Meeting Overview
59+
Industry Speaker
1,599+
Professional Visitors
22+
Special Topic
2+
Featured Event
Highlights
- •Focus on the North China region and strengthen CMC case exchange.
- •Lock in C-level executives at a closed-door policy seminar with 818 + 828.
Forum Schedule
5 21
Venue 1 - Biologic Drug Innovation Development and CMC
09:00-10:30
09:00-09:15
Opening Remarks
Deng Yatian (Founder and CEO of E-Trade Medical), Meng Fanyong (Member of the Party Leadership Group and Deputy Director of Beijing Investment Promotion Service Center)
09:15-10:10
Interview: Driving Future Biologic Development Through Innovation
Moderator: Fu Daotian (Co-founder, Yiming Kangda); Guests: Zhao Chunlin (Founder, Anlong Bio), Hui Aimin (Chairman & CEO, Huizhengqi Pharma), Gao Xin (Founder & CEO, Immune Ark)
10:10-10:30
Report: AI-Driven Innovation in Biologic Drug Development – Application Case Studies
Pengyu Ma (Director of Solutions, XtalPi)
11:00-12:30
11:00-11:20
Rethinking Process Characterization: A Systematic Approach to Developing Control Strategies from Process Understanding
Zeng Jun (Deputy Director, Henlius)
11:20-11:40
Overview of Bomei Biologics Cell Line Development Platform and Application Cases
Li Ying, Deputy Director at Bo'an Biopharma
11:40-12:00
Fusion protein process development and adaptability optimization
Wang Zhenyu (Senior Director, GEEKO Biopharma)
12:00-12:20
Process Control Strategy Throughout the Biologic Product Lifecycle
He Chuan (Director of Production Science and Technology, Tian Guang Shi)
12:20-12:30
Interactive Discussion
13:30-15:30
13:30-13:50
Development Strategies and Case Studies for Dual-Target Protein Drug Analysis
Li Fengzhi (Senior Director of AD, GENE Biopharma)
13:50-14:10
BeiGene Large Molecule CMC Analysis Strategy
Ma Xin, Deputy Director of CMC Analytics at BeiGene
14:10-14:30
Business Environment Overview of Daxing Biomedical Industrial Base
Xian Yan Kuan, Deputy Secretary of the Party Committee and General Manager of Biomedical Base Company
14:30-14:50
XDC Process Characterization and Process Validation
Aixianwei (Vice Director, Qilu Pharmaceutical)
14:50-15:10
Innovation and Process Intensification in Downstream Biopharmaceutical Processing
Jiang Tao (Senior Engineer, Institute of Genetics and Developmental Biology, Chinese Academy of Sciences)
15:10-15:30
Interactive Discussion
16:00-18:00
16:00-16:20
Material Optimization and Process Adaptation for Commercial Cost Reduction
Ma Huijing (Deputy Chief Engineer, Beijing Kanghong Technology)
16:20-16:40
Lifecycle Management of Process Validation and Practical Implementation of Bioprocess Verification
Chen Junfu (Head of Process Validation, United Laboratories Shunxin Pharmaceutical)
16:40-17:40
Interview: From Lab to Commercialization: Challenges in Antibody Drug Process Development and Process Performance Qualification (PPQ)
Moderator: Sun Chuanying (Quality Director, InnoCare Pharma); Guests: Xin Xin (Executive Director of CMC Operations Management, Yilian Biopharma), Zeng Jun (Deputy Director, BeiHeng Lianzhi), He Chuan (Director of Production Science and Technology, Tian Guang Shi)
Venue 2 - Innovative Therapy Development and CMC
09:30-10:30
09:30-10:30
Interview: Considerations and Choices for CAR-T Process Changes and Future Commercial Manufacturing
Host: Qifei Qi (Co-founder & CTO, Yimiao神州); Guests: Min Wang (VP, Bosunji), Yuzhong Peng (General Manager of Production Base, Heyuan Bio), Jianqiang Li (Chairman & Chief Scientist, Jinyao Bio)
11:00-12:30
11:00-11:20
Selection and Process Development of Vectors for In Vivo CAR-T Therapy
Wang Min (Vice President, Boshengji)
11:20-11:40
Quality Control Strategy for In Vivo CAR-T LVV Delivery System
Qifei Qi (Co-founder & CTO, Yimiao Bio)
11:40-12:30
Interview: Clinical Breakthroughs, Regulatory Challenges, and Ecosystem Collaboration in In Vivo Cell Therapy
Moderator: Su Zhenbo (CEO & Co-founder, Tiankeya Biotech) Guests: Zhang Yu (Co-President, Zhongyuan Xiehe), Wang Wei (VP, Youkadi Bio), Cao Zhuoxiao (CEO, Xianbo Bio), and Zhong Shi (CSO, Xuesheng Life Science).
