祝贺艾美斐小分子MIF抑制剂IPG1094获US FDA临床试验批准

上海, 8月27日, 2021 –祝贺我们的合作伙伴南京艾美斐生物医药科技有限公司自主研发的小分子抑制剂IPG1094获得美国食品药品监督管理局(FDA)批准临床试验的许可申请(IND)。祝贺我们的合作伙伴南京艾美斐生物医药科技有限公司获得美国食品药品监督管理局(FDA)的批准,启动其小分子抑制剂IPG1094的临床试验。IPG1094为靶向MIF(巨噬细胞迁移抑制因子Macrophage Migration Inhibitory Factor)抑制剂,适应症为实体瘤、血液瘤、银屑病和多发性硬化症。

保诺-桑迪亚对艾美斐医药取得的成果表示热烈祝贺!也期待该药物能早日上市,造福更多患者!

保诺-桑迪亚有幸协助艾美斐医药完成了IPG1094研发API CMC中的毒理批, 工艺优化与放大, 工艺确认, non-GMP与GMP API生产等药品生产服务; 原料药,稳定性研究,分析方法开发与验证等药品分析服务; 晶型筛选;以及临床前IND申报支持。此次合作为IPG1094的研发提供了全面的临床前一站式服务,加速了艾美斐的新药研发进程。

艾美斐医药首席科学官(CSO)王建飞博士说道:“感谢公司各团队和保诺-桑迪亚等合作团队的密切配合,使我们在很短的时间中高效完成了美国FDA PIND会议和new IND的所有工作!真实的见证了大家在项目执行中的信任、努力,合作和坚持!感谢每一个在项目中辛勤付出的公司内外的同事们!也希望大家继续努力,加强合作,取得更大的成绩!”

“我们非常高兴看到艾美斐IPG1094获得美国Fda批准,这是全球患者的福音。我们非常有幸能参与到这项事业中来”,保诺-桑迪亚全球CMC解决方案总裁李建昌博士说到,“保诺-桑迪亚致力于为全球合作伙伴提供全面的综合服务和技术支持,以推进新型药物的研发。我们期待艾美斐将带来更多的优质创新药,也希望能与合作伙伴共同开发出更多造福世界患者的创新药”。

MIF是一种经典的促炎因子, 参与先天性和适应性免疫应答调节。大量研究显示, MIF 在多种肿瘤组织中表达显著增加, 促进肿瘤生长、转移、血管新生, 并诱导形成促肿瘤免疫微环境。鉴于MIF在肿瘤发生、发展过程中的重要促进作用, 靶向MIF被认为是治疗肿瘤的潜在策略。目前,全球尚无MIF靶点药物上市,在研的MIF项目均处于临床前阶段。IPG1094的临床前研究显示其具有极高的安全性,安全窗口大于40倍,罕见的无显著毒副作用。其在澳大利亚进行的临床I期试验显示了良好的耐受性和安全性。

艾美斐医药创始人兼首席执行官(CEO)范国煌博士表示:MIF小分子抑制剂作为全球最领先的新药研发项目,取得美国FDA临床批件是公司发展历程中的重要里程碑,也是对艾美斐医药研发创新能力的肯定和激励。我们非常期待美国临床试验的启动开展,这将为艾美斐医药在探索肿瘤免疫治疗提供丰富的临床经验。

关于艾美斐

艾美斐生物医药科技有限公司于2016年成立,是一家基于全球领先靶点的创新药研发公司。公司致力于恶性肿瘤、自身免疫性疾病、代谢性疾病和神经退行性疾病等重大疾病的小分子或大分子的新药开发及商业化。公司于2018年和2021年分别成立上海研发中心和澳大利亚全资子公司,并计划在2021年下半年成立美国全资子公司,从而实现全球化布局。公司核心管理团队由GSK高管组成,汇聚了一批来自GSK、辉瑞等知名药企的中层技术骨干,形成具有强大竞争力的新药研发团队。技术核心团队从全球领先靶点出发,并基于疾病细胞表型进行药物研发,目前已建立10多条全球创新的研发管线,其中2个产品即将完成IND申报迈入临床试验阶段。

关于保诺-桑迪亚

保诺-桑迪亚,安宏资本旗下投资企业之一。保诺-桑迪亚是一家领先的合同研究、工艺开发和生产公司(CRDMO公司),旨在为生物制药客户提供全面整合的药物发现、开发和生产服务,包括原料药和制剂。作为国内第三大CRDMO公司,保诺-桑迪亚在全球10大分支机构拥有超过2,200名团队成员,在中国和美国开展其主要业务。

保诺-桑迪亚在大小分子发现、开发和放大方面有深厚而丰富的专业知识,支持IND申报,拥有独特的专利技术平台(例如难溶化合物生物有效性增强平台)。公司在中国和美国均设有研发中心和生产基地。保诺-桑迪亚“一站式”运营模式,有效帮助生物制药客户加速研发进程和降低开发风险,从而创造更高的价值。

图片来源:ZHOU Dan-dan, YU Jiao-jiao, HUA Fang, HU Zhuo-wei. Macrophage migration inhibitory factor, a critical link between inflammation and cancer[J]. Acta Pharmaceutica Sinica, 2018, 53(11): 1761-1769. 

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 built 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 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 achievements 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 in 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 Tayebi
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 Dong
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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Teo Nee Chuan
Teo Nee Chuan

Chief Financial Officer

Teo Nee Chuan joined us in May 2021 as chief financial officer. Prior to joining us, he was chief financial officer of Huazhu Group from November 2015 to May 2021, and was the chief financial officer for Rnomac International Limited, from November 2011 to August 2015. Mr. Teo worked in DDB Greater China Group, was appointed as the chief financial officer in September 2009, and was additionally appointed as the director of operations in January 2011. He previously served in Focus Media Group and was appointed as the financial deputy director in June 2007. Prior to that, from September 1994 to May 2007, Mr. Teo worked at Ernst & Young and Ernst & Young Business Services Ltd. in various positions in Kuala Lumpur and Toronto, including as a senior manager in the Transaction Advisory Services. Mr. Teo has been an independent director of 111, Inc. (a company listed on the NASDAQ, ticker symbol: YI) since September 2018. Mr. Teo received his Bachelor of Science in Accounting and Financial Analysis degree from The University of Warwick in the United Kingdom in July 1994. He is a Chartered Certified Accountant in the United Kingdom, who has obtained his qualification in July 1998 from The Association of Chartered Certified Accountants, and is a Certified Public Accountant in the United States and Hong Kong, who has obtained his qualification from American Institute of Certified Public Accountants in May 2002 and Hong Kong Society of Accountants in October 2003, respectively.

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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 Payne
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 Broudy
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 Xu
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 Yen
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
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 2021, this site is designed to handle non-GMP manufacturing, advanced intermediates, GMP starting material(RSM) for IND enabling sttudies as well as clinical and commercial use. 

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

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

Our Shanghai-Changli site supports FTE cheimistry and advanced Discovery Chemistry processes.z

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
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
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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