'No Need to Hustle, Just Go Further': CGT Industry Upgrading Series – Shanghai Park Tour

Conference Name:[No Need for the Rat Race, Go Further] CGT Industry Upgrade Series · Shanghai Park Tour, First Stop

Co-organized by:HIEA, Hangzhou Xingcheng Biotechnology Co., Ltd., Yeasen, Saifu Pharmaceutical, BRC BIOTECHNOLOGY, Austar Group, Legend Capital, ATLATL Innovation Center

Organizer:Artery New Medicine

Event Duration:Wednesday, November 29, 2023, 13:30

Event Venue:Lecture Hall, 1st Floor, ATLATL Innovation R&D Center, No. 1077 Zhangheng Road, Pudong New Area, Shanghai

Conference Name:[No Need to Compete Fiercely, Go Further] CGT Industry Upgrade Series · Shanghai Industrial Park Tour, Stop 2

Co-organizers:HIEA, Xingcheng Biotechnology, Yeasen, Saifu Pharmaceutical, BRC BIOTECHNOLOGY, Austar Group, Legend Capital

Organizer:VCBeat New Medicine

Supporting Organizations:Xingbei · Free Trade No.1, No.1 Entrepreneurs Club

Event Time:Thursday, November 30, 2023, 13:30

Venue:Conference Hall, 1st Floor, Building 6, Free Trade No.1 Life Science and Technology Industrial Park, No. 215 Fute South Road, Pudong New Area, Shanghai

To ensure the quality of the event

This event adopts a registration review system.

Event Scale:50 people/session

Event Collaboration:Ms. Fu 17851017836 (WeChat ID same)

Event Registration:Capillary 17782369627 (WeChat ID same)

Following the first wave of development, multiple CAR-T products have been submitted for marketing approval in China, and several gene therapy products have entered Phase III clinical trials, continuously expanding into more disease areas and unlocking significant potential.

Meanwhile, the cell and gene therapy (CGT) industry continues to face numerous challenges, such as issues with product quality and batch-to-batch consistency, as well as constraints imposed by high costs and pricing. These factors have made the optimization and iteration of CGT products increasingly urgent. At the same time, the importance of chemistry, manufacturing, and controls (CMC) cannot be overlooked. Designing superior products, reducing costs while improving efficiency, and developing effective therapeutics are the aspirations of every CGT company. Consequently, service providers across the industry chain and high-quality suppliers have become important drivers of industrial upgrading.

Based on this,CGT Industry Chain Service Providers Jointly Launch Park Tour Initiative, Leveraging Collective Strengths in Equipment, Raw Materials, Consumables, Process Design, and Advanced Analytical Methods to Support Innovative Enterprises in Developing High-Quality Therapeutics and Driving Industrial Upgrading in the CGT Sector.

■ 13:30-13:35 Opening Remarks by the Host + Introduction to the Ecosystem

Event Expectations and Ecosystem Synergy

Liu Xiao | Vice President of Business and Marketing, Xingcheng Biotechnology

■ 13:35-13:40 Address by Park Leadership

Zhangjiang Group

■ Keynote Speech

13：40-14：05

Investment and Financing in the Cell and Gene Therapy Industry from a Capital Perspective

Qi Fei | Legend Capital, Executive Director

14：05-14：30

Cell and Gene Therapy ManufacturingRaw Material ScienceThe Secret to Cost Reduction and Efficiency Enhancement

Teng Yigang | R&D Scientist, Yeasen

14：30-14：55

Key Points of CMC in Cell and Gene Therapy

Li Junhui |Xingcheng Biotechnology · Scientific and Technological ProductionVice President

14：55-15：20

Preclinical Research under the Dual-Track Integration of IIT and IND for Cell-Based Products

Liu Jing | Deputy General Manager, Safety Evaluation Center (South Beijing), Saifu Pharmaceutical

■ 15:20-15:30 Tea Break

■ Keynote Speech

15：30-15：55

Local Practice of International Quality Standards for Cell and Gene Therapy

Wang Xin | Chief Strategy Officer (CSO), BRC BIOTECHNOLOGY

15：55-16：20

Delivering Technology-Driven Pharmaceutical Engineering Solutions to Enhance Cell Therapy Process Efficiency

Jin Lei | Cell Therapy Solutions Expert, Austar Group

■ 16:20–17:00 Attendee Self-Introductions + Open-Mic Discussion

Leveraging CMC Synergy to Help Innovative Companies Achieve a Robust, Rapid, and Cost-Effective Transition from IIT/IND to BLA

Featured Guest Speaker:

Lu Wenyuan | Executive Director, Innovation Department, ATLATL Innovation Center

Other Participating Organizations:

Shanghai Jiao Tong University, Beijing Friendship Hospital of Capital Medical University, Yangtze River Pharmaceutical Group, Gracell Biotechnologies, Ucarbio, Moslight Biotech, BioProcess Know-It-All, Longxin Biopharma, Xingao Tuowei Biotech, Caizhong Financial Holdings Group, Fudan Science Park Venture Capital, Pengxin Group, Shanghai Liding Investment, AnJie Broad Law Firm, Shanghai Rural Commercial Bank, etc.

