Yimiao Shenzhou's IM19 CAR-T Cell Injection NDA Accepted by China's NMPA, Files for STAR Market IPO

November 27, 2024, Beijing, China,Beijing Yimiao Shenzhou Medical Technology Co., Ltd. ("Yimiao Shenzhou") announced that the New Drug Application (NDA) for its first self-developed autologous CAR-T cell candidate product, IM19 Chimeric Antigen Receptor T-cell Injection (referred to as "IM19"), which targets CD19 for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), has been officially accepted by the National Medical Products Administration (NMPA).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 demonstrated favorable efficacy and safety data in the treatment of r/r DLBCL patients.

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, DLBCL accounts for approximately 30-40% of NHL cases, while in China it constitutes about 50%. Globally, there are approximately 150,000 new cases each year. DLBCL exhibits significant heterogeneity, and after standard first- and second-line treatments, about one-third of patients will develop relapsed or refractory disease. Once progressed to relapse or refractory status, the disease advances rapidly with a high mortality rate. Current treatment options still present challenges such as increased incidence of severe neuropathy, substantial hematological toxicity, and poor tolerability in elderly or frail patients. Hematopoietic stem cell transplantation has limitations including a low proportion of eligible patients and carries risks of high relapse and mortality rates. The treatment of r/r DLBCL in China still faces a significant unmet clinical need.

As an independently developed CAR-T cell therapy drug capable of precisely identifying and eliminating tumor cells, IM19 features an innovative CAR molecular design and production process, offering more specific therapeutic effects. It significantly improves the survival time and quality of life for patients with r/r DLBCL, bringing the possibility of a cure. To date, the U.S. FDA has approved several CAR-T cell therapy products for advanced lymphoma indications, while China has not yet approved any domestically produced CAR-T cell therapy drugs for marketing. Once IM19 is approved for marketing, it will effectively fill the market gap for domestically produced CAR-T cell therapies in the lymphoma indication field, bringing new hope to hundreds of thousands of lymphoma patients in 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, the global sales of CAR-T treatment drugs for DLBCL were approximately $2.36 billion, accounting for 63.6%.

Professor Zhu Jun stated：IM19 Demonstrates Surprising Efficacy and Safety in Registration Clinical Trials. As the Principal Investigator, I am highly honored to witness this significant milestone. The acceptance of IM19’s drug marketing authorization application implies that this innovative drug is expected to benefit more patients as soon as possible, offering new treatment options for a wide range of lymphoma patients. We will continue to closely collaborate with Beijing Yimiaoshenzhou Medical Techology Co., Ltd. to expedite the widespread clinical application of this product.

A Decade of Dedication, Perseverance Leads to Success. In the future, Beijing Yimiaoshenzhou Medical Technology Co., Ltd. will maintain an efficient R&D pace, continuing to focus on the independent innovation and development of domestically produced CAR-T cell therapies. The company aims to provide patients suffering from major diseases such as malignant tumors and autoimmune disorders with treatment options that are safer, more effective, and less costly, truly bringing innovative CAR-T drugs "into the homes of ordinary people."