BioDuro and Sundia Partner as an Industry Leading Contract Research, Development and Manufacturing Organization

San Diego and Shanghai, 25 September 2020BioDuro, a global life science research and development organization backed by Advent International (“Advent”), and Sundia, a leading contract research and manufacturing organization, today announced that they have partnered to create one of the largest CRDMOs (contract research, development and manufacturing organizations) with major operations in China and the US. The combined company will operate as BioDuro-Sundia, providing fully integrated drug discovery, development and manufacturing for both API (Active Pharmaceutical Ingredients) and drug products. Advent led a majority investment in Sundia, with Bridgewest Capital as co-investors. Financial terms were not disclosed.

BioDuro-Sundia has a combined talent pool of over 2,000 employees across 10 global sites, enabling operational scale and integrated capabilities that provide its biopharma customers a single end-to-end solution from early stage drug discovery to late stage manufacturing. With strong financials and committed investment, BioDuro-Sundia is already expanding operations to bolster its strategic locations, including two new sites in China — an R&D base in Wuxi City and a manufacturing center in Bengbu – as well as capacity to add more than 1,000 employees over the next two years.

Together, the new partnership’s teams, facilities and investments are well positioned to provide continuity of services to their combined clients ensuring more success, faster timelines, and higher confidence to achieving drug discovery and development milestones.

BioDuro-Sundia’s Board of Directors includes BioDuro’s existing Board with the addition of Cathy Yen, Chairman of Sundia. Mrs. Yen is an independent director, joining hands with industry veterans such as David Preston, Kewen Jin and Masood Tayebi.

Jim Li, CEO of Sundia, joins the senior management team of BioDuro-Sundia as President of China Global CMC (Chemistry, Manufacturing and Controls) Solutions, with responsibility towards critical growth in that market, including build-out of the company’s late stage GMP and non-GMP API scale-up capabilities. Mr. Li will report directly to Cyrus K. Mirsaidi, CEO of BioDuro-Sundia.

“BioDuro and Sundia share the same core values that include respect, teamwork and tenacity,” said Cyrus K. Mirsaidi, CEO of BioDuro-Sundia. “Together, we help our biopharma partners research and develop medicines that improve the lives of patients, as we keep our clients and their patients at the core of every project we undertake. This common cause makes the BioDuro-Sundia partnership a great fit — not only for our employees, who will benefit from an extended global reach and new career opportunities, but also for our partner clients whom we help every day to speed up their precious programs to the clinic and the patients in need.”

David Preston, Chairman of BioDuro-Sundia, commented, “China represents the world’s fastest growing biopharma sector. We are thrilled to be partnering with such a well-established provider in Sundia, which already has extensive discovery and CMC offerings in China. The combined company gives us the scale, leadership, capability and talent required to outpace growth in this rapidly accelerating market. It is an example of truly being stronger together.”

Cathy Yen, Director of BioDuro-Sundia, said, “We are greatly looking forward to this new venture with BioDuro combining our discovery, R&D and CMC expertise to provide customers with a highly competitive and innovative end-to-end CRDMO solution.  As a service provider, this kind of productivity creates a ripple effect to the benefit of the whole biopharma sector. It enables us to accelerate timelines for hundreds of companies and to help bring medicines to patients faster for countless programs.

Andrew Li, Managing Director and Head of Greater China of Advent, remarked, “BioDuro and Sundia both have strong track records in providing quality CRDMO services to the world’s leading pharmaceutical and biotech customers, and we believe this new partnership will achieve higher value outcomes for all stakeholders.

“This deal plays to Advent’s strong track record in the healthcare sector, our Asian regional investing and our ongoing support of Chinese pharmaceutical and healthcare businesses. We look forward to helping BioDuro-Sundia grow further and to working closely with its experienced management teams to expand the firm’s Chinese and global footprint.”

Advent has significant investment experience in the healthcare industry. Over the past 30 years, the firm has invested US$8.6 billion in 47 companies in the sector across 16 countries worldwide. In addition to BioDuro, recent pharmaceutical and CRO investments include Bharat Serums and Vaccines, ICE Group, Zentiva, Somar and Syneos Health, Inc. (NASDAQ: SYNH).

