Bringing cutting-edge innovation to more patients and expanding access to CAR-T therapy through advanced manufacturing in China

 

CAR-T cell therapy brought new hope for a cure to patients with relapsed or refractory hematologic malignancies. Yet the high cost, often described as “RMB 1 million per infusion,” put that hope out of reach for many patients and their families.

 

That is now beginning to change.

 

With the official release of China’s 2026 National Reimbursement Drug List (NRDL), relevant indications for Carteyva® (relmacabtagene autoleucel injection), the CAR-T product independently developed by JW Therapeutics, have been included in China’s basic medical insurance coverage. Carteyva® is the only CAR-T product added to the NRDL in this update.¹

 

This marks an important milestone in the development of China’s CAR-T industry.

 

The shift from having a treatment available to being able to afford it goes beyond a reimbursement milestone for one innovative medicine. It means that advanced cell therapy has the potential to reach a broader patient population.

 

Technological innovation lowers costs, insurance coverage expands access, and patients benefit from advances in treatment.

 

This is why JW Therapeutics has invested over many years in clinical research, technological innovation, and the capabilities needed to manufacture at commercial scale.

 

 

1. Lowering Financial Barriers to Treatment

For patients with relapsed or refractory lymphoma, every treatment option matters.

 

CAR-T cell therapy has provided a new option for some patients who did not respond adequately to prior treatment. Historically, however, the high cost has been a major barrier to wider use.

 

The inclusion of relevant Carteyva® indications in China’s basic medical insurance program will help reduce the financial burden on patients who meet the reimbursement criteria and give more patients with a clinical need the opportunity to receive CAR-T therapy.

 

With stronger reimbursement support, a treatment that offers hope in the clinic can become a practical option for more patients.

 

As the reimbursement policy takes effect, CAR-T therapy is expected to be more fully integrated into clinical decision-making, helping clinicians identify patients who may benefit, refer them through appropriate pathways, and assess them in a timely manner.

 

For JW Therapeutics, reimbursement is an important commercial milestone and a step toward the company’s longstanding goal of improving patient access.

 

 

2. Eight Years of Clinical Follow-up

Whether an innovative therapy can deliver meaningful benefits for patients must ultimately be assessed through robust clinical evidence and continued use in practice.

 

Carteyva® was the first CAR-T product approved in China as a Category 1 biologic and is currently the only CAR-T product in China approved for three lymphoma indications.² Since its launch, the company has continued to gather long-term follow-up data from registrational clinical studies and build experience with the product in real-world practice.

 

As of October 31, 2026, key clinical and commercial milestones for Carteyva® included:

8 years — the longest follow-up in a registrational clinical study.

1,200+ patients — more than 1,200 patients have received Carteyva®.

200+ centers — the product is available through more than 200 certified treatment centers nationwide.³

Carteyva® has also been recommended for clinical use in leading Chinese medical guidelines.⁴ Its post-marketing real-world study (CTR20221920) enrolled 200 patients, adding to the body of efficacy and safety data collected in routine clinical practice.⁵

 

The evidence gathered from registrational studies, long-term follow-up, and real-world use across multiple centers supports appropriate clinical use of Carteyva® and continued assessment of its clinical value.

 

Establishing clinical value takes time. Better reimbursement coverage gives more patients the opportunity to benefit from treatments whose value has been documented in clinical practice.

 

 

3. Individualized Manufacturing and Reliable Delivery

Expanding access to CAR-T therapy requires more than lowering the financial barrier. It also raises an important question.

 

As more patients gain access to treatment, can high-quality products be supplied reliably and consistently?

 

Unlike conventional medicines, autologous CAR-T therapy is highly individualized. Each batch starts with a patient’s own cells and goes through complex manufacturing, quality testing, and delivery processes.

 

An established commercial manufacturing system is therefore essential to bringing CAR-T from a pioneering technology into wider clinical use.

