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https://nccur.lib.nccu.edu.tw/handle/140.119/71714
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| Title: | 中國一類新藥發展與本土創新生技新藥公司成功關鍵因素
Domestic First-in-Class New Drug Development and the Key Successful Factors of the Innovative Bio-pharmaceutical Companies in China |
| Authors: | 邱肇誠
Chiu, Dustin |
| Contributors: | 陳桂恒
邱肇誠
Chiu, Dustin |
| Keywords: | 中國
一類新藥
新藥分子
成功關鍵因素
創新價值鏈
產業供應鏈
新藥法規
新藥查驗登記
新藥保護
新藥開發
臨床試驗
公共衛生
重大疾病
藥品目錄
醫療保險
海歸學人
創新策略
逆向創新
不連續式創新
低破式創新
藥品招標制度
雙信封
國家食品藥品監督管理總局
貝達藥業
雙鷺藥業
中信國健藥業
先聲藥業
太景生技
喜康生技
默沙東
China (Chinese)
first-in-class new drug
new chemical entity (NCE) or new biological entity (NBE)
key successful factor
innovation value chain
industrial supply chain
new drug law and regulation
new drug registration
new drug exclusivity
new drug development
clinical trial
public health
critical disease
drug catalog
medical insurance
overseas professionals
innovation strategy
reverse innovation
discontinuous innovation
disruptive innovation
drug tender system
double-envelop
CFDA
Bettapharma
SL Pharm
CP Guojian Pharmaceutical
Simcere Pharmaceutical
TaiGen Biotechnology
JHL Biotech
MSD China |
| Date: | 2013 |
| Issue Date: | 2014-12-01 14:18:45 (UTC+8) |
| Abstract: | 本研究目的是探討中國本土一類新藥發展與其創新生技新藥公司成功關鍵因素，並分別從中國或台灣廠商角度，探討中國生技醫藥市場未來的機會與挑戰。首先，本研究探討中國社會結構變遷如何驅動醫藥需求，中國醫藥產業價值體系各利益攸關者（stakeholder）各自扮演何種角色，以及之間互動的關係－包含控制機制、上下游關係，利益流動等。第二，中國新藥由科學創新到商品化過程中，包含法規政策、監管機關、臨床試驗流程、查驗登記流程、法規機關效能、新藥保護、創新創業、與政策輔導等因素如何運作，如何影響新藥開發的效率與成功機會；並就中國新藥創新創業體系、創新聚落、以及受矚目新創新藥團隊進行探討。第三，本研究並從過去曾擁有一類新藥研發成功經驗，並取得商業成功的本土公司，進行個案探討，歸納成功關鍵因素，以期提供中國生技醫藥產業創新之洞見，而提供中國與台灣企業，在未來中國醫藥市場創造價值的建議。
本研究認為，老年化、城鎮化、以及經濟發展驅動社會安全與新醫藥需求，例如近年嚴重威脅中國民眾健康的重大疾病，包含心血管疾病、糖尿病、癌症、呼吸、消化系統病變－氣喘與肺癌，因盛行率與致死率成長快速，新產生的未滿足需求廣大；然而，當前中國醫藥產業以學名藥開發為主要營運主軸，對新需求回應有限，且產業秩序混亂，管銷成本高，除產生轉嫁造成看病藥價自付額高的現象，亦排擠企業創新資源。
本論文結合政策（由上而下）與需求驅動（由下而上）兩角度，探討未來產業創新的機會與挑戰。中國本土新藥開發的優勢，可從臨床試驗、政策資源、以及海歸學人等三項因素來探討。首先，中國臨床試驗進行的優勢在成本低廉、病患群大、收案容易；第二，中國政府以政策協助建立從本土學研至產品上市，完整的創新價值鏈，包含資金、租稅、基礎建設、業師輔導等，形成目前以北京、上海、廣東、四川為中心的新藥研發聚落，對資源共享與技術外部化有正面作用；第三，海歸學人將人脈、先進醫療研究、商品化經驗、以及創業精神帶回中國，將中國與世界新藥創新產業鏈連結，是未來中國生技醫藥產業創新升級的主要能量。然而，中國本土新藥開發的挑戰，主要來自於查驗登記制度，以中國國家食品藥品監督管理總局為首的查驗登記體系，審查能量與資源不足，流程與規定僵化，造成開發風險與時間成本增加；其次，臨床資源整體控制在政府機構，且整體試驗品質仍有待提升；部分研究專科資源稀少，而阻礙了臨床研究；第三，招標與定價制度，無法提供足夠創新誘因。面對以上挑戰，雖過去有不少政策性宣示，但實際變革仍緩慢。
本研究以工研院「國際小型新興生技公司成功關鍵因素」學術研究計畫之成果為基礎，針對中國本土新藥創新的成功企業，包含雙鷺藥業、先聲藥業、與中信國健藥業進行個案研究。歸納中國本土一類新藥公司發展關鍵成功因素，與國際經驗並無不同。首先，成功企業皆有優異商業領導者，正確有效率的分配資源，以聚焦聚焦核心能耐為原則，支持自主創新，或透過納入外部資源，以策略聯盟方式向學界或跨國藥廠合作，建立學習曲線；第二，中國新藥產業整體創新不足，反而使專注研發創新者差異化優勢，得以快速回應本土市場需求，取得先行者優勢；第三，利用人脈網路取得政策資源，並利用過去查驗登記制度寬鬆環境，擬定商品化策略，維持成長與擴大優勢。
台灣廠商為掌握未來中國生技醫藥產業成長機遇，除需認識創業資源、管理文化、以及法規等實際執行層面的差異，更應積極從創新研發與管理思維出發，基於對中國醫療市場需求的瞭解，借鏡成功案例，從零開始，針對研發與組織擬定逆向創新策略，以創造中國市場可負擔，且具備安全、有效性的產品。具體而言，全新的商業模式、既有技術的低破式創新、既有產品的市場重新定位、以及足以動態因應中國市場環境變化的創新組織管理等策略的互相搭配，皆是在中國獨特生技醫藥產業環境下，建立成功經營模式的重要策略。
總結本研究藉由對中國生技醫藥產業價值體系運作各環節的梳理：對產業環境對創新優勢與挑戰的分析，對中國本土新藥成功企業個案探討，並與國際成功關鍵因素做對照與歸納，為台灣產業提出具體的策略建議，以期能掌握未來的商機，在中國創造成功優勢。
The aim of the research is to investigate both Chinese first-in-class drug market potential and the key successful factors of the Chinese bio-pharmaceutical companies that are specialized in innovative product development. The thesis also discusses opportunities and challenges of pharmaceutical innovation from both Chinese and Taiwanese companies’ perspectives. Firstly, the thesis analyzes social drivers of emerging unmet medical needs. It also identifies major stakeholders and their interplay in the Chinese bio-pharmaceutical industry. Secondly, from domestic scientific research to