promote tcm globalization by scientific & technological...
TRANSCRIPT
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Promote TCM Globalization by Scientific & Technological Innovation
Yan Xijun, Chairman of Tasly Group
August 11, 2011
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I. Innovation in the Standards, Technologies and Methods of TCM Products
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TCM Globalization: 3 steps → Prescription Drug
Go out: out of China (spirit of innovation)Probe, Practice, Pioneer & Push
Go in: to the world (technical upgrading)integration of TCM and western medicine, technical standard synchronization, international “drug”
Go up: to high-end (clinical)(doctors, patients and medical institutions) accept and useTCM
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• Standard Compliance• Language Barrier-free
• Attractive Product• Customer Trust
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Essential StrategyTCM Globalization
Chances and challenges co-exist
Business opportunities and difficulties mix
Scientific Methods
Daring Innovation
Bold Practice
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Systematic Innovation
TCM Globalization Means Systematic Innovation
• Product – Technology – Theory• Basic Study – Application Study – Industrial
Development• Enterprise – Industrial Chain – Industrial Cluster• R&D – Production – Logistics – Marketing – Usage• Individual – Team – Group• Product Export – Brand Building
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1. On the basis of multi-component TCM,
innovate the model of TCM product development and
promote systematic building and overall upgrading
of the industrial chain of modernized TCM
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TCM RebuildingChinese Herb & Prescription
Multi-component TCM
Active Ingredients New Direction
Modernized TCM preparation made from active ingredients of Chinese herbs on the basis of TCM theories and by means of modern technologies
Extract
Active Positions & Ingredients
Specific Pharmacological Actions
Compound of Clear Chemical Composition
Chinese Herb —— New Drug——
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Basically solid physical foundation, roughly clear working mechanism and more precise clinical orientation;
Suitable for modern manufacturing technologies as well as quality standards and requirements;
Favorable for acquiring patent-protected intellectual property rights;
Easy to enter major international markets as prescription drug;
Helpful for differentiated instruction, research, management and development.
Combination Single Component MonomericCompound
MonomericCombination
ComponentDetermination
Direction & Features of Multi-component TCM Studies
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Establish a technical platform for multi-component TCM products and a TCM component library as the technical system and material base
By now 13,000-odd components have been
made from 300 herbs and 20 Chinese drugs,
which physically lays foundations for new TCM
drug development
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International standards (ISO9000, ISO14000 sFDA GMP & TGA GMP) adopted
Compatible with all quality standards on planting (GAP), extraction (cGEP), manufacture (cGMP), lab study (GAP), clinical study (cGCP) and supply (GSP)
CNAS-certified quality inspection center
Build an International Practices-compliantBilingual SOP System & GxP Template
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Form a robust industrial chain: for the purpose of technical integration, industrial collaboration, linkage between the upstream and downstream, and overall standardization
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Speed up IT-based Industrial Upgrading
Build an advanced manufacturing platform for modernized TCM products with standardized management, streamlined operation and informationized control to achieve the qualities as special commodity and modern drug product
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2. Innovate Research Methodologies
by Means of International Registration
of New TCM Drugs
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Philosophies Priorities
• Teamwork• Sharing• Win-win
Feasible Program
Reliable Data
Typical Results
Principles
ScientificPrudentEthicalFaithful
Philosophies, Principles & Priorities for International Registration
Direction of Innovation: International Registration of Prescriptions Used for Years
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Marketing
NDA
IND
ApprovalPhase IIIPhase IIPhase IPre-clinical Study
Discovery
Clinical Use orPhase-IV Clinical Study
UnderstandWorking Mechanism
OptimizeApplication Program Pursue Best Effects
Model of Innovation: Reverse R&D Based on Clinical Experience
From the PhaseFrom the Phase--II clinical study, directly study the best dose, the best II clinical study, directly study the best dose, the best usage program and applicable people with the active ingredientsusage program and applicable people with the active ingredients and and working mechanism roughly understood, and then carry out some working mechanism roughly understood, and then carry out some fundamental research tasksfundamental research tasks
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Create Opportunities Build Platforms
• Know existing gap• Take on an equal basis• Discuss & solve problems
• For technical innovation• For standard compatibility• For talent recruitment• For resource consolidation
Base on the project, consolidate R&D resources, seek breakthroughs in key points, carry out in-depth communication, reach understanding and achieve consensus
TCM Product Registration
Approach of Innovation: Based on TCM Product Registration
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The Road of Dantonic® to FDA-approved Registration in the U.S.
