Bronchitis
Arthritis
Gallbladder Disorders
Acute Gastritis
Genitourinary Diseases
Cerebrovascular Diseases
Diabetes
Heart Diseases
Hypertension
2003
1998
1993
Source: MOH statistics yearbook 2008
Urban Patient Number (Mil)
7.4%
6.9%
-3.3%
7.0%
1.4%
0.9%
-2.2%
-1.0%
0.5%
-0.5%
2.4%
8.6%
16.7%
4.8%
12.5%
7.4%
6.9%
-3.3%
7.0%
1.4%
0.9%
-2.2%
-1.0%
0.5%
-0.5%
2.4%
8.6%
16.7%
4.8%
12.5%
CAGR93-03
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.
Source: National Bureau of Statistics
Population composition by age
0
20
40
60
80
100
120
Sh
are
of
To
tal p
op
ula
tio
n %
>65 5.58 7.09 9.35
15~64 66.81 69.99 72.78
0~14 27.7 22.9 17.88
1990 2000 2007
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
0%
5%
10%
15%
20%
25%
30%
35%
SYS. ANTIBACTERIALS
TCM
ONCOLOGICS
INTRAVENOUS SOLUTIONS
CEREB.+PERIPHE.VASOTHERAP
ANTI-ULCERANTS
ANTI-HYPERTENSION
CARDIAC THERAPY
IMMUNOSTIMULATING AGENTS
DRUGS USED IN DIABETES
Market share (%)
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
CAGR (%)
1999 Value Share 2008 Value Share CAGR99-08
Chronic diseaes
Source: IMS 4Q08
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 high-tech 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
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
•Pharma R&D can focus on R&D with their key competence 38
Marketing Authorization System
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
About clinical trial in China
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, ChinaChina Is Underrepresented Relative To Other CountriesBased On Its Population And Market Size
Source: Clinicaltrials.gov; Global Insight; IMS; team analysis*CAGR Cumulative Annual Growth Rate
Phase III trials sponsored by industry
32
54
25
26
26
36
28
25
CAGR* of trials
(2003-2007)
89
92
99
58China
106India
100Czech
144Poland
128Russia
Argentina
Brazil
Mexico
9
4
963
378
90
250
48
85
Number of trials
(2007)
Number of trials per 100 million population (2007)
8
6
3
11
44
23
17
34
Number of trials per
$1bn drug sales (2007)
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
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
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Simultaneous Global Development
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
• 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
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RDPAC’s suggestion on SGD
For SGD, it is a race to change! Who will be left behind ?
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Source: RDPAC Drug Registration Timeline Survey
Trend – Increasing IMCT in China
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
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Drug Development Model in China
Yeste
rda
yT
od
ay
Global Development CPP R-CTA Review Clinical Trial IDL Review
4 YearsApproval
Outside China
ApprovalIn China
A Linear Development Model Following International Approval
≥4 years drug lag
A Parallel Development Model
Global Development CPP R-CTA Review Clinical Trial IDL Review
Clinical TrialGCTA Review IDL Review
2 Years
CPP
CPP = Certificate of Pharmaceutical ProductR-CTA = Regional Clinical Trial ApplicationIDL = Import Drug LicenseGCTA = Global Clinical Trial Application
≥2 years drug lag
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
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The Road To Enlightenment…Follow The Lights
2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China
Many thanks for your kind attention!
www.astellas.com.cn
www.rdpac.org
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