01(2 3)HN Exploring China Symposium 20143.ppt...Commercial Medical Insurance China Healthcare...

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Helen Niu Product Development In Selected Asian Countries 1 China’s Role In Biomedical Industry: Past, Present, and Future November 1 st , 2014 USC International Regulatory Science Symposium Helen Niu, MD, PhD Beijing, China Agenda The World Story The China Story China Healthcare System China Pharmaceutical Industry Historical perspective on Globalization of Drug Development China Pharmaceutical Regulations

Transcript of 01(2 3)HN Exploring China Symposium 20143.ppt...Commercial Medical Insurance China Healthcare...

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China’s Role In Biomedical Industry: Past, Present, and Future

November 1st, 2014USC International Regulatory Science Symposium

Helen Niu, MD, PhDBeijing, China

Agenda

The World Story

The China Story

China Healthcare System

China Pharmaceutical Industry

Historical perspective on Globalization of Drug Development

China Pharmaceutical Regulations

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=

The World Story

The China Story

Source: China NBS figures:figures of 1952-2008: Originated from China Statistical Yearbook 2013

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The China Story (cont.)

Source: China NBS figures:figures of 1952-2008: Originated from China Statistical Yearbook 2012,http://www.usgovernmentspending.com/us_gdp_history; McKinsey Quarterly July2011; www.economywatch.com

The Transformation of Chinese Society

Sources: K Eggleston, Stanford University, Asia Health Policy Program working paper, January 9, 2012, http://asiahealthpolicy.stanford.edu; http://data.worldbank.org/indicator/SP.DYN.TFRT.IN?page=6

Early 1950’s 2010

Population 0.5 Billion, 36% less than 15ys,

80% rural

1.34 Billion, 16.6% less than 15ys,

50.3% rural

Literate Rate 70% 96%

Life Expectancy

@40 yrs 72.5 yrs for Man76.8 yrs for Women

Economy System

a closed, centrally planned system

more market-oriented; plays a major global role

FertilityRate

@6 1.7

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China Healthcare System -Health Insurance

Sources: K Eggleston, Stanford University, Asia Health Policy Program working paper, January 9, 2012, http://asiahealthpolicy.stanford.edu

Prior to China Economic Reform (50s-70s)Wide spread basic coverage: the rural population had access to basic health services under cooperative medical schemes (CMS) managed by agricultural communes.The urban population was largely covered by work unit based health insurance either through the Labor Insurance System or the Government Insurance System.

Between 1980 and 2000The majority of China’s population did not have health insurance: the implementation of user fees as public funding declined in urban setting; and the dissolution of rural cooperatives and association of cooperative medical schemes (CMS).

China Healthcare System-Health Insurance (cont.)

Sources: K Eggleston, Stanford University, Asia Health Policy Program working paper, January 9, 2012, http://asiahealthpolicy.stanford.edu

Basic Medical Insurance:In 1996, the Central Government experimented with the re‐establishment of cooperative medical schemes (CMS) in rural areas. The Government announced direct budgetary support for the Rural CMS (RCMS) in 2002. By 2009, 94% of rural counties offered RCMS.

In urban areas, the Urban Employees’ Basic Medical Insurance system (UEBMI) Was established in 1998. By the end of 2006, UEBMI covered 64% of the Urban employed population (31% of the total urban population). In 2007, the government launched and rolled out the Urban Residents’ Basic Medical Insurance program (URBMI) nationwide, which covers urban residents not enrolled in the employee insurance program, including students, retirees, and other dependents.

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Basic Medical Insurance:

NCMS

UEBMI

URBMI

Supplementary Medical Insurance:

Civil Servant Subsidies

Supplementary Company Insurance

Target group Insurance

Commercial Medical Insurance

China Healthcare System-Health Insurance (cont.)