■ 17:00-19:00 Dinner Networking

■ 13:30-13:35 Opening Remarks by the Moderator + Introduction to the Ecosystem

Event Outlook and Ecosystem Synergy

Liu Xiao | Vice President of Business and Marketing, Xingcheng Biotechnology

■ 13:35-13:40 Address by Park Leadership

Wu Haixia | CEO of Xingbei Group, Co-founder of Shanghai FTZ No.1 Life Science and Technology Industrial Park

■ Keynote Speech

13：40-14：05

Investment and Financing in the Cell and Gene Therapy Industry from a Capital Perspective

Wang Haotian | Vice President, Legend Capital

14：05-14：30

Cell and Gene Therapy ManufacturingRaw Material ScienceThe Secret to Cost Reduction and Efficiency Improvement

Teng Yigang | Yeasen, R&D Scientist

14：30-14：55

Key Points of CMC in Cell and Gene Therapy

Li Junhui | Vice President of Science, Technology and Production, Xingcheng Biotechnology

14：55-15：20

Preclinical Research on Cell Therapy Products under the Integrated Dual-Track System of IIT and IND

Liu Jing | Deputy General Manager, Safety Assessment Center (Southern Beijing), Saifu Pharmaceutical

■ 15:20-15:30 Tea Break

■ Keynote Speech

15：30-15：55

Local Practice of International Quality Standards for Cell and Gene Therapy

Wang Xin | Chief Strategy Officer, BRC BIOTECHNOLOGY

15：55-16：20

Providing Technology-Driven Pharmaceutical Engineering Solutions to Enhance Cell Therapy Process Efficiency

Jin Lei | Cell Therapy Solutions Expert, Austar Group

■ 16:20–17:00 Attendee Self-Introductions + Open-Mic Discussion

Leveraging CMC Synergy to Enable Innovative Enterprises to Achieve a Robust, Rapid, and Cost-Effective Transition from IIT/IND to BLA

VCBeat:

Beijing Friendship Hospital, Capital Medical University; Huida Gene; Dingxin Gene; Pingpu Medical; Ucardi Bio; Fudan Science Park Venture Capital; Pengxin Group; AnJie Broad Law Firm; Shanghai Rural Commercial Bank; etc.

■ 17:00-19:00 Dinner Gathering

*The above guests are listed in agenda order, not in any particular sequence.

CoJourney is a professional gene and cell therapy CDMO integrating plasmid, viral vector, and mRNA production, preparation, and analytical testing. The company has successfully filed Investigational New Drug (IND) applications for plasmids and viral vectors in both China and the United States with zero deficiency letters. CoJourney provides customized services including process development, cGMP manufacturing, analytical method development, and product release testing for plasmids, viral vectors, and mRNA.Founded by senior CMC experts with commercialization experience in the gene and cell therapy sector, along with accomplished scientists and entrepreneurs, CoJourney operates dual headquarters in Zhejiang, China, and Pennsylvania, USA. The company has established GMP manufacturing facilities for plasmids, viral vectors, and mRNA that comply with FDA, EU, and NMPA regulations. Equipped with advanced production and analytical instruments, and backed by a team with extensive process development expertise and practical experience, CoJourney adheres to its philosophy of "Action Rooted in Sincerity." By employing robust processes that exceed industry standards, the company ensures high-quality, high-purity, high-yield, and cost-effective solutions for partners, delivering plasmid, viral vector, and mRNA products at various scales from R&D to GMP-grade manufacturing.

