An independent biologics CDMO headquartered in Lin-gang New Area, Shanghai Pilot Free Trade Zone — from cell line to commercial medicine, with integrity at our core.
Zencore Biologics Co., Ltd., headquartered in Lin-gang New Area, Shanghai Pilot Free Trade Zone, China, is an independent Contract Development and Manufacturing Organization (CDMO). Zencore is solely focused on providing CDMO services and does not engage in or invest in any business as a Marketing Authorization Holder (MAH) of pharmaceutical products.
Zencore supports biopharmaceutical companies across all stages of clinical development and commercial manufacturing. Leveraging deep industry experience and strong technical expertise, Zencore delivers comprehensive end-to-end CMC (Chemistry, Manufacturing, and Controls) services. These include developability assessments, stable cell line development, process and analytical development, method transfer and validation, drug substance manufacturing, drug product fill/finish/packaging, lot release testing, stability studies, regulatory submission support, as well as catalog and customized development and production of mammalian cell culture media.
Zencore operates three CDMO facilities with a total area of over 80,000 square meters. Pilot-scale production is supported by 4×200L and 3×500L single-use bioreactors. For commercial GMP manufacturing, Zencore offers advanced production suites equipped with 3×500L single-use, 3×2,000L single-use, and 3×5,000L stainless steel bioreactors. These capabilities are fully integrated with downstream purification, formulation, and fill/finish lines to meet global regulatory and quality standards.
The biopharmaceutical industry is entering an unprecedented golden age. As life sciences, modern technology and healthcare converge, diseases that once posed grave threats to human health are being brought under effective control, and patients' survival rates and quality of life keep improving — changes that will profoundly reshape new drug R&D and the entire pharmaceutical value chain. Zencore was born in this great era, and we are eager to serve and support this fast-growing industry.
Pioneering a meaningful enterprise requires more than visionary, like-minded leaders; it requires the struggle and dedication of a team that is both highly skilled and deeply experienced. Zencore is honored to have such a group of people who never stop striving for their dreams.
Since our founding in 2017, Zencore has been committed to building a world-leading biologics R&D and manufacturing enterprise — innovating relentlessly in technology, operating with high efficiency in management, and working shoulder to shoulder with our partners to earn a strong reputation across the industry. Going forward, guided by our creed of perfecting process science to benefit society, and built on industry-leading technology platforms, we will continue to provide pharmaceutical clients at home and abroad with advanced, high-quality drug development and commercial manufacturing services.
We firmly believe that putting people first unlocks potential; putting the enterprise first creates value; and putting the industry first saves lives. Zencore stands ready to advance hand in hand with biopharmaceutical companies and to share this golden age of biomedicine.
Zencore's professional team brings extensive experience in large-molecule drug R&D, analytics, manufacturing, quality, supply chain and regulatory affairs at home and abroad. Total headcount has doubled year over year since the company's founding and now exceeds 600. Our senior technical management team, many with overseas backgrounds, has worked in China for years, created multiple "China firsts", and cultivated a bench of technical backbone with 10+ years in biologics development and manufacturing.
27 years' experience in biopharmaceutical industries, specialized on fermentation, cell culture process, cell culture media development, and bioreactor design
Led the National Key Research projects of China and World Bank-sponsored projects (assigned to the Chinese Academy of Sciences)
Developed a high-titer fed-batch cell culture platform with antibody titers up to 15 g/L and won the President's Award at AstraZeneca
Developed a biosimilar cell culture platform for the first biosimilar marketed in China with Henlius
Developed a high-yield cell culture platform which resulted in the first innovative anti-PD-1 antibody marketed in China for TopAlliance
Founded and co-founded several biotech and biopharmaceutical start-ups
Founded Zencore Biologics in 2017
Worked at MIT, Harvard University, University of Pittsburgh, Xencor, AstraZeneca, and Henlius
B.S. of Bioengineering at Tsinghua University, M.S. of Bioengineering at Chinese Academy of Sciences, M.S. of Computer Science at Northeastern University
Nearly 30 years of dedicated experience in the biopharmaceutical industry.