13:30-15:30
13:30-14:30
Interview: CMC Innovation Technology Development from a BD Perspective
Moderator: Wang Zhixuan (CMC Director, Sanofi); Guests: Huang Conghai (Founder & CEO, Maiba Biotech), He Saichao (Former Head of CMC Platform, Shenjichanghua), Yuan Zifei (Deputy General Manager & CTO, Gansu Pharmaceutical)
14:30-14:50
Report: The Breakthrough in AI Drug Discovery: From an "Efficiency Race" to a "Disease Understanding Revolution"
Zhao Yu (Co-founder of Zheyuan Technology & Deputy Director of the Turing-Darwin Lab)
14:50-15:30
Interview: How AI Bridges the "Last Few Miles" of Drug Development — From Target Discovery to Process Implementation
Host: Qu Wei (CTO, Shangkang Pharma); Guests: Ma Pengyu (Solutions Director, XtalPi), Li Xiaron (Senior Director of Life Sciences Solutions Architecture, DeepModeling), and Zhao Yu (Co-founder & Deputy Director, Turing-Darwin Lab, Zeyuan Technology)
16:00-18:00
16:00-16:30
Recent Advances in Nucleic Acid Drug Delivery Technologies
Huiya Huang (Vice President, Astekang)
16:30-17:00
Case Study: Extrahepatic Delivery of siRNA Drugs
Zheng Wenzhi (Manager, Anlong Bio)
17:00-17:30
Peptide Formulation Process Development
Qu Wei (CTO, Shangkang Medicine)
17:30-18:00
Interactive Discussion
5 22
Venue 1 - Biologic Drug Innovation Development and CMC
09:00-10:30
09:00-09:20
XDC Complex Molecule Innovation Development
Zhenwei Miao, Chairman and CEO of Akeris & Yingbairui
09:20-09:40
Early Process and Conjugate Development for ADC Drugs
Shao Wenjie (Executive Director, Chemical Drug Development Department, Gan & Lee Pharmaceuticals)
09:40-10:00
ADC Downstream Process Development and Validation
Hu Fengjuan (Director of Pilot Purification Research Department, Boan Biopharma)
10:00-10:20
ADC Process Development and Compatibility Optimization
Zou Changrui (Director of Purification and Conjugation Process, RemeGen)
10:20-10:30
Interactive Discussion
11:00-12:30
11:00-11:30
Development Strategies and Progress of mRNA Delivery Systems
Tang Jianbin (Professor, School of Chemical and Biological Engineering, Zhejiang University); Liu Dongmei (Deputy Director of Quality, San Li He Ze)
11:30-12:00
GCT Potency Assay: Lifecycle Strategy and Design from Early Research to Post-Marketing
Zhang Lei (Fosun Kary Technical Operations Department)
12:00-12:30
Interactive Discussion
13:30-16:10
13:30-13:50
Regulatory Science Policies at the Start of the 15th Five-Year Plan Accelerate Corporate Innovation and R&D
Zhang Ran (Chief Pharmaceutical Regulatory Advisor at BeiHai Cheng)
13:50-14:10
Latest Regulatory Requirements for Biosimilar Comparative Clinical Study (CES) Exemption in Europe and the US, and Their Impact on Chinese Pharmaceutical Companies Going Global
De Xiang Mao (Head of Registration Center, Sinopharm)
14:10-14:30
Stability Studies for Biologics Throughout the Product Lifecycle (ICH Q1/Q5C Revision)
Pan Yongzhao (Associate Director, RA CMC at Enzyvant)
14:30-15:30
Interview: Differences in Pharmaceutical Registration Submissions and CMC Regulations Between China and International Markets
Moderator: Pan Yongzhao, Deputy Director of RA CMC at Bio-Thera Solutions; Guests: Wei Chunchun, Director of RA CMC at Yilian Biologics; Li Xiaorong, Senior Director of Regulatory Affairs at InnoCare Pharma; Mao Dexiang, Head of the Registration Center at Sinopharm; Zhang Miao, Senior Director at China Resources Biology.