CEC Capital Group is serving as the exclusive financial advisor to Sundia.

 

About Sundia

Founded in 2004, Sundia is a well-established pre-clinical contract research and manufacturing organization (“CRMO”), which has built an integrated drug discovery and development platform from synthetic and medicinal chemistry, DMPK and in vitro/in vivo biology, process chemistry, formulation to analytical as well as API/starting material manufacturing of small molecules. The company has long-term collaboration with several top 10 global pharmaceutical companies and has served over 250 clients worldwide. It has a strong reputation in China for possessing an experienced technical and regulatory team who advise clients on IND submissions. Headquartered in Shanghai, Sundia currently has four R&D facilities in Shanghai, one in Shijiazhuang and one in Taiwan.
For more information, visit:

www.sundia.com

 

About BioDuro

BioDuro, an Advent International portfolio company, is a leading global life sciences research and development organization that provides biopharmaceutical clients and partners with comprehensive, fully integrated drug discovery and development services, from lead development and IND-enabling studies to GMP manufacture of drug product for clinical trials. Core expertise includes small and large molecule discovery, development and scale up, combined with unique technology platforms such as bioavailability enhancement of insoluble compounds. The company has 4 global sites: headquarters in San Diego, California and 3 major operations in Beijing, Shanghai and Jiangsu, China. BioDuro’s integrated China and US teams afford partners with the benefits of a truly global and seamless operation, significantly accelerating discovery and de-risking development to create higher value outcomes.

For more information, visit:

www.bioduro.com

www.linkedin.com/company/bioduro

 

About Advent International

Founded in 1984, Advent International is one of the largest and most experienced global private equity investors. The firm has invested in over 350 private equity transactions in 41 countries, and as of June 30, 2020, had $58.4 billion in assets under management. With 15 offices in 12 countries, Advent has established a globally integrated team of over 200 investment professionals across North America, Europe, Latin America and Asia. The firm focuses on investments in five core sectors, including business and financial services; health care; industrial; retail, consumer and leisure; and technology. After 35 years dedicated to international investing, Advent remains committed to partnering with management teams to deliver sustained revenue and earnings growth for its portfolio companies.

For more information, visit:

www.adventinternational.com

 

About Bridgewest Capital

Founded in 1999, The Bridgewest Group is a closely held investment company that seeks to create long term value through application of superior industry knowledge, operational expertise and significant financial resources to attractive investment opportunities. The Group structures its global investments across four functional areas including private equity, real estate, capital markets and financial services. The Group’s private equity investments are primarily in biotech, wireless communications, infrastructure for IoT, and semiconductor. Bridgewest is based in San Diego, CA and has investments across the USA, Europe, Asia and Australasia.

For more information, visit:

www.bridgewestgroup.com

 

MEDIA CONTACTS

For BioDuro-Sundia
media@bioduro-sundia.com

For Advent International

Asia:
FTI Consulting
Maggie Geng (Beijing) / Anna Bartram (Hong Kong)
Tel: | +8610 5634 1797 / +852 6790 1093
adventasia@fticonsulting.com

US:
Finsbury
Anna Epstein or Sophia Templin
Tel: | 646-805-2000
AdventInternational-US@finsbury.com

David Preston
David Preston

Chairman

David Preston has had 38 years of healthcare experience with publicly – Traded and Private companies in the fields of Pharmaceutical’s, Animal Health and Biotechnology as a Board Member. The last 30 years of his experience has been in China, Taiwan and Hong Kong building successful high growth businesses. David Has been Chairman and CEO for Greater China for Sanofi and Boehringer – Ingelheim as well as the Janssen Corporation since 1991 in China. During this time he build high Growth businesses in China through diversified strategies in Innovative Pharmaceuticals, branded Generics, Biotechnology, and Animal Healthcare.


Key highlights in this period included building of the first Western Multinational Biotechnology C.M.O. facility as well as obtaining the first Test C.M.O.[ MAH] license. Establishment of a number of High tech Vaccine Plants, and R and D facilities in in the field of Animal Health. Signing and development of numerous JV’s as well as Wholly owned  Subsidiaries, Mergers and Acquisitions across Pharmaceutical’s, Animal Health, and Biotechnology industries.