Sources: K Eggleston, Stanford University, Asia Health Policy Program working paper, January 9, 2012, http://asiahealthpolicy.stanford.edu

China Healthcare System-Government Stakeholders

Sources: K Eggleston, Stanford University, Asia Health Policy Program working paper, January 9, 2012, http://asiahealthpolicy.stanford.edu

Stakeholder Function and ResponsibilityNDRC (nationaldevelopment & reform commission

Monitoring and evaluating healthcare system reform; setting the price for drugs and medical services

Ministry of Finance Financial support and investment in healthcare; subsides for health care insurance

Ministry of Health Operations of RCMS; public hospital reform

Ministry of Human Resources & Social Security

Management of UEBMI and URBMI

Ministry of Civil Affaires

Poverty alleviation; medical aid for the poor

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China Healthcare System-Public Hospital System

Public hospital accreditation began in 1989.

In 2011, China had 1,350 public tertiary hospitals, 6034 secondary hospitals and 2908 Primary hospitals

Source: “The classification and management of the hospitals” MOH China November 29, 1989; http://www.sda.gov.cn

Class I (Primary) Class II (Secondary) Class III (Tertiary)

Hospital bed # 20-99 100-499 Over 500

Departments Minimal clinical departments: ER, Internal Medicine, Surgery Dept, OB/GYN, and Preventive Medicine

More specialty departments More specialty departments

Resource >0.7 Healthcare professional/bed >0.4 nurse /bed>0.88 Healthcare professional/bed

>0.4 nurse /bed>1.03 Healthcare professional/bed

Approval party City government health department

Provincial, Municipalgovernment

Provincial, Municipalgovernment

MOH for Special class 3

China Pharmaceutical Market

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China Pharmaceutical Market – Major Changes in Recent Years

Source: Healthcare in China Entering uncharted waters. McKinsey&Company July 2012

2006 2011

Total HC Expenditure $156 bn $357 bn

Per capita healthcare expenditure $119 $261

Population with health insurance 43% 95%

Market▪ Size▪ Global ranking

▪ $27 bn▪ Number 9

▪ $71 bn▪ Number 3

Combined revenues of top 10 pharmaceuticalmultinationals

$4 bn $10 bn

Number of sales reps from top -10 multinationals

6,000 25,000

Traditional Chinese Medicine, market size

$6 bn $13 bn

Vaccines, market size ~$1.2 bn ~$2 bn

Market▪ Size▪ Global ranking

▪ $8 bn▪ Number 6

▪ $20 bn▪ Number 3

Pharmaceuticals

Others

Medical Device

Overall

China's Macro-Economy -Significant Structural Changes

2005 2010 2015 Trend through 2015

10% 11% 7~8%GDP growth moderates potentially with volatility

~26% ~17% ~10%Export sees slow growth but structural upgrade

38% 37% 40%Consumption rapidly expands & outgrows GDP

41% 43% 45%Service rapidly expands & outgrows GDP

44% 47% 52%1 Inland accounts for more than half of China GDP

2% 21% 50%MAC pop. increases drastically

$1.1 $2.2 $4.6Labor cost keeps increasing rapidly

8.2 6.8 5.7RMB keeps appreciation at ~3% a year

Real GDP growth

Five-year avg export growth

Consumption GDP share

Service GDP share

Inland GDP share

Middle-class & affluent pop.2

Hourly labor wage

USD : RMB

1. Based on the preliminary GDP growth target for 12th FYP already announced by 23 out of 31 provinces or municipalities directly under administration of Central Government2. Annual household income > $10,000 Source: EIU, National Bureau of Statistics, State Information Center, analyst reports, literal research, BCG analysis

Consumer expansion

Wealth redistribution

Environ. protection

Quality urbanization

R&D and high tech upgrade

Equitable society (corruption & compliance)

Policy levers Implications

• Reassess the underlying drivers and build scenarios for the pharma market growth

• Ride the wave of consumer expansion

• More demand for upgraded products and services

• Rising operational cost promoting commercial model redesign using new tech and different cost structure

• Learn from and prepare for rising local competition with more innovation

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Key Consumer Trends - the Future of the China Market

1.Middle and Affluent Class ("MAC"), defined as households with annual disposable incomes of at least 72,000 Rmb (in constant 2010 prices)Source: BCG Analysis

