Global First-in-Class CD19-CAR-DNT Cell Therapy RJMty19 Initiated Phase I Registration Trial for B-cell Non-Hodgkin Lymphoma

Recently, Zhejiang Ruishun Biotech Co., Ltd. (hereinafter referred to as "Ruishun Biotech") announced that its self-developed globally innovative CD19-CAR-DNT cell drug ——RJMty19 InjectionThe Phase I clinical trial for the treatment of B-cell non-Hodgkin lymphoma has officially started at three research centers.

This registered clinical research project is led by Professor Zhao Weili, a renowned lymphoma treatment expert from Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine, with the participation of Professor Li Yuhua from Zhujiang Hospital of Southern Medical University and Director Hu Kai from Beijing GaoBo Hospital. As of May 17, all three research centers have completed the preparatory work, including project approval, ethics review, and genetic office procedures, and are about to begin enrolling the first subject.

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Zhujiang Hospital, Southern Medical University

Beijing Gaobo Hospital

The launch meeting was held in a combination of online and offline formats. The researchers unanimously agreed that although several autologous CAR-T cell therapy products have been launched in the B-NHL field, these products are personalized treatments with prices nearing a million RMB, making them unaffordable for most patients and resulting in poor accessibility. The market urgently needs an off-the-shelf, universal cell therapy product to meet the unmet clinical needs.

RJMty19 Injection, an off-the-shelf universal product developed by Zhejiang Ruishun Biotech Co., Ltd., has shown promising results in investigator-initiated clinical studies for the treatment of B-NHL.Safety and Preliminary EfficacyData, relevant data recently published through the international renowned medical journal The Lancet's subsidiary journal.

We look forward to further validating our preliminary research results in the ongoing registrational clinical trials, providing a novel and accessible CAR-DNT cell therapy product for patients with relapsed/refractory B-NHL.

RJMty19-B-NHL002A Phase I Clinical Study to Evaluate the Tolerability, Safety, and Efficacy of Off-the-Shelf Universal CAR-DNT Cell Injection in CD19-Positive Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma Patients.

At the kick-off meeting, the project team introduced the clinical research plan for RJMty19-B-NHL002, including the study background, investigational drug, study design, study procedures, inclusion and exclusion criteria, central laboratory management, safety events, data management, GCP, monitoring plan, and the team.

The clinical research team and the project operations team had in-depth discussions and exchanges regarding the conduct of the study, hoping to accelerate the clinical translation and application of this product through the joint efforts of all parties.

About RJMty19 Injection

RJMty19 Injection (with the main active ingredient being CD19-CAR-DNT cells), developed by Zhejiang Ruishun Biotech Co., Ltd. based on a global patent for humanized CD19-CAR, is an innovative, off-the-shelf, universal second-generation DNT cell therapy product. Compared with the 11 autologous CD19-CAR-T cell therapy products currently approved worldwide, CD19-CAR-DNT cells derived from healthy donors offer numerous advantages, such as standardized preparation, lower production costs, and immediate availability for patients. With immense potential in future market competition, it can fundamentally transform the current commercial disadvantages of autologous CAR-T cell products.

About Zhejiang Ruishun Biotech Co., Ltd.

Zhejiang Ruishun Biotech Co., Ltd. envisions "caring for life and benefiting humanity" and is on a mission to "develop innovative cellular medicines affordable for the common people." The company focuses on developing off-the-shelf, universal immune cell products based on the DNT cell technology platform. As a pioneer of DNT cell immunotherapy globally, it has developed multiple off-the-shelf, universal cell therapy products using the DNT cell technology platform, including RC1012 injection and RJMty19 injection. Currently, the company has five registered clinical trials ongoing (covering hematological tumors and autoimmune diseases). It has completed three investigator-initiated clinical trials for treating hematological tumors and has another investigator-initiated clinical trial for treating autoimmune diseases underway.