Yimiao Shenzhou Submits NDA for Its First-in-Class Domestic CD19 CAR-T Therapy IM19 for Relapsed/Refractory DLBCL

On November 27, Beijing Yimiaoshenzhou Medical Techology Co., Ltd. announced IM19, the company’s first self-developed autologous CAR-T cell candidate product targeting CD19, Chimeric Antigen Receptor T-Cell Injection.（IM19）Marketing application accepted by NMPA for the treatment ofRelapsed or Refractory Diffuse Large B-Cell Lymphoma（r/r DLBCL）。

Screenshot source: Official WeChat account of the company

This NDA acceptance is based on an open-label, single-arm, multi-center confirmatory clinical trial conducted in China. The study results showed that IM19 achieved favorable efficacy and safety data in the treatment of r/r DLBCL patients.

IM19 CAR-T Cell Injection is the first blood tumor CAR-T cell candidate drug independently developed by Beijing Yimiaoshenzhou Medical Technology Co., Ltd. It features an innovative CAR molecular design and internationally leading production technology. Three indications have been approved for clinical trials by the NMPA, respectively.Relapsed/Refractory Diffuse Large B-Cell Lymphoma（r/r DLBCL）、Acute B Lymphoblastic Leukemia（r/r B-ALL）AndMantle Cell Lymphoma（r/r MCL）, and have all entered the registered clinical research stage.

In August 2024, the company regarding IM19 withHuadong MedicineReach a commercial authorization cooperation in mainland China.

It is reported that the global CAR-T drug sales in 2023 were $3.712 billion, increasing by 37.5% year-on-year. Among them,Global sales of CAR-T therapies for DLBCL amount to approximately $2.36 billion, accounting for 63.6%.。

Diffuse Large B-Cell Lymphoma (DLBCL) is an aggressive tumor derived from mature B-cells and represents the most common type of non-Hodgkin lymphoma (NHL). It predominantly occurs in individuals aged 50-70. In Western countries, it accounts for 30-40% of NHL cases, while in China it comprises approximately 50%. Globally, there are about 150,000 new cases annually.

DLBCL has high heterogeneity, and about one-third of patients become relapsed or refractory after first- and second-line standard treatment. Once progressed to relapse or refractory, the disease advances rapidly with a high mortality rate.Existing treatment methods still have issues such as increased incidence of severe neuropathy, significant hematological toxicity, and intolerance in elderly or frail patients. Hematopoietic stem cell transplantation has a low proportion of suitable candidates and carries high risks of relapse and mortality. The treatment of r/r DLBCL in China still has a large number of unmet clinical needs.

IM19, Once Approved, Will Bring New Treatment Options to Patients in China.

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