Shanghai, China, September 8, 2026 — JW Therapeutics (HKEX: 2126), a biotechnology company dedicated to advancing innovative cell immunotherapies, announced that the post-marketing supplemental application for its proprietary anti-CD19 autologous CAR-T cell immunotherapy product Carteyva® (relmacabtagene autoleucel injection, relma-cel) has been officially approved by the National Medical Products Administration (NMPA). The supplemental application (Acceptance No. CYSB2600072) covers the extension of the cryopreservation period for T cells following cell sorting.
The approval to extend the cryopreservation period is supported by JW Therapeutics’ comprehensive process validation data. The results demonstrated that T cells cryopreserved following CD4/CD8 magnetic bead sorting can be stored for up to 36 months and, when used as starting material, can still consistently generate relma-cel products that meet predefined quality standards. This extension further enhances flexibility in CAR-T manufacturing scheduling and provides greater flexibility for the selection and implementation of individualized treatment strategies.
The starting material for autologous CAR-T cell manufacturing is derived from patients’ leukapheresis products. As part of the standardized manufacturing process for Carteyva®, T cells are first sorted and enriched from patients’ clinically collected leukapheresis products and then cryopreserved at temperatures of -130°C or below in the vapor phase of liquid nitrogen. The subsequent CAR-T cell manufacturing process is initiated according to clinical needs.
At the cell manufacturing process level, JW Therapeutics employs a differentiated approach involving the cryopreservation of highly purified T cells following cell sorting, in contrast to the commonly used industry practice of cryopreserving the entire peripheral blood mononuclear cell (PBMC) sample. This approach enables optimization of manufacturing conditions at the source and helps reduce process variability.
Leukapheresis samples from patients with non-Hodgkin lymphoma can have complex cellular compositions, with monocytes often accounting for more than 50% of the sample and with a certain proportion of granulocytes and other myeloid contaminants. These myeloid cells have relatively poor tolerance to cryopreservation. During PBMC cryopreservation and thawing, they may undergo lysis and release proteases and reactive oxygen species (ROS), potentially exerting bystander toxicity, impairing T-cell function, and reducing effective cell recovery rates[1,2]. Monocytes may also nonspecifically engulf CD3/CD28 activation beads, resulting in insufficient T-cell activation[3,4], which may in turn lead to lower viral transduction efficiency and restricted cell expansion[5,6], thereby increasing manufacturing uncertainty.
For lymphoma patients with extensive bone marrow involvement, T-cell sorting is a critical step in the manufacturing process. Carteyva® incorporates a preemptive magnetic bead-based cell sorting and purification process to remove myeloid contaminants such as granulocytes and monocytes before cryopreservation of highly purified T cells. This approach can effectively mitigate the aforementioned process challenges and help stabilize and optimize T-cell activation, transduction, and expansion throughout the manufacturing process[7,8]. It also offers better adaptability for leukapheresis samples with suboptimal initial quality, thereby supporting manufacturing consistency and stability.
In addition, cell sorting and purification may help obtain healthier CAR-T cells while avoiding the expansion of tumor cells. Therefore, T-cell sorting is now commonly used globally for lymphoma subtypes associated with extensive bone marrow involvement, such as mantle cell lymphoma (MCL).
Extending the cryopreservation period creates practical benefits across both manufacturing and clinical settings. From a manufacturing perspective, it significantly increases scheduling flexibility and expands the operational window for material inventory management and production planning, further supporting stable and continuous commercial supply.
From a clinical perspective, it can optimize the patient treatment journey. Clinicians may choose to collect patients’ autologous T cells and complete post-sorting T-cell cryopreservation at an earlier stage, when the patient’s immune status is relatively favorable. When the disease subsequently progresses to a stage where CAR-T therapy is indicated, the previously cryopreserved, high-quality T cells can be retrieved to initiate manufacturing.