product commercialization, the thesis depicts how Chinese government policies and regulatory pathway work for drug innovation, and discusses how they influence on efficiency and successful rate of first-in-class drug development. It also puts spotlights on the ecosystem of Chinese bio-pharmaceutical innovation, including the value chain, research clusters, and selective start-ups which focus on first-in-class drug discovery. Thirdly, the thesis conducts case studies on companies which have proven track records in domestic first-in-class drug innovation and commercialization. Together, this study is trying to provide business insights for Chinese local and Taiwanese companies which wish to pursuit future opportunities in the Chinese market through innovation.
The first finding of the thesis suggests that ageing population, urbanization, and rapid economic growth drive new unmet medical needs of certain key therapeutic areas, including cardiovascular disease, diabetes, cancer, respiratory and gastroenterology diseases. These diseases of affluence are growing rapidly not only in prevalence, but in mortality rates. However, currently, overall Chinese bio-pharmaceutical industry responds emerging demands poorly because generic business is its major focus. Moreover, high selling, general, & administrative (SG&A) expenses of the Chinese bio-pharmaceutical industry precludes drug makers from allocating sufficient business resource on innovation.
The thesis discusses future chances and challenges of Chinese new drug creation from both policy (top-down) and demand driven (bottom-up) perspectives. Domestic opportunities and challenges of the first-in-class drug innovation can be viewed from three major perspectives: the clinical study, government policy, and the overseas professionals. Firstly, cost effectiveness, large naïve patient pool, and ease of patient recruitments are key advantages of trial deployment in China. Secondly, the Chinese government authorities create solid innovation ecosystem to help local academia spin-off. The innovation ecosystem was maintained through providing both material assets such as research fund, tax reduction, and infrastructure, and services such as managerial consultation and mentor coach. Currently, China has four bio-pharmaceutical innovation clusters, including Beijing, Shanghai, Guangdong, and Sichuan. Synergies through resource sharing and technology externalization benefit greatly to domestic teams. Thirdly, overseas professionals help bring advanced research, global connections, experiences in management and commercialization, and spirit of entrepreneurship back to China. Recent successful stories suggest that overseas professionals could not only help connect Chinese clinical study with global network, but play key roles in future advances of Chinese bio-pharmaceutical innovation. On the other hand, outdated and rigid regulatory framework is the primary challenge of Chinese first-in-class drug discovery. Insufficient workforce and lack of experienced professionals lead to inept CFDA drug review process. Incompetent Chinese regulatory framework causes uprising risks and costs on innovation. In addition, quality clinical resource is generally inadequate and controlled by the government. Clinical sites for some medical specialties are rare. Thirdly, statewide pricing control and provincial tender system discourage incentives for innovation. In spite of many policy amendments for supporting drug innovation, the industry sees little real progress.