Venue 2 - Innovative Therapy Development and CMC
09:00-10:30
09:00-09:20
Good Manufacturing and Quality Control Practices for Human Mesenchymal Stem Cell Drugs Based on the QbD Concept
Long Haomiao, CMC Quality Director at Beilai Bio
09:20-09:40
Construction and Control of a Clinical-Grade iPSC Bank
Zhang Yu (Co-President of Zhongyuan Xiehe)
09:40-10:00
Strategies for Stem Cell Process Development Under New Regulations
Zhang Huiyuan (Executive Partner, Chengnuo Medical; Senior Director, Quality Center)
10:00-10:20
Registration and Submission Requirements for Stem Cell Products and Pharmaceutical Review Criteria
Wang Hao (Head of Regulatory Affairs, Belay Biotech / Secretary to the Chairman for Academic Affairs)
10:20-10:30
Interactive Discussion
11:00-12:30
11:00-12:00
Interview: 818/828 Discusses Challenges and Implementation Strategies for Stem Cell Drug CMC, Quality Control, and Scalable Manufacturing
Moderator: Guangyang Liu, CTO and Director of R&D at Beilai Biotech; Guests: Huiyuan Zhang, Executive Partner and Senior Director of Quality Center at Chengnuo Medical; Fangfang Zhu, Founder and CEO of Xueji Biotechnology
12:00-12:20
Definition and Control of Critical Quality Attributes (CQAs) for Gene Therapy Products
Zhu Xudong (Quality Director, Kanglin Bio)
12:20-12:30
Interactive Discussion
13:30-15:50
13:30-13:50
Exosome Quality Research and Industrialization Exploration
Ge Xiaohu (Chairman of Tianjin Exosome Technology, President of Tianjin Biomedical Industry Association)
13:50-14:10
Analysis and Characterization Strategies for Extracellular Vesicle Therapeutic Products
Zhao Libo (CTO, Enze Kangtai)
14:10-14:30
Quality Control for Exosome Product Development
Yang Shuangshuang (R&D Manager, Qilu Cell Therapy)
14:30-14:50
Technical Challenges in Developing Exosome-Based Drug Delivery Systems
Gao Bo (Founder and CEO of Yumeibo Biotechnology)
14:50-15:50
Interview: From Lab to GMP Facility – Process Bottlenecks, Quality Control, and Regulatory Challenges
Moderator: Bo Gao (Founder & CEO, Ymbio Biotech); Guests: Xiaohu Ge (Chairman, Tianjin Exosome Technology; President, Tianjin Biomedical Industry Association), Libo Zhao (CTO, Enze Kangtai), Shuangshuang Yang (R&D Manager, Qilu Cell Therapy), Haoran Wang (CEO, Newland Bio)
5 22
Venue 1 - Biologic Drug Innovation Development and CMC
09:00-10:30
09:00-09:20
XDC Complex Molecule Innovation Development
Zhenwei Miao, Chairman and CEO of Akeris & Yingbairui
09:20-09:40
Early Process and Conjugate Development for ADC Drugs
Shao Wenjie (Executive Director, Chemical Drug Development Department, Gan & Lee Pharmaceuticals)
09:40-10:00
ADC Downstream Process Development and Validation
Hu Fengjuan (Director of Pilot Purification Research Department, Boan Biopharma)
10:00-10:20
ADC Process Development and Compatibility Optimization
Zou Changrui (Director of Purification and Conjugation Process, RemeGen)
10:20-10:30
Interactive Discussion
11:00-12:30
11:00-11:30
Development Strategies and Progress of mRNA Delivery Systems
Tang Jianbin (Professor, School of Chemical and Biological Engineering, Zhejiang University); Liu Dongmei (Deputy Director of Quality, San Li He Ze)
11:30-12:00
GCT Potency Assay: Lifecycle Strategy and Design from Early Research to Post-Marketing
Zhang Lei (Fosun Kary Technical Operations Department)
12:00-12:30
Interactive Discussion
13:30-16:10
13:30-13:50
Regulatory Science Policies at the Start of the 15th Five-Year Plan Accelerate Corporate Innovation and R&D
Zhang Ran (Chief Pharmaceutical Regulatory Advisor at BeiHai Cheng)
13:50-14:10
Latest Regulatory Requirements for Biosimilar Comparative Clinical Study (CES) Exemption in Europe and the US, and Their Impact on Chinese Pharmaceutical Companies Going Global
De Xiang Mao (Head of Registration Center, Sinopharm)
14:10-14:30
Stability Studies for Biologics Throughout the Product Lifecycle (ICH Q1/Q5C Revision)
Pan Yongzhao (Associate Director, RA CMC at Enzyvant)
14:30-15:30
Interview: Differences in Pharmaceutical Registration Submissions and CMC Regulations Between China and International Markets
Moderator: Pan Yongzhao, Deputy Director of RA CMC at Bio-Thera Solutions; Guests: Wei Chunchun, Director of RA CMC at Yilian Biologics; Li Xiaorong, Senior Director of Regulatory Affairs at InnoCare Pharma; Mao Dexiang, Head of the Registration Center at Sinopharm; Zhang Miao, Senior Director at China Resources Biology.