 

David’s achievement’s in the Healthcare industry and it Growth and development in China is widely recognized By the Chinese Government and the City of Shanghai. In 2013 he was awarded the Silver Magnolia followed in 2015 the Gold Magnolia award. This was then followed by being awarded in 2017 the Honorary Citizen of Shanghai by 40th People’s Municipal Congress of Shanghai. David Holds a Business Science Degree .

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Filippo
Filippo de Vecchi

Director, Advent Partner

Filippo de Vecchi joined Advent in February 2000. He started in the Advent São Paulo office, then moved to Milan in 2002, in 2012 set up the Advent office in Shanghai and in 2016 set up the Hong Kong office. Before joining Advent, he was a senior consultant with Value Partners, in São Paulo and Milan, focusing on strategy and organization in the automotive, energy, cable and media sectors. He began his career at Wasserstein Perella & Co., working as an analyst in the Mergers and Acquisitions department in London and New York. Filippo holds an undergraduate degree cum laude in Economics, with a major in Business Administration, from the LUISS University and an MBA from Columbia Business School, where he currently serves as a member of the Board of Overseers.

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Andrew Li
Andrew Li

Director, Advent Partner

Andrew Li joined Advent in 2012. He previously worked at Warburg Pincus, HSBC PE, Solera Capital and Credit Suisse where he focused on the retail and consumer, healthcare, industrial, and energy sectors. Andrew has worked in finance and private equity throughout the U.S. and China since 1999. Andrew holds a BA from Middlebury College and an MBA from Harvard Business School.

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Michael Miltenberger
Michael Miltenberger

Director, Advent Partner

Michael Miltenberger joined Advent in 2011 as an associate on the healthcare team. Following business school, he rejoined Advent’s Boston office, focusing on healthcare investments. Prior to Advent, Michael was a consultant at McKinsey & Company in their Washington DC office, serving a range of healthcare and private equity clients. Michael earned a BA, cum laude, from Harvard College and an MBA from Harvard Business School, graduating with High Distinction as a Baker Scholar and a Harvey Fellow.

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Masood
Masood Tayebi, PhD

Director, Operating Partner

Dr. Masood Tayebi is the Founder of BioDuro. He currently serves as CEO of a nationwide real estate portfolio and is a Partner and Chief Executive Officer of the Bridgewest Group. Prior to BioDuro, Dr. Tayebi was Co-Founder and Chairman of Wireless Facilities, Inc. (NASDAQ: WFI), a global leader in telecommunications outsourcing.

Achievements
  • Co-Founder of Wireless Facilities, Inc.
  • Co-Founder of BioAtla, LLC
  • Recipient of the Ernst and Young 2000 Entrepreneur of the Year award in San Diego

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Kewen Jin
Kewen Jin, PhD

Director, Operating Partner

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Amit patel
Amit Patel

Director, Operating Partner

Amit Patel has twenty years of healthcare industry experience with publicly-traded, private equity-backed, and start-up companies in the capacity of executive, board member, advisor, and investor.  He is currently Executive Chairman of Azurity Pharmaceuticals (a NovaQuest Capital Management portfolio company) and a board member at BioDuro (Advent International portfolio company), Tergus Pharma (Great Point Partners portfolio company) and Calyptus Pharma.  Recently, Amit was SVP & President of Dosage Form Solutions at Capsugel, a KKR portfolio company (purchased from Pfizer in 2011 and sold to Lonza in 2017).


Prior to Capsugel, he worked at Dr. Reddy’s Laboratories, Inc. as EVP & Head of North America, and SVP & Head of Global Corporate Development & Strategic Planning. Earlier, Amit was VP of Corporate Development at CTIS, Inc., and Co-founder & CEO of MedOnTime, Inc. (acquired by CTIS).  He started his career as a strategy consultant with Marakon Associates. Amit holds an M.B.A. degree from Harvard Business School, a B.S. degree in Economics from the Wharton School of Business, University of Pennsylvania, and a B.A.S. degree in Systems Engineering from the Moore School of Engineering, University of Pennsylvania

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Haijun photo - 2.4.21 black and white
Haijun Dong

Chief Executive Officer

Dr. Haijun Dong currently serves as global CEO of BioDuro-Sundia. He previously was CEO for over 5 years at PharmaBlock Sciences Inc., a public company listed in the Shenzhen Stock Exchange (300725.SZ). The positions he held prior to PharmaBlock includes, among others, Senior Scientist at Boehringer Ingelheim Pharmaceuticals in Ridgefield, Connecticut; Senior Principal Scientist at Roche in Nutley, New Jersey; Head of DMPK and Drug Safety at Roche China R&D Company in Shanghai; Chief Operating Officer of Eli Lilly China R&D Center in Shanghai.