Yeasen Biotechnology (Shanghai) Co., Ltd. is a high-tech enterprise focused on core raw materials in the upstream life science industry chain, engaged in the research and development, production, and sales of biological reagents across three major categories: molecular biology, proteins, and cells. By integrating technological development pathways for molecular enzymes, proteins, antibodies, nucleic acids, and cells, Yeasen has become one of the few domestic companies that simultaneously cover all three major categories of biological reagents, possessing both independent R&D capabilities for core technologies and large-scale production capacity. The company develops, produces, and sells thousands of types of biological reagents, meeting customers' integrated procurement needs for various types of biological reagents. Its core products span multiple categories, including qPCR series, NGS series, reverse transcription series, nucleic acid extraction and purification series, PCR series, molecular cloning series, in vitro transcription series, antibodies, protein purification series, protein analysis series, recombinant proteins, cell analysis series, cell culture series, cell transfection series, and reporter gene detection series, which are widely applied in fields such as life science research, diagnostic testing, and biopharmaceuticals.

Saifu Pharmaceutical is committed to becoming a world-class, one-stop pharmaceutical CRO service provider, delivering top-tier pharmaceutical CRO evaluation services. By integrating technology development, financing, and the translation of innovative pharmaceutical products, we provide enterprises with comprehensive R&D planning for innovative medicines, accelerating the drug development process and facilitating faster corporate growth. Our organization comprises departments specializing in pharmaceutical R&D consulting, NMPA/FDA registration and filing, antibody drug discovery, drug screening, druggability assessment, pharmacology and efficacy studies, drug metabolism analysis, non-clinical safety evaluation, and bioanalysis. We are equipped to offer one-stop professional pharmaceutical R&D services to companies in the industry.

Saifu Pharmaceutical has been successively honored as a National Specialized, Refined, Differential, and Innovative “Little Giant” Enterprise, a National High-Tech Enterprise, a Beijing Municipal Enterprise Science and Technology Research and Development Institution, and a Zhongguancun High-Tech Enterprise. The company also operates two postdoctoral research stations. Saifu Pharmaceutical owns the Jingnan Gu’an Drug GLP Center, Pharmacology and Efficacy Center, Pharmacokinetic Analysis Center, Shenzhen Center (Saifu Jiayuan) Ophthalmic Drug Evaluation Center, Drug Innovation Research Center, Drug Screening Center, Antibody Discovery Center, Central Laboratory, and its U.S. office responsible for FDA registration and submissions.

BRC BIOTECHNOLOGY (SHANGHAI) CO., LTD. specializes in biosafety testing and regulatory compliance support within the biopharmaceutical sector. Headquartered in the Free Trade Zone No. 1 Industrial Park of the Shanghai Pilot Free Trade Zone, the company occupies nearly 6,000 square meters, featuring a cGMP-compliant BSL-2 testing center and a customer service center. Its capabilities span multiple testing platforms, including molecular biology, immunology, microbiology, virology, cell biology, and zoology. The BRC team possesses extensive experience in quality control for antibody and cell and gene therapy (CGT) products, as well as in viral testing and process validation, having successfully facilitated the international regulatory submissions of nearly 100 biopharmaceutical projects both domestically and abroad. As a vital link in the biopharmaceutical industry, BRC Biotechnology is committed to addressing the urgent need for biosafety testing and accelerating the regulatory approval and market launch of innovative biopharmaceutical products.

Austar Group is an advanced technology-driven provider of pharmaceutical engineering solutions, possessing comprehensive knowledge and expertise in life sciences process technologies, applications, industry regulatory guidelines, and best practices. We help clients address challenges related to quality, compliance, and operational excellence, and are committed to delivering turnkey solutions encompassing equipment, engineering, services, and consumables, thereby driving industry progress and creating sustained value.

Austar Life Sciences Equipment and Consumables is a key business segment of Austar Group. By introducing advanced research, industrial consumables, and instrumentation from Europe and the United States, we provide comprehensive, high-quality solutions encompassing consumables, equipment, and services to clients in the pharmaceutical, life sciences, laboratory animal science, biosafety, medical devices, health supplements, and daily chemical industries. We specifically cater to customers requiring compliance with EU GMP, cGMP, COS, and other relevant certifications, while offering diversified technical guidance, training, and application support.

Legend Capital, established in April 2001, is a leading fund management company in China specializing in early-stage venture capital and growth-stage private equity investments. Over its more than two decades of development, Legend Capital has adhered to international standards, creating best practices in fund operations and management. Through its proactive value-added service system, Legend Capital fosters corporate innovation and growth, delivering strong investment returns across multiple sectors while promoting industrial advancement and social progress in China. With the vision of “becoming an investment firm with global influence,” Legend Capital upholds the core value of “Prosperity with Integrity” and actively fulfills its social responsibilities.

Legend Capital has maintained a deep focus on investments in the healthcare sector, systematically deploying capital across the broader health industry. In this field, it has invested in leading companies in various sub-sectors that are listed on the A-share and Hong Kong stock markets, including Pharmaron (300759.SZ) (03759.HK), WuXi AppTec (603259.SH) (02359.HK), WuXi Biologics (02269.HK), Innovent Biologics (01801.HK), New Horizon Health (06606.HK), and Mingde Biology (002932.SZ).

