BRL Medicine's Allogeneic CAR-T BRL-303 Wins IND Approval for Systemic Sclerosis, Enters CDE Care Program

For patients with systemic sclerosis, a rare and relentless autoimmune disease that hardens skin and scars internal organs, there is no cure. Most continue to deteriorate even after conventional treatment. Disability and death rates remain stubbornly high. But on October 9, 2026, Shanghai-based BRL Medicine offered a new reason for hope.

The company announced that its off-the-shelf CAR-T therapy, BRL-303 (also known as TyU19), has secured dual regulatory milestones in China: an Investigational New Drug (IND) approval for relapsed/refractory systemic sclerosis (SSc) on September 10, 2026, and inclusion in the Center for Drug Evaluation's (CDE) prestigious "Care Program-Extension" pilot project on October 8, 2026.

BRL-303 is the first CAR-T product ever admitted to the Care Program-Extension, a fast-track initiative launched by the CDE in May 2026 for breakthrough therapies targeting rare diseases. Selected programs receive customized regulatory support under a framework the agency describes as "early intervention, company-specific strategy, full guidance, and integrated research-review coordination."

From Lupus to Scleroderma: A Platform Expands

The SSc IND marks BRL Medicine's second autoimmune indication for BRL-303. The product already has IND clearance for moderate-to-severe systemic lupus erythematosus (SLE), with a Phase I dose-escalation trial underway in China. The company now plans to launch registrational clinical research for SSc.

Unlike traditional autologous CAR-T therapies, which require harvesting and engineering a patient's own cells — a process that can take weeks and cost hundreds of thousands of dollars — BRL-303 is derived from healthy donor T cells. Built on the company's proprietary TyUCell allogeneic platform, the product is designed for immediate availability, scalable manufacturing, and controlled costs.

The therapeutic logic is straightforward: by targeting CD19, a protein expressed on B cells, BRL-303 aims to deplete the abnormally activated B cells that drive autoimmune destruction, then allow the immune system to rebuild itself.

Published Evidence: 'A Paradigm Shift'

The clinical rationale is not theoretical. In July 2024, early human study results for BRL-303 in severe refractory autoimmune diseases were published in Cell, one of the world's top scientific journals. That paper represented the first global report of allogeneic CD19 CAR-T cells used in patients with systemic autoimmune disease.

In patients with diffuse cutaneous systemic sclerosis (dcSSc), treatment with BRL-303 produced deep B-cell depletion. The Clinical Response Index for Systemic Sclerosis (CRISS) showed significant improvement. The modified Rodnan Skin Score (mRSS) declined steadily. Fibrosis-related indicators in the lungs and heart also improved, with clinical benefits sustained throughout a six-month follow-up period.

On safety, no cytokine release syndrome (CRS), graft-versus-host disease (GvHD), or immune effector cell-associated neurotoxicity syndrome (ICANS) was observed during the reported follow-up.

The study was selected for Cell's "Best of Cell 2024" list, named among China's Top 10 Advances in Medical Biotechnology in 2024, and included in China's Top 10 Scientific Advances of 2024. In a commentary published alongside the paper, Carl June, widely regarded as the "Father of CAR-T," noted that the research represented the first report of allogeneic CAR-T cells in patients with systemic autoimmune disease and identified the technology as having "tremendous potential to drive a paradigm shift" in autoimmune disease treatment.

Additional results have since appeared in Cell Research (2025) and Med (2025).

'A Core Strategic Bet'

"Autoimmune disease is one of the core strategic focus areas for our company in the gene and cell therapy track," said Dr. Xiang Yu, CEO of BRL Medicine. "Leveraging our proprietary TyUCell allogeneic cell platform, BRL-303 has overcome the pain points of traditional autologous CAR-T therapy — long preparation cycles, high costs, and individualized constraints — delivering core advantages including off-the-shelf availability, scalable manufacturing, controllable costs, and an excellent safety profile."

Dr. Xiang added that the company will continue to accelerate Phase I registrational clinical development in both SLE and SSc, while exploring additional refractory autoimmune indications to expand the product's multi-indication portfolio.

What Comes Next

The inclusion of BRL-303 in the Care Program-Extension signals that Chinese regulators see genuine innovation in the product — and genuine urgency in the patient population it aims to serve. The program's "research-review coordination" mechanism is designed to compress timelines between early clinical evidence and formal drug development, potentially accelerating the path from exploratory studies to registrational trials.

BRL-303 remains in clinical research and has not received marketing approval in any country or region. Its safety and efficacy are still under investigation. But with two autoimmune INDs, top-tier journal publications, and regulatory fast-track status, BRL Medicine is building a platform play that could reshape how rare autoimmune diseases are treated — not just in China, but potentially worldwide.

Note: BRL-303 is currently in the clinical research stage and has not received marketing approval in any country or region. Its safety and efficacy are still being validated through clinical research. This article does not constitute any drug promotion or investment advice.