The thesis studies three Chinese companies (SL Pharmaceutical, Simcere Pharmaceutical, and CP Guojian Pharmaceutical) with proven track records on first-in-class drug innovation and commercialization. The analysis is based on previous conclusion of ITRI academic project “Key Successful Factors of U.S. And Global Emerging Biotechnology Companies”. The case study of Chinese firms concludes that there is no difference between global and local experiences of business success through bio-pharmaceutical innovation. Firstly, every successful business story has an active leader who prudently allocates company resources around its core competence. A visionary leader also plans for feasible management strategies that are relied on either internal research or external collaborations, including open innovation, research alliance, or merger & acquisition. Secondly, the overall innovation inadequacy of Chinese bio-pharmaceutical industry gives SL, Simcere, and CP Guojian Pharmaceutical chances to reap great benefits by providing differentiated first-in-class pharmaceutical products in various therapeutic fields. By efficiently responding to local unmet medical needs, these firms gain frontrunner advantages. Thirdly, these successful companies gain business growth through taking advantage of favorable policy and regulatory environments.
Based on above understanding and analysis of the Chinese bio-pharmaceutical innovation, the thesis would provide suggested action plans to Taiwanese firms. Foreign bio-pharmaceutical companies would face China-specific challenges such as limited accessibility to policy resources, innovation gap, and unpredictability of regulatory practice. The thesis suggests that reverse innovation strategy could help overcome these challenges and bring effective and safe innovative products to the market. Reverse innovation measures include business model renovation, disruptive innovation, product or service reposition, and innovative management. Creative measures that bring innovative products or services that meet local demands and flexible management style that responds changing business environment promptly can help Taiwanese companies gain business success in future Chinese market.
摘要.....................................................................................i
Abstract..............................................................................iii
關鍵字.................................................................................v
目次....................................................................................vii
圖目次.................................................................................ix
表目次.................................................................................xi
第一章 緒論..........................................................................1
第一節 研究背景與動機......................................................2
第二節 研究目的................................................................4
第三節 研究範圍、限制與說明.............................................5
第四節 論文分析架構..........................................................6
第二章 中國醫藥產業..............................................................9
第一節 驅動中國醫藥市場結構性因素..................................10
壹、醫療支出成長.........................................................10
貳、中國老齡化社會來臨...............................................13
參、現代化對生活品質影響............................................16
第二節 中國重大疾病分析與醫療需求..................................17
壹、疾病盛行率............................................................17
貳、疾病死亡率............................................................20
參、中國重大疾病.........................................................24
第三節 中國醫藥市場供應鏈...............................................25
壹、中國醫藥產業綜觀...................................................25
貳、中國藥品銷售體系...................................................36
參、中國藥品目錄與保險制度.........................................40
肆、中國製藥產業價值鏈................................................50
伍、中國藥品招標制度與藥價管理...................................59
陸、中國醫藥體系改革...................................................69
第四節 小結：中國醫藥產業發展趨勢探討............................74
第三章 中國一類新藥價值鏈：由創新到商品化.........................79
第一節 中國一類新藥法規..................................................80
壹、中國新藥臨床開發法規與管理..................................83
貳、中國一類新藥審查與批准規範................................100
參、中國一類新藥研發與上市現況................................117
肆、中國查驗登記制度與環境對新藥創新機會與挑戰......125
第二節 中國新藥創新環境................................................131
壹、新藥上市保護制度................................................131
貳、政策與新藥研發...................................................139
