Wednesday, January 27, 2016

Athenex口服Docetaxel 進入IND (藥華Oraxol口服紫杉醇/ Oratecan口服喜樹鹼)

Athenex宣佈美國FDA批准Oradoxel的新藥臨床試驗申請 20160126 下午02:26紐約州 布法羅和香港2016126日電 /美通社/ -- Athenex, Inc.今天宣佈,該公司已經獲得了美國食品藥品監督管理局(美國FDA)對繼續進行其自主研發的口服型多西他賽的臨床研究的批准。此次獲准繼續研究讓 Athenex 第六次向美國 FDA 成功提交了腫瘤新藥臨床試驗申請(IND)(這六次申請分別涉及五種口服抗癌藥和一種藥膏),這也預示著該公司的口服吸收平臺將推出第三種此類臨床候選藥物。多西他賽是一種成熟有效的高效能抗癌藥物。Athenex 已經為其開發了名為「Oradoxel」的口服型藥物。相應的 Athenex 腫瘤口服吸收技術以自主研發的 P-糖蛋白(Pgp)泵抑制劑(「Orascovery」平臺)為基礎,而這種泵抑制劑源自於Athenex 從商業合作夥伴 Hanmi Pharmaceuticals(韓美藥品)那裏獲得的獨家授權,2011年,Athenex獲得了相關技術在全球各主要地區的授權,但 Hanmi Pharmaceuticals 保留在韓國和日本地區進行開發的權利。Athenex 目前擁有處於晚期臨床研究階段的口服型紫杉醇和伊立替康,這些藥物在更早的臨床評估中展現出了頗有開發前途的特性。 Athenex 臨床開發和監管事務副總裁 Douglas Kramer 博士表示:「我們的團隊為 Oradoxel  FDA 提交了超過35,000頁的綜合 IND 資料,包括關於我們口服吸收平臺的信息。我們的 Pgp 泵抑制劑被證明能幫助提升知名腫瘤藥物的口服吸收水平,而如今這些藥物只能通過靜脈注射的方式向病人提供。我們現在很高興能夠創造無限的可能性,在幫助更多的癌症病人上面有一番作為。」 Athenex 臨床藥理學副總裁 Gerald Fetterly 博士補充說:「我們已經在臨床上瞭解到,將現有的靜脈注射高效能腫瘤藥物轉變成口服形式,可以為優化多種多樣的病人給藥方案開啟大門,而這些方案是不可能通過靜脈注射來實現的。以口服形式給藥能讓病人在更長的時間裏吸收活性強效藥物成分,臨床研究也表明在藥代動力學方面,口服型藥物在血液中的含量能達到預期,與靜脈注射形式相比,這樣臨床效果好,不良副作用也較少。」 Athenex 主席兼行政總裁 Johnson YN Lau(劉耀南)博士(擁有內外全科醫學士(MBBS)學位,並且是英國皇家內科醫師學會會員(FRCP))則評論說:「我要祝賀我們的 Athenex 香港團隊和 Athenex 美國團隊,並且要感謝我們的合作者協助我們開展這個項目,達到了這一具有重要意義的成功監管里程碑。Oradoxel 項目最初由 Athenex 香港團隊在香港理工大學(The Hong Kong Polytechnic University)應用生物及化學科技學系(ABCT)的鄭家純藥物研發實驗室(Henry Cheng Research Laboratory)開發,這個項目還獲得了香港創新科技署(Hong Kong Innovation and Technology Commission) SERAP(小型企業研究資助計劃)等額撥款的部分支持。現在應該祝賀香港成為了面向全球癌症病人的重要藥物開發科學創新基地。我們所取得的這一成就還幫助加強了我們業務策略的成功實施,即在中國和美國之間搭建一座醫療科技的『橋樑』。」 除了公司業務所覆蓋的主要區域之外,Athenex 現在還和 Orascovery 平臺的發起者 Hanmi Pharmaceuticals,一起在韓國和日本開發 Oraxol  Oratecan並和 PharmaEssentia(藥華醫藥股份有限公司)與 ZenRx 分別在臺灣和新加坡地區與新西蘭和澳洲地區進行開發。

Athenex, Inc.簡介 Athenex 創立於2003年,是一家全球專業腫瘤醫藥公司,主要關注新一代癌症疾病療法和支持療法的商業化開發。Athenex致力於提供能大大改善癌症病人的病情的創新藥物。我們的業務包含十種正在開發的自主研髮型創新藥物、醫療科技創新中心、產品開發團隊,以及跨越中國與北美的獨一無二的新興製造供應鏈。我們的雇員包括幾百名具有奉獻精神的專業人員,他們致力於達成改善全球癌症病人的生活的使命。憑藉我們主要集中於中美兩國並相互聯繫的創新、開發與製造事業,我們能在不同的大陸和多個監管環境中發現、開發和提供自主研發的醫療技術。我們已經在紐約州布法羅和克拉倫斯、新澤西州克蘭福德、香港、臺灣臺北及中國內地重慶市內的多個地點設立了辦事處。除了我們的辦事處之外,我們還在新西蘭但尼丁、香港、中國內地的廣州、韓國首爾、臺灣的臺北、危地馬拉的危地馬拉城與阿根廷布宜諾斯艾利斯擁有地區層面的開發合作夥伴。

 

Reference: 藥華 開發 Oraxol(口服紫杉醇)/ Oratecan(口服喜樹鹼) (licensed by Kinex)

 

