SHANGHAI, CHINA, Dec 8, 2025- JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that the Company presented IIT study data for JWCAR201 at the 67th American Society of Hematology Annual Meeting.
About JWCAR201
JWCAR201 is an autologous CAR-T product developed by JW Therapeutics that targets CD19/CD20.
JWCAR201 IIT Study Data Summary
This updated data comes from a single-arm, open-label, multicenter, dose-exploration IIT study conducted in China. The starting dose was set at 25 × 106 CAR+ T cells. A two-stage CRM-designed dose-exploration protocol was used to evaluate the safety and preliminary efficacy of JWCAR201 in patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) at three dose levels: 25 × 106 CAR+ T cells, 50 × 106 CAR+ T cells, and 100 × 106 CAR+ T cells.
As of October 30, 2025, seven enrolled subjects in this study have completed JWCAR201 infusion, and preliminary safety, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) studies have been completed across the three dose groups.
The seven patients who underwent infusion in this study had a median age of 56 years (range: 42–72 years) and 42.9% were male. Those patients have significantly high-risk characteristics: 85.7% had DLBCL-Not Otherwise Specified (NOS), 57.1% had non-Germinal Center B-cell-like (GCB) subtypes, 57.1% had an International Prognostic Index (IPI) score ≥3, 71.4% had double-expression lymphoma (MYC/BCL2), 28.6% had bulky lesions (≥7 cm), and 42.9% had abnormal P53 levels. Furthermore, 42.9% of patients had received ≥3 lines of prior therapy, 71.4% were primary refractory, and 85.7% were resistant to their most recent treatment regimen. All patients had received multiple treatments prior to this study but still experienced disease progression, highlighting the urgent need for new and effective treatments.
As of October 30, 2025, preliminary results from this study showed that the best overall response rate (ORR) reached 100% (7/7) and the complete response rate (CRR) reached 85.7% (6/7) among the seven patients. Except for one patient who withdrew from the study at D90 with partial response (PR), the remaining six patients maintained remission until D180 or longer follow-up. The median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) have not yet been reached, demonstrating significant preliminary efficacy.
Preliminary safety results showed that among the seven patients who received infusions: three patients (42.9%) experienced Grade 1 Cytokine Release Syndrome (CRS); one patient (14.3%) experienced Grade 1 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). No high-grade CRS or ICANS occurred, and no dose-limiting toxicities (DLTs) occurred. Other adverse events: all patients experienced treatment-related adverse events, mainly predictable and manageable hematological toxicities, including neutropenia, thrombocytopenia, and anemia, all of which recovered to baseline or completely recovered. The safety results of this study indicate that JWCAR201 treatment for r/r DLBCL is safe and manageable.
This study is still ongoing, in order to accumulate data over a longer follow-up period.
Based on the aforementioned findings, we believe that JWCAR201 demonstrates excellent efficacy, a favorable safety profile with manageable adverse reactions, and exhibits significant potential for rapid advancement to the Investigational New Drug stage. We will continue our efforts to accelerate the development of this innovative therapy.
About JW Therapeutics
JW Therapeutics (HKEx:2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Since its founding in 2016, JW Therapeutics has built an integrated platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and beyond, and to leading the healthy and standardized development of China’s cell immunotherapy industry. For more information, please visit www.jwtherapeutics.com.
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.
Forward-Looking Statements
The forward-looking statements are based on the management's expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: www.jwtherapeutics.com/en/forward-looking-statements/.