第三節 小結：中國醫藥產業創新挑戰與機會......................151
第四章 中國生技新藥公司成功關鍵因素：個案研究................155
第一節 國際生技公司成功因素.........................................156
壹、管理組織............................................................157
貳、科技研發............................................................160
參、法律制度............................................................163
第二節 個案研究目的與範圍............................................166
壹、成功定義與公司篩選條件......................................166
貳、成功要素分析構面...............................................169
第三節 雙鷺藥業............................................................170
壹、基本資料............................................................170
貳、成功要素............................................................173
第四節 先聲藥業............................................................178
壹、基本資料............................................................178
貳、成功要素............................................................181
第五節 中信國健............................................................187
壹、基本資料............................................................187
貳、成功要素............................................................190
第六節 小結：中國生技新藥產業成功因素歸納..................192
壹、管理組織............................................................192
貳、科技研發............................................................195
參、法規制度............................................................197
第五章 討論：機遇與挑戰－由台灣生技新藥創新廠商為視角...199
第一節 前言...................................................................200
第二節 台灣藥廠進入中國策略.........................................201
壹、滿足中國醫療需求落差的不連續式創新模式.............205
貳、滿足中國醫療需求落差的商業與管理創新................211
結論..................................................................................219
參考文獻............................................................................225
書籍..............................................................................225
期刊論文........................................................................225
研究報告........................................................................226
資料庫...........................................................................229 |
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▪ Vicki Loise, Ashley J. Stevens, The Bayh-Dole Act Turns 30, Boston University (2010)
▪ Victoria Elegant, Critical Success Factors for Clinical Trials in Emerging Markets, p.17 Baxter Healthcare (2013)
▪ Weiping Li, Regulatory Environment in China, Janssen China (2013)
▪ WHO expert committee, WHO technical report series: the selection of the essential drugs, WHO (1975)
▪ WHO, Countries Statistics-2012, China, WHO (2014)
▪ WHO, World health statistics 2013, p.50, WHO (2013)
▪ WHO: Country Cooperation Strategy, 2013–2015 (2013)
▪ World Bank, The Path to Integrated Insurance Systems in China, World Bank (2010)
中文
▪ BCG Consulting Group, 在中國打造世界領先的創新型生物技術藥品產業, p.17, RDPAC (2013)
▪ Brian Yang, 中國準備批准首次人體試驗研究機構，但尚存安全性擔憂, Elsevier Med (2012)
▪ RDPAC&CAEFI, 全力提升中國醫藥產業創新能力, p.17-21, 中國外商投資企業協會藥品研製和開發行業委員會 (2012)
▪ 于洋, 新格局,新機遇, 2014 年醫藥行業投資策略，p.14, 華創證券 (2013)
▪ 中華人民共和國國家統計局, 2012年國民經濟和社會發展統計公報 (2013)
▪ 王輝耀, 《中國海歸創業發展報告2012》綜述, 金融時報中文網 (2013)
▪ 王輝耀, 國際人才藍皮書--中國海歸發展報告(2013) , 中國與全球化智庫(2014)
▪ 吳蘋, 新時代-中國醫藥市場機遇無限，勤業 (2011)
▪ 李衛平, 產業對於我國臨床試驗環境的總體認知, RDPAC (2012)
▪ 杜依蘭等，中國醫藥行業展望-第二版, p.15，普華永道 (2009)
▪ 國家統計局 科學技術部, 2012年全國科技經費投入統計公報，（中國）財政部 (2013)
▪ 陳瑋、陳景璉，誰將成為中國生物仿製藥的主角，LEK Consulting (2013)
▪ 項軍, 徐佳熹, 鄧曉倩 & 孫曉東, 穿越政策迷霧,尋找確定成長-醫藥行業 2014 年投資策略，p.10, 興業證券 (2013)
▪ 馮育勤, 謝憶璐, Andrew Weir, Norbert Meyring, 中國醫藥行業－蓄勢待發, KPMG (2011)
▪ 趙冰, 新形勢,新航程, 2014年醫藥行業年度投資策略，p.18, 上海證券 (2013)
▪ 趙雪芹, 醫藥行業2014年投資策略，p.19, 中信證券 (2013)
▪ 衛生和計生委, 2012中國衛生統計年鑑, 中國協和醫科大學出版社 (2013)
▪ 衛生部統計信息中心, 2008年我國衛生改革與發展情況, 中華人民共和國國家衛生和計劃生育委員會 (2009)
▪ 戰略研究報告編委會，"健康中國2020"，健康中國2020，中國衛生出版社(2012)
資料庫
▪ CFDA, 資料庫, 藥品臨床試驗機構名單，http://goo.gl/3WkNo8
▪ CFDA, 數據查詢：國產藥品，http://goo.gl/eWgBlP
▪ MorningStar, MorningStar Database，http://goo.gl/mGOXzA
▪ Bloomberg, Bloomberg Professional Database
▪ OECD, Health Profile- Health Expenditure database，http://goo.gl/SsjjzA
▪ WHO, Global Health Expenditure Database，http://goo.gl/IsIbdL
▪ WHO, Global Health Observatory Data Repository- Life expectancy: China Database, http://goo.gl/caes3A
▪ WHO, World Health Rankings Database, http://goo.gl/O8Ltfp
▪ 中華人民共和國國家統計局，「data國家數據」資料庫，http://goo.gl/tyl7fw
▪ 深圳交易所，巨潮資訊投資者關係互動平台，http://goo.gl/w3TkfY |
| Description: | 碩士
國立政治大學
科技管理與智慧財產研究所
101359014
102 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0101359014 |
| Data Type: | thesis |
| Appears in Collections: | [科技管理與智慧財產研究所] 學位論文
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