Athenex Announces US FDA Allowance of the Investigation New Drug Application of Oradoxel, the Proprietary Oral Form of Docetaxel  Buffalo, NY and Hong Kong- Athenex, Inc. announced today that it has received United States Food and Drug Administration (US FDA) allowance to proceed in the clinic with its proprietary oral form of Docetaxel. This allowance to proceed represents Athenex's sixth successful oncology investigational new drug (IND) application by the US FDA (5 oral anticancer drugs, one ointment) and the third such clinical drug candidate in Athenex's oral absorption platform. Docetaxel is an established and effective high potency anti-cancer drug. Athenex has developed an oral form, called Oradoxel. The Athenex oncology oral absorption technology is based on a proprietary P-glycoprotein (Pgp) pump inhibitor ("Orascovery" platform) licensed exclusively from our business partner, Hanmi Pharmaceuticals, in 2011 for all major worldwide territories except Korea and Japan that were retained by Hanmi Pharmaceuticals. Athenex currently has the oral forms of paclitaxel and irinotecan in later stage clinical studies, which showed promising profiles in earlier clinical evaluations. Douglas Kramer, MD, Athenex Vice President of Clinical Development and Regulatory Affairs stated "Our team submitted to the FDA a comprehensive IND package for Oradoxel of over 35,000 pages, including information on our oral absorption platform. Our Pgp pump inhibitor has been demonstrated to enhance the oral absorption of well-known oncology drugs that today are only available to patients as intravenous medicines. We are excited for the possibilities to make a difference in helping more cancer patients." Gerald Fetterly, PhD, Athenex Vice President of Clinical Pharmacology added "We have learned in the clinic that converting existing intravenous high potency oncology drugs into oral forms opens the door to optimizing a wide array of patient dosing regimens which cannot be achieved with IV. Oral forms of dosing allow the patients to be exposed over a longer period of time to the potent active pharmaceutical ingredients and clinical studies have shown expected pharmacokinetic blood levels of exposure; leading to good clinical efficacy with less adverse side effects compared with the intravenous counterparts." Athenex Chairman and CEO Johnson YN Lau, MBBS, MD, FRCP, commented, "I want to congratulate both our Athenex Hong Kong team and the Athenex US team, and thank our collaborators on this project on achieving this important successful regulatory milestone. The Oradoxel project was initially developed by the Athenex Hong Kong team in the Henry Cheng Research Laboratory for Drug Development, Department of Applied Biology and Chemical Technology (ABCT), The Hong Kong Polytechnic University and this project was also partially supported by a SERAP matching grant from the Hong Kong Innovation and Technology Commission. Hong Kong should be congratulated as an innovator of important drug development science for cancer patients globally. This accomplishment also reinforces the successful execution of our business strategy creating a medical technology bridge between China and the United States." In addition to its primary territories, Athenex is also developing Oraxol and Oratecan with Hanmi Pharmaceuticals, the originator of the Orascovery platform, in Korea and Japan, with PharmaEssentia in Taiwan and Singapore, and with ZenRx in New Zealand and Australia.

About Athenex, Inc. Founded in 2003, Athenex is a global specialty oncology pharmaceutical company focused on the development and commercialization of next generation therapies for cancer diseases and supportive therapies. The company is dedicated to delivering innovative drugs that can have a life-changing impact on cancer patients. Our business includes 10 innovative proprietary products under development, medical technology innovation centers, product development teams and a unique emerging manufacturing supply chain across both China and North America. Our employees include several hundred dedicated professionals to the mission of improving the lives of cancer patients throughout the world. With our connected innovation, development and manufacturing presence concentrated in China and the US, we can identify, develop, and deliver proprietary medical technology across continents and multiple regulatory environments. We have offices in: Buffalo and Clarence New York, Cranford New Jersey, Hong Kong, Taipei Taiwan, and multiple locations in Chongqing, China. In addition to our offices, we have regional development partners in Dunedin New Zealand, Hong Kong, Guangzhou China, Seoul South Korea, Taipei Taiwan, Guatemala City, Guatemala, and Buenos Aires Argentina. Any opinions, findings, conclusions or recommendations expressed in this material/event do not reflect the views of the Government of the Hong Kong Special Administrative Region, the Innovation and Technology Commission or the Small Entrepreneur Research Assistance Programme (SERAP) Project Assessment Panel.

 

Athenex Leadership Team

Athenex is led by an experienced global team in pharmaceutical drug development.

Johnson Y.N. Lau, MBBS, MD, FRCP  Chief Executive Officer & Board ChairmanJohnson is a successful pharmaceutical executive who has had extensive leadership experience in both scientific and business management. As Chairman and CEO of Ribapharm, he launched the second largest biotech IPO in US history. During his tenure at Ribapharm, he met or exceeded Wall Street expectations each and every quarter. Prior to Ribapharm, he served as the Head of Worldwide Research and Development for ICN Pharmaceuticals. Prior, Johnson served as the Senior Director of Antiviral Therapy at Schering-Plough, where he played a key role in the FDA approval of Ribavirin/Interferon and Pegylated Interferon alpha-2b. Johnson has contributed more than 250 scientific publications in peer reviewed scientific journals, more than 50 editorials/reviews/chapters and has edited three books. He was a former Managing Director at Roth Capital Partners at its headquarters in Newport Beach, California and was also a Director of the Board of Chelsea Therapeutics (CHTP), serving as the Chair of the Audit and Finance Committee as well as the Corporate Governance Committee. He has served on the Board for a number of privately held companies. Johnson received his medical degree (MBBS) and medical doctorate degree (MD) from the University of Hong Kong. He is also a Fellow of the Royal College of Physicians. Johnson has served as the Chairman of the Board of Athenex since its inception and assumed the role of CEO in mid 2011.

