Huadong Medicine's Exclusive Commercialized Product IM19 CAR-T Cell Injection NDA Accepted by NMPA
Huadong Medicine
Large Comprehensive Pharmaceutical Product Developer
Imunopharm
Developer of Gene and Cell Therapy Technologies
On November 27, 2024, Huadong Medicine Co., Ltd. (hereinafter referred to as "the Company") announced that its wholly-owned subsidiary, Huadong Medicine (Hangzhou) Co., Ltd. [hereinafter referred to as "Huadong Medicine (Hangzhou)"], had received acceptance from the National Medical Products Administration for the marketing authorization application of IM19 Chimeric Antigen Receptor T-cell Injection, an autologous CAR-T candidate product targeting CD19 that is exclusively commercialized by Huadong Medicine (Hangzhou).The declared indication is for the treatment of relapsed or refractory CD19-positive non-Hodgkin lymphoma.
About IM19 CAR-T Cell Injection
IM19 Chimeric Antigen Receptor T-Cell Injection (IM19 CAR-T Cell Injection) is the first CAR-T cell therapy product independently developed by Beijing Yimiao Shenzhou Medical Technology Co., Ltd. ("Yimiao Shenzhou"), and Huadong Medicine (Hangzhou) holds the exclusive commercial rights for this product in mainland China.
IM19 CAR-T Cell Injection is an autologous CD19 (a leukocyte differentiation antigen on the surface of B cells) targeted CAR-T cell (chimeric antigen receptor T cell) product, which is generated through lentiviral transduction of T cells.
IM19 CAR-T Cell Injection has successively received clinical trial approval notices for three indications from the National Medical Products Administration, namely, relapsed/refractory diffuse large B-cell lymphoma (r/r-DLBCL), acute B-cell lymphoblastic leukemia (B-ALL), and mantle-cell lymphoma (MCL).
The acceptance of the marketing authorization application for IM19 CAR-T cell injection is based on an open-label, single-arm, multi-center Phase I/II clinical trial conducted in China. The study results showed that IM19 CAR-T cell injection has good efficacy and safety for relapsed or refractory CD19-positive non-Hodgkin lymphoma.
Impact on Listed Companies
Lymphoma is a common malignant tumor of the hematological system, and it is divided into two categories based on the tumor cells: non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). NHL accounts for approximately 90% of lymphomas. According to GLOBOCAN 2022 data, NHL ranks 10th in global malignant tumor incidence and 11th in mortality, making it the most common malignant tumor of the hematological system. In 2022, there were 553,000 new cases of NHL globally and 250,000 deaths, accounting for 2.8% and 2.6% of all malignant tumor incidences and deaths, respectively. GLOBOCAN 2020 data showed that in 2020, China reported 92,834 new cases of NHL and 54,351 deaths.
Diffuse Large B-Cell Lymphoma (DLBCL) is the most common type of NHL, typically occurring in individuals aged 50-70, with a slightly higher incidence in men than women. It accounts for approximately 30-40% of NHL cases in Western countries and around 50% in China. After receiving first- and second-line standard treatments, about one-third of DLBCL patients become relapsed or refractory. Current treatment methods still present challenges such as increased incidence of severe neuropathy, significant hematologic toxicity, and poor tolerance among elderly or frail patients. Hematopoietic stem cell transplantation carries risks such as a low proportion of eligible patients and high rates of relapse and mortality. There remains a substantial unmet clinical need for DLBCL treatment in China. CAR-T cell therapy can precisely identify and eliminate cancer cells, offering more specific therapeutic effects and significantly improving patients' quality of life, bringing the possibility of a cure to cancer patients. If IM19 CAR-T Cell Injection is successfully approved and launched, it is expected to provide more treatment options for Chinese DLBCL patients.
This successful acceptance marks another significant progress in the development process of this drug, which is conducive to further enhancing the company's core competitiveness in the CAR-T field.
Statement
1. This news aims to share the frontier progress of the company's (or partners') R&D work, not for advertising purposes. The relevant information is not targeted at patients and is only for reference by healthcare professionals.
2. The content in this press release does not involve any recommendation for any drug and/or indication;
3. The information contained in this press release is for reference only and should not be considered as a substitute for professional medical advice or treatment recommendations in any way. If you wish to obtain specific disease diagnosis and treatment information, please follow the advice or guidance of doctors or other healthcare professionals.
4. As of the publication of this article, IM19 CAR-T Cell InjectionNot yet approved for marketing by the National Medical Products Administration;
5. This press release may contain certain forward-looking statements. These statements are inherently subject to significant risks and uncertainties. When using terms such as "expect," "believe," "forecast," "anticipate," "intend," and similar expressions related to our company, they are considered forward-looking statements. Our company has no obligation to continuously update these predictive statements.
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