China's In Vivo CAR-T Landscape: Technology, Ecosystem, and Clinical Innovation Momentum

— Insights from China’s rapidly evolving next-generation cell therapy field

In Vivo CAR-T—directly delivering CAR genes into the human body to engineer immune cells in situ—is emerging as one of the most transformative directions in global cell and gene therapy. Compared with traditional ex vivo CAR-T manufacturing, in vivo technologies offer the promise of simplified production, reduced cost, faster turnaround, repeat dosing, and broader applicability in solid tumors.

Based on industry data, clinical progress, and ecosystem analysis, China is rapidly becoming one of the world’s most dynamic hubs for In Vivo CAR-T innovation.

A Rapidly Expanding Industry Ecosystem

After several years of development, China has formed a relatively complete In Vivo CAR-T industry landscape, with over 15 companies at advanced stages in R&D as of 2025. This growing ecosystem includes leading innovators such as:

• MagicRNA Biotechnology

• IASO Bio

• Simnova

• Pregene

• Genocury

• Immorna Bio

• Everest Medicines

• Byterna

• Immunofoco

• Legend Biotech

• Juventas

• Weitao Biotech

• Bellastem Biotechnology

• Starna Therapeutics

Geographic clustering accelerates innovation

Industry distribution demonstrates a high degree of geographic concentration:

• Yangtze River Delta: 67% of all companies

• Beijing–Tianjin region

• Greater Bay Area (Shenzhen–Guangzhou–Hong Kong)

Together, these three innovation clusters account for over 80% of companies and market activity. Such clustering strengthens technology exchange, talent flow, and resource sharing—key drivers behind China’s accelerating progress.

Core Technology Trends: Delivery Systems + CAR Architecture

China’s In Vivo CAR-T innovation centers on two fundamental technology pillars:

1. Delivery systems

A dual-track viral + non-viral landscape has formed.

Non-viral systems (LNP-led)

Domestic innovations focus on:

• Targeting ligand engineering

• Lipid structure optimization

• Enhanced encapsulation efficiency

MagicRNA Biotechnology developed a CD8 nanobody-conjugated LNP for T-cell-specific delivery, significantly improving targeting precision. Weitao Bio uses a proprietary LNP targeting system that increases T-cell tropism while reducing off-target risk.

Viral systems (T-cell-targeted lentivirus)

Innovation focuses on enhancing targeting and safety.

For example, Immunofoco’s IMV101 uses:

• A modified MxV envelope protein for improved viral tropism

• A next-generation T-cell targeting module (TCM3)

• Efficient and selective T-cell infection in vivo

China’s Clinical Research Acceleration: “From Concept to Clinic”

China now has 10+ preclinical or early clinical In Vivo CAR studies, many of which are IIT studies conducted in leading hospitals. Thanks to mature gene therapy clinical platforms, abundant patient resources, and streamlined ethics reviews, China can move from preclinical study to first-patient-in at exceptional speed. GCP ClinPlus was able to launch an IIT study in 2 months.

GCP ClinPlus: A Key Enabler of In Vivo CAR-T Clinical Translation

As one of China’s most experienced CROs in cell and gene therapy, GCP ClinPlus has become a major force supporting the industry’s rapid rise.

Our experience includes:

• 80+ CGT clinical studies across autoimmune diseases, hematologic malignancies, and solid tumors

• 35 Investigator-Initiated Trials (IITs) supported across China’s top academic hospitals

• Deep collaborations with major Class-A tertiary hospitals in oncology, immunology, neurology, and rare diseases

• Helping EU and U.S. biotech companies designing & implementing In Vivo CAR-T IIT studies in China

With over 22 years in China’s clinical ecosystem and proven success supporting early-phase, complex, and high-risk studies, GCP ClinPlus provides:

• Regulatory strategy and IND/IIT pathway consulting

• Protocol, risk management, and clinical operations support

• Vendor management and partnership with top CGT CDMOs in China

• Biometrics, data science, and AI-enabled quality oversight

• Access to China’s largest clinical networks for rapid enrollment

Our mission is to help global innovators efficiently validate next-generation cell and gene therapies in China—accelerating safe, high-quality, and impactful clinical progress.

China’s Future in In Vivo CAR-T

In Vivo CAR-T represents the next major frontier in cell therapy. With a fast-building innovation ecosystem, world-leading patient access, and strong policy support, China is positioned to become one of the most important global centers for:

• Delivery technology innovation

• CAR structure engineering

• Translational research

• Early-phase clinical development

• IIT-driven exploratory therapies

CROs like GCP ClinPlus, with deep local expertise and global-standard quality systems, are enabling this progress—helping bridge scientific innovation and clinical reality.