East Asia's Cell and Gene Therapy Landscape: Latest Advancements and Pipelines
East Asia is quickly becoming a global hub for cell and gene therapy (CGT), with countries like China, Japan, South Korea, and Taiwan leading the charge.This eBook offers a snapshot of the latest trends, partnerships, and pipeline developments driving CGT innovation across East Asia.
Cell and Gene Therapy (CGT) is transforming the treatment landscape for cancer, rare diseases, and degenerative conditions. East Asia comprising of China, Japan, South Korea, and Taiwan has emerged as a global innovation hub, driven by:
- Supportive regulatory frameworks
- World-class clinical research
- Growing Manufacturing capacity
- Strong public–private investments
- CAR-T Leadership: As of 2024, there is over 400 CAR-T in the pipeline and 300 active CAR-T trials in China. Approvals include Yescarta (Fosun Kite) and Relma-cel (JW Therapeutics). BCMA-targeted therapies from CARsgen and IASO Bio are advancing rapidly.
- Cell and Gene Therapy Momentum:
- Late-stage progress for Novartis’s Zolgensma (SMA) and Neurophth’s NR082 (LHON).
- CSPC Pharmaceutical Group received approval in June 2024 to conduct clinical trials for SYS6020, an mRNA-LNP-based cell therapy targeting multiple myeloma, marking China's first approval for such a therapy.
- Manufacturing & CDMO:
- WuXi Biologics received EMA GMP certification for five facilities.
- Joinn Biologics acquired Lonza’s former Guangzhou biologics plant to expand CGT CDMO capabilities in China in 2025.
- Porton Advanced became the first CDMO in China to use clinical-grade flow electroporation for non-viral gene editing.
- Bayer Co.Lab and MilliporeSigma expanded operations in Shanghai.
- Regulatory: Highest among the region with 21 regenerative medicine products approved by the MHLW, including 4 gene therapies.
- iPSC & Innovation:
- Heartseed is advancing its Phase I/II clinical trial for HS-001, an iPSC-derived cardiomyocyte therapy aimed at treating heart failure.
- Astellas and Osaka University developing cartilage cell therapies using iPSCs.
- Shinobi Therapeutics partners with Panasonic for a next-gen CGT platform.
- I Peace and iCamuno Biotherapeutics initiate NK cell trials for ovarian cancer.
- Manufacturing:
- AGC Biologics is building a new CGT facility in Yokohama, bolstering domestic manufacturing capacity.
- Astellas and Yaskawa to establish joint venture in Japan focused on robotic cell therapy manufacturing.
- Shinobi partners with Panasonic to develop an innovative cell therapy manufacturing platform.
- Regulatory:
- Effective from February 21, 2025, the Regenerative Medicine Law allows patients with severe, rare, or incurable conditions to access unapproved cell and gene therapies under certain conditions.
- 15 CGT products now approved (12 cell, 3 gene). New policies are expanding access to regenerative medicine for serious illnesses.
- Company Milestones:
- Cha Biotech licensed its cell differentiation technology to Astellas for $32 million.
- Medipost pioneered and commercialized Cartistem®, the world’s first allogeneic stem cell therapy from umbilical cord blood for knee osteoarthritis, generating $14.4 million in annual sales.
- Helixmith’s gene therapy Engensis (VM202) earns FDA RMAT designation, advancing in Phase 3 trials for diabetic complications and Phase 2 for ALS and heart disease.
- GC Cell and DAAN Biotherapeutics signed an exclusive technology transfer agreement to advance CAR-T and CAR-NK therapies, while also partnering with Taiwan's Lukas Biomedical to advance cell therapies in Korea and Taiwan.
- Manufacturing:
- VaxCell-Bio secures approval for manufacturing license and cell processing facility, advancing Korea’s first regenerative heart failure trial.
- SK Bioscience acquired Germany’s IDT Biologika to strengthen CGT manufacturing.
- MilliporeSigma invested $326M into its Korean site for CGT production.
- ENCell expands global reach through collaboration with Thermo Fisher and Japan market entry via MOU with Cell Resources.
- Trial Growth: 102 cell and 51 gene therapy trials reported by TFDA in 2024 which is a 28% increase in cell therapy trials, 82% increase in gene therapy trials since 2022.
- Company Milestones:
- Steminent Biotherapeutics completed Phase 2 trials with positive results for Stemchymal® , , an allogeneic MSC therapy for spinocerebellar ataxia (SCA) which granted orphan drug designation in U.S. and Japan
- Medigen Biotech’s Magicell-NK therapy approved for advanced-stage solid tumors. (Jan 2025)
- StemCyte to list on the Taipei Stock Exchange after receiving FDA BLA for REGENECYTE™ at the end of 2024.
- Budding CDMO ExpansionManufacturing:
- Locus Cell and Hitachi’s Zhubei facility projected to become Asia’s largest CGT production base by 2025.
- TFBS Bioscience and Minaris Regenerative Medicine formed a major CDMO alliance.
- Hexun Bioscience signed a US$6M MSC technology licensing deal to enhance production.
Closing Remarks Driven by robust pipelines, advanced manufacturing, and supportive policies, China, Japan, South Korea, and Taiwan are reshaping the global cell and gene therapy (CGT) landscape. These East Asian leaders are translating scientific breakthroughs into real-world treatments—faster, smarter, and at scale. As innovation continues to accelerate, the region is poised to deliver safer, more personalized, and transformative therapies for patients across the globe.
Cell & Gene Therapy East Asia 2025
Powering Innovation in Cell & Gene Therapy Across East Asia
📍 Songdo Convensia, Incheon, South Korea 📆 25 September 2025
2025 SPEAKERS
Heon-Ju Lee
CEO, CarBio Therapeutics, South Korea
James Lin
Chief Science Officer, Medigen Biotechnology, Taiwan
Cheng-Yi Jerry Kuo
Vice General Manager, UWELL Biopharma, Taiwan
KwangJun Yoon
Managing Director, CHA Biotech, South Korea
Seokjoong Kim
Chief Strategy Officer, GenEdit, South Korea
Manh-Cuong Vo
General Manager, R&D Center, Vaxcell-Bio, South Korea
Bryan Choi
ISCT Asia Regional Vice-President and Professor, Inha University, Korea
Sungjun Yoon
CEO, Fortuga Bio,South Korea
Phil Huang
Technical Director, StemCyte, Taiwan
Chaemin Lim
Director of EV/Exosome Center, CHA Advanced Research Institute, Korea
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