Flint D. Besecker, CPA  Chief Operating Officer & Board DirectorFlint is a veteran in the healthcare industry with a proven track record building large-scale growth oriented platforms focused in the US. Flint has held a number of nationwide executive positions in the healthcare and financial industry, including founding Care Investment Trust (CRE-NYSE), a healthcare focused Real Estate Investment Trust and founding CIT Healthcare (CIT-NYSE) where he served as its President. Flint has served on numerous Boards including Board Chair of Care Investment Trust and subsequently its lead Independent Director after its sale. He has also served as Board Director and Chair of Compensation Committee of Allion Healthcare (ALLI- NASDAQ) and has served on numerous private boards. Prior to 2004, Flint held a variety of national executive leadership positions in the healthcare industry including GE Healthcare Financial Services (GE-NYSE), Heller Healthcare Finance (HF-NYSE) and Healthcare Financial Partners (HCF-NYSE). He received a BS in Accounting from Canisius College in 1988 and is a Certified Public Accountant. Flint resides in Western New York.

Rudolf Kwan, MBBS, MRCP  Chief Medical OfficerRudolf has had a successful career in the pharmaceutical industry with over twenty years of experience in global clinical development and operations.  Before joining Athenex, he served dual roles at Schering-Plough (SP) as Vice President and Regional Head of Asia Pacific Global Clinical Operations and Vice President of Global Clinical Development, CNS. In the clinical operations position, Rudolf successfully recruited Heads of Clinical Operations for China, South East Asia, Australia, Taiwan and South Korea and set up the infrastructure to conduct global clinical trials in Asia Pacific for Schering-Plough.  As Vice President of Global Clinical Development, CNS, he was responsible for the clinical development of all SP central nervous system drugs, globally. Major achievements included developing and executing a bioequivalence registration strategy for a new formulation of Temodol, for glioblastoma, which led to a simultaneous global registration.  He also designed and executed multiple global development programs. Earlier at Schering-Plough, Rudolf held various clinical operation positions with increasing responsibility.  He held similar positions at Chiron Corporation and at Smith Kline Beecham. Rudolf obtained his medical degree in Hong Kong and did subsequent training in England.  He is a member and Chair of the Data Monitoring and Safety Board and Protocol Review Board for the Clinical Trial Network of the National Institute on Drug Abuse of the National Institute of Health in the USA (NIH). He is also a member of several advisory panels and grant review panels for NIH.

David Hangauer, PhD  Chief Scientific OfficerDavid is a leader in the field of structure based drug design.  Following doctoral studies in chemistry at the University at Buffalo, he spent ten years at Merck Sharp and Dohme Research Laboratories, where he directed a variety of drug discovery projects.  In 1989, he returned to academia and joined the chemistry faculty at SUNY at Buffalo, where he has had a productive career that has focused on developing protein kinase inhibitors. David's expertise has been sought by pharmaceutical and biotechnology companies worldwide, including: Lederle/Wyeth-Ayerst Research Laboratories; New Medical Technologies; Sphinx/Eli Lilly Pharmaceuticals Inc.; Yuhan Corporation; Periodontix, Inc.; ICAgen, Inc.; ARPIDA, Scientific Advisory Board & Founding Scientist; and Signal Pharmaceuticals, Inc. Most notably, he led the chemistry effort at Hypnion, Inc., which was sold to Eli Lilly in 2009 for more than $300 million. The company's major asset was an insomnia drug that was designed and discovered under the leadership of David.

Wing-Kai Chan, MD, MBBS, FRACP  Head of Asia / Pacific Clinical , Wing-Kai's roles have included Director, National Center of Excellence for Clinical Trial and Research at the National University Hospital, Taiwan, and Medical Director in Roche Asia/Pacific and in that capacity, participated in the clinical development of a number of anti-cancer drugs such as: Rituxan, Herceptin and Xeloda, to name a few. Wing-Kai is a medical graduate of the University of New South Wales, Sydney, Australia and a Fellow of the Royal Australian College of Physicians. He is also a member of American Society of Clinical Oncology. Wing-Kai has authored many publications in clinical oncology over the course of his distinguished career. Wing-Kai is based in Taipei, Taiwan and Hong Kong.

William ZuoWilliam Zuo, PhD  President of Polymed Therapeutics, William has over 21 years of experience in pharmaceutical business, and specializes in the manufacturing, sale and marketing of various complex "Active Pharmaceutical Ingredients." William received his PhD in Nanotechnology from Rice University.

Teresa Bair, ESQ  Senior VP of Corporate Development & Legal Affairs  Teresa is a seasoned commercial attorney who has extensive experience handling complex business matters in both the board room and court room. Prior to joining Athenex, she served as a partner at Harris Beach PLLC, a nationally recognized law firm. Teresa successfully represented business clients, including Fortune 500 companies, in matters involving mergers and acquisitions, intellectual property, international law, equity investments, corporate governance, and contract transactions. Teresa has been consistently recognized by peer journals as a "Super Lawyer" in Business Litigation and Intellectual Property. Teresa received her law degree (JD) from University at Buffalo School of Law, and a Bachelor of Science in Business Administration from Bowling Green State University.