Behavior: Evolving mind of Chinese consumers

Size: Changes of income and geography

Shape: Shifting Chinese demographics

Power of brand and trading Up

• Trading up and brand power continue to resonate with consumers

Urbanization• By 2020, ~270 cities as

wealthy as Shanghai in 2010 level

Health and wellness• Health and wellness

become the #1 reason to trade up

Growing small cities• Mid-tier cities will see

the most significant MAC population growth

Rise of middle and affluent class1 (MACs)

• MACs will be ~50% of urban population (450Mn) in 2020 vs. 21% in 2010

Digital generation• China is already the

largest digital nation with 560 million on-line population, and largest e-commerce volume

Aging population• China one of the fastest

aging countries in the world, expected to have ~16% of population aged 60+ in 2020

New births• ~16-18M new born

babies annually from 2005 to 2015

Female economy• Women control 50% of

household spending in China—and are earning more than ever

The magnitude of footprint expansion required continues to grow

Product and service offerings for the senior, the young and the female

Product and service offerings for prevention; Digital channel to reach

and educate patients

Historical perspective on Globalization of Drug Development

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Before 1975:

FDA accepted non-US clinical studies as supportive only.

In 1978:

Dr. J. Richard Crout stated that it was the credibility of data, not their country of origin, which should be the determining factor in the use of these data as primary evidence for drug approval.

1981:

Timolol for prevention of myocardial re-infarction based on Norwegian data was the first approval of a new indication for a marketed drug based on foreign data alone.

FDA History of Acceptance of Foreign Clinical Data

Khin Maung, DIA 40th meeting Washington DC 2004

CFR on Acceptance of Foreign Data

CFR Title 21

Part 312: Investigational New Drug Application21 CFR 312.120: Foreign clinical studies not conducted under an IND

Part 314: Applications for FDA Approval to Market a New Drug

21 CFR 314.106: Foreign Data (marketing approval based solely on foreign data)

[52 FR 883, Mar. 19, 1987, as amended at 52 FR 23031, Jun. 17, 1987; 56 FR 22113, May 14, 1991; 64 FR 401, Jan. 5, 1999; 67 FR 9586, Mar. 4, 2002]

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ICH Founder Members

EMEA European Medicines Agency

EFPIA European Federation of Pharmaceutical

Industries and Associations

FDA US Food and Drug Administration

PhRMA Pharmaceutical Research and

Manufacturers of America

JMHLW Japan Ministry of Health, Labour

and Welfare, Japan

JPMA Japan Pharmaceutical Manufacturers

Association

ICH E5 - Acceptance of Foreign Data

The ICH guideline E5: Ethnic Factors in the Acceptability of Foreign Clinical Data was endorsed by ICH Feb 98, and issued by FDA June 1998

In general, if the data developed in one region satisfy the requirement for evidence in a new region, but there is a concern about possible intrinsic or extrinsic ethnic differences between the two regions, then it should be possible to extrapolate the data to the new region with a single bridging study. The bridging study could be a pharmacodynamic study or a full clinical trial or possible a dose-response study.

http://www.fda.gov/cber/gdlns/iche5ethnic.htm#ii

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The Globalization of Drug Development

Trends in the globalization of clinical trials Fabio A. Thiers, Anthony J. Sinskey & Ernst R. BerndtNature Reviews Drug Discovery 7, 13-14 (January 2008)

The Globalization of Drug Development

Industry-sponsored clinical research of investigational drugs has traditionally been carried out in relatively developed countries in the North American, Western European, and Pacific regions.

Significant growth of activity in so-called emerging economies in Eastern Europe, Latin America, and Southeast Asia.

