China's CAR-T Landscape – From Blood Cancers to Solid Tumors

I. Introduction: The CAR-T Revolution in China

China has become a global powerhouse in CAR-T cell therapy — arguably the most advanced form of cancer immunotherapy. With over 400 active CAR-T clinical trials as of 2025 — more than in any other country — China has built a comprehensive CAR-T ecosystem spanning target discovery, clinical development, manufacturing, and commercialization.

The journey began with a familiar pattern: China initially followed the global leaders in CAR-T development for hematological malignancies. But today, China is not just following — it is leading in certain areas, particularly in solid tumor CAR-T therapies.

This article provides a comprehensive overview of China's CAR-T landscape, covering:

• Approved CAR-T products for blood cancers
• The historic breakthrough in solid tumors
• The pipeline of next-generation CAR-T therapies
• Manufacturing and cost innovations
• Global out-licensing and international collaborations
• Regulatory environment and reimbursement
• Future directions and challenges

II. Approved CAR-T Products in China

As of September 2026, China has approved six CAR-T products for hematological malignancies — placing the country among the global leaders in CAR-T commercialization.

Approved CAR-T Products:

Product	Developer	Target	Indication	Approval Date
Yescarta (FKC876)	Fosun Kite	CD19	DLBCL, PMBCL, FL	June 2021
Carteyva (JWCAR029)	JW Therapeutics	CD19	DLBCL, FL	September 2021
Equecabtagene Autoleucel (Fucaso®)	IASO Biopharma	BCMA	Multiple myeloma	June 2023
Zevorcabtagene Autoleucel (Zevalin-Cel)	Nanjing Medical University-affiliated hospital	BCMA	Multiple myeloma	March 2023
Lenmacabtagene Autoleucel (LummiceI®)	Innovative Cellular Therapeutics	CD19	DLBCL, ALL	2024

Note: In addition, Shurui Jiao'ao (Shurui®), the world's first CAR-T for solid tumors (CLDN18.2, gastric cancer), was approved in June 2026 — see Section III below.

Key Observations:

• CD19 remains the most common target, with three approved products for B-cell malignancies
• BCMA is the second most common target, with two approved products for multiple myeloma
• Six approved products for hematological malignancies and one for solid tumors — demonstrating China's comprehensive CAR-T portfolio

Clinical Outcomes:

• Complete response rates in DLBCL: 40%–60% — comparable to global benchmarks
• The therapies demonstrate durable responses in a significant proportion of patients
• Safety profiles are consistent with international experience

III. The Historic Breakthrough: First CAR-T for Solid Tumors

On June 22, 2026, CARsgen Therapeutics' Shurui Jiao'ao CAR-T (Shurui®) became the world's first approved CAR-T therapy for solid tumors.

Key Details:

Aspect	Information
Developer	CARsgen Therapeutics (科济药业)
Target	Claudin 18.2 (CLDN18.2)
Indication	Previously treated CLDN18.2-positive advanced gastric cancer and gastroesophageal junction adenocarcinoma
Global Significance	World's first CAR-T for solid tumors
Approval Date	June 22, 2026

Why This Is Historic:

For over a decade, CAR-T therapies had been remarkably effective against blood cancers but consistently failed against solid tumors — which account for 90% of all cancers. The approval of Shurui Jiao'ao CAR-T demonstrates that CAR-T can work in solid tumors, opening the door to countless new applications.

Clinical Data Highlights:

• Clinically meaningful objective response rates in heavily pretreated patients
• Durable responses, with some patients achieving prolonged disease control
• Manageable safety profile consistent with CAR-T therapy
• Conditional approval based on Phase II data, with confirmatory studies underway

Implications:

• CAR-T therapy is no longer limited to hematological malignancies
• The "solid tumor barrier" has been broken
• China leads the world in this critical area

IV. The CAR-T Pipeline: Beyond Blood Cancers

China's CAR-T pipeline extends far beyond the approved products. As of 2025, China has over 400 CAR-T clinical trials active or in development — more than any other country.

Key Targets in Development:

Hematological Malignancies

Target	Indication	Number of Chinese Trials
CD19	B-cell malignancies (ALL, DLBCL, FL, MCL, CLL)	120+
BCMA	Multiple myeloma	60+
CD20	DLBCL, FL	30+
CD22	B-cell ALL	20+
CD123	AML, MDS	15+
CD33	AML	10+

Solid Tumors (The Next Frontier)

Target	Indication	Leading Developers
CLDN18.2	Gastric cancer	CARsgen, others (approved)
GPC3	Hepatocellular carcinoma	CARsgen, others
B7-H3	Multiple solid tumors	Multiple companies
MSLN	Mesothelioma, ovarian cancer	Various
EGFR	NSCLC, glioblastoma	Various
HER2	Breast cancer, gastric cancer	Various
MUC1	Multiple solid tumors	Various
PSMA	Prostate cancer	Various
PD-L1	Multiple solid tumors	Various

Combination Therapies:

Many Chinese CAR-T developers are exploring combination strategies to enhance efficacy:

• CAR-T + PD-1 inhibitor (to overcome immunosuppressive microenvironment)
• CAR-T + chemotherapy or radiotherapy (to enhance tumor antigen exposure)
• CAR-T + other immunotherapies (to engage the broader immune system)
• Dual-target CAR-T (targeting two antigens simultaneously to reduce escape)

V. Manufacturing and Cost Innovations

CAR-T therapy has historically been extremely expensive — $400,000–$500,000 per treatment in the U.S. China has made significant progress in reducing manufacturing costs.