Previously served in senior management positions at internationally renowned pharmaceutical companies such as BI, AZ, LONZA, and Innoforce. Holds multiple technical patents.
Led the process development and commercial manufacturing of multiple key biopharmaceutical products, demonstrating outstanding leadership in registration applications, project management, supply chain management, and market expansion.
Led the development of the first commercial continuous flow upstream and downstream integrated system, iSKID, and chaired key communications with the FDA regarding the regulatory pathways for novel reactors, multi-component PAT (Process Analytical Technology), and continuous downstream processing equipment.
Bachelor's and Master's degrees in Chemistry from Fudan University, Ph.D. in Chemistry from Nankai University, postdoctoral fellow at the Max Planck Institute and the University of California, Santa Cruz, published more than 20 articles in peer-reviewed journals, and has delivered multiple presentations at international biopharmaceutical conferences.
Over 30 years profound experience in the international pharmaceutical industry. Educational background and career journey span North America and Asia.
Held progressive leadership roles at Apotex, Pfizer, Abbvie, Omeros, Adello Bio. Advanced from a bench scientist, Associate Director, Sr. Director to VP roles. Chief Operating Officer (COO) at MabPlex and Frontier Biotech.
Extensive knowledge and experience in the full lifecycle management of antibodies, ADCs, peptides,and small molecules. Possesses end-to-end in-depth understanding in CMC strategies, global regulatory submissions, quality system establishment, CDMO technology transfer, and commercial operations.
B.Sc and M.Sc in Biology at Sun Yat-sen University, and Ph.D in Plant Biochemistry at the University of Western Ontario in Canada.Rewarded with the well-known NSERC/Industry Post-doctoral Fellowship and completed two years's post-doctoral research at Labatts Breweries R&D Institute.
With over 30 years of experience in R&D, production and quality management in the pharmaceutical industry, including 29 years of experience in biopharmaceuticals and 27 years in quality management
As a key member, I have participated in new product launch inspections and GMP certification inspections in China, EMA, and FDA. At the same time, I have GMP audit experience in Southeast Asia, South America, the Middle East, and the Commonwealth of Independent States.
One of the contributors to the Quality Management System volume of the 2023 Edition of the "GMP Guidelines for Pharmaceuticals" (2nd Edition)
He has successively held positions as the R&D team leader at the Sixth Pharmaceutical Factory in Northeast China, quality manager at Shenyang Sansheng, quality director at Changchun Jinsai, executive director of the Quality Assurance Department at wuxi Biologics, QA director at Wuxi Helian, vice president of quality at Kaituo Biologics, and quality director and vice president at Conagen.
Graduated from the Chemistry Department of Nanjing University
30+ years of experience in R&D and manufacturing for biopharmaceutical industry
Worked at Protein Sciences, Human Genome Sciences, Eli Lilly, Progenics, RemeGen, Henlius, and Zelgen
Led the development of over 50 monoclonal and polyclonal antibody drugs
Supported the launch of 11 products in China, Europe, and USA
Achieved technical breakthroughs in large-scale production of monoclonal antibodies and recombinant proteins using mammalian cells in terms of titer, scale, and quality.
Familiar with cGMP standards in Europe and the US, with extensive management experience in large-scale antibody and recombinant protein production; proficient in the entire process of cGMP production facility design, construction, validation, and operation, including expertise in designing large-scale cell culture facilities; led the design and construction of cGMP a variety of production facilities (with 200 liters to 20,000 liters in scale, single-use or stainless steel bio-reactors) .
Published over 50 papers and scientific reports
Selected into the National Talent Program, the Innovation of Shanghai Program, and the Entrepreneurship and Innovation of Jiangsu Program
Served as a member of the Global Expert Group on ICH Q13 Continuous Manufacturing Technical Guidelines, a contributor of technical guidelines for the China National Medical Products Administration (NMPA), a member of the Drug Development Committee of China Pharmaceutical Promotion Association
B.S.& M.S. of Chemical Engineering at China University of Petroleum, MBA of University of Phoenix, Ph.D. of Biotechnology at University of Calgary
18 years' experience in biological quality analysis and project management
Practical experiences in building an analytical laboratory and setting up biopharmaceutical quality analysis team, with the ability to establish a lean operation management process and document system for the analytical department and excellent biopharmaceutical quality analysis ability
Extensive experience in building a project management team and establishing a project management system, including project planning, milestone management, project risk analysis and control strategy, project delivery management, project quality management, etc.