13% Global phase IIb-III sites are from the emerging area (23% average annual growth rate); North America stable; Western Europe experienced average -8% growth rate

Trends in the globalization of clinical trials Fabio A. Thiers, Anthony J. Sinskey & Ernst R. BerndtNature Reviews Drug Discovery 7, 13-14 (January 2008)

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Industry Sponsored Trials & MNC R&D Center in China

Industry Sponsored Trials

Source: wwww.clinicaltrial.gov; RDPAC Survey Report 2012

Phase 1 (96)Phase 2 (146)Phase 3 (514)

China Pharmaceutical Regulations

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Practical Steps in MAB Production

CFDA History

In 1998, the Ministry of Health's Department of Drug Administration merged with the State Pharmaceutical Administration of China to become the State Drug Administration (SDA).

The State Food and Drug Administration was founded on the basis of the State Drug Administration in 2003, and modeled after the US FDA.

In March 2013, CFDA has been elevated to ministry level which was announced during 18th National People’s Congress

Source: China Pharmaceutical Regulation Report 2006, Pacific Bridge Medical; Elsevier Business Intelligence , March 18, 2013

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GCP-Legal Status in China

Cao Cai, SFDA, DIA 41th Annual meeting, Washington D.C

Before 1998 Recommended for implementation

1998-Aug 1999 Trial period for GCP as rules

Sept 1999- Feb 2001

Implemented as rules

After Feb 2001 Upgraded to national law

Since Dec 2001 Mandatory implementation as National law

Chinese GCP Characteristics

No clinical trial can be conducted prior to official approval by CFDA

Applicant shall select a lawfully certified institution to conduct clinical trials and submit report for record

All clinical trial institutions subject to qualification by CFDA

Investigational products manufactured under GMP

Protection of trial subjects & written informed consent required

Cao Cai, SFDA, DIA 41th Annual meeting, Washington D.C

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The clinical trial of the medical device shall be conducted within qualified clinical trial institutes according to the requirements of the Good Clinical Practice (GCP) for medical devices.

Requirements for qualified hospitals are under review by MOH.

Notification to SH FDA before initiation.

Testing report will be valid for 1 year to support local clinical trial since issuing date.

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GCP (draft) Requirement for Device Trials

China Hospital System& SFDA Certified CTB (Clinical Trial Base)

Source: “The classification and management of the hospitals” MOH China November 29, 1989; http://www.sda.gov.cn

Class I Class II Class III

Hospital bed # 20-99 100-499 Over 500

Departments Minimal clinical departments: ER, Internal Medicine, Surgery Dept, OB/GYN, and Preventive Medicine

More specialty departments More specialty departments

Resource >0.7 Healthcare professional/bed >0.4 nurse /bed>0.88 Healthcare professional/bed

>0.4 nurse /bed>1.03 Healthcare professional/bed

Approval party City government health department

Provincial, Municipalgovernment

Provincial, Municipalgovernment

MOH for Special class 3

SFDA Certified CTBs

Number of Hospitals

Number of Dermatology Departments

Number of Ophthalmology Departments

Number of Plastic Surgery Departments

462 118(9 Traditional Medicine)

68 (7 Traditional Medicine)

6 (3 specialized on Burn)

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General Drug Registration Process

Clinical Trial Application

• CDE review

• CFDA approval

NDA•CDE review

• CFDA approval Ph IPh IIPh III

•New CTA needed

IND Stage

Clinical Trail

NDA Stage

Two submissions, two review processes with two approvals

LaunchLaunch

Type of Regulatory Applications

New drug application

(CTA & NDA)

For Chemical products: Cat. 1-4

For Biologics : Cat. 1-12

Generic drug application

(ANDA)

For Chemical products: Cat. 5-6 (Generally BE study is needed)

For Biologics : Cat. 13-15 (Ph3 clinical trial is needed)

Import drug application

(IMCT/Domestic CTA+NDA)

For drugs manufactured out of China: Cat 1& 3 for chemicals, Cat 1 & 7 for biologics

Supplementary application Variations

Renewal The approved certificate valid time is 5 years.

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Import Drug Registration Flow Chart –Both CTA & NDA

Application approval by CFDA

*

Chemicals IMCT: Sample testing is not applicable for IMCT. NDA needs QC testing with 3 batches.