 

JW Therapeutics’ commercial manufacturing facility in Suzhou has six independent production modules. Its modular manufacturing, standardized processes, and end-to-end quality management system underpin its commercial CAR-T manufacturing and delivery capabilities.⁶

 

Since the commercialization of Carteyva®, JW Therapeutics has maintained:

A 99% first-pass manufacturing success rate

A 100% product delivery rate

This performance reflects years of investment in technical capabilities, quality management, and commercial operations.

 

The company continues to optimize manufacturing processes, upgrade facilities, and improve operational efficiency. It adheres to Good Manufacturing Practice requirements and prioritizes product quality and patient safety as it strengthens the reliability of manufacturing and delivery.

 

Reaching more patients takes more than developing a good medicine. It also requires the ability to manufacture and deliver it reliably over time.

 

If demand increases after reimbursement takes effect, JW Therapeutics’ established commercial manufacturing system will help more patients receive high-quality CAR-T therapy in a timely manner.

 

 

4. How Manufacturing Innovation in China Supports Long-Term Access

Reimbursement creates a pathway to treatment. Continued innovation and cost optimization help keep that pathway open over the long term.

 

CAR-T is a technically complex therapy with several demanding and costly manufacturing steps. Lentiviral vectors, a key raw material in CAR-T manufacturing, have long been sourced from high-cost imports, making it harder to reduce manufacturing costs and scale up production.

 

Lower prices alone cannot sustain long-term access to CAR-T therapy. Companies also need to solve the technical problems that drive costs and use their own innovations to bring manufacturing costs down materially.

 

In recent years, JW Therapeutics has increased investment in its own core cell therapy manufacturing technologies and made significant advances in lentiviral vectors.

 

The company’s in-house suspension lentiviral vector (sLVV) manufacturing platform brings together process development, commercial-scale manufacturing, and quality control capabilities.⁷ By developing core processes in-house, improving efficiency, and sourcing key raw materials domestically, the company expects to substantially reduce its reliance on high-cost imported viral vectors. This would address a major source of CAR-T manufacturing costs and give the company more control over its supply chain.

 

The company’s proprietary manufacturing technology has significant potential for use at commercial scale and has gained recognition from leading international biopharmaceutical companies.

 

In 2025, JW Therapeutics signed a lentiviral vector manufacturing process licensing agreement with Bristol Myers Squibb (BMS), a global leader in CAR-T, bringing core manufacturing technology developed by JW Therapeutics to a leading international CAR-T company.⁸

 

JW Therapeutics also expanded its strategic collaboration with Regeneron to include a license to its proprietary drug product manufacturing process and granted Regeneron an option to license its lentiviral vector manufacturing process.⁹

 

JW Therapeutics has progressed from bringing in advanced technology from abroad to developing core processes independently and licensing technology to leading global pharmaceutical companies. That progression shows how far the company’s technical capabilities have come and illustrates the capacity of Chinese cell therapy companies to innovate and compete internationally.

 

These advances also answer a key question. Does materially lowering manufacturing costs mean compromising product quality?

 

Quite the opposite. JW Therapeutics is lowering manufacturing costs without lowering quality standards. It is doing so through technical advances without compromising on quality.

 

Licensing its core manufacturing processes to leading international pharmaceutical companies demonstrates the technology’s sophistication and potential for industrial application. As JW Therapeutics reduces costs and improves efficiency, it continues to apply strict manufacturing quality standards and to safeguard product quality and patient safety through ongoing process optimization, quality control, and regulatory compliance.

 

High quality and lower costs can go hand in hand. Solving technical challenges in-house and improving efficiency through advanced manufacturing are important to the sustainable development of China’s cell therapy industry.

 

JW Therapeutics will continue to improve its core manufacturing processes, increase domestic sourcing of key raw materials, and refine production operations. The company aims to improve efficiency and optimize its cost structure while upholding product quality and patient safety, laying the groundwork for a reliable long-term supply of CAR-T therapies.