Stephen Yeung, CA Chief Business Officer – Asia Pacific, Stephen is a seasoned financial professional with a proven track record of over 35 years of leadership experience in accounting, treasury, corporate finance, business and project development and management in direct and private equity investments, private family wealth and fund management. After launching his career in Canada with the largest multinational oil conglomerate in the country, Stephen relocated to the company's Asia Pacific regional head office in Hong Kong. Capitalizing on the significant economic growth in Greater China in the 1980's, Stephen moved into investment banking/corporate finance; direct, private equity, and private family fund investment development and management; all with large local corporations and local listed companies in Hong Kong, including a fortune 500 group. He holds a Bachelor of Arts in Mathematics and Accounting from St. John's University, Minn., USA, and a Master of Business Administration in Finance from The University of Toronto, Ont., Canada. He is also a Chartered Accountant registered with the Province of Ontario in Canada.

Benjamin Lee, PharmD, Hong Kong Research & Product Development LeaderBenjamin is the President of Comprehensive Drug Enterprises Ltd, an award winning, technology-driven company that provides innovative solutions for drug delivery system. Founded in 2005 and located in HK Science Park, it has products from the pre-clinical to the clinical stage of development. Benjamin was also an adjunct member of the Faculty of Medicine at the Chinese University in Hong Kong School of Pharmacy. He holds a Doctorate from the University of Kentucky College of Pharmacy. He trained under Drug Development and Clinical Research Fellowships at Glaxo Wellcome and the University of North Carolina, School of Pharmacy. Upon completion of his Fellowships, Benjamin joined Glaxo Wellcome as a Senior Research Scientist, rising to Lead Scientist and group manager in Clinical Development Center at GlaxoSmithKline. He has participated in the development of several of the GlaxoSmithKline respiratory drugs development, regulatory approval and marketing; and has also participated in product development and registration in neurology and pain management.

Tracey Burr, PhD, Chief Scientific Officer, Active Pharmaceutical IngredientsTracey has been engaged in leading product development, portfolio management and lifecycle management for nearly 20 years, including over 10 as a successful executive in the international pharmaceutical industry. Tracey is the CSO of our API manufacturing platform, with significant pharmaceutical product and regulatory experience in worldwide markets. She has been instrumental in successfully filing numerous ANDA/NDAs/Dossiers and has actively contributed to the development of over 20 products through the drug development process, from target identification, R&D, regulatory approval, product launch and post-commercialization support.   Under her leadership, pharmaceutical companies have seen dramatic increases in R&D scope, regulatory approvals, sales, and global production. She now brings her characteristic combination of discipline, vigor and vision to the development and commercialization of Athenex products. Prior to joining Athenex as CSO, Tracey worked for 15 years as a CSO for pharmaceutical companies in the USA, China, Switzerland and Germany.  Tracey received an MSc in Organic Chemistry from the California Institute of Technology (Caltech), and a PhD at the Massachusetts Institute of Technology (MIT) in Materials Science and Engineering.

Stephen A. Panaro, PhD QuaDPharma, PresidentStephen has over 12 years of experience in the pharmaceutical industry. His experience spans from drug discovery and API synthesis, to large-scale commercial production of finished products across many different dosage forms and packaging configurations. Throughout his carrier, Stephen has overseen personnel in nanotechnology, quality control (QC) chemistry, QC microbiology, customer service, project management and production, to name a few. Most recently, Stephen founded QuaDPharma based on his experience with clinical and commercial manufacturing. He wanted to create a company unlike the large-scale contract manufacturing organizations of today and focus on projects, and products, that require small to mid-scale manufacturing. The clients that sponsor these products require a unique blend of customer service and technical expertise. QuaDPharma provides just the right environment for development and commercialization of these innovative pharmaceutical products.

Board of Directors The Athenex Board of Directors is composed of carefully selected professionals who bring a wealth of governance and global corporate experience.     

Johnson Y.N. Lau, MBBS, MD, FRCP  Chief Executive Officer & Board Chairman  Johnson is a successful pharmaceutical executive who has had extensive leadership experience in both scientific and business management. As Chairman and CEO of Ribapharm, he launched the second largest biotech IPO in US history. During his tenure at Ribapharm, he met or exceeded Wall Street expectations each and every quarter. Prior to Ribapharm, he served as the Head of Worldwide Research and Development for ICN Pharmaceuticals. Prior, Johnson served as the Senior Director of Antiviral Therapy at Schering-Plough, where he played a key role in the FDA approval of Ribavirin/Interferon and Pegylated Interferon alpha-2b. Johnson has contributed more than 250 scientific publications in peer reviewed scientific journals, more than 50 editorials/reviews/chapters and has edited three books. He was a former Managing Director at Roth Capital Partners at its headquarters in Newport Beach, California and was also a Director of the Board of Chelsea Therapeutics (CHTP), serving as the Chair of the Audit and Finance Committee as well as the Corporate Governance Committee. He has served on the Board for a number of privately held companies. Johnson received his medical degree (MBBS) and medical doctorate degree (MD) from the University of Hong Kong. He is also a Fellow of the Royal College of Physicians. Johnson has served as the Chairman of the Board of Athenex since its inception and assumed the role of CEO in mid 2011. 