Dr. Dong received his PhD in organic chemistry from the University of Washington in Seattle, Washington, and MBA from China Europe International Business School in Shanghai. 

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Jeffery
Jeffery Blazevich

Chief Financial Officer

Jeff brings over 30 years of professional experience working for publicly traded, venture-backed, and private equity companies in the technology, health care and medical device industries. Prior to joining BioDuro, Jeff was the CFO for Zest Dental Solutions, a private-equity-owned manufacturer of a diverse portfolio of dental products.  From 2008 to 2013, he served as Senior Vice President and Corporate Controller for DJO Global, formerly a Blackstone-owned manufacturer of orthopedic products.

Jeff is a Certified Public Accountant and started his career at Ernst & Young LLP after receiving his bachelor’s degree in Accounting from the University of San Diego.

Achievements

 

  • Jeff held CFO positions at Vativ Technologies Inc. Staccato Communications, and Applied Micro Circuits Corporation, a publicly listed semiconductor company.

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TJ
TJ Deng, PhD

President, Discovery

Dr TJ Deng joined BioDuro in the initial stages of the company and helped BioDuro grow to an industry leading discovery services organization. He established and managed several scientific departments, including DMPK, before transitioning to a leader of the business and operations functions. Prior to joining BioDuro, Dr. Deng spent six years at PPD, in positions with increasing responsibilities from scientist to scientific manager.

Achievements

 

 

  • Developed the extractable/leachable capabilities at PPD
  • 18 years industry experience

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Kent
Kent M. Payne, PhD

President, Global CMC Solutions

Kent is distinguished as a business operator and leader in areas of sales, commercial manufacturing and product development. He has extensive executive experience in M&A as well as successfully running, start up, growth and turn around businesses. This includes both Fortune 500 and Private Equity environments. He combines strong business leadership, successful P&L track record, and technical background to strategically lead and grow enterprise value across Biotechnology and Pharmaceutical market segments. He has successfully led the geographic expansion of businesses into Europe, Asia, South America in addition to the United States.

He also currently serves as a board member for Goodwin Biotechnologies (a biological contract manufacturer), and board advisor for Vitruvias Therapeutics (a specialty generic pharmaceutical business)

Achievements

  • CEO Socorro Pharmaceuticals, a generic pharmaceutical company
  • President Americas, Qualicaps Inc.
  • Principal Consultant and Partner at CoreFactor LLC, providing executive strategic, licensing and operational advisory services to clients.
  • Vice President/General Manager Catalent Pharma Solutions, Inc. (a Blackstone Group company formed in 2007, formerly part of Cardinal Health)
  • Progressive leadership responsibility at: Novartis, Monsanto and G.D. Searle.
    Prior Board Positions:
  • Board Advisor, Corporate Strategy Office, Life Science Institute Inc. (a wholly-owned subsidiary of Mitsubishi Chemical Holdings.
  • Board member for Technophar, Inc.; Qualicaps, Inc.
  • Non-executive Chair and Board Member PDS Biotechnology (PDS

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Tommy
Tommy Broudy, PhD

Executive Vice President, Marketing

Tommy Broudy joined BioDuro as Executive Vice President, Translational Sciences in 2018 following the acquisition of Molecular Response, a patient-derived tumor modeling company he cofounded in 2010. Tommy is now leading BioDuro’s translational oncology group, with focus on in vivo and in vitro oncology testing services that help more efficiently translate novel anti-cancer medicines into the clinic. Tommy previously served as General Manager of Crown Bioscience San Diego, where he led the US preclinical operation. Prior to that, Tommy served as Director at AltheaDx, working closely with the Business Development and R&D teams to establish gene expression-based companion diagnostics for oncology therapeutics. He also spent six years at Affymetrix, where he managed the company’s pharmacogenomic and toxicogenomic solutions in support of pharmaceutical R&D.

