In September 2021, China’s National Medical Products Administration (NMPA) approved relmacabtagene autoleucel (relma-cel), trade name Carteyva, for adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more prior lines of therapy.
Developed by JW Therapeutics, relma-cel is the first CAR-T therapy independently developed in China and the first approved as a Category 1 biologics product in the country. It is also the sixth CAR-T therapy approved globally.
The approval was based on results from the RELIANCE study, which demonstrated high response rates, durable remission outcomes, and a manageable safety profile in heavily pretreated LBCL patients.
This milestone highlights China’s growing leadership in CAR-T innovation and expands treatment options for lymphoma patients seeking advanced cell therapy solutions.
What Does This Mean for Patients?
Large B-cell lymphoma that returns after multiple treatments can be very difficult to control. CAR-T therapy offers a different approach:
- Your own T cells are collected
- They are genetically modified to target CD19 on lymphoma cells
- The engineered cells are infused back into your body to attack the cancer
In clinical studies conducted in China, relma-cel showed:
- High overall response rates
- Encouraging durable remission results
- Lower rates of severe CAR-T-related toxicities compared with earlier-generation therapies
The approval was based on the RELIANCE study led by lymphoma specialists at Peking University Cancer Hospital, one of China’s leading cancer centers.
Why International Patients Are Watching China’s CAR-T Progress
Over the past few years, China has made remarkable progress in CAR-T research, clinical development, and large-scale manufacturing. The approval of Carteyva signals more than just a new treatment — it reflects:
- A maturing and science-driven regulatory system led by the National Medical Products Administration
- Robust clinical trial data generated at leading cancer centers
- Increasing physician experience in delivering advanced cell therapies safely
For international patients exploring options after multiple lines of treatment, China now provides access to an approved, locally developed CAR-T therapy backed by clinical evidence and growing real-world experience.
Considering CAR-T Treatment in China?
If you or your loved one has relapsed or refractory large B-cell lymphoma after multiple treatments, CAR-T therapy in China may be an option worth exploring.
A medical evaluation is required to determine eligibility, including:
- Confirmation of diagnosis
- Review of prior treatments
- Overall health assessment
Our team can assist with medical record review, hospital coordination, and treatment planning in China.