• Included in products for official promotion of TCM globalization
1996 1997
Stage 1: 1996-2003, take steps, find gaps and determine direction
1998 2003
• First composite CPMaccepted by FDA as IND
• First IND approved (56,956)
• First national GAP-certified Danshen base in Shangluo, Shaanxi
• Concentrate on raising quality standards, building industrial chain and conducting clinical studies after domestic launch rather than rush into international clinical research in haste
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Stage 2: 2004-2010, Phase-II clinical trials completed, Phase III started
2004• Multiple talks with FDA and clinical indication determined:
chronic stable angina pectoris
2006• Second FDA IND approved (70,359)
2007• TGA Approval obtained from AUS & NZ• Worldwide multi-center clinical trials
2008• Marketing in CAN approved as (therapeutic)
traditional drug
2009.12.5• 18-month Phase-II clinical trials completed
2010• Review Phase II and Start Phase III
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Dosages & Dosage Range
Patient Groups,Ages & Baselines
Obedience
Different Dosage
Regimens
PharmacodynamicPeak/Trough
EffectsCourse of TreatmentBasic MedicationCombined Medication
Trial Protocol
Methodological Innovation:
Integrated application of
multiple interdisciplinary
methods in the design of
clinical trial protocol is
essential for feasible
protocol, reliable data and
typical outcomes.
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Protocol of FDA-approved new antianginal drug Ranolazine studied
Study the dosage, dosage range and racial features through interdisciplinary methods and technical models
Based on considerable domestic clinical application experience and safety data
In light of the “gold standard” for cardiovascular drug in EU, US & Japan
Featuring TCM drug
Ensuring standard stringency & consistency
Protocol of Phase-II Clinical Trials of Dantonic® ——
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BID dosage results in significant effectiveness at primary endpoints. The difference between 187.5mg Dantonic® and placebo in prolonging TED (Total Exercise Duration) shows clinical and statistical significance (p < 0.05).As for total exercise duration (TED), Dantonic® shows clear dose-response relationship. In comparison with placebo, the 187.5mg group is better than the 125mg group in terms of trough drug concentration .At each dosing level in week 4 and 8, with regard to the maximalpharmacodynamic effect of Dantonic®, the trough/peak rate >1, larger than the value expected for this type of study.
Conclusions of Phase-II Clinical Trials of Dantonic® (T89-005-0003-US)
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Other secondary endpoints, e.g.: weekly frequency of angina, weekly nitroglycerin consumption, time to chest pain, time to ST depression and some biomarkers, all point to the same direction and almost show identical dose-response relationship, and are of both clinical and statistical significance. Hence a chain of evidence is formed and primary indexes are supported.
No sign indicates that Dantonic® prolongs corrected QT interval on day 14, week 4 and week 8.
Both intention to treat (ITT) analysis and per-protocol (PP) analysis indicate the above outcomes are exactly the same.
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The Significance of FDA-regulated Phase-II Clinical Trials of Dantonic®
Prove the scientific quality of TCM drugs: the outcomes are of clinical and statistical significance, and primary endpoints are positive and secondary endpoints are supportive, forming a chain of evidence for safety, effectiveness and controllable quality;Confirm the stringency of TCM drug standards: TCM drugs can meet the “gold standard” of cardiovascular disease-oriented clinical trials (exercise treadmill test) and challenge the utmost;Pioneer in TCM globalization: by inventing a research model; overcoming research bottlenecks; establishing a research platform; creating a communication channel; building a professional team.
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Understanding:TCM globalization is a process of comprehensive innovation to realize
multiple goals
Integration of TCM& Western MedicineIntegration of TCM
& Western Medicine
Technical InnovationTechnical Innovation
Synchronization ofTechnical StandardsSynchronization of
Technical Standards
China
Target Nation
Sino-foreign Culture ExchangeSino-foreign Culture Exchange
Language ConversionLanguage Conversion
Concept RecognitionConcept Recognition
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II. Resource Sharing via Association & Cooperation
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AllianceAllianceMechanism for Globalization
Organizational Support
Capital Support
Work together to consolidate resource and form a joint force
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Board
Secretariat
Drug Registration andTechnical Research Center
International Marketing andService Trading Center
TCM Technical Service Center
Industrial Fund
Tasly Pharmaceuticals, Inc.
Members&
Projects
Organizational Support for TCM Globalization —— Take TCMA for Example
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International Talent BaseInternational Talent Base
Well-ordered Product LinesWell-ordered
Product Lines- A sustainable
growth-oriented talent base for competence to take on critical tasks
- Solve critical common technical difficulties by joint efforts
- Import advanced foreign technologies
Specific Functions:
Technical Innovation Platform
Technical Innovation Platform
Organization of All-in-1 Functions
Organization of All-in-1 Functions
- Perform all-in-1 functions which a single enterprise “longs for but can not fulfill”
- Screen products, consolidate resources and move forward by echelon
- Standardize clinics and product market, exercise mutual supervision and intensify industrial self-discipline
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Significant progress: North America multifunction center established
Contract signed Jun.
2, 2011 in Shanghai
Tasly invests in a multifunction base of TCM drug making, exhibition and training in Maryland and sets up a TCM product R&D platform at the Johns Hopkins University
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Thank You !