ATLATL Dart Innovation Center is an international R&D hub for biopharmaceutical innovation. By integrating common elements of biopharmaceutical research and development, it improves resource utilization efficiency and transforms the traditional heavy-asset investment model into an asset-light operational model. This business model originated in Boston and was further optimized and upgraded in China in 2017.

ATLATL not only provides world-class laboratory facilities and refined operational management but also features multiple specialized R&D platforms, offering on-site scientists and project management teams focused on current high-interest fields. By collaborating with internationally renowned pharmaceutical companies, academic and research institutions, as well as service and instrument providers, ATLATL integrates global resources to empower innovation and foster integrated development. Currently, ATLATL has established R&D platforms in multiple cities worldwide, including Beijing, Shanghai, Singapore, and Boston, leveraging complementary resources to help innovative enterprises rapidly achieve their next R&D milestones.

[On-Site R&D Services] ATLATL’s on-site R&D team provides research and development assembly services to pharmaceutical companies both in China and overseas, including gene and cell therapy, AI-driven drug screening, macromolecular drug research, gene editing, single-cell high-throughput screening, GMP process optimization, as well as preclinical pharmacology and toxicology studies, and animal disease models.

Shanghai Free Trade Zone No. 1 Life Science and Technology Industrial Park (hereinafter referred to as “Xingbei · Free Trade No. 1 Simbay Park”) is located in the Waigaoqiao Bonded Zone of Pudong New Area, Shanghai. It is a specialized, innovation-oriented service industrial park under Xingbei Group, dedicated to the incubation, cultivation, and commercialization transformation of medical enterprises. Leveraging the unique advantages of the “Free Trade + Bonded” export-oriented economic zone, the park integrates full-industry-chain service resources—including CRO, CDMO, CSO, and EHS—along with government policies supporting mass entrepreneurship and innovation, and numerous renowned investment institutions. By providing deep technical incubation tailored to the medical industry and acting as a steward for the transformation of technological achievements, the park strives to build an international base for innovation and entrepreneurship in the biopharmaceutical sector. To date, it has gathered more than 150 biopharmaceutical companies, including innovative leaders in gene therapy such as Huida Gene and Dingxin Gene; innovative leaders in cell therapy such as Westlake Biology, Xingyi’ang, and Yuesai Biotechnology; Orange Sail Pharma, an innovative leader in large-molecule drugs; AI drug discovery unicorns such as XtalPi and Iceberg Biosciences; and Porton Intellect, a leading enterprise in the CRO and CDMO sectors.

SIMBAY Club is an open platform for communication, collaborative assistance, and mutual learning, independently initiated by a group of founders from SIMBAY PARK (Zimao Yihao) enterprises. It aims to unite independent innovative enterprises within the SIMBAY ecosystem, pool members’ wisdom and industry resources, and establish various development platforms covering corporate management, cutting-edge technological advancements, and technical regulatory training. Additionally, it assists members and their enterprises in connecting with diverse external resources, including government and regulatory bodies, investment and financing institutions, academic and research organizations, as well as industry and technical associations. By doing so, the club fosters the growth of medical innovation leaders and promotes sustainable enterprise development, providing substantial support for member entrepreneurship and corporate innovation.

VB Pharma is a media and research platform under VCBeat, focusing on the biopharmaceutical sector. It delivers “in-depth” and “incremental” communication value to innovators and entrepreneurs through both content and operations. In terms of content, it features exclusive financing announcements, corporate interviews, the “Drug Developers” column, in-depth industry analyses, and sector reports. On the operational front, its branded series “VB Think Tank” focuses on practical challenges and discusses industrial trends, fostering tangible collaborations through the exchange of ideas.

Special Topic Achievements:【Organoids and Organ-on-a-Chip】【CXO】【iPSC】【CGT】【Nuclear Medicine Drugs】【Upstream Tools】【Peptide】【Exosomes】【NASH】【Protein Degraders]【Synthetic Biology】【AI + New Drugs】【VB Think Tank】【IPO-Financial Report Analysis】【New Pharma Dialogue】Wait

*The above organizations are listed in agenda order, not in order of precedence.

To Ensure Event Quality

Registration for this event is subject to review and approval.

Event Scale:50 people/session

Event Collaboration:Ms. Fu 17851017836 (WeChat ID same)

Event Registration:Capillary 17782369627 (WeChat ID same)