East China Medicine's CD19-Targeted Autologous CAR-T Therapy IM19 Receives NMPA Marketing Authorization Application Acceptance

Nov 28, 2024 08:20 CST Updated 08:20

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. This is a CD19-targeted autologous CAR-T cell gene therapy candidate product 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 gene 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's lymphoma.

Impact on Listed Companies

Lymphoma is a common malignant tumor of the hematological system, which 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 the total incidence and mortality of all malignant tumors, respectively. GLOBOCAN 2020 data shows 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 males than females. It accounts for approximately 30-40% of NHL cases in Western countries and around 50% in China. After standard first- and second-line treatments, about one-third of DLBCL patients become relapsed or refractory. Current treatment options still present issues such as an increased incidence of severe neuropathy, significant hematologic toxicity, and poor tolerability among elderly and frail patients. Hematopoietic stem cell transplantation carries risks of low eligibility rates and high recurrence and mortality rates. 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 successfully gains approval and comes to market, it is expected to provide more treatment options for Chinese DLBCL patients.

This successful acceptance marks another important progress in the development process of this drug, which is conducive to further enhancing the company's core competitiveness in the field of CAR-T cell gene therapy.

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 involved 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.

These forward-looking statements are based on the current views, assumptions, expectations, estimates, forecasts, and understandings of the Company's management regarding future events at the time the statements are made. These statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond the Company’s control and are difficult to predict. Therefore, actual results may differ significantly from the information contained in the forward-looking statements due to future changes and developments in our business, competitive environment, political, economic, legal, and social conditions.

Neither the Company, its directors nor its employees assume any obligation (a) to correct or update any forward-looking statements contained on this website; and (b) for any liability arising from or related to any forward-looking statements that fail to materialize or become inaccurate.

E.N.D

Previous article recommendations:

$1.5 Billion! Roche Acquires a Cell and Gene Therapy Company

Shanghai Releases "Science and Technology Innovation Action Plan" Cell and Gene Therapy Special Project Approval Notice

Why Are Cell Therapy Products Costing Millions Per Injection So Expensive

Phase I Clinical Data of iPSC-derived CAR-T Cell Therapy for Lupus Erythematosus Released

The "Zhujiang Protocol" of CART Cell Therapy Summarized by the Hematology Department of Zhujiang Hospital, Southern Medical University, Helps Patients Achieve High-Quality Cure

Hefei SASAC Takes Action Again! This Innovative Immunotherapy Company Focusing on NK Cell Field Receives New Round of Financing

George Church's Team Develops mRNA Anti-Aging Therapy, Reversing Skin Aging

Focusing on the Cell and Gene Therapy Field, a R&D and Industrial Base in China Completed and Commissioned

CSPC Initiates Phase I Clinical Trial of CAR-T Cell Therapy for Systemic Lupus Erythematosus

Ministry of Commerce: Forward-looking Layout of Key Industries such as Cell and Gene Therapy, Supporting Suzhou Industrial Park in Conducting Pilot Programs for Open Innovation in the Entire Biomedical Industry Chain

Breakthrough in Solid Tumors: Latest 'Nature' Publishes CAR-T Clinical Trial Results for Deadly Brain Tumors

CDE Releases "Technical Guideline for Clinical Pharmacology Studies of Cell Therapy Products (Trial)"

A Biotech Company in Guangdong Officially Opens, Focusing on Cell and Gene Therapy Fields

Breakthrough in AAV Payload Limit: Research on StitchR™ RNA Assembly Technology and Its Application in Treating Muscular Dystrophy Published in "Science"

The World’s First In Vivo CAR Gene Therapy Approved for Phase I Clinical Trial Completes First Patient Dosing

Total investment of approximately 3 billion yuan, with a construction area of 100,000 square meters, a domestic cell therapy drug research and development and production base has officially started construction.

World's First TIL Cell Therapy Generates $640 Million in Half-Year Revenue, Projected to Exceed $1.1 Billion for the Full Year

The World's First Stem Cell Therapy for Type 1 Diabetes Advances to Phase 3 Clinical Trials

Acquisition Price Approximately 187 Million Yuan: Northeast Pharmaceutical to Officially Acquire 70% Equity of a Cell Therapy Company in China

Official Announcement! Stem Cell Exosomes Not Managed as Medical Devices

World's First! Bionbase's Non-Viral Targeted Integration PD1-CAR-T Therapy for Treating Lupus Erythematosus Approved for Clinical Trials in China

Focusing on CGT and other cell industries, a cell technology company in China officially opens.

Shanghai Releases Three-Year Action Plan, Continuously Supporting Innovation and R&D in Frontier Fields Such as Cell and Gene Therapy, Nucleic Acid Drugs, and Brain-Computer Interfaces (with Policy Interpretation)

Guangzhou Issues New Policy to Accelerate the Industrialization of Antibody Drugs, Vaccines, Cell and Gene Therapies, Recombinant Proteins, and Peptides

CDE Releases Common Issues and Technical Requirements for Lentivirus Testing in the Cell and Gene Therapy Field

Statement: The content is sourced from Huadong Medicine's official channel.The aim of this article isKnowledge sharing, all content is for reference only and does not constitute any advice.