Venue 2 - Innovative Therapy Development and CMC
09:00-10:30
09:00-09:20
Good Manufacturing and Quality Control Practices for Human Mesenchymal Stem Cell Drugs Based on the QbD Concept
Long Haomiao, CMC Quality Director at Beilai Bio
09:20-09:40
Construction and Control of a Clinical-Grade iPSC Bank
Zhang Yu (Co-President of Zhongyuan Xiehe)
09:40-10:00
Strategies for Stem Cell Process Development Under New Regulations
Zhang Huiyuan (Executive Partner, Chengnuo Medical; Senior Director, Quality Center)
10:00-10:20
Registration and Submission Requirements for Stem Cell Products and Pharmaceutical Review Criteria
Wang Hao (Head of Regulatory Affairs, Belay Biotech / Secretary to the Chairman for Academic Affairs)
10:20-10:30
Interactive Discussion
11:00-12:30
11:00-12:00
Interview: 818/828 Discusses Challenges and Implementation Strategies for Stem Cell Drug CMC, Quality Control, and Scalable Manufacturing
Moderator: Guangyang Liu, CTO and Director of R&D at Beilai Biotech; Guests: Huiyuan Zhang, Executive Partner and Senior Director of Quality Center at Chengnuo Medical; Fangfang Zhu, Founder and CEO of Xueji Biotechnology
12:00-12:20
Definition and Control of Critical Quality Attributes (CQAs) for Gene Therapy Products
Zhu Xudong (Quality Director, Kanglin Bio)
12:20-12:30
Interactive Discussion
13:30-15:50
13:30-13:50
Exosome Quality Research and Industrialization Exploration
Ge Xiaohu (Chairman of Tianjin Exosome Technology, President of Tianjin Biomedical Industry Association)
13:50-14:10
Analysis and Characterization Strategies for Extracellular Vesicle Therapeutic Products
Zhao Libo (CTO, Enze Kangtai)
14:10-14:30
Quality Control for Exosome Product Development
Yang Shuangshuang (R&D Manager, Qilu Cell Therapy)
14:30-14:50
Technical Challenges in Developing Exosome-Based Drug Delivery Systems
Gao Bo (Founder and CEO of Yumeibo Biotechnology)
14:50-15:50
Interview: From Lab to GMP Facility – Process Bottlenecks, Quality Control, and Regulatory Challenges
Moderator: Bo Gao (Founder & CEO, Ymbio Biotech); Guests: Xiaohu Ge (Chairman, Tianjin Exosome Technology; President, Tianjin Biomedical Industry Association), Libo Zhao (CTO, Enze Kangtai), Shuangshuang Yang (R&D Manager, Qilu Cell Therapy), Haoran Wang (CEO, Newland Bio)
Special Guest
Exhibitor Directory
NEST Ernst
WePuzzle
Insilico Medicine
Bio Scientific Shanghai Biotech Industry
Shanghai Saniuse Technology
Sepax Technologies
Beianji Biotechnology BIOENGINE
Pfanstiehl
Phenomenex
optimize
NEST Ernst
WePuzzle
Insilico Medicine
Bio Scientific Shanghai Biotech Industry
Shanghai Saniuse Technology
Sepax Technologies
Beianji Biotechnology BIOENGINE
Pfanstiehl
Phenomenex