JW Therapeutics Announces JWCAR201 IIT Study Data at the 67th American Society of Hematology Annual Meeting
Shanghai, China, December 8, 2025 – JW Therapeutics (HKEx: 2126), an independent innovative biotechnology company focused on the development, production and commercialization of cellular immunotherapy products, announced the release of JWCAR201 IIT research data at the 67th American Society of Hematology Annual Meeting.
About JWCAR201
JWCAR201 is an autologous CAR-T product independently developed by JW Therapeutics targeting CD19/CD20.
JWCAR201 IIT Research Data Summary
The updated data comes from a single-arm, open-label, multi-center, dose-finding IIT study conducted in China. The starting dose was set at 25×10⁶ CAR+ T cells. The dose-finding rules of the two-stage CRM design were adopted. After 25×10⁶ CAR+ T cells, 50×10⁶ CAR+ T cells, and 100×10⁶ CAR+ Three dose levels of T cells were explored to evaluate the safety and preliminary efficacy of the CAR-T cell product JWCAR201 in patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
As of October 30, 2025, 7 subjects enrolled in this study have completed the reinfusion of JWCAR201, and have initially completed the exploration of the safety, efficacy, pharmacokinetics and pharmacodynamics (PK/PD) of the three dose groups.
The median age of the 7 patients reinfused in this study was 56 years old (range: 42 to 72 years old), and 42.9% were male. This cohort of patients showed significant high-risk characteristics: 85.7% DLBCL-NOS, 57.1% non-GCB subtype, 57.1% International Prognostic Index (IPI) score ≥3, 71.4% dual-expression lymphoma (MYC/BCL2), 28.6% giant lesions (≥7cm), and 42.9% P53 abnormalities. In addition, 42.9% of patients had received ≥3 lines of treatment in the past, 71.4% of patients were primary refractory, and 85.7% of patients were resistant to the latest treatment regimen. All patients had received a variety of treatment options before participating in this study, but the disease still progressed and new effective treatments were urgently needed.
As of October 30, 2025, preliminary results of this study show that among 7 patients, the best overall response rate (ORR) reached 100% (7/7), and the complete response rate (CRR) reached 85.7% (6/7). Except for one patient who withdrew from the study after partial response (PR) at D90, the response of the remaining 6 patients continued to D180 or during longer follow-up. The median duration of response (DOR), progression-free survival (PFS) and overall survival (OS) have not yet been reached, and a significant initial effect has been shown.
Preliminary safety results show that among the 7 patients who have been reinfused: 3 patients (42.9%) developed grade 1 cytokine release syndrome (CRS); 1 patient (14.3%) developed grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS). There were no high-grade CRS or ICANS, and no dose-limiting toxicity (DLT) occurred. Other Adverse Events: All patients experienced treatment-related adverse events, primarily hematological toxicities that were expected and controllable, including neutropenia, thrombocytopenia, and anemia, and all patients recovered to baseline or fully recovered. The safety results of this study show that JWCAR201 is safe and controllable in the treatment of r/r DLBCL.
As of now, this study is still ongoing to accumulate data with a longer follow-up period.
Based on the above research results, we believe that JWCAR201 has excellent efficacy, good overall safety, and controllable adverse reactions, showing great potential to quickly advance to the IND stage. We will continue our efforts to accelerate the development of this innovative treatment.
About JW Therapeutics
JW Therapeutics (HKEx code: 2126) is a biotechnology company with cellular immunotherapy innovation as its core. The company was co-founded by WuXi AppTec and Juno Therapeutics in 2016. It combines international cell therapy research and development experience with China's local industrialization capabilities and is committed to promoting the research and development, production and commercialization of cellular immunotherapy products and improving the accessibility of innovative treatments in China and the global market. We continue to build integrated platform capabilities covering academic discovery, process development, manufacturing, quality management and clinical application. Focusing on hematological tumors, solid tumors and autoimmune diseases, we continue to promote R&D pipelines with differentiated potential, and have established a system covering commercial production and full-process quality management. Adhering to the concept of "healing the present with innovation and reshaping the new life with vision", JW Therapeutics is committed to bringing more high-quality cellular immunotherapy options to patients and bringing hope of cure to patients in China and around the world.
About relmacabtagene autoleucel Injection (trade name: Carteyva®)
Relma-cel Injection (relma-cel for short, its trade name for hematological tumor indications: Carteyva®) is an autologous CAR-T cell immunotherapy product targeting CD19 independently developed by JW Therapeutics based on the CAR-T cell technology platform of Juno Therapeutics (a subsidiary of Bristol-Myers Squibb). As the first product of JW Therapeutics, relmacabtagene autoleucel Injection has been approved by the China National Medical Products Administration for three indications, including the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) in adult patients after second-line or above systemic therapy, and the treatment of refractory or relapsed follicular lymphoma within 24 months (r/r) in adults after second-line or above systemic therapy. FL), and for the treatment of adults with relapsed or refractory mantle cell lymphoma (r/r MCL) who have undergone second-line and systemic treatment including Bruton's tyrosine kinase inhibitor (BTKi) treatment, becoming the first CAR-T product approved as a Class 1 biological product in China. Carteyva® is also a Class 1 new drug CAR-T cell immunotherapy product that has won three awards: the "Major New Drug Creation" project, the priority review qualification for new drug marketing applications, and the breakthrough therapeutic drug designation.
forward-looking statements
The forward-looking statements contained in this release are based on management's current expectations and beliefs and are subject to certain uncertainties or risks that could cause actual results to differ materially from those described. Significant risks and uncertainties may include those discussed below and are more fully described in the company's reports filed with the Hong Kong Stock Exchange (HKEx). Unless otherwise noted, the Company provides information as of the date of publication and expressly undertakes no obligation to update matters and their content or to provide any explanations. For specific content, please see the company’s official website: www.jwtherapeutics.com/cn/forward-looking-statements/