Jinn Wu, PhD  Chief Executive Officer, Xenobiotic Laboratories  Jinn is the Founder and President of Xenobiotics Laboratory (XBL) in Princeton, New Jersey, a contract research organization that provides an extensive array of clinical and preclinical research services to the biotechnology and pharmaceutical industry. Jinn earned a PhD in Natural Products and Medicinal Chemistry from Ohio State University and spent several years as a research scientist at FMC Corporation before starting XBL. He is an adjunct professor at the University of Medicine and Dentistry of New Jersey and is a member of the American Association of Pharmaceutical Scientists (AAPS), the International Society for the Study of Xenobiotics (ISSX), the American Society of Pharmacognosy (ASP) and the American Chemical Society (ACS). He serves on the Board of Directors of Enhance Biotech Inc. and has served on the Board of Ardent Pharmaceuticals. 

Flint D. Besecker, CPA  Chief Operating Officer & Board Director  Flint is a veteran in the healthcare industry with a proven track record building large-scale growth oriented platforms focused in the US. Flint has held a number of nationwide executive positions in the healthcare and financial industry, including founding Care Investment Trust (CRE-NYSE), a healthcare focused Real Estate Investment Trust and founding CIT Healthcare (CIT-NYSE) where he served as its President. Flint has served on numerous Boards including Board Chair of Care Investment Trust and subsequently its lead Independent Director after its sale. He has also served as Board Director and Chair of Compensation Committee of Allion Healthcare (ALLI- NASDAQ) and has served on numerous private boards. Prior to 2004, Flint held a variety of national executive leadership positions in the healthcare industry including GE Healthcare Financial Services (GE-NYSE), Heller Healthcare Finance (HF-NYSE) and Healthcare Financial Partners (HCF-NYSE). He received a BS in Accounting from Canisius College in 1988 and is a Certified Public Accountant. Flint resides in Western New York. 

kim-cKim Campbell, PC, CC, OBC, QC  Canada's 19th Prime Minister  The Right Honourable Kim Campbell served as Canada's nineteenth and first female Prime Minister in 1993. She previously held cabinet portfolios as Minister of Justice and Attorney General, Minister of State for Indian Affairs and Northern Development and Minister of National Defence and Minister of Veterans' Affairs. She was the first woman to hold the Justice and Defence portfolios, and the first woman to be Defence Minister of a NATO country. Kim participated in major international meetings including the Commonwealth, NATO, the G-7 Summit and the United Nations General Assembly.  After her tenure as Prime Minister, Kim was a fellow at the Institute of Politics (Spring 1994) and the Joan Shorenstein Center for the Study of Press and Politics (1994-1995) at the Harvard Kennedy School of Government. She served as the Canadian Consul General in Los Angeles (1996-2000), then returned to Harvard to teach at the Center for Public Leadership at the Kennedy School (2001- 2004).  Kim is a founding member of the Club of Madrid, an organization of former heads of government and state who work to promote democratic values. She served as Secretary General (2004- 2006). She also has served as its Acting President in 2002, its Vice President in 2003-2004 and served on its Board of Directors from 2007-2011.  Kim is a member and chair emerita of the Council of Women World Leaders (1999-2003). The Council's membership consists of women who hold or have held the office of President or Prime Minister. Kim is a member of the International Women's Forum, a global organization of women of significant and diverse achievement. She served as its president (2003-2005) and was inducted into the IWF Hall of Fame in 2008.  Today, Kim devotes the majority of her time to serving as the founding principal of the new Peter Lougheed Leadership College at the University of Alberta. She also chairs the steering committee for the World Movement for Democracy, and is a trustee of the International Center for the Study of Radicalisation and Political Violence (ICSR) at King's College London. She is a member of the Pacific Council on International Policy, (the West Coast affiliate of the Council on Foreign Relations) and the Global Council of the Asia Society of New York. She is on the advisory board of Equal Voice and an honorary patron of Informed Opinions. She is also a senior advisor to the Crisis Group and an honorary board member of the Climate Action Reserve and previously served as a trustee of the Salk Institute for Biological Studies 2007-2010. 

Song-Yi_Zhang-500x500Song-Yi Zhang, JD  Founder and Chairman, Mandra Capital Ltd.  Song-Yi is the founder of Mandra Capital, an investment holding company focused on early stage opportunities in internet, biomedicine, materials and technologies. Song-Yi has more than twenty years of investment banking and direct investment experience. In addition to his responsibilities at Mandra Capital, Song-Yi serves as a director of SINA Corporation, a company listed on the Nasdaq Stock Market, and an independent non-executive director of China Long Yuan Electric Power Group Corp., a company listed on Hong Kong Stock Exchange. Prior to founding Mandra Capital, Song-Yi served as a managing director of Asia Merger, Acquisition and Divestiture Group, and the co-head of Asia Resources and Infrastructure Group of Morgan Stanley, and a senior associate of Milbank, Tweed, Hadley & McCloy LLP. Song-Yi holds a Juris Doctor degree from Yale University. 

