CGT Industry Upgrade Series – Suzhou BioBAY Stop: Driving Innovation from IND to BLA

Ye Zhisheng

VectorBuilder, Deputy General Manager of Technology

Dr. Ye Zhisheng, who holds a Ph.D. in Developmental Biology from Fudan University, currently serves as the Deputy General Manager of Technology at VectorBuilder, where he oversees the company’s technical strategy and overall R&D management. Since joining VectorBuilder in 2018, Dr. Ye has led the establishment of the company’s suspension cell production platform, GMP purification processes, and quality control systems. He also spearheaded the development of an efficacy evaluation platform, providing pharmaceutical and pharmacological research support for the screening, R&D, and process development of gene therapy drugs. These efforts have significantly enhanced the quality of VectorBuilder’s GMP manufacturing platform for gene therapy drugs, achieving single-cell productivity levels 2–5 times higher than international standards.Dr. Ye possesses extensive theoretical knowledge and practical experience in the R&D and production of therapeutic viral vectors. He is currently dedicated to the screening and optimization of gene therapy drugs, as well as the continuous improvement of related manufacturing processes. Under his leadership, VectorBuilder has expanded its CDMO business in the international market by establishing preclinical and Phase I clinical collaborations with leading pharmaceutical companies and research institutions in China, South Korea, Japan, and the United States. This alignment with global standards enables the company to meet regulatory submission requirements for gene therapies across various countries. Furthermore, the VectorBuilder Gene Delivery R&D and Production Base, established under Dr. Ye’s direction, serves as a platform for developing and optimizing gene delivery solutions and scaled-up manufacturing processes for preclinical and clinical studies. This platform aims to address core technical challenges in gene delivery, including efficiency, cargo capacity, targeting, and safety, thereby empowering gene therapy research.

Liang Zhuo

iCell Bioscience CTO

Liang Zhuo specializes in the CMC development and management of various innovative biological drugs, covering vaccines, large molecules, nucleic acid therapeutics, and cell and gene therapies. With nearly 10 years of experience in the cell and gene therapy industry, he has participated in and led the CMC development, technology transfer, and production management for multiple cell and gene therapy products. He has secured five IND approvals, including two Class I new drug approvals, with one product currently in Phase III clinical trials.

Guo Ying

Chairman, Xiatong Biotechnology

Guo Ying, Ph.D. from the University of Barcelona; Postdoctoral Fellow at the University of California, Davis School of Medicine and Shriners Hospitals for Children; Recognized as a Leading Entrepreneur in Gusu District and a Leading Talent in Suzhou Industrial Park. With 12 years of experience in stem cell therapy research for neurological disorders, she has led her team to establish an iPSC/iNSC differentiation platform and advance the clinical translation of cell-based therapies. She has published 17 high-impact SCI papers, served as principal investigator or key participant in 15 national and provincial/ministerial-level stem cell research projects, and holds 8 granted or published invention patents.

Gao Peng

Abogen Biosciences Vice President

Dr. Gao Peng graduated from the Department of Biology at Nankai University and later earned his Ph.D. in Molecular Biology from the University of Texas at Austin. He has published more than 30 papers in fields such as vaccine development, antibody engineering, and enzyme engineering, and has been granted four patents. With over twenty years of experience in macromolecular drug development, protein engineering, and tumor immunology, Dr. Gao has previously served as Senior Scientist and R&D Director, accumulating extensive expertise in drug development, team management, and project operations. Dr. Gao joined Suzhou Abogen Biosciences Co., Ltd. in 2019 and currently serves as Vice President, where he is responsible for establishing the mRNA platform and driving innovation in nucleic acid science research and development. He led the nucleic acid science component of China’s first mRNA vaccine project to enter clinical trials.

Tan Chang

Vice President, Xingming Youjian

Tan Chang holds a Ph.D. in Biochemistry and Molecular Biology from the Department of Biochemistry, School of Life Sciences, Fudan University. His research focuses on RNAi technology and major human diseases, including cancer, hepatitis B virus, and influenza virus. After graduation, he worked at several companies, such as Tellgen Corporation and GeneChem. He has extensive experience in the R&D of IVD reagents for tumor genetic testing and molecular detection of pathogenic microorganisms, the discovery of novel therapeutic targets for cancer treatment, the development and application of viral vectors, and quality and process studies of viral vectors. He served as a sub-project leader or key R&D personnel for major national projects, including the National 863 Program, the National Key Technologies R&D Program, Shanghai’s Biopharmaceutical Industrialization Project, and Shanghai’s Key Technology Research Project for Industrialization. He holds twenty authorized invention patents. He led the establishment of GeneChem Group’s Cell and Gene Therapy CDMO platform and served as its head. In 2022, he joined Xingming Youjian, where he is responsible for vector development, production, and quality control.

