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19

2023-04

Pharmaceutical Source Workshop, Session 2 | Antibody Discovery and Drug-likeness Analysis

Focusing on the fields of biomacromolecules, cell therapy, and gene therapy, this program takes a comprehensive, end-to-end approach to drug discovery and development, addressing key challenges and bottlenecks throughout the entire R&D process. It features carefully designed knowledge modules and invites industry experts to deliver small-scale, in-person presentations, making it a truly focused platform for technical exchange and interaction. This course is designed to provide professionals in the field with a new, on-the-job platform for in-depth learning.

2023-04-19

He Yousheng

03

2023-04

Major Positive News: CDE Issues for Public Comment the “Procedures for Accelerating the Review and Approval of Marketing Applications for Innovative Drugs (Trial)”!

Just now, the CDE issued a notice soliciting public comments on the “Procedures for Accelerating the Review and Approval of Marketing Applications for Innovative Drugs by the Center for Drug Evaluation (Trial).” Details are provided below.

2023-04-03

He Yousheng

03

2023-04

Domestic Launch | New Tool for Detecting CAR Positive Rates—Easily Achieves Positive Detection with a Single Primary Antibody

Are you still frustrated by substantial data bias and non-specific staining in negative controls when quantifying CAR-positive rates in both in vitro and in vivo CAR-T studies? Are you overwhelmed by the myriad of CAR constructs, direct and indirect antibodies, and antigen proteins, all deterred by the high cost of these assay reagents?

2023-04-03

He Yousheng

30

2023-03

Materials for the Administration of Human Genetic Resources

Materials for the Administration of Human Genetic Resources

2023-03-30

He Yousheng

27

2023-03

Is there a bubble in China’s cell and gene therapy industry?

At the beginning of 2023, following a high-profile yet now decidedly