Specialist in General Surgery, Pedder Clinic  Manson is a very successful doctor, entrepreneur and philanthropist. Manson is the Founder of the Pedder Clinic, which is one of the largest private medical practices in Hong Kong. Manson is also the Dean of the Faculty of Health Sciences at the University of Macau (MUST), President of the Macau Healthcare Management and Promotion Association (MHMPA), Vice-Chairman of Chinese Endoscopic Doctors Association, and Vice Director of Specialist Committee for Quality Evaluation of Clinical Endoscopy Diagnosis and Treatment, Department of Medical Service Supervision, Ministry of Health of People's Republic of China, among many other leadership positions. Manson received the 2009 "ENDOS Medical Science and Technology Award – International Outstanding Leadership Award in Endoscopy" during the First World Conference and World Endoscopy Expo. Having received his medical degree (MBBS) from the University of Hong Kong in 1982, Manson was appointed faculty in the Surgical Unit of the University of Hong Kong. Manson has published many original research papers in high-ranking international medical journals and as chapters in various academic books which is focusing on minimally invasive treatment for esophageal surgery. Manson is actively assisting Athenex to develop an Asian Business Strategy.  Manson, has been awarded the 2014 Gusi Peace Prize in Humanitarianism for his remarkable contributions to medical education, healthcare delivery and cross-border biotechnology developments that act as a bridge both within Asia and across continents  

Board of Directors The Athenex Board of Directors is composed of carefully selected professionals who bring a wealth of governance and global corporate experience.     

Johnson Y.N. Lau, MBBS, MD, FRCP  Chief Executive Officer & Board Chairman  Johnson is a successful pharmaceutical executive who has had extensive leadership experience in both scientific and business management. As Chairman and CEO of Ribapharm, he launched the second largest biotech IPO in US history. During his tenure at Ribapharm, he met or exceeded Wall Street expectations each and every quarter. Prior to Ribapharm, he served as the Head of Worldwide Research and Development for ICN Pharmaceuticals. Prior, Johnson served as the Senior Director of Antiviral Therapy at Schering-Plough, where he played a key role in the FDA approval of Ribavirin/Interferon and Pegylated Interferon alpha-2b. Johnson has contributed more than 250 scientific publications in peer reviewed scientific journals, more than 50 editorials/reviews/chapters and has edited three books. He was a former Managing Director at Roth Capital Partners at its headquarters in Newport Beach, California and was also a Director of the Board of Chelsea Therapeutics (CHTP), serving as the Chair of the Audit and Finance Committee as well as the Corporate Governance Committee. He has served on the Board for a number of privately held companies. Johnson received his medical degree (MBBS) and medical doctorate degree (MD) from the University of Hong Kong. He is also a Fellow of the Royal College of Physicians. Johnson has served as the Chairman of the Board of Athenex since its inception and assumed the role of CEO in mid 2011. 

Jinn Wu, PhD  Chief Executive Officer, Xenobiotic Laboratories  Jinn is the Founder and President of Xenobiotics Laboratory (XBL) in Princeton, New Jersey, a contract research organization that provides an extensive array of clinical and preclinical research services to the biotechnology and pharmaceutical industry. Jinn earned a PhD in Natural Products and Medicinal Chemistry from Ohio State University and spent several years as a research scientist at FMC Corporation before starting XBL. He is an adjunct professor at the University of Medicine and Dentistry of New Jersey and is a member of the American Association of Pharmaceutical Scientists (AAPS), the International Society for the Study of Xenobiotics (ISSX), the American Society of Pharmacognosy (ASP) and the American Chemical Society (ACS). He serves on the Board of Directors of Enhance Biotech Inc. and has served on the Board of Ardent Pharmaceuticals. 

Flint D. Besecker, CPA  Chief Operating Officer & Board Director  Flint is a veteran in the healthcare industry with a proven track record building large-scale growth oriented platforms focused in the US. Flint has held a number of nationwide executive positions in the healthcare and financial industry, including founding Care Investment Trust (CRE-NYSE), a healthcare focused Real Estate Investment Trust and founding CIT Healthcare (CIT-NYSE) where he served as its President. Flint has served on numerous Boards including Board Chair of Care Investment Trust and subsequently its lead Independent Director after its sale. He has also served as Board Director and Chair of Compensation Committee of Allion Healthcare (ALLI- NASDAQ) and has served on numerous private boards. Prior to 2004, Flint held a variety of national executive leadership positions in the healthcare industry including GE Healthcare Financial Services (GE-NYSE), Heller Healthcare Finance (HF-NYSE) and Healthcare Financial Partners (HCF-NYSE). He received a BS in Accounting from Canisius College in 1988 and is a Certified Public Accountant. Flint resides in Western New York. 

kim-cKim Campbell, PC, CC, OBC, QC  Canada's 19th Prime Minister  The Right Honourable Kim Campbell served as Canada's nineteenth and first female Prime Minister in 1993. She previously held cabinet portfolios as Minister of Justice and Attorney General, Minister of State for Indian Affairs and Northern Development and Minister of National Defence and Minister of Veterans' Affairs. She was the first woman to hold the Justice and Defence portfolios, and the first woman to be Defence Minister of a NATO country. Kim participated in major international meetings including the Commonwealth, NATO, the G-7 Summit and the United Nations General Assembly.  After her tenure as Prime Minister, Kim was a fellow at the Institute of Politics (Spring 1994) and the Joan Shorenstein Center for the Study of Press and Politics (1994-1995) at the Harvard Kennedy School of Government. She served as the Canadian Consul General in Los Angeles (1996-2000), then returned to Harvard to teach at the Center for Public Leadership at the Kennedy School (2001- 2004).  Kim is a founding member of the Club of Madrid, an organization of former heads of government and state who work to promote democratic values. She served as Secretary General (2004- 2006). She also has served as its Acting President in 2002, its Vice President in 2003-2004 and served on its Board of Directors from 2007-2011.  Kim is a member and chair emerita of the Council of Women World Leaders (1999-2003). The Council's membership consists of women who hold or have held the office of President or Prime Minister. Kim is a member of the International Women's Forum, a global organization of women of significant and diverse achievement. She served as its president (2003-2005) and was inducted into the IWF Hall of Fame in 2008.  Today, Kim devotes the majority of her time to serving as the founding principal of the new Peter Lougheed Leadership College at the University of Alberta. She also chairs the steering committee for the World Movement for Democracy, and is a trustee of the International Center for the Study of Radicalisation and Political Violence (ICSR) at King's College London. She is a member of the Pacific Council on International Policy, (the West Coast affiliate of the Council on Foreign Relations) and the Global Council of the Asia Society of New York. She is on the advisory board of Equal Voice and an honorary patron of Informed Opinions. She is also a senior advisor to the Crisis Group and an honorary board member of the Climate Action Reserve and previously served as a trustee of the Salk Institute for Biological Studies 2007-2010. 

