JW Therapeutics' Relma-cel IIT Study in Systemic Sclerosis (SSc) Selected as Late-Breaking Abstract at the Systemic Sclerosis World Congress (SSWC)

SHANGHAI, CHINA, Mar 5, 2026 - JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that the results from an investigator-initiated trial (IIT) of its CAR-T product relmacabtagene autoleucel (relma-cel) in systemic sclerosis (SSc) have been selected for a Late-Breaking presentation at the 9th Systemic Sclerosis World Congress (SSWC). The study explored the molecular characteristics of CD19 CAR-T therapy in patients with systemic sclerosis, and the results showed that relma-cel was well-tolerated and demonstrated promising efficacy in patients with progressive diffuse cutaneous SSc.

Presentation Title: Multi-omic Profiling of Patients with Progressive Systemic Sclerosis Undergoing CD19 CAR-T Cell Therapy

Presentation Type: Late-Breaking Poster Presentation

Date & Time: March 6, 2026

Location: Systemic Sclerosis World Congress (SSWC), ATHENS, GREECE

Presenter: Dr. Hanlin Yin (Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine)

CAR T-cell therapy targeting CD19 has shown potential in autoimmune diseases such as SSc, yet molecular profiling in these patients remains unexplored. In a phase 1 open-label trial (NCT06414135), we assessed relmacabtagene autoleucel (relma-cel) in progressive diffuse cutaneous SSc. The study is being conducted at Renji Hospital Affiliated toShanghai Jiao Tong University School of Medicine, , by the team of Professor Liangjing Lu, Director of the Rheumatology Department.

Relma-cel demonstrated a favorable safety profile across six patients, with only one case of grade 3 cytokine release syndrome and one case of grade 1 immune effector cell-associated neurotoxicity syndrome reported, and no other dose-limiting toxicities observed. All patients achieved deep B-cell depletion, significant improvement in skin thickness scores, stabilization or improvement of interstitial lung disease, and marked reduction in autoantibody levels, indicating preliminary efficacy. Here we applied a multi-omic analysis to discern the underling mechanism associated with clinical improvement.

We performed integrated single-cell RNA sequencing, T- and B-cell receptor repertoire analysis, plasma proteomics, and spatial transcriptomics at multiple timepoints to characterize molecular changes following CD19 CAR-T-mediated B-cell depletion in SSc patients.

Conclusions:Our multi-omic analysis demonstrates that CD19 CAR-T cell therapy induces profound B-cell depletion and remodeling of the immune landscape in patients with progressive SSc. The observed reduction in pathogenic B-cell subsets, autoantibody production, and fibrotic gene module expression correlates with clinical improvements in skin and lung involvement. These findings suggest that CAR-T therapy may mitigate disease progression through coordinated modulation of adaptive immunity and fibroblast activation.

 

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/.