BPD 北京站 - 生物药工艺发展大会

Meeting Overview

41+

Industry Speaker

1,093+

Professional Visitors

15+

Special Topic

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

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, Gansu Pharma)

09:40-10:00

Downstream Process Development and Validation for ADCs

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 Stage Design and Strategy from Early Research to Post-Marketing

Zhang Lei (Fosun Kary Technology Operations)

12:00-12:30

Interactive Discussion

13:30-16:10

13:30-13:50

Regulatory Science Policies for the 15th Five-Year Plan Launch to Accelerate Corporate R&D Innovation

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

Maode Xiang (Head of Registration Center, Sinopharm)

14:10-14:30

Stability Studies for Biologics Throughout Their Lifecycle (ICH Q1/Q5C Revision)

Pan Yongzhao (Vice Director of RA CMC, BioInvent)

14:30-15:30

Interview: Differences in Pharmaceutical Registration Submissions and CMC Regulation Between Domestic 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 Practice and Quality Control Specifications for Human Mesenchymal Stem Cell Products Based on the QbD Approach

Long Haomiao (Head of CMC Quality, 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

Stem Cell Process Development Strategies 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 Discuss Challenges and Implementation Practices in CMC, Quality, and Scalable Production of Stem Cell Drugs

Moderator: Guangyang Liu, CTO and Head of R&D at Beilai Biologics; Guests: Huiyuan Zhang, Managing Partner and Senior Director of Quality Center at Chengnuo Medical; Fangfang Zhu, Founder and CEO of Xueji Bio

12:00-12:20

Definition and Control of Critical Quality Attributes (CQAs) for Gene Therapy Products

Zhu Xudong (Quality Director, Kanglin Biology)

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 Strategy 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 Carriers

Gaobo (Founder & CEO of Yumeibo Bio)

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, Gansu Pharma)

09:40-10:00

Downstream Process Development and Validation for ADCs

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 You Li He Ze)

11:30-12:00

GCT Potency Assay: Lifecycle Stage Design and Strategy from Early Research to Post-Marketing

Zhang Lei (Fosun Kary Technology Operations)

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, Northcon)

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

Maode Xiang (Head of Registration Center, Sinopharm)

14:10-14:30

Stability Studies for Biologics Throughout Their Lifecycle (ICH Q1/Q5C Revision)

Pan Yongzhao (Vice Director of RA CMC, BioInvent)

14:30-15:30

Interview: Differences in Pharmaceutical Registration Submissions and CMC Regulation Between Domestic and International Markets

Venue 2 - Innovative Therapy Development and CMC

09:00-10:30

09:00-09:20

Good Manufacturing Practice and Quality Control Specifications for Human Mesenchymal Stem Cell Products Based on the QbD Approach

Long Haomiao (Head of CMC Quality, 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

Stem Cell Process Development Strategies 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 Registration, BeiLai Biologics / Secretary to the Chairman for Academic Affairs)

10:20-10:30

Interactive Discussion

11:00-12:30

11:00-12:00

Interview: 818/828 Discuss Challenges and Implementation Practices in CMC, Quality, and Scalable Production of Stem Cell Drugs

12:00-12:20

Definition and Control of Critical Quality Attributes (CQAs) for Gene Therapy Products

Zhu Xudong (Quality Director, Kanglin Biology)

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 Strategy 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 Carriers

Gaobo (Founder & CEO of Yumeibo Bio)

14:50-15:50

Interview: From Lab to GMP Facility – Process Bottlenecks, Quality Control, and Regulatory Challenges

Special Guest

Zhang Ran

Chief Certification Officer

Beijing Kangcheng (Beijing) Pharmaceutical Technology Co., Ltd.

Zheng Wenzhi

Manager

Beijing Anlong Biology

Qifei Qi

Chief Technology Officer

Beijing Yimiao神州Biopharmaceuticals Co., Ltd.

Zhao Libo

Chief Technology Officer

Beijing Enze Kangtai Biological Technology Co., Ltd.

Huang Huiya

Vice President

Aistokang Pharmaceutical Technology (Beijing) Co., Ltd.

Ge Xiaohu

Chairman

Tianjin Exosome Technology Co., Ltd.