Song-Yi_Zhang-500x500Song-Yi Zhang, JD  Founder and Chairman, Mandra Capital Ltd.  Song-Yi is the founder of Mandra Capital, an investment holding company focused on early stage opportunities in internet, biomedicine, materials and technologies. Song-Yi has more than twenty years of investment banking and direct investment experience. In addition to his responsibilities at Mandra Capital, Song-Yi serves as a director of SINA Corporation, a company listed on the Nasdaq Stock Market, and an independent non-executive director of China Long Yuan Electric Power Group Corp., a company listed on Hong Kong Stock Exchange. Prior to founding Mandra Capital, Song-Yi served as a managing director of Asia Merger, Acquisition and Divestiture Group, and the co-head of Asia Resources and Infrastructure Group of Morgan Stanley, and a senior associate of Milbank, Tweed, Hadley & McCloy LLP. Song-Yi holds a Juris Doctor degree from Yale University. 

Specialist in General Surgery, Pedder Clinic  Manson is a very successful doctor, entrepreneur and philanthropist. Manson is the Founder of the Pedder Clinic, which is one of the largest private medical practices in Hong Kong. Manson is also the Dean of the Faculty of Health Sciences at the University of Macau (MUST), President of the Macau Healthcare Management and Promotion Association (MHMPA), Vice-Chairman of Chinese Endoscopic Doctors Association, and Vice Director of Specialist Committee for Quality Evaluation of Clinical Endoscopy Diagnosis and Treatment, Department of Medical Service Supervision, Ministry of Health of People's Republic of China, among many other leadership positions. Manson received the 2009 "ENDOS Medical Science and Technology Award – International Outstanding Leadership Award in Endoscopy" during the First World Conference and World Endoscopy Expo. Having received his medical degree (MBBS) from the University of Hong Kong in 1982, Manson was appointed faculty in the Surgical Unit of the University of Hong Kong. Manson has published many original research papers in high-ranking international medical journals and as chapters in various academic books which is focusing on minimally invasive treatment for esophageal surgery. Manson is actively assisting Athenex to develop an Asian Business Strategy.  Manson, has been awarded the 2014 Gusi Peace Prize in Humanitarianism for his remarkable contributions to medical education, healthcare delivery and cross-border biotechnology developments that act as a bridge both within Asia and across continents  

 

Athenex Board of Directors    

Johnson Y.N. Lau, MBBS, MD, FRCP  Chief Executive Officer & Board Chairman  Johnson is a successful pharmaceutical executive who has had extensive leadership experience in both scientific and business management. As Chairman and CEO of Ribapharm, he launched the second largest biotech IPO in US history. During his tenure at Ribapharm, he met or exceeded Wall Street expectations each and every quarter. Prior to Ribapharm, he served as the Head of Worldwide Research and Development for ICN Pharmaceuticals. Prior, Johnson served as the Senior Director of Antiviral Therapy at Schering-Plough, where he played a key role in the FDA approval of Ribavirin/Interferon and Pegylated Interferon alpha-2b. Johnson has contributed more than 250 scientific publications in peer reviewed scientific journals, more than 50 editorials/reviews/chapters and has edited three books. He was a former Managing Director at Roth Capital Partners at its headquarters in Newport Beach, California and was also a Director of the Board of Chelsea Therapeutics (CHTP), serving as the Chair of the Audit and Finance Committee as well as the Corporate Governance Committee. He has served on the Board for a number of privately held companies. Johnson received his medical degree (MBBS) and medical doctorate degree (MD) from the University of Hong Kong. He is also a Fellow of the Royal College of Physicians. Johnson has served as the Chairman of the Board of Athenex since its inception and assumed the role of CEO in mid 2011. 

Jinn Wu, PhD  Chief Executive Officer, Xenobiotic Laboratories  Jinn is the Founder and President of Xenobiotics Laboratory (XBL) in Princeton, New Jersey, a contract research organization that provides an extensive array of clinical and preclinical research services to the biotechnology and pharmaceutical industry. Jinn earned a PhD in Natural Products and Medicinal Chemistry from Ohio State University and spent several years as a research scientist at FMC Corporation before starting XBL. He is an adjunct professor at the University of Medicine and Dentistry of New Jersey and is a member of the American Association of Pharmaceutical Scientists (AAPS), the International Society for the Study of Xenobiotics (ISSX), the American Society of Pharmacognosy (ASP) and the American Chemical Society (ACS). He serves on the Board of Directors of Enhance Biotech Inc. and has served on the Board of Ardent Pharmaceuticals. 

