CGT Rising: Navigating the Commercialization Challenges in Cell and Gene Therapy

Over the two-year pandemic, import and export trade slowed, and supply chain issues became prominent.

2021–2022, Cell and Gene Therapy（Cellular and Gene Therapy, CGT）The industry has reaped substantial rewards.

In 2021, two domestically produced cell therapy products were approved for marketing in China, bringing benefits to hundreds of patients. In early 2022, Legend Biotech’s BCMA-targeted cell therapy product received successive approvals in the United States and the European Union, marking the beginning of international expansion for Chinese cell therapies. The gene therapy sector has also seen frequent breakthroughs. In early 2021, Boya Gene’s ET-01 became the first domestically developed gene-editing therapeutic product approved to enter registrational clinical trials. Over the past year, companies such as Xinian, Neurophth, and Langxin Biologics have successively obtained clinical trial approvals, signaling that China’s gene therapy industry has officially entered the clinical era.

The sudden acceleration has propelled the cell and gene therapy industry into the spotlight, while intensifying market competition in the antibody drug sector is also driving capital toward more cutting-edge biotechnology tracks. What pain points in this burgeoning industry urgently need to be addressed? And when will it witness its next breakthrough?

On June 14, 2022, the Cell and Gene Therapy Forum will be held online. The event is hosted by VCBeat, VB100, and VCBeat New Medicine, with Legend Capital as a co-host., this event will focus on the current applications of innovative technologies in the cell and gene therapy industry, inviting leading enterprises and investors to share insights into industry development and future trends, thereby providing impetus for the growth of the cell and gene therapy sector.

From cutting-edge technologies to industrial implementation, experts and entrepreneurs shared insights on a wide range of frontier topics.

Hot Topic 1: The Future of the Gene Therapy Industry Is Here—An Analysis of Its Development Prospects

Cell and gene therapies are developing with great momentum,This Report Released by VBInsight2022 Gene Therapy Industry Research Report: Analyzing Challenges and Future Trends in Gene Therapy from the Dimensions of Technology, Manufacturing, and Commercialization. Providing Forward-Looking Trend Assessments for Entrepreneurs, Investors, and Strategic Planners to Uncover Hidden Business Logics.

Hotspot 2: Technological Innovations and Application Advances in Cell and Gene Therapy

As a promising rising star in the CGT industry, iPSCs continue to deliver positive news in clinical translation.United StatesiPSC-Derived Cell Therapy ProductsExciting clinical data continue to emerge,National Medical Products AdministrationContinuously publishing withGuidelines Related to iPSCs. As an emerging therapeutic modality that can serve as an alternative to conventional treatments, cell and gene therapy has demonstrated significant potential in the management of numerous diseases, particularly cancer, genetic disorders, and infectious diseases. With continuous advancements in technology and industrialization, the number of approved products is expected to further increase in the future.

Hot Topic 3: What Are the Pain Points and Challenges in the Clinical Translation of CGT Products?

Compared to the fields of large molecules and small molecules,CGT products, as a relatively new form of drug,Full of hope, yet full of challenges.From a clinical perspective,The higher success rate in product development within the CGT field has also brought many more effective therapies to patients,At the same time,Both clinical project initiation and clinical development face numerous challenges.InIn the field of preclinical evaluation, various guidelines have been continuously issued by the state, but at the same timePreclinical Evaluation of CGT Products: Many Challenges Remain to Be Overcome。GMP compliance is the critical path and rate-limiting step in the R&D of all novel drug modalities. What, then, are the pain points and challenges specific to CGT within the GMP landscape?

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Cell and Gene Therapy Forum Agenda

Forum Time: Afternoon of June 14, 2022

Forum Organizers: VB100, VCBeat, Artery Orange, Eggshell Research Institute, Artery New Medicine

Co-organizer: Legend Capital

14:00-14:20

Gene Therapy: Curing at the Root, the Future Is Here

Wan Yuxi | Senior Researcher, VCBeat

14:20-14:40

Frontiers in Cell Therapy R&D: The Path to Industrializing iPSC Technology in China

Ying Zhang | Co-founder of Zhongsheng Suyuan

14:40-15:00

Gene Therapy-Opportunities and Challenges

Wu Zhenhua | Founder and CEO of Hangzhou Jiayin Biotech

15:00-15:20

Gene Editing: From Cutting-Edge Technology to Accessible Therapeutics

Wang Yongzhong | Founder, Chairman, and CEO of Ruizheng Gene

15:20-15:40

Targeted Gene and Stem Cell Therapy

Liang Desheng | Deputy Director of the State Key Laboratory of Medical Genetics, Central South University

15:40-16:00

Pioneer of Next-Generation Chemically Induced Cell Therapy

Wei Jun | Founder and CEO of Ruijian Pharma

16:00-16:20

Preclinical Evaluation of Products in the CGT Field

Wang Quanjun | Deputy Dean, Suzhou Institute of Chinese Academy of Sciences for Drug Research

16:20-17:00

Expert Roundtable: Pain Points and Challenges in the Clinical Translation of CGT Products

Moderator: Wang Haotian | Vice President of Investment, Legend Capital

Wang Fenghua | CEO of Langxin Biotech

Wang Quanjun | Deputy Director of the Suzhou Institute for Drug Research, Chinese Academy of Sciences

Lu Xin’an | CEO of Xiji Biotech

Wei Jun | Founder and CEO, Ruijian Pharma