In order to standardize and guide the pharmaceutical research and development, production and registration of immune cell therapy products, under the deployment of the National Medical Products Admini...
It is reported that Shanghai Xianbo Biotechnology Co., Ltd. and Jiangsu Puxin Biopharmaceutical Co., Ltd. have reached a strategic cooperation agreement, entrusting Puxin Bio to carry out the second p...
In accordance with Article 310 of the Good Manufacturing Practice for Pharmaceuticals (Revised in 2010), the Appendix to the Drugs for Clinical Trial Use (Trial) is hereby issued as a supporting docum...
On May 11, the unveiling ceremony of the "Judges' Studio in the Park" of Wuzhong District People's Court was held in Suzhou (Taihu) Software Industrial Park. Dong Qihai, Party Secret...
Tumor immunotherapy is a hot topic in the current research and development of new anti-tumor drugs. How to improve the scientificity and robustness of the identification and judgment of immune-related...
In order to strengthen the supervision and management of drug marketing authorization holders (hereinafter referred to as holders), supervise the holders to fulfill the quality management responsibili...
2022 marks the 10th anniversary of Emily Whitehead, the world's first child with leukemia cured by CAR-T cell immunotherapy, achieving cancer-free survival.In 2012, Emily, who suffered from acute ...
Recently, Jiangsu Puxin Biopharmaceutical Co., Ltd. ("Puxin Bio" or "the Company") completed a Pre-A round of financing of nearly 100 million yuan. This round of financing was led ...
Chimeric antigen receptor CAR-T cells (CAR-T) refer to a type of T cell that can recognize a specific antigen by introducing vectors such as viruses into autologous or allogeneic T cells through gene ...
Chapter I ScopeArticle 1 This Appendix applies to the preparation of drugs for clinical trials (including test drugs and placebos). This Appendix also applies to changes in packaging and labeling of m...
The era of cell therapy has arrived, bringing hope to complex and intractable diseases, and CDMO has helped it develop rapidlyIn 2021, Fosun Kite's Akilencel injection and WuXi Junuo's Rekioll...
Chapter 1 ScopeArticle 1 [Scope] The cell therapy products (hereinafter referred to as cell products) described in this appendix refer to living cell products of human origin, including cells that hav...
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