The National Health and Health Commission's suggestion to encourage the innovative research and development and application of stem cells: The National Health and Health Commission's website published the National People's Congress "On Accelerating Stem cell legislation to encourage innovative research and development applications in the field of stem cells to make them better serve the human race”, said that it would continue to advance relevant work with relevant departments, and continuously strengthen the supervision and management of stem cell clinical research standards; continue to support stem cells and Transform related research; coordinate and strengthen the platform construction of relevant scientific research bases such as state key laboratories; compact the scientific and technological ethics supervision responsibilities of various scientific research units, and further improve the standardization of stem cell research.  

Health Commission website 

FDA priority review of CAR-T therapy Breyanzi for second-line treatment of large B-cell lymphoma: Bristol-Myers Squibb (BMS) announced that the U.S. The FDA has accepted a supplemental Biologics License Application (sBLA) for the CD19 CAR-T cell therapy Breyanzi: second-line treatment of adult patients with relapsed or refractory large B-cell lymphoma (R/R LBCL). The sBLA is designed to expand the current indication to include adult patients with R/R LBCL who have failed earlier first-line therapy with Breyanzi. The FDA has granted Priority Review to the sBLA and has assigned a Prescription Drug User Fee Act (PDUFA) target date of June 24, 2022.  

Bio Valley 

Bristol-Myers Squibb CAR-T immune cell therapy Breyanzi was recommended for approval by the EU: Bristol-Myers Squibb (BMS) announced that the European The Committee for Medicinal Products for Human Use (CHMP) of the Medicines Agency (EMA) has issued a positive review opinion recommending approval of the CD19 CAR-T cell therapy Breyanzi: for the treatment of patients with relapsed or refractory ( R/R) adult patients with diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B). The CHMP's comments will now be submitted to the European Commission (EC) for review, which usually makes a final review decision in about 2 months (67 days).  

Bio Valley 

International giants BMS and Bayer invest $3 billion to develop cell medicine: at JPMorgan Healthcare Conference in January this year , Bristol-Myers Squibb (BMS) and Bayer jointly announced a $3 billion investment in the development of cell medicine programs, including the development of NK cells, iNK and T cells. Through the deal, Bristol-Myers Squibb has access to natural killer (NK cell) and T-cell studies in blood and solid tumors. And, Bristol-Myers Squibb is working with the Bayer-backed Philadelphia biotech on potential natural killer, iNK and/or T cell programs. Pharmaceutical investment Placenta-derived NK cell therapy received FDA orphan drug designation again: Celularity, which focuses on the development of placenta-derived allogeneic cell therapy, announced that the US FDA has granted its placental hematopoietic stem cell-derived natural killer (NK) cell therapy CYNK-101 orphan drug designation, For the treatment of gastric or gastroesophageal junction (G/GEJ) cancer. CYNK-101 is an experimental genetically engineered NK cell therapy designed to enhance antibody-dependent cell-mediated cytotoxicity (ADCC) through an approved novel antibody therapy. On January 18, 2022, the US FDA granted CYNK-101 Fast Track designation.  

Medical 

Gilead CAR-T immune cell therapy Yescarta US label update: Gilead's Kite Pharmaceuticals announced that the US FDA has approved the update of CD19 Prescribing information for CAR-T cell therapy Yescarta: Include prophylactic use of corticosteroids in all approved indications. Yescarta is now the first and only CAR-T cell therapy with information on the label to help physicians manage and potentially prevent side effects of the treatment. Updated toxicity management strategies may improve some adverse events without affecting Yescarta activity. Gilead Scientists use CAR-T immune cells to treat type 1 diabetes: Scientists at the University of Toledo have found that type 1 may be cured by reprogramming the immune cells of diabetic patients to heal the pancreas and restore the body's ability to make insulin Diabetic patients. First, they collected immune cells from a patient's blood and modified them in the lab to target specific targets. After a period of reproduction, the modified T cells were reinfused into the patient. function in the body. The developed regulatory CAR-T cells are capable of blocking target-specific immune responses, rather than enhancing the host's immune response.