Chemical domestic CTA : 3 batches DP per strength are required.

Biologics IMCT: 1 batch DP/strength

Biologics domestic CTA: 3 batches DP/strength; analysis method validation; 3 batches drug substance

Panel meeting will be held for critical issues

Yes.Review clock stops

Review will not be closed until testing report transferred to CDE

CDE technical review

Additional data requested?

CFDA Reception center

China Regulatory Applicant

Sample testing* by NIFDC

CDE technical review conclusion sent to CFDA

No

China Regulatory Agent

Application submissionwith paper documents

Paper receipt

Dossier and e-task transfer

Additional data supplement to CDE

directly

Registration Categories– for Chemical Drugs

Category 2 Category 6

Category 5Category 3

Drugs

Category 4

Category 1

Cat 1: Product never marketed in any country

Cat 2: Administration route Change and never marketed in any country

Cat 3: Drug marketed outside of China

Cat 4: Change API acid and alkaline

Cat 5: Change dosage form without changing administrationroute

Cat 6: Me-too/Following National Standard

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Minimum Sample Size for Chemical Drug

Category 1Cases

Category 2Cases

Category 3Cases

Category 4Cases

Category 5Cases

Category 6Cases

Phase I 20-30 20-30 PK PK PK NA

Phase II 100 100 NA NA NA NA

Phase III

300Per treatment

arm& Meet

Statistical requirement

300Per treatment

arm& Meet

Statistical requirement

100 pairs 100 pairs 100 pairs*100 pairs

for injection only

Phase IV 2000 2000 NA NA NA NA

BE NA NA NA NA 18-24** 18-24***

* For sustained release products, single, repeat PK and 100 pairs trial required ** For oral solid products, if BE can’t be conducted, then 100 pairs’ CT is requested*** BE not require for injection or non-oral solid products, but replaced by CT

Requirement for Clinical Trial(Chemical Drugs)Category Phase Minimum Sample Size

1 & 2(approved neither outside nor in China)

Randomized & Controlled Single Arm

I / 20-30

II 100 pairs /

III 300 ( test group)

IV / > 2000

3 & 4(approved outside China)

PK 10-12

Phase III

100 pairs( 60 pairs for additional indication)

/

5 & 6 (formulation change or generics)

BE or Phase III BE 18-24 or Phase III 100 pairs

The sample size should meet both the statistical requirement and the minimum sample size requirement by drug registration regulation.

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Global/Regional trialCategory 1: Biological product never marketed anywhere worldwide

Category 2: Monoclonal antibody

Category 3: Gene therapy, somatic cell therapy as well as the preparations

Category 4: Allergen products

Category 5: Multi component products with bioactivity extracted from, or by fermentation from

human and/or animal tissues and /or body fluid

Category 6: New combination product made from the already marketed biological products

Category 7: Biological product that approved overseas but not approved in China

Category 8: Some for the strains used for preparing of micro-ecological projects not yet approved

Category 9: Products with not completely same structure with the already marketed products and not yet marketed at domestic or overseas

Category 10: Products with a method of preparation different with the already marketed one

Category 11: Products first time made with DNA recombination technology

Category 12: Products transformed from non-injection into injection, or topical use into systemic

use, and not yet marketed at domestic or oversees

Category 13: The marketed products with a change in dosage form but no change in route of administration

Category 14: Products with a change in route of administration (excluding the above Cat 12)

Category 15: Biological product already approved in China

Local trial

Registration Categories – for Biologic Drugs

Minimum Sample Size for Biologic Product

Category 1-12 Cases

Category 13-15Cases

Phase I 20-30 NA/ PK*

Phase II 100 NA

Phase III300

Per treatment armMeet statistical requirement

300Per treatment arm

Phase IV 2000 NA

* For sustained release products, PK data are required .

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Requirement for Clinical Trial(Biological Product)

The sample size should meet both the statistical requirement and the minimum sample size requirement by drug registration regulation.

