Hengrunda Sheng Submits NDA for CD19-Directed CAR-T Therapy RunDa Ji Aolun Sai (HR001) in r/r B-NHL
Hrain Biotechnology
Developer of Tumor Immunotherapy Technology R&D
▎WuXi AppTec Content Team Report
On December 14, the official website of the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) announced that Shanghai Hengrun Dasheng Biotechnology Co., Ltd. had submittedRunda Carfilzomib Injection(The proposed) listing application has been accepted for review.According to the introduction in the earlier prospectus of Shanghai Hengrun Dasheng Biotechnology Co., Ltd., the companyCD19-Targeted CAR-T ProductThe clinical trial application for HR001 in the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) was previously included in the priority review.Shanghai Hengrun Dasheng Biotechnology Co., Ltd. inThe prospectus statesIt is expected to submit the new drug marketing application for this drug in 2023.
Screenshot source: CDE official website
According to the introduction on the official website of Shanghai Hengrun Dasheng Biotechnology Co., Ltd., the company was established in 2015. It is an innovative biopharmaceutical company focusing on the research and production of breakthrough immunotherapy drugs, primarily concentrating on treatment areas such as malignant hematological diseases and solid tumors. Hengrun Dasheng relies on independent research and development.CAR-T Cell Therapy ProductsTaking the lead, simultaneously layout the product development pipeline of international cutting-edge technologies such as CAR-NK, aiming to develop safe, effective, cost-controllable immune cell therapy products that benefit more patients.
The product with the fastest progress in Hengrun Dasheng's R&D pipeline isA CAR-T product targeting CD19HR001。It uses genetic engineering technology to express CAR on the surface of T cells, enabling them to specifically recognize the CD19 target antigen on the surface of malignant tumor cells.The intracellular region of the CAR molecule contains fragments that initiate an immune activation cascade, a structure that enables CAR-T cells to specifically recognize and kill tumor cells. Completed preclinical and clinical studies have shown that HR001 demonstrates good safety and efficacy.
In addition to the CD19-targeting CAR-T product HR001, Shanghai Hengrun Dasheng Biotechnology Co., Ltd's R&D pipeline also includes multiple CAR-T products, such asBCMA-Targeted CAR-T ProductHR003、CD19/CD22 Dual-Target CAR-T ProductHR004、CD70-Targeted CAR-T ProductHR010, as well as the development targeting malignant hematological diseasesCAR-T Cell Therapy Product Targeting FLT3HR014; CAR-T cell therapy products HR010 and HR011 developed for solid tumors; rapidly producible DASH CAR-T cell therapy products HR016 and HR017; and "off-the-shelf" allogeneic CAR-NK cell therapy products HR012 and HR018.
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