SHANGHAI, CHINA, Oct 21, 2025 - JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that announced that the company has submitted the Phase I study data of Relma-cel in adult patients with active systemic lupus erythematosus in China to the China National Medical Products Administration (NMPA). NMPA accepted both data and meeting application.
Updates on the Safety and Efficacy of Relma-cel in Adults with Active Systemic Lupus Erythematosus (SLE) in China
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can cause damage to multiple organs and tissues throughout the body. It is estimated that in China there are approximately one million SLE patients, ranking first in the world in total number and second in incidence. Traditional treatments for SLE include corticosteroids, antimalarial drugs, nonsteroidal anti-inflammatory drugs, cytotoxic drugs, and immunosuppressants/modulators. However, these traditional therapies are associated with various side effects and poor long-term tolerability, leading to poor patient compliance and disease control, further compromising mid- to long-term prognosis and quality of life. This population, particularly those with moderately to severely active SLE who require high-dose steroids and immunosuppressants, faces a significant unmet treatment need.
This updated data comes from a Phase I, single-arm, open-label, multicenter, dose-finding study conducted in China. The starting dose was 50×106 CAR+ T cells. Using a Bayesian Optimal Interval (BOIN) design, three dose levels (50×106 CAR+ T cells, 75×106 CAR+ T cells, and 100×106 CAR+ T cells) were explored to evaluate the safety of Relma-cel injection in patients with SLE and ultimately determine the recommended dose for the Phase II study.
As of July 2025, a total of 12 subjects had been enrolled and completed Relma-cel injection infusions. Preliminary safety, efficacy, and pharmacokinetics and pharmacodynamics (PK/PD) were explored in the low, medium, and high dose groups.
A total of 12 patients were infused in this study. All were female, with a median age of 27 years (range: 20 to 41 years) and a median disease history of 9.5 years (range: 4 to 20 years). The highest SELENA-SLEDAI score was 16, the lowest was 4, and the median was 10, all representing moderately to severely active SLE. Eleven patients (91.7%) had abnormal ANA, 33.3% had elevated dsDNA antibodies, and 16.7% had urine protein greater than 2000 mg/24 hours. All 12 patients (100%) had renal involvement, with other common organ system involvement including skin (50%), hematology (50%), and joints (16.7%). Prior to enrollment in this study, all patients had received combined therapy with steroids, multiple immunosuppressants, and/or biologics, but their disease remained recurrent, necessitating new and effective treatments.
As of July 2025, Phase I results from this study showed that among the 12 patients evaluable for 6-month efficacy, 12 (100%) achieved SRI-4 remission, 6 (50%) achieved LLDAS remission, and 12 (100%) achieved drug-free status. Scores on the Disease Activity Index (SLEDAI-2K), SELENA-SLEDAI, SLE-DAS, and PGA scales all showed a downward trend, demonstrating preliminary and significant efficacy.
Preliminary safety results showed that among the 12 patients who received the infusion, 11 experienced CRS, all of which were Grade 1. One patient (at a dose of 75 × 10⁶) developed Grade 2 ICANS, which resolved with symptomatic treatment. None of the 12 patients experienced dose-limiting toxicities (DLTs). The safety results of this study demonstrate that Relma-cel has a favorable safety profile in the treatment of moderately to severely active SLE.
Currently, this study is ongoing to accumulate data with longterm follow-up.
Based on the results of the previous Phase I trial and this Phase I clinical study, Relma-cel has a favorable overall safety profile, manageable adverse reactions, and significant efficacy in the treatment of moderately to severely active SLE in Chinese adults. As the first commercial CAR-T therapy to receive an IND (Investigational Designation) for the treatment of SLE, Relma-cel demonstrated a favorable safety profile and significant efficacy in a Phase I study for the treatment of moderately to severely active SLE, demonstrating strong potential for rapid advancement to the Biologics License Application (BLA) stage. We have submitted the data and have received acceptance, and we look forward to further discussions with regulatory authorities regarding the Phase II pivotal study to accelerate the development of this innovative therapy and provide a groundbreaking treatment option for SLE patients.
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
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