Category Phase Minimum Sample size

1 – 12*

(new product)

Category 7: biologics only approved outside China

Randomized &

Controlled

Single Arm

I / 20-30

II ≥100(test group)

III ≥300(test group)

IV / >2000

13 -15 (

formulation/administration change or

biosimilars)

Phase III ≥300(test group)

International Multi-center Clinical Trial (IMCT)

An international multi-center clinical trial (IMCT) is established in 2002 to facilitate China join international trial without a CPP

An IMCT CTA for a Ph3 can be filed after global Ph2 is initiated

At least three countries participate in IMCT

Clinical data requirement in IMCT meet Category 3/7 requirements (100 pairs for chemicals and 300 on test arm for biologics)

File an NDA under Category 3/7: CN NDA approval will be based on PK data in CN + IMCT data

Importation drug registration in China• Local CTA/NDA pathway with CPP• IMCT CTA/NDA pathway

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IMCT To NDA Process Update

-Established in 2002

- Facilitate China joining international trial without a CPP

- Precondition is the global Ph II is initiated

- At least three countries participate IMCT

2 submissions/2 approvals to 3 submissions to 3 approvals process

- Additional local CTA submission to obtain a waiver on local trial

- Time delayed to NDA over 2-3 years

Regulatory Background

Process Revision

Implication

- Still encourage simultaneous global development (SGD)- To draft a detailed technical guidelines of IMCT- But change IMCT definition as “Multi-Regional Clinical Trials”- Aim to promote local company to participate in the global SGD.

CFDA Next Step Plan

IMCT To NDA Process Update- Cont.

2 sub/2 Approval

3 sub/3 Approval

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DRR Amendment update- Draft version

Keyregulatorychanges Implication

• Amendmentsystem‐ Currentnoamendmentsystem,datainCTAareallfinal‐ AllowCMCchangestobesubmittedfornewdrugCTA

• Supportearlyphasedrugdevelopment

• Encourageinnovativedrugdevelopmentespeciallyearlyphase,e.g.phaseIandII,FIM

• Adjustdomesticsiteinspectionaftertechnicalreviewwithpositiveconclusion‐ CurrentdomesticinspectionwillbeinitiatedimmediatelyaftertheCTAsubmission‐ AvoidwastingCFDAresourcesandtimeifnegativereviewconclusion

• Fitdrugdevelopmentprocess• Encouragedomesticnewdrugdevelopment

• Linkagebetweendrugregistrationandpatentprotection‐ Currentanapplicationcanonlybe

submitted2‐yrbeforepatentexpiration.‐ Thegenericdrug’sapplicationcouldbe

submittedatanytime,butonlycanbeonmarketaftertheoriginalpatentexpiration

• Encouragedomesticfirsttogenericdrugs’development

Expedite clinical development for new imported drugs:•Currently 2 pathway of imported drug : local CTA with CPP or IMCT (3 sub/3 approval)•Internal discussion in CFDA to allow new imported drug to initiate a local trial •New drug: has never been approved in any country •This pathway ever available before 2009(mainly for ph III)•Re-discussion in Q3 2014

Key Changes

Implication

Provision of Standardizing Drug’s Applications - Draft version

• Encourage simultaneous global development for new drugs;

• Can file a local CTA without a CPP

- No clear criteria available

- No definition on CT phases

- Global data requirement unknown

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China CFDA (SFDA) Meeting

45Source: http://www.cde.org.cn/newspic.do?method=view&id=312809

46

CFDA (SFDA) – Technical Review

Source: http://www.sda.gov.cn/WS01/CL0001/

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CFDA (SFDA) – Technical Review

Source: http://www.sda.gov.cn/WS01/CL0001/

48

CFDA (SFDA) – Technical Review

Source: http://www.sda.gov.cn/WS01/CL0001/

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CFDA (SFDA) Application Submission Volume 2009-2012