 

Advances in technology can translate into cost advantages. Advanced manufacturing in China can support internationally competitive quality and help more patients benefit from innovative treatments.

 

 

5. Reimbursement and the Next Generation of Cell Therapy

The inclusion of Carteyva® in China’s basic medical insurance program gives more eligible patients a chance to receive treatment and creates new opportunities for China’s cell therapy industry.

 

As access expands, wider use of CAR-T could generate more real-world experience and help strengthen clinical care pathways, treatment center networks, and the broader cell therapy ecosystem.

 

These developments could also create better conditions for the research, development, and clinical translation of next-generation cell therapy technologies.

 

Reimbursement is a starting point for bringing further innovations to patients.

 

Building on its commercial experience, clinical development capabilities, and proprietary technology platforms, JW Therapeutics is accelerating the development of next-generation cell therapies.

 

JWCAR239, an internally developed autologous CAR-T candidate with two targets and two armoring elements, has first-in-class potential. Its CD19/CD20 dual-target design and two armoring elements are being explored for their potential to improve treatment efficacy and durability.¹⁰

 

JW Therapeutics is also advancing its proprietary in vivo CAR-T technology platform. The company has made progress in developing and optimizing key components, including lentiviral vector envelope fusion proteins, as it continues to explore the potential for clinical translation of next-generation cell therapy technologies.¹¹

 

From ongoing improvements to its first-generation commercial product to research into next-generation autologous and in vivo CAR-T technologies, JW Therapeutics is building a broader and more differentiated cell therapy portfolio.

 

The company aims to bring today’s innovations to more patients and create more opportunities for tomorrow’s treatments.

 

JW Therapeutics will continue to put patient benefit first, invest in proprietary technologies, and maintain high manufacturing standards. It will advance research, clinical translation, and adoption at scale to contribute to the continued development of cell therapy in China and globally.

 

Feng Tian, Chairman and Chief Executive Officer of JW Therapeutics, said:

• “Cell and gene therapy is at the forefront of global biopharmaceutical innovation and competition. CAR-T therapy has brought new hope for a cure to some patients with relapsed or refractory hematologic malignancies. Yet the high cost, often described as ‘RMB 1 million per infusion,’ put that hope out of reach for many patients and their families.

 

• “Today, with relevant Carteyva® indications now covered by China’s basic medical insurance program, we are seeing a major step forward in access to CAR-T therapy.

 

• “Moving from having a treatment available to being able to afford it is an important step in bringing China’s innovative medicines to patients. It is something we have worked toward for years.

 

• “This progress was made possible first and foremost by the strong support of China’s national reimbursement policy. It also reflects years of sustained investment by JW Therapeutics in clinical research, technological innovation, and commercial-scale manufacturing.

 

• “What is especially encouraging is that our own research and development has delivered important breakthroughs in key manufacturing technologies, including lentiviral vectors. These advances have laid the groundwork for further cost optimization and enabled us to license core technology to leading international pharmaceutical companies.

 

• “This has reinforced our belief that Chinese biopharmaceutical companies can develop world-class treatments and make them more accessible through their own innovation and high-quality manufacturing.

 

• “Innovation lowers costs, reimbursement broadens access, and reasonable returns support further innovation. We hope this cycle will help build a healthier and more sustainable cell therapy industry in China.

 

• “The value of innovation lies not only in how far technology can advance, but also in how many patients it can genuinely help.

 

• “JW Therapeutics will stay true to that purpose, bringing innovation from the laboratory to the manufacturing floor, into clinical practice, and ultimately into the lives of more patients.”
  

 

 

Notes and References

1. National reimbursement and scope of exclusivity. Based on the 2026 edition of the National Drug List for Basic Medical Insurance, Maternity Insurance, and Work-Related Injury Insurance, as officially published by the National Healthcare Security Administration (NHSA). “Only” refers to CAR-T cell therapy products included in that edition of the NRDL and excludes the Commercial Health Insurance Innovative Drug Directory. The scope of coverage, effective dates, and reimbursement rules are subject to official national and local medical insurance policies.