This approach may help mitigate the impact of disease progression, declining physical condition, and T-cell depletion resulting from multiple prior lines of treatment, while providing additional preparation time for clinical treatment and supporting improved overall patient care and treatment outcomes.
Since the commercial launch of Carteyva®, JW Therapeutics has maintained a high level of quality and consistency in commercial manufacturing and delivery, supported by its mature and stable manufacturing process system. Since launch, Carteyva® has maintained a 99% one-time manufacturing success rate and a 100% product delivery rate. Since early 2025, the one-time manufacturing success rate has remained at 100%.
Built on a technology platform sharing common roots with Liso-cel, Carteyva® combines global expertise in cell therapy development with China’s manufacturing capabilities. As China’s first anti-CD19 CAR-T cell product approved as a Category 1 biologics product, Carteyva® integrates international cell therapy development experience with local manufacturing capabilities in China. Guided by clinical needs, JW Therapeutics continues to advance manufacturing process optimization and technological upgrades. The approval to extend the cryopreservation period represents an important advancement in the Company’s efforts to further optimize cell therapy manufacturing and refine its manufacturing processes.
Looking ahead, JW Therapeutics will continue to advance innovative cell immunotherapies, further optimize manufacturing processes, and strengthen its supply chain capabilities. Through stable, high-quality innovative cell immunotherapy products, the Company is committed to expanding access to high-quality cell immunotherapies and bringing new hope to patients in China and around the world.
References
- NMDP, Cryopreservation Frequently Asked Questions, August 2023.
- Bioscience Reports. 2019 Aug 29;39(8):BSR20191601. doi: 10.1042/BSR20191601.
- Molecular Therapy – Methods & Clinical Development. 2021 Jul 16;22:377–387. doi: 10.1016/j.omtm.2021.06.014.
- Matreyek & Engelman, Viruses, 2013; Korin & Zack, Journal of Virology, 1998.
- Cytotherapy. 2016;18(7):893–901.
- Journal of Translational Medicine. 2017 Mar 16;15(1):59; Cytotherapy. 2016;18(7):893–901.
- Molecular Therapy – Methods & Clinical Development. 2021;20:675–687.
- Journal of Clinical Oncology. 2020;38:1938–1950. Volume 38, Number 17. doi: 10.1200/JCO.19.03279.
Disclaimer
This material is intended solely to provide industry information and facilitate academic exchange, as well as to provide disease-related knowledge and raise awareness of relevant diseases. It is not intended for advertising purposes. The information contained herein is for reference only and does not constitute a recommendation for the use of any medicine. Specific diagnosis and treatment decisions should be made in accordance with the advice and guidance of qualified healthcare professionals.
About JW Therapeutics
JW Therapeutics (HKEX: 2126) is a biotechnology company dedicated to advancing innovative cell immunotherapies.
Founded in 2016 in partnership with Juno Therapeutics*, the Company combines global expertise in cell therapy development with China's manufacturing capabilities to accelerate the research, development, manufacturing, and commercialization of innovative cell immunotherapy products, improving patient access to high-quality therapies in China and worldwide.
JW Therapeutics has established an integrated platform spanning scientific discovery, process development, manufacturing, quality management, and clinical application. Focusing on hematologic malignancies, solid tumors, and autoimmune diseases, the Company continues to advance a differentiated pipeline while building robust commercial manufacturing capabilities and a comprehensive quality management system.
Guided by the vision of "Innovating cures, shaping what's next.", JW Therapeutics is committed to expanding access to high-quality cell immunotherapies and bringing new hope to patients in China and around the world.
*Juno Therapeutics is an innovative biotechnology company specializing in cell therapy research and development and is currently a wholly owned subsidiary of Bristol Myers Squibb (BMS).
About Relmacabtagene Autoleucel Injection
Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company).
Being the first product of JW Therapeutics, Carteyva® has been approved by NMPA for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors (BTKi), making it the first CAR-T product approved as a Category 1 biologics product in China.
Currently, it is the CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations.
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