Chemical TCM Biologics

Source: http://www.cde.org.cn/newspic.do?method=view&id=312809

2012 (CFDA) SFDA Submission Approvals

2012 NDA Approvals

2012 CTA Approval Class

Source: http://www.cde.org.cn/newspic.do?method=view&id=312809

Class

TCM

Biologics

Total

Chemical

Class

Class

TCM

Biologics

Total

NCENew

Formulation

Generic Imported Sub -T

Clinical Trial

Class Bioequivalence Sub - T

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Review Timeline by RDPAC Survey

31 out of 38 member companies participated timeline survey for 2011

510 drug applications were added / updated for 2011 survey

This report reflects all milestones achieved in 2011

Chemical drug and Biological product are covered

Import Drug License (IDL)

Multi-regional Clinical Trial (MRCT)

Import Drug License renewal (IDL renewal)

Source: RDPAC report 2011

51

15

59

39

62

17

0

10

20

30

40

50

60

70

IDL-CTA IDL-NDA MRCT IDL-Renewal

Chemical Therepeutic Biological Vaccine

# of submissions in 2011 (Total 150)

3439 39 37

49

57

1420 21

15

34

17

26

5155

64

87

76

0

20

40

60

80

100

2006 2007 2008 2009 2010 2011

# of CTA Filing # of NDA Filing # of MRCT Filing

# of submissions in 2006-2011

Source: RDPAC report 2011

numbernumber

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2417

35 38

66

23

5 8

2314

20

913

23

42

56

99

78

0

20

40

60

80

100

2006 2007 2008 2009 2010 2011

# of CTA Approval # of NDA Approval # of MRCT Approval

# of approvals in 2006--2011

22

7

63

39

0

10

20

30

40

50

60

70

IDL-CTA IDL-NDA MRCT IDL-Renewal

Chemical Therepeutic Biological Vaccine

# of approvals in 2011 (Total 110)

Source: RDPAC report 2011

numbernumber

IDL- CTA and IDL- NDA of Therapeutic Biological Products Approval time

Year 2009 2010 2011

IDL-CTA 16.1M(N=1) 17.8 M (N=15) 11.9M (N=1)

IDL-NDA N=0 18.6 M (N=1) 19.9M(N=2)

Source: RDPAC report 2011

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Helen Niu Product Development In Selected Asian Countries

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12.113.6

17.515.7

17.6

21.5

0

5

10

15

20

25

2006 2007 2008 2009 2010 2011

IDL-CTA (category 3.1)

N=16 N=18

IDL- CTA and IDL- NDA of Chemical Product approval Time

11.5

15.1

18.217.2

18

21.4

0

5

10

15

20

25

2006 2007 2008 2009 2010 2011

IDL-NDA (category 3.1)

N=5

N=23 N=34 N=35 N=14 N=17N=5 N=8N=17N=6

Source: RDPAC report 2011

Mon

th(i

n m

edia

)

7.1

9.310

9.4 99.8

0

2

4

6

8

10

12

2006 2007 2008 2009 2010 2011

Chemical Product (Category 1.1)

Timeline from date of submission to date of approval for IMCT of Chemical Product approved in 2006-2011

N=9 N=14 N=43N=29 N=28 N=37

Source: RDPAC report 2011

Mon

th(i

n m

edia

)

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Helen Niu Product Development In Selected Asian Countries

29

China Pharmaceutical Market –More Changes to come

Source: Healthcare in China Entering uncharted waters. McKinsey&Company July 2012

2006 2011

Total HC Expenditure $156 bn $357 bn

Per capita healthcare expenditure $119 $261

Population with health insurance 43% 95%

Market▪ Size▪ Global ranking

▪ $27 bn▪ Number 9

▪ $71 bn▪ Number 3

Combined revenues of top 10 pharmaceuticalmultinationals

$4 bn $10 bn

Number of sales reps from top -10 multinationals

6,000 25,000

Traditional Chinese Medicine, market size

$6 bn $13 bn

Vaccines, market size ~$12 bn ~$2 bn

Market▪ Size▪ Global ranking

▪ $8 bn▪ Number 6

▪ $20 bn▪ Number 3

Pharmaceutical

s

Others

Medical Device

Overall

$1 trillion in 2020

Question?