 

2. Marketing approval and indications. Based on registration approval information published by the National Medical Products Administration (NMPA) and the current approved prescribing information for relmacabtagene autoleucel injection. The product received marketing approval in September 2021 and was subsequently approved for a total of three adult indications in large B-cell lymphoma (LBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). “First” and “only” refer to CAR-T products approved for marketing in mainland China as of November 14, 2026.

 

3. Clinical follow-up and commercial data. Data as of October 31, 2026. The longest follow-up is from a registrational clinical study of Carteyva®. The cumulative number of patients treated and the number of certified treatment centers are from JW Therapeutics’ internal commercial data. Data on file, JW Therapeutics.

 

4. Clinical guideline recommendations. Chinese Society of Clinical Oncology (CSCO). CSCO Guidelines for the Diagnosis and Treatment of Lymphoma (2025). See the original guidelines for the relevant sections and specific recommendations.

 

5. Post-marketing real-world study. Post-marketing real-world study of relmacabtagene autoleucel injection, registration number CTR20221920. Actual enrollment as of October 31, 2026 is based on study records. Data on file, JW Therapeutics.

 

6. Manufacturing and delivery data. JW Therapeutics commercial manufacturing and quality management records. The 99% first-pass manufacturing success rate and the 100% product delivery rate are historical figures since Carteyva® was commercialized. Definitions and calculation methods are based on the company’s internally verified manufacturing quality data. See JW Therapeutics’ September 8, 2026 press release and related company disclosures.

 

7. In-house lentiviral vector and regulatory status. JW Therapeutics. NMPA Accepts Post-Marketing Supplemental Application for the Use of a Domestically Produced Viral Vector in Carteyva®. October 9, 2025. Implementation of the relevant process change is subject to formal regulatory approval.

 

8. Juno technology license. JW Therapeutics. JW Therapeutics Announces sLVV License Agreement with Juno Therapeutics. April 18, 2025.

 

9. Regeneron technology collaboration. JW Therapeutics. JW Therapeutics and Regeneron Expand Strategic Collaboration Agreement to Advance TCR-T Cell Therapy Development. October 30, 2025. The scope of the licenses, the option, and the conditions for effectiveness are subject to the company’s announcements and the relevant agreements.

 

10. JWCAR239 research data. JW Therapeutics. JWCAR239: An enhanced anti-CD19/CD20 dual CAR-T therapy enabled by armored modules for persistence, co-stimulation and immune shielding. ASGCT 2026, Abstract 3249. The findings are primarily preclinical and do not establish clinical efficacy or safety.

 

11. In vivo CAR-T research progress. JW Therapeutics’ in vivo CAR-T platform research and development records. As of publication, the relevant technologies remain under investigation. The progress described does not indicate that a product has received marketing approval. Data on file, JW Therapeutics.

 

 

Important Information

This article provides information on JW Therapeutics’ corporate development, research and development, and relevant reimbursement policies. It is not intended as a basis for individual diagnosis, treatment decisions, or medication use.

 

Carteyva® (relmacabtagene autoleucel injection) is a prescription medicine. Refer to the latest prescribing information approved by China’s drug regulatory authorities for the approved indications, eligible patient populations, dosage and administration, contraindications, and adverse reactions. A qualified physician should assess whether CAR-T therapy is appropriate and determine the treatment plan based on the individual patient’s circumstances. Clinical outcomes may vary.

 

Reimbursement is subject to the scope of national medical insurance coverage and applicable local policies. Reimbursement rates and out-of-pocket costs may vary according to insurance enrollment type, location of treatment, and other factors.

 

Investigational products, technologies under development, plans to optimize manufacturing processes, and forward-looking statements in this article are subject to uncertainty. They do not imply that the products or technologies have received regulatory approval and do not guarantee future research outcomes, product performance, or commercial progress.