Head of Project Management and Head of Analytical Sciences Department during the tenure at WuXi Biologics (Suzhou site)
B.S. of Science Degree at Jiamusi University, M.S. of Science Degree at Zhejiang Normal University, M.S. of Science Degree at Institute of Botany, the Chinese Academy of Sciences
17+ years' of experience in biopharmaceutical industry
Extensive working experience ranging from antigen and antibody preparation, drug screening to CMC related pharmaceutical research and IND filing, with project experience spanning monoclonal antibodies, bispecific antibodies, combination antibodies, and ADCs
Worked at Shanghai Cancer Research Institute, Shanghai Cellgene, The Central Research Institute of Shanghai Pharmaceuticals Holding Co., Ltd., and Hansoh Pharmaceuticals
Led or involved in the construction of laboratories, production workshops, teams, and document systems from scratch on multiple occasions
Served as project leaders for multiple projects and successfully pushed them from the exploratory phase to IND approval
Authored more than 20 patent applications
B.S. of Chemical Engineering and Technology at Shanghai Normal University, M.S. of Bioengineering at East China University of Science and Technology
15 years of IT experience, the main achievements including the building of agile product team, e-commerce, digital construction, as well as IT strategic planning and management
Gile development advocate and global architect for the Chinese team, serving as a leader of multiple teams during Dow Chemical
Head of IT Department, responsible for taking over and transferring the e-commerce development team of the US branch, ERP team and all IT solutions for the business counterparts of the domestic company during WuXi AppTec
Senior director of IT Department, build a new IT team for application and solution in one and a half years from scratch during WuXi Diagnostics
Director of IT Department, build a new IT department, and promoted major projects such as e-DOC system implementation, OA upgrade to E9, BI platform construction, GCP system construction and CTMS system selection within a short period of time during Genor Biopharma
Worked at Dow Chemical, WuXi AppTec, WuXi Diagnostics, and Genor Biopharma
B.S. of Information Management and Information System at Tongji University, M.S. of Management Information System at Tongji University
A selection of recent recognitions — from national high-tech certification to GMP licensing and industry supplier awards.
"Investigate things" echoes The Great Learning: "The extension of knowledge lies in the investigation of things; when things are investigated, knowledge becomes complete."
"Carry the weight of life" echoes the Book of Changes: "The superior man carries all things through abundant virtue."
"The good" and "the consummate" echo The Great Learning: "The way of great learning lies in manifesting luminous virtue, in caring for the people, and in resting upon the highest good."
Our core values are the concentrated expression of Zencore's spirit, character and work ethic.
"The mastery of process" is Zencore's meticulous craft across process, workflow, R&D and manufacturing. We listen to our customers' voices, move with the pulse of the era, honor the inheritance of classics — and achieve innovation through innovation.
"Good medicines everyone can afford" has grounded Zencore since day one: standing with the people, carrying a craftsman's heart — relentless refinement of process technology, strict control of product quality, rigorous management, and growing together with our partners.
May our original intent warm the hardest winter; may technology change lives; may the world be free of disease; may everyone be free of worry.
"Consummate quality" — the utmost rigor Zencore demands of process, workflow and product.
"Serving China" — the steadfast promise Zencore keeps to patients, customers and the country.
"Devoted craftsmanship" — Zencore's professional pursuit of resting at the highest good in research, technology and manufacturing.
"A healthy world" — the enduring vision Zencore holds for past, present and future.
Zencore pursues the highest quality and compliance standards in everything we deliver.
Honesty and integrity are the foundation of Zencore's culture and every business relationship.
Zencore maintains a zero-tolerance policy toward any violation of business ethics or compliance.
We rigorously protect client IP and trade secrets — neutrality and confidentiality by design.