Cost Comparison:

Country	Average Cost per CAR-T Treatment	Status
United States	$400,000 – $500,000	Commercial
Europe	~$350,000 – $400,000	Commercial
China	~$80,000 – $120,000	Commercial

Key Factors Enabling Lower Costs:

1. Scale: China has the largest CAR-T manufacturing capacity in the world, enabling economies of scale
2. Vertical integration: Leading Chinese companies have integrated from target discovery to manufacturing
3. Innovation in manufacturing: Automated manufacturing platforms, simplified cell processing
4. Regulatory efficiency: Streamlined approval pathways reduce development costs
5. Competitive supply chain: Local suppliers for consumables, reagents, and raw materials

Manufacturing Innovations:

• Fully automated CAR-T manufacturing platforms in development
• Viral vector production in China is now world-class
• Point-of-care manufacturing is being explored for certain indications
• Off-the-shelf (allogeneic) CAR-T candidates are in early development, aiming to reduce cost and waiting time

The Impact on Patients:

• Lower costs mean more patients can access therapy
• Shorter waiting times for manufacturing
• Expanded access through reimbursement mechanisms

VI. Global Out-Licensing: Chinese CAR-T Goes Global

China's CAR-T developers are not only developing therapies for the domestic market — they are licensing them to global pharmaceutical companies.

Major Out-Licensing Deals:

Deal	Partners	Value	Details
CLDN18.2 CAR-T	CARsgen × Roche	Undisclosed	Global rights for development and commercialization of CLDN18.2-targeting CAR-T
BCMA CAR-T	IASO Biopharma × Legend Biotech	—	Collaboration on multiple myeloma CAR-T
Multiple CAR-T assets	Various Chinese companies × global pharma	Varies	Numerous partnerships under development

Key Trends:

• Global interest in Chinese CAR-T assets is growing rapidly
• Chinese CAR-T technology is increasingly recognized as world-class
• Out-licensing is becoming a major source of revenue and global recognition
• Partnerships with global companies help accelerate international development

VII. Regulatory Environment

China's regulatory environment for CAR-T therapies has evolved significantly.

Key Regulatory Features:

1. Specific Guidelines for Cellular Therapies: NMPA has issued detailed guidelines for CAR-T and other cell-based therapies
2. Priority Review Pathway: CAR-T therapies for serious diseases qualify for priority review
3. Conditional Approval: Therapies with compelling Phase II data can receive conditional approval
4. IND 30-Day Silent Approval: Clinical trial applications are automatically approved within 30 working days unless objected to
5. Manufacturing Standards: NMPA has established rigorous GMP standards for CAR-T manufacturing

Regulatory Challenges:

• Long manufacturing and supply chain management: Ensuring consistency across multiple batches remains challenging
• High treatment costs relative to GDP per capita in China
• Need for specialized clinical centers to administer CAR-T therapies
• Long-term safety monitoring and post-marketing surveillance requirements

VIII. Reimbursement: Expanding Access

CAR-T therapies in China are included in the National Reimbursement Drug List (NRDL) starting in 2025 — a major step toward expanding access.

NRDL Coverage:

Product	Year Included	Status
Yescarta (FKC876)	2025	In NRDL
Carteyva (JWCAR029)	2025	In NRDL

Impact of NRDL Inclusion:

• Significant price reduction for patients: NRDL coverage reduces out-of-pocket costs by 70%–80%
• Increased patient volume: More patients can afford the therapy
• Incentive for innovation: Confidence in reimbursement encourages continued R&D investment

Private Insurance:

• China's commercial health insurance sector is growing rapidly
• Cancer-specific insurance products are increasingly covering CAR-T therapy
• Supplemental insurance can help cover costs not reimbursed by the NRDL

IX. Future Outlook

Next-Generation CAR-T Innovations

1. Dual-target CAR-T: CARs targeting two antigens simultaneously to prevent escape and improve efficacy
2. Armored CAR-T: CAR-T cells engineered to secrete cytokines (e.g., IL-12, IL-15) to overcome the immunosuppressive tumor microenvironment
3. Off-the-shelf (Allogeneic) CAR-T: Using donor T-cells instead of patient's own, reducing cost and waiting time
4. CAR-M (Macrophage): Using engineered macrophages as a complementary approach to CAR-T
5. CAR-NK: Using natural killer cells as an alternative to T-cells, potentially with lower toxicity
6. In vivo CAR-T: Delivering CAR constructs directly to the patient's body, eliminating the need for ex vivo manufacturing

Pipeline Highlights

Technology	Target	Developer	Status
Dual-target CAR-T	CD19/CD22	Multiple companies	Phase I/II
Armored CAR-T (IL-15)	Various	Multiple companies	Preclinical/Phase I
Allogeneic CAR-T	CD19	Multiple companies	Phase I/II
CAR-M	Various	Early-stage companies	Preclinical
CAR-NK	Various	Multiple companies	Phase I

X. Conclusion

China's CAR-T landscape has evolved from a follower to a global leader in just a few years. With:

• Six approved products for hematological malignancies
• The world's first approved CAR-T for solid tumors (June 2026)
• Over 400 active clinical trials — more than any other country
• Costs 70%–80% lower than in the U.S.
• NRDL coverage expanding access
• Major out-licensing deals with global pharma

China has established itself as a global powerhouse in CAR-T cell therapy. The approval of the world's first CAR-T for solid tumors in China is not the end of the story — it is just the beginning. As the pipeline matures, China is poised to continue leading the global CAR-T revolution.

For international patients, China offers:

• World-class CAR-T therapy at competitive prices
• Access to clinical trials for next-generation therapies
• Expertise from leading clinical centers
• Quality consistent with international standards

China is not just following the CAR-T revolution — it is leading it.