Another domestic CAR-T immune cell** submitted a marketing application and was accepted
On December 14, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that Hengrundarsheng Biologics submitted the marketing application of Runda-cel autoleucel injection (proposed) and was accepted. According to the information in Hengrun Dasheng's earlier prospectus, the clinical trial application of the company's CD19-targeted CAR-T product HR001*** for the indication of refractory B-cell non-Hodgkin lymphoma (R r B-NHL) has previously been included in the priority review. Hengrun Dasheng said in the prospectus that it is expected to submit a new drug application for the drug in 2023.
The first case of mesenchymal stem cells** asthma was clinically announced to help patients return to normal
Recently, foreign scholars published an article in the international journal "Current Stem Cell Research & Therapy", detailing a clinical case of refractory asthma by intravenous infusion of umbilical cord mesenchymal stem cells**. It is reported that this is the first case report of asthma using mesenchymal stem cells**, which significantly improved the patient's asthma attacks, the frequency of asthma attacks in this patient was significantly reduced, and the dependence on inhalation nebulizers and oxygen machines was significantly reduced. "I feel like my symptoms have improved a lot, and there are no restrictions on my activities," he says.
Zhejiang Province issued the "Several Measures to Support the Innovation and Development of the Biomedical Industry" to support the development of cells and other fields
On December 12, the notice of the Office of the Leading Group for the High-quality Development of the Manufacturing Industry of Zhejiang Province on the issuance of the "Several Measures to Support the Innovation and Development of the Biomedical Industry" stated that it would adhere to innovation-driven development, accelerate the deep integration of government, industry, academia and research funds, and work together to promote the high-quality development of the innovation and development of the biomedical industry in our province, and accelerate the construction of a world-class advanced manufacturing cluster. According to the relevant national requirements, continue to do a good job in the provincial preliminary review, filing and supervision of cell clinical research. Support the development of cell and gene **, rare diseases and other subdivisions.
Milestones!Two gene edits** were approved in the U.S. with a price tag of $1 million
Recently, the official website of the U.S. Food and Drug Administration (FDA) announced that it approved the listing of CRISPR Therapeutics Vertex gene **Casgevy and Bluebird Bio's gene **Lyfgenia, which is the first time that the United States has approved a cell-based gene ** for sickle cell disease (SCD) patients aged 12 years and older. Among them, CASGEVY is the first FDA-approved product to use CRISPR Cas9 gene editing technology, marking an innovative progress in the field of genetics.
Jilin Province focuses on the research on key technologies such as large-scale preparation and quality control of mesenchymal stem cells, NK cells and other cells
Recently, Jilin Province officially released the "Implementation Plan on Building a New Track for Biomedicine and High-end Medical Device Industry in Jilin Province". The plan clearly focuses on the pharmacodynamics, production process, inspection and quality standards, safety evaluation and other related research of stem cells and immune cell drugs. Accelerate the localization of core equipment, reagents and materials in the field of cell **. Focus on the research of key technologies such as large-scale preparation and quality control of mesenchymal stem cells, T lymphocytes, NK cells, dendritic cells and other cells.
Zafrens Secures $23 Million in Funding to Build a Platform to Study Cell-Accelerated Drug Discovery
Zafrens, a California-based, multimodal drug discovery company, has pioneered an ultra-high-throughput platform that isolates, cultures, images, and sequences millions of cells per day. The company's mission is to unlock the complete story of each cell to accelerate drug discovery. Recently, Zafrens announced that it has raised $23 million in funding. The company intends to use the funding to optimize the breakthrough application of its Z-Screen platform and advance its internal pipeline.