LONDON,Nov. 21,2024 --GenScript Biotech Corporation,a global leader in life sciences R&D and manufacturing services,successfully hosted the European debut of its GenScript Biotech Global Forum in London,UK. Since its inaugural session at the J.P. Morgan Healthcare Conference in San Francisco in 2020,the forum has become a significant platform for advancing cell and gene therapy (CGT). This year's move to Europe underscores GenScript's commitment to driving the global CGT innovation and fostering international collaboration.

"Putting patients first" is the underlying principle driving progress in the pharmaceutical industry and the inspiration behind this year's forum. "All our efforts in creating this platform for open dialogue and international collaboration in the CGT industry ultimately aim to address patient needs," said Jesse Chen,VP of Government Affairs and Corporate Communications at GenScript,in a pre-event interview.

The forum brought together global thought leaders from academia,industry,and investment sectors in CGT to explore the theme "Unlock the Full Potential of Cell and Gene Therapies." Discussions focused on the latest breakthroughs,technological innovations,and future trends,offering multi-dimensional perspectives on advancing the CGT industry to benefit more patients.

The forum was moderated by Dr. Shawn Wu,President of European Division at GenScript. Sherry Shao,Rotating CEO of GenScript,delivered the opening remarks,emphasizing:

"Every step forward in CGT,every innovation,is ultimately about serving patients better." She reaffirmed GenScript's commitment to driving innovation in CGT and collaborating with global partners to bring life-changing therapies to more patients worldwide.

The forum featured two keynote sessions with distinguished speakers: Dr. Miguel Forte,President of the International Society for Cell & Gene Therapy (ISCT),ARM Board Member,and CEO of Kiji Therapeutics,and Dr. James Wilson,a pioneer in gene therapy and President & CEO of Gemma Biotherapeutics (GEMMABio); Founder and Advisor of Scout Bio,Passage Bio,iECURE; Executive Chair at Franklin Biolabs. Their thought-provoking presentations not only deepened attendees' understanding of the field but also offered valuable insights into the future of cell and gene therapy (CGT).

Dr. Forte's delivered a keynote titled "Status and Expectations for Cell and Gene Therapy in 2024 and Beyond,"focused on the transformative potential of cell therapy. He delved into gene editing,in vivo therapies,and the challenges and opportunities associated with regulatory approval. He emphasized the importance of understanding the long-term nature of cell therapy development and the significance of global collaboration.

Dr. Wilson's keynote,"The Case for Rare Diseases in Genetic Medicine Development,"He emphasized the importance of gene therapy for rare diseases and elaborated on the commercialization challenges of gene therapy products and discussed issues encountered in clinical development,such as technological shortcomings,the complexity of clinical trials,and production challenges. Dr. Wilson also emphasized the importance of patient advocacy and social media in promoting drug accessibility and raising public awareness. Additionally,he highlighted the need to focus on reimbursement mechanisms and achieve a balance between innovation and the resource utilization of health authorities.

In addition to the compelling keynote speeches,the forum featured a range of dynamic interactive sessions,including three roundtable discussions and a fireside chat. These sessions attracted significant attention,offering lively debates and actionable insights that resonated with the audience.

The success of CAR-T therapies in hematologic malignancies has revealed the vast potential of cell therapies. Now,the focus is on extending these breakthroughs to broader patient populations,including those with solid tumors and autoimmune diseases,which have become a shared goal across the industry.

During the "Technology Innovation and Breakthroughs in Cell Therapy"roundtable,Mr. Stephen Hansen,Director of Biopharma Intelligence at BioCentury,moderated a vibrant discussion featuring leaders such as Dr. Ying Huang,CEO of Legend Biotech,Dr. Reagan Jarvis,CEO and Co-founder of Anocca,Dr. Pascal Touchon,Chairman of the Board at Atara Biotherapeutics,Mr. Jason Foster,CEO and Executive Director of Ori Biotech,and Dr. Biao Zheng,CEO of BRL Medicine.

They approached the topic from the patient's perspective,highlighting the exceptional efficacy of CAR-T therapy. The experts also shared promising clinical data on the use of CAR-T drugs for autoimmune diseases and expressed high hopes for their future development. They emphasized that developing more patient-friendly,user-friendly CAR-T therapies is critical for increasing patient acceptance. Additionally,expanding production capacity,improving product accessibility,and ensuring product safety are urgent priorities. Collaboration with medical centers is key to developing commercially viable products. As innovative therapies continue to be researched,the potential applications of CAR-T therapy will be further unlocked,offering patients more treatment options.

Driven by technological breakthroughs,significant progress has been made in gene therapy and mRNA vaccine fields,with applications expanding rapidly. However,the production of these therapies is complex,particularly when it comes to the choice,production,and optimization of delivery vectors,which have a profound impact on their development. In the roundtable discussion on "Progress in Gene Therapy and mRNA Vaccine," hosted by Ms. Kristina Cornish,Partner at Pinsent Masons,London & European and UK Patent Attorney,leading researchers including Mr. Deividas Pazeraitis,Senior Scientist at AstraZeneca,Dr. Karim Benabdellah,Principal Investigator at GENYO,Dr. Maelle Quere,Scientist at Sanofi,Dr. Vincenzo Di Cerbo,Lead Technical Scientist at Cell and Gene Therapy Catapult,and Dr. Lumeng Ye,Director of Novel therapeutic materials at GenScript; all agreed that long-term delivery efficiency and technological bottlenecks remain key challenges in translating innovations into clinical applications.