Flint D. Besecker, CPA  Chief Operating Officer & Board Director  Flint is a veteran in the healthcare industry with a proven track record building large-scale growth oriented platforms focused in the US. Flint has held a number of nationwide executive positions in the healthcare and financial industry, including founding Care Investment Trust (CRE-NYSE), a healthcare focused Real Estate Investment Trust and founding CIT Healthcare (CIT-NYSE) where he served as its President. Flint has served on numerous Boards including Board Chair of Care Investment Trust and subsequently its lead Independent Director after its sale. He has also served as Board Director and Chair of Compensation Committee of Allion Healthcare (ALLI- NASDAQ) and has served on numerous private boards. Prior to 2004, Flint held a variety of national executive leadership positions in the healthcare industry including GE Healthcare Financial Services (GE-NYSE), Heller Healthcare Finance (HF-NYSE) and Healthcare Financial Partners (HCF-NYSE). He received a BS in Accounting from Canisius College in 1988 and is a Certified Public Accountant. Flint resides in Western New York. 

kim-cKim Campbell, PC, CC, OBC, QC  Canada's 19th Prime Minister  The Right Honourable Kim Campbell served as Canada's nineteenth and first female Prime Minister in 1993. She previously held cabinet portfolios as Minister of Justice and Attorney General, Minister of State for Indian Affairs and Northern Development and Minister of National Defence and Minister of Veterans' Affairs. She was the first woman to hold the Justice and Defence portfolios, and the first woman to be Defence Minister of a NATO country. Kim participated in major international meetings including the Commonwealth, NATO, the G-7 Summit and the United Nations General Assembly.  After her tenure as Prime Minister, Kim was a fellow at the Institute of Politics (Spring 1994) and the Joan Shorenstein Center for the Study of Press and Politics (1994-1995) at the Harvard Kennedy School of Government. She served as the Canadian Consul General in Los Angeles (1996-2000), then returned to Harvard to teach at the Center for Public Leadership at the Kennedy School (2001- 2004).  Kim is a founding member of the Club of Madrid, an organization of former heads of government and state who work to promote democratic values. She served as Secretary General (2004- 2006). She also has served as its Acting President in 2002, its Vice President in 2003-2004 and served on its Board of Directors from 2007-2011.  Kim is a member and chair emerita of the Council of Women World Leaders (1999-2003). The Council's membership consists of women who hold or have held the office of President or Prime Minister. Kim is a member of the International Women's Forum, a global organization of women of significant and diverse achievement. She served as its president (2003-2005) and was inducted into the IWF Hall of Fame in 2008.  Today, Kim devotes the majority of her time to serving as the founding principal of the new Peter Lougheed Leadership College at the University of Alberta. She also chairs the steering committee for the World Movement for Democracy, and is a trustee of the International Center for the Study of Radicalisation and Political Violence (ICSR) at King's College London. She is a member of the Pacific Council on International Policy, (the West Coast affiliate of the Council on Foreign Relations) and the Global Council of the Asia Society of New York. She is on the advisory board of Equal Voice and an honorary patron of Informed Opinions. She is also a senior advisor to the Crisis Group and an honorary board member of the Climate Action Reserve and previously served as a trustee of the Salk Institute for Biological Studies 2007-2010. 

Song-Yi_Zhang-500x500Song-Yi Zhang, JD  Founder and Chairman, Mandra Capital Ltd.  Song-Yi is the founder of Mandra Capital, an investment holding company focused on early stage opportunities in internet, biomedicine, materials and technologies. Song-Yi has more than twenty years of investment banking and direct investment experience. In addition to his responsibilities at Mandra Capital, Song-Yi serves as a director of SINA Corporation, a company listed on the Nasdaq Stock Market, and an independent non-executive director of China Long Yuan Electric Power Group Corp., a company listed on Hong Kong Stock Exchange. Prior to founding Mandra Capital, Song-Yi served as a managing director of Asia Merger, Acquisition and Divestiture Group, and the co-head of Asia Resources and Infrastructure Group of Morgan Stanley, and a senior associate of Milbank, Tweed, Hadley & McCloy LLP. Song-Yi holds a Juris Doctor degree from Yale University. 

Specialist in General Surgery, Pedder Clinic  Manson is a very successful doctor, entrepreneur and philanthropist. Manson is the Founder of the Pedder Clinic, which is one of the largest private medical practices in Hong Kong. Manson is also the Dean of the Faculty of Health Sciences at the University of Macau (MUST), President of the Macau Healthcare Management and Promotion Association (MHMPA), Vice-Chairman of Chinese Endoscopic Doctors Association, and Vice Director of Specialist Committee for Quality Evaluation of Clinical Endoscopy Diagnosis and Treatment, Department of Medical Service Supervision, Ministry of Health of People's Republic of China, among many other leadership positions. Manson received the 2009 "ENDOS Medical Science and Technology Award – International Outstanding Leadership Award in Endoscopy" during the First World Conference and World Endoscopy Expo. Having received his medical degree (MBBS) from the University of Hong Kong in 1982, Manson was appointed faculty in the Surgical Unit of the University of Hong Kong. Manson has published many original research papers in high-ranking international medical journals and as chapters in various academic books which is focusing on minimally invasive treatment for esophageal surgery. Manson is actively assisting Athenex to develop an Asian Business Strategy.  Manson, has been awarded the 2014 Gusi Peace Prize in Humanitarianism for his remarkable contributions to medical education, healthcare delivery and cross-border biotechnology developments that act as a bridge both within Asia and across continents  

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