Shanghai, China, November 9, 2026 —— BRL Medicine announced today the completion of a new round of equity financing. To date, BRL Medicine has completed two rounds of equity financing within the year, with total funding exceeding RMB 700 million. Both rounds were supported by multiple professional investment institutions and existing shareholders.

The successful completion of this financing round will further support BRL Medicine in accelerating the clinical development and regulatory submissions of its core products, continuously improving its industrialization and large-scale manufacturing capabilities, and advancing its gene and cell therapy technology platforms as well as subsequent innovative pipelines.

As an innovative biotech company focusing on gene and cell therapies, BRL Medicine has established proprietary technology platforms and differentiated product pipelines in areas such as genetic diseases, autoimmune diseases, and malignancies. Currently, multiple innovative products of the company have entered the clinical development stage. Among them, BRL-101 and BRL-303 represent the company's major strategic initiatives in gene-edited hematopoietic stem cell therapy and allogeneic universal CAR-T therapy, respectively, and are continuously achieving key progress.

BRL-101: Pivotal Clinical Study Reaches Primary Endpoint, Accelerating Towards Regulatory Submission

BRL-101 is an autologous hematopoietic stem cell product independently developed by BRL Medicine, utilizing a non-viral vector to deliver gene-editing tools. It is intended for the treatment of severe inherited blood diseases such as transfusion-dependent β-thalassemia (TDT) and sickle cell disease (SCD). By editing the genes of patients' autologous hematopoietic stem cells to reactivate fetal hemoglobin expression, the product aims to free patients from long-term transfusion dependence with a one-time treatment.

Currently, BRL-101 has completed the pivotal clinical study for TDT and reached the primary efficacy endpoint. The first patient has been free from transfusion dependence for over 6 years, setting a new record for the longest long-term follow-up in thalassemia gene therapy in China. This further validates the product's clinical value and lays a solid foundation for subsequent regulatory submission. The company is actively advancing the regulatory submission and industrialization preparations for BRL-101, driving this proprietary gene-editing therapy from clinical research to patient application as soon as possible.

BRL-303: Expanding from SLE to SSc, Accelerating Multi-Indication Platform Development

BRL-303 is a CD19-targeted allogeneic universal CAR-T product. Utilizing T cells from healthy donors and multiple gene edits to achieve allogeneic universality, the product combines the potential for off-the-shelf supply, standardized production, and large-scale manufacturing. It is expected to overcome the limitations of traditional autologous CAR-T therapies regarding manufacturing cycles, individualized production, and treatment accessibility.

BRL-303 is not limited to a single indication but is a platform product targeting B-cell-mediated autoimmune diseases. Leveraging the mechanism of targeting CD19 to eliminate abnormally activated B cells, the company is building a clinical development matrix covering multiple severe and refractory autoimmune diseases around this core product in a well-paced manner.

Currently, a Phase I registrational clinical study of BRL-303 for moderate or severe refractory systemic lupus erythematosus (SLE) is underway. Its Investigational New Drug (IND) application for relapsed or refractory systemic sclerosis (SSc) has received tacit approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration, making it one of the earliest projects included in the CDE's "Care Program - Extension" pilot. From SLE to SSc, BRL-303 is accelerating cross-indication expansion, continuously unleashing its clinical development value as a core platform product for autoimmune diseases.

Mr. JIANG Xiaoxu, Chief Financial Officer of BRL Medicine

Mr. JIANG Xiaoxu, Chief Financial Officer of BRL Medicine, stated: "This round of financing further replenishes the company's capital reserves, providing strong support for the clinical development, regulatory submission, and industrialization preparation of our core products. The company will continue to focus on its core pipelines, prudently allocate resources, and improve operational efficiency, prioritizing investments in projects with clear clinical value and key milestones to support the company's high-quality and sustainable development."

Dr. XIANG Yu, Chief Executive Officer of BRL Medicine

Dr. XIANG Yu, Chief Executive Officer of BRL Medicine, stated: "Thank you to the investment institutions and shareholders for their continued trust and support in BRL Medicine. Currently, the company's two core products are entering a crucial stage of accelerated value release: BRL-101 has completed the pivotal Phase II clinical study and reached the primary efficacy endpoint, and is accelerating towards regulatory submission; BRL-303 is transitioning from early clinical validation to registrational clinical development for multiple indications such as SLE and SSc, further demonstrating its platform value. In the future, we will continue to focus on disease areas with significant unmet clinical needs, fully leverage the company's technological advantages in gene editing and cell therapy, and accelerate the clinical translation of next-generation innovative achievements, including in vivo CAR-T for solid tumors, striving to provide safe, effective, and accessible innovative treatment options for patients worldwide."

About BRL Medicine

About BRL-101

BRL-101 is an autologous hematopoietic stem cell therapy developed based on gene-editing technology, intended for the treatment of severe inherited blood diseases such as transfusion-dependent β-thalassemia and sickle cell disease.

BRL-101 primarily edits key regulatory regions in patients' own hematopoietic stem cells to promote fetal hemoglobin expression, thereby enhancing hemoglobin production. BRL-101 was developed relying on BRL Medicine's independently developed hematopoietic stem cell platform. The company is continuously advancing related clinical research, regulatory development, and industrialization preparations.

About BRL-303

BRL-303 is a CD19-targeted allogeneic universal CAR-T platform product intended for the treatment of severe B-cell-mediated autoimmune diseases, such as systemic lupus erythematosus and systemic sclerosis, rather than being developed for a single indication. BRL-303 primarily improves disease activity by eliminating CD19-positive B cells and promoting immune system reconstitution.

【Risk Warning】

This press release contains forward-looking statements regarding the company's future R&D plans, clinical development, regulatory submissions, and industrialization. These 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.

Both BRL-101 and BRL-303 are in the clinical development stage and have not been approved for marketing in any country or region. Their safety and efficacy still require confirmation through further clinical research and regulatory review. This press release does not constitute drug promotion or investment advice.