Li Junhui

Hangzhou Xingcheng Biotechnology Co., Ltd. Vice President of Science, Technology and Production

Li Junhui holds a Ph.D. in Biochemical Engineering from East China University of Science and Technology and an MBA from Antai College of Economics and Management, Shanghai Jiao Tong University. He has nearly 20 years of experience in the R&D and industrialization of biopharmaceuticals. He previously served as Production Director at Shanghai ICT Co., Ltd., and as Manager and Director at Shanghai RAAS Blood Products Co., Ltd., where he was responsible for R&D, regulatory affairs, and quality management. He is proficient in plasmid and lentiviral vector preparation, CAR-T cell manufacturing processes, and quality control. He has extensive expertise in process development for mammalian cell platforms, upstream process development for viral vector production, and GMP manufacturing. Multiple projects under his leadership have received Investigational New Drug (IND) approval. He possesses rich experience in team management.

Yuan Jun

Head of BioService at LePure Biotechnology and CTO of Kangsheng Biotechnology

Dr. Yuan Jun serves as Vice President of Zhongshan Kangtian Shenghe Biotechnology Co., Ltd. He graduated from École Centrale de Lyon and has 14 years of experience in the biopharmaceutical industry. He has participated in and led the design and development of innovative protein therapeutics, overseeing more than 10 pilot-scale R&D projects, successfully filing 7 clinical trial applications, and advancing 2 industrialization projects.

Tan Guosheng

Yeasen, Director of Key Accounts

Tan Guosheng, a graduate of Nanjing University, brings years of experience in pharmaceutical and biological raw material sales and marketing. Currently serving as the Key Account Director at Yeasen, he focuses on driving collaborations with key accounts and participates in shaping the company’s product portfolio and market strategies within the Cell and Gene Therapy (CGT) sector, possessing in-depth knowledge of the upstream and downstream CGT industry chain.

Wang Haotian

Legend Capital, Vice President of Investment

Wang Haotian graduated with a degree in Clinical Medicine from Tsinghua University/Peking Union Medical College. He has 10 years of experience in clinical medicine and 8 years of experience in the GCP industry. He has participated in numerous clinical trials for drugs and medical devices, specializing in clinical development of innovative drugs. During the translational medicine and early-stage clinical development phases, he supported over 70 IND applications in China and the United States, as well as more than 100 Phase I/IIa clinical trial projects. He previously contributed to team building and management at healthcare startups and CRO ventures. In 2021, he joined Legend Capital, focusing on investments in the field of innovative pharmaceuticals.

Guo Zebiao Bronson Koh

Assistant to the President of ETANA / Head of Business Development, China Region

Bronson Koh, Founding Member of BBI Indonesia – Involved in one of the first projects for Chinese pharmaceutical companies expanding into Southeast Asia with technology transfer components. Participated in local facility planning and construction, established the initial team, coordinated collaborations between Chinese and Indonesian partners, and facilitated the technology transfer of small-molecule active pharmaceutical ingredients (APIs) and finished formulations for local production.

Assistant to the President of Etana / Head of Business Development, China Region – Responsible for project introduction; facilitating the export and technology transfer of mature domestic products to Southeast Asia in alignment with local policies; assisting in the establishment of supply chains and related systems; and participating in corporate financing and investment projects.

Zhao Lixiang

Huiliao Bio CTO

Co-founder of Suzhou Huiliao Biopharmaceutical Technology Co., Ltd.; Professor and Doctoral Supervisor at the School of Medicine, Soochow University. Main research interests include mRNA vaccines, cell therapy, and tumor immunology. Has published dozens of SCI papers on tumor immunology as first or corresponding author, and holds two authorized invention patents for tumor vaccines as the primary inventor. Has presided over multiple national and provincial-level projects.