Shanghai, China, October 9, 2026 — BRL Medicine announced that its next-generation allogeneic universal CAR-T product, “CD19-targeted gene-modified allogeneic chimeric antigen receptor T-cell injection” (TyU19; pipeline code: BRL-303), developed on its proprietary universal cell platform (TyUCell), has reached dual milestones: its Investigational New Drug (IND) application for relapsed/refractory systemic sclerosis (SSc) received implied clinical trial approval from the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA) on September 10, 2026; and BRL-303 was officially included in CDE’s “Care Plan-Extension” pilot program on October 8, 2026. This follows IND approval for BRL-303 in moderate/severe refractory systemic lupus erythematosus (SLE) and marks another key breakthrough for BRL Medicine in autoimmune diseases. It signals that the company’s core autoimmune pipeline has formally achieved cross-indication expansion from SLE to SSc and is accelerating the construction of a platform-based, multi-indication clinical development model based on the same core product.

BRL-303 Receives IND Approval for SSc Indication

BRL-303 Officially Included in the “Care Plan-Extension” Pilot Program

Notably, BRL-303 is the first CAR-T product in China to be included in the “Care Plan-Extension” pilot program. According to the latest “Rare Disease Innovative Drug R&D Encouragement Pilot Program (‘Care Plan-Extension’)” issued by CDE in May 2026, this pilot is a dedicated fast track created by CDE to address original innovation in rare disease drug R&D. It provides priority review support featuring “early intervention, one enterprise one policy, full-process guidance, and R&D-review collaboration,” with highly stringent eligibility criteria. The successful inclusion of BRL-303 not only provides customized review support from CDE but also reflects regulators’ recognition of and attention to BRL-303’s original innovation as first-in-class research, the urgent clinical need in SSc, and its further clinical development value. Previously, results related to TyU19 (pipeline code: BRL-303) were published in leading international journals including Cell (2024), Cell Research (2025), and Med (2025).

From SLE to SSc: One Product Drives Accelerated Platform-Based Development

As a CD19-targeted universal product under BRL Medicine’s TyUCell universal cell platform, TyU19 (pipeline code: BRL-303) differs from traditional single-indication drugs and combines technical versatility, expandability, and scalable advantages. Through its core mechanism of precisely eliminating abnormally activated B cells by targeting CD19, TyU19 can broadly address multiple refractory autoimmune diseases driven by abnormal B-cell activation.

Based on this core technical advantage, the company uses BRL-303 as a core asset to continuously advance stepwise multi-indication development. For moderate or severe refractory SLE, Phase I clinical study has been approved and is currently advancing dose escalation according to protocol. Following this IND approval for relapsed/refractory SSc, the company will advance registrational clinical research for this indication. In the future, based on clinical needs, risk-benefit profiles, and early evidence across different diseases, the company will expand the development potential of BRL-303 in other B-cell-mediated autoimmune diseases in a measured manner. Starting from SLE and extending successfully to SSc, the company is gradually building a clinical development matrix covering multiple severe, refractory autoimmune diseases. This layout fully validates the platform potential and broad technical applicability of BRL-303 and further strengthens its strategic positioning as BRL Medicine’s core platform product for autoimmune diseases.

SSc IND and the “Care Plan”: From Exploratory Clinical Research to Formal Registrational Clinical Development

Systemic sclerosis (SSc) is a rare and complex autoimmune connective tissue disease characterized by significant heterogeneity. SSc progresses insidiously and irreversibly, lacks curative treatment, and most patients continue to progress despite conventional drug therapy, with high disability and mortality rates. There is a major unmet clinical treatment need. This IND approval for BRL-303 in SSc will bring a new breakthrough treatment option for a broad population of relapsed/refractory SSc patients.

Previously, in July 2024, early human study results of TyU19 (pipeline code: BRL-303) in severe refractory autoimmune diseases were published in the leading international journal Cell. This study was the world’s first public report of the clinical application of allogeneic CD19 CAR-T cells in patients with systemic autoimmune diseases.