The discussion focused on the technological trends and innovative developments in the clinical applications of gene editing,the topics cover the selection of viral vectors (VP),non-viral vectors (NVP),lipid nanoparticles (LNP),and virus-like particles (VLP) in different application areas,the innovative developments in gene therapy and mRNA vaccines,as well as an analysis of the advantages and disadvantages of mRNA vaccines compared to traditional vaccines,along with development trends and application prospects. They also provided a comprehensive review of the progress from technological innovation to clinical application in this field and unanimously agreed that long-term delivery technology and in vitro cell line technology remain key challenges.

The development process for CGT is highly complex and personalized,and these characteristics are seen as major challenges to the continuous supply of these therapies. In the subsequent roundtable discussion on "CMC Challenges with Developing & Manufacturing Cell and Gene Therapies,"led by Dr. Qingyu Cao,Senior Director & head of European Business Development at ProBio,and panelists are Dr. Jim Faulkner,CEO of JDB BioConsulting,Mr. Arindam Mitra,CMC Director at Leucid Bio,Dr. Dima Al-hadithi,Director at Minaret Consulting Limited,and Ms. Ming Ewe,CEO of Smarter Biotech Solutions,engaged in lively discussions on key issues such as production process standardization,quality control,and viral vector production.

The discussion presented practical strategies and solutions,providing important references for the widespread application of CGT. The experts emphasized the need for early planning of CMC and regulatory strategies in the context of accelerated approval processes,ensuring that product development and quality control can proceed in parallel. They also highlighted the importance of selecting the right CDMO partners to support full collaboration. Furthermore,they suggested that efforts should begin early in the R&D phase,with active communication with regulatory agencies to enhance the understanding of new technologies and methods,and a clear supply chain map should be created to ensure stable supply.

Regarding future trends,the experts believe that AI technology will play a key role in optimizing gene therapy design,improving production efficiency,and advancing automation processes. They are confident that,with ongoing technological advancements and increasing market competition,the price of CGT therapies will gradually decrease,making them a widely accessible treatment option.

R&D and manufacturing in the cell and gene therapy field require substantial financial investment,with long return cycles,making funding pressure a key constraint on industry growth. In the closing fireside chat,"Navigating the Future of CGT: Insights from Investors,"was moderated by Dr. Kelly Shi,Senior VP & Research Analys at Jefferies LLC,Dr. Josh Resnick,Senior Managing Director at RA Capital Management,and Mr. Ping Shek,Managing Director at Stifel's Investment Banking Division,discussed the investment landscape for CGT.

The speakers shared their investment insights in the CGT field,reviewing the evolution of the sector from its early boom to the current adjustment phase. When discussing investment strategies,the participants highlighted key considerations such as addressing patient needs,reducing uncertainty in research and development as well as manufacturing,and increasing commercialization success rates. They also emphasized the need for continued innovation in reducing manufacturing costs.

Regarding the investment trend in CGT,despite market fluctuations,signs of recovery began to emerge in 2023,indicating a positive outlook for future capital inflows. Currently,investment behavior is becoming more cautious,and the market is steadily moving toward normalization. Furthermore,the evolving regulatory environment and changes in reimbursement policies have had a profound impact on investment decisions. Addressing infrastructure development and therapy accessibility is viewed as a core driver for the sustained growth of the industry.

The GenScript Biotech Global Forum concluded successfully with engaging discussions from experts and scholars. This event brought together global leaders from the biopharmaceutical industry,who shared valuable experiences and unique insights,injecting fresh momentum into the continued development and innovation of the global cell and gene therapy sector. Moving forward,GenScript Biotech remains committed to building more open and inclusive collaboration platforms to drive innovation and progress in the field of cell and gene therapy. As an annual event,the GenScript Global Forum will continue to uphold its core focus of "patient-centered" goals,advancing scientific innovation and market applications in cell and gene therapies,bringing greater hope for a healthier global future.

About GenScript Biotech Corporation

GenScript Biotech Corporation (HK.1548) is a world leader in technologies and services for life science R&D and manufacture. Built upon its solid DNA synthesis technology,the company comprises four major business units: a life-science services and products business unit,a biologics contract development and manufacturing organization (CDMO) business unit,an industrial synthetic products business unit,and Cell Therapy Business Unit. GenScript accelerates scientific discovery and therapeutic breakthrough with its customers. Since its founding in New Jersey,USA in 2002,GenScript has expanded its operations to serve more than 200,000 customers across 100 countries with a dedicated team of 5060 employees. As of June 30,2024,over 100,000 peer-reviewed journal articles worldwide had cited GenScript 's services and products. Guided by its mission to make people and nature healthier through biotechnology,GenScript strives to become the most trustworthy biotech company in the world.

For more information,please visit GenScript Biotech's official websitehttps://www.genscript.com