Achievements

 

  • Earned his PhD at Rockefeller University in the Laboratory of Bacterial Pathogenesis and Immunology
  • Held postdoctoral appointments at Rockefeller and Stanford University studying host/microbial genomics

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Roy
Roy Xu

Chief Strategy Officer

Roy has over 25 years of healthcare industry experience.  He started his career as an orthopedic surgeon.  Roy joined Eli Lilly as a sales rep in 1997.  Since then he has had various roles in market research, business intelligence, BU head, strategy, regional general management, business development etc., both at Eli Lilly and Boehringer Ingelheim (BI).  Roy also spent more than two years in Germany where he was BI’s Director of Corporate Business and Enabling Strategy.

Roy obtained a bachelor’s degree in Clinical Medicine at Zhejiang Traditional Chinese Medicine University, and an MBA from Zhejiang University.

Achievements

 

  • 25 years of healthcare industry experience including Eli Lily and Boehringer Ingelheim. 
  • Former Director of Corporate Business & Enabling Strategy at oehringer Ingelheim in Germany.

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San Diego/圣地亚哥

BioDuro- San Diego Facility

Our San Diego site is our corporate headquarters. The facility is home to BioDuro’s drug product development technologies and has 9 GMP clean rooms. Development and manufacturing operations are conducted for projects up to Phase III clinical trials.

Size: 44,000 sq. ft.
Featured capabilites: Tableting, Coating, Hot Melt Extrusion, Spray Dried Dispersion

11011 Torreyana Rd.
San Diego
CA 92121
United States

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Beijing/北京

BioDuro Beijing
Operating since 2006, our Beijing site is home to BioDuro’s first wet chemistry operations. With 300 regular fume hoods and 18 scale-up chemistry hoods the Beijing facility houses most of BioDuro’s chemistry operations, while also hosting labs for biology and monoclonal antibody discovery.

Size: 100,000 sq. ft. 
Featured capabilities: Radioactivity Lab, Monoclonal Antibody Discovery, Medicinal Chemistry

No. 29 Life Science Park Road
Changping District Beijing,
102206
P.R. China

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Shanghai-Waigaoqiao/上海-外高桥

BioDuro- Shanghai Facility

Established in 2012, BioDuro’s Shanghai facility has been growing with its departments. The cutting edge facility contains labs for ADME, bioanalysis, in vitro assays and translational research. The site includes a 18,000 sq. ft vivarium and 20,000 sq. ft of office space.

Size: 92,000 sq. ft.
Featured capabilities: Scale-up Chemistry, Discovery Biology, DMPK, In Vivo Pharmacology

No. 233 North Fu Te Road
Waigaoqiao Free Trade Zone
Shanghai, 200131
P.R. China

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Cathy
Cathy Yen

Director, Operating Partner

Cathy joined the Board of Directors of BioDuro-Sundia in 2020, with the Advent-led acquisition of Sundia and creation of BioDuro-Sundia. Prior to that, she was Chairman of the Board at Sundia Meditech Group, where she was the key architect of Sundia’s strategic vision and growth. Under her leadership, Sundia solidified its position as one of the leading pre-clinical CROs in China.

Prior to Sundia, Cathy had a distinguished career as a seasoned venture capitalist, having led numerous investments in high-growth companies in Asia. Cathy served as a Partner of AsiaVest Partners, TCW/YFY Ltd., a global venture capital firm, for over a decade, Vice President at Global Financial Services, Vice President at Crimson Ventures/Chinatrust Bank and Senior Manager at Fortune Capital. She brings over 20 years of experience in corporate finance, accounting, strategic planning and private equity investments.

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Wuxi/无锡

Wuxi - BioDuro

Established in 2019, BioDuro-Sundia’s fully integrated discovery facility located at the heart of Jiangsu Wuxi Life Science & Technology Industrial Park with plans of growing staff to 1000+ scientists

Size: 300,000 sq. ft.
Featured capabilities:
Discovery Chemistry & Biologics, Biology, DMPK, Pharmacology, CMC Services

no.1699,Huishan avenue

Huishan Economic 

Development Zone,Wuxi

P.R. China

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Hebei/河北

Hebei - Sundia
Established in 2011, this pilot plant this handles mg to kg scale up

Size: 45,208 sq. ft.

Featured capabilities: SFFS Chemistry: mg to kg scale up
(150 hood)

238 Changjiang Road

Shijiazhuang,

Hebei province
P.R. China

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Taiwan/台湾

Taiwan - Sundia (1)
Our site in Taiwan supports Discovery Biology and Chemistry

Size: 3,352sq.ft.
Featured capabilities: Chemistry;Biology

7F, No. 107, Sec. 4

Ren Ai Road,

Da-an District,

Taipei, Taiwan

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Bengbu/蚌埠

Bengbu - Sundia
Scheduled to open in fall of 2020, this site is designed to handle API manufacturing and additional expertise in intermediates, GMP starting material upto IND enabling sttudies

Size: 43,056 sq. ft.
Featured capabilities: Intermediates, GMP starting materials, API manufacturing

Mohekou Industrial Park,

Huaishang District, Bengbu, 

Anhui province
P.R. China

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Shanghai-Changli/上海-长利园区

Shanghai-changli - Sundia-min (1)
Our Shanghai-Changli site supports FTE cheimistry and advanced Discovery Chemistry processes.

Size: 71,844 sq. ft.
Featured capabilities: Chiral Analytical Lab, Analytical and Purification Lab, NMR Lab, Synthetic Lab, Parallel Synthesis Lab, Flash Chromatography Lab..(380 hoods)

法拉第路251号8号楼;

Building 8, 251 Faladi Road,

Zhangjiang Hi-Tech Park,

Shanghai,China
P.R. China

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Shanghai-Halei/上海哈雷园区

Shanghai-halei - Sundia
Opened recently in 2018, BioDuro-Sundia’s Shanghai-Halei contains facilities that supports both Discovery and CMC parts of the drug development & manufacturing process. Facilities include amorphous dispersion techniques like SDD & Discovery Biology.

Size: 31,043 sq. ft.

Featured capabilities: Formulation : Preformulation, Wet Granulation, Compression, Tablet Coating, Fluid Bed Room, Spray Dryer, Hot Melt Extrusion, Dry Granulation Biology: Kinase selectivity, Cellular Assay, Compound Screen, Immune oncology service

哈雷路917弄1号;

Building 1, 917 Halei Road,

Zhangjiang Hi-Tech Park,

Shanghai,China

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Shanghai-Kelun/上海-克伦

Shanghai-kelun - Sundia-min (1)
Established in 2008, our Shangahi-Kelun site is desgined to handle advanced process and analytical chemistry including process GMP and non-GMP kilo lab

Size: 98,503 sq. ft.

Featured capabilities: general chemistry; Process: GMP & non-GMP kilo lab, Process analytical, Column Purification , Flow Chemistry. Analytical: 22 HPLC/UPLC. 8 Stability Chambers . DMPK: animal PK, Bioanlysis Metabolite ID, In Vitro Studies, In- Life studies

Building 8, 388 Jialilue Road,
Zhangjiang Hi-Tech Park,

Shanghai China, 201203

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Jim-Li
Jim Li PhD

President, Global CMC Solutions (China)

Dr. Li has led a distinguished career in the pharmaceutical industry, having spent over 18 years at various companies including Henkel, Wyeth, Pfizer and Wuxi Apptec in the area of process research and medicinal chemistry. During his career, he was involved in numerous drug discovery programs such as COPD, asthma, Rheumatoid/osteoarthritis, and diabetes. Dr. Li has co-authored more than 60 research articles and patents.

Dr. Li received his Ph.D in Organic Chemistry from University of Central Lancashire UK followed by a Postdoctoral fellow at the University of Chicago with Dr. Philip Eaton.

Achievements

  • Earned his PhD at University of Central Lancashire UK 
  • Held postdoctoral appointments at University of Chicago with Dr Philip Eaton
  • Dr. Jim Li was chief executive officer of Sundia. In this role, Dr. Li was responsible for the oversight of all business divisions across the organization as well as formulating and driving key strategies for diversifying and growing the company. Dr. Li also leads the company’s executive committee, helping to drive Sundia’s overall global strategy.

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