In patients with diffuse cutaneous systemic sclerosis (dcSSc), deep B-cell depletion was observed after BRL-303 treatment, with significant improvement in the Composite Response Index in Systemic Sclerosis (CRISS) and continuous decline in the modified Rodnan skin score (mRSS). Indicators related to skin sclerosis and fibrosis in organs such as the lungs and heart also showed marked improvement, and clinical benefit was continuously observed during the 6-month follow-up period reported in the study. In terms of safety, no cytokine release syndrome (CRS), graft-versus-host disease (GvHD), or immune effector cell-associated neurotoxicity syndrome (ICANS) was observed during the follow-up period.

The positive results of this exploratory study provide important human evidence for the safety, tolerability, and clinical activity of BRL-303 in treating SSc. The study was selected for “Best of Cell 2024,” the “Top 10 Advances in China’s Medical Biotechnology 2024,” and the “Top 10 Scientific Advances in China 2024.” In a commentary published concurrently in Cell, Professor Carl June, the “father of CAR-T,” noted that the study was the first to report the application of allogeneic CAR-T cells in patients with systemic autoimmune diseases and pointed out that this technological approach has great potential to drive a paradigm shift in the treatment of autoimmune diseases.

BRL Medicine CEO Dr. XIANG Yu said: “Autoimmune diseases are one of the company’s core strategic areas in the gene and cell therapy field. Leveraging the independently developed TyUCell universal cell platform, BRL-303 overcomes the limitations of traditional autologous CAR-T therapies, including long manufacturing cycles, high costs, and individualized constraints. It has core advantages including off-the-shelf availability, scalable manufacturing, controllable cost, and an excellent safety profile, and can efficiently meet the clinical treatment needs of severe refractory autoimmune diseases. In the future, the company will continue to accelerate Phase I registrational clinical development of BRL-303 in the dual indications of SLE and SSc, continuously explore the product’s platform value, investigate more refractory autoimmune disease indications, and improve its multi-indication clinical layout. We aim to provide affordable, effective, and accessible next-generation cell therapy options for patients with refractory autoimmune diseases worldwide as soon as possible, and to support technological innovation and upgrading in China’s autoimmune disease treatment field.”

About BRL-303

BRL-303 (TyU19, CD19-targeted gene-modified allogeneic chimeric antigen receptor T-cell injection) is a CD19-targeted allogeneic universal CAR-T investigational product independently developed by BRL Medicine based on its TyUCell allogeneic universal cell platform. BRL-303 uses T cells from healthy donors and, after multiplex gene editing and scalable manufacturing, is designed to deeply deplete CD19-positive B cells and promote immune system reconstitution, exploring treatment for B-cell-mediated refractory autoimmune diseases.

Currently, a Phase I clinical study of BRL-303 in moderate or severe refractory SLE is ongoing in China; its treatment for relapsed/refractory SSc has received implied clinical trial approval in China and has been included in the CDE’s “Care Plan-Extension” pilot program. Early human study results of TyU19 (BRL-303) in SSc, SLE, and other refractory autoimmune diseases have been published in leading international journals including Cell, Cell Research, and Med.

BRL-303 is currently in clinical research and has not been approved for marketing in any country or region. Its safety and efficacy remain under further clinical investigation.

About BRL Medicine

BRL Medicine is a platform biotechnology company focused on the research, development, and clinical application of gene and cell therapies. With expertise in gene editing and a combination of six modular platforms, we have independently developed a comprehensive product pipeline covering innovative therapeutic solutions for genetic diseases, autoimmune diseases, hematologic malignancies, and solid tumors. These areas have major medical needs but currently lack effective solutions, offering broad market potential. Since its founding, BRL Medicine has advanced from building core technology platforms and research capabilities to progressing investigational products toward commercialization.

About Systemic Sclerosis (SSc)

Forward-Looking Statements：This press release contains forward-looking statements regarding the company’s future R&D plans, clinical development, regulatory filings, commercialization, and globalization. Such statements are based on information and judgments currently available to the company, and actual results may differ due to clinical research, regulatory review, manufacturing, and other factors. The company’s investigational products are still in clinical research and have not been approved for marketing; their safety and efficacy remain subject to regulatory review and confirmation. This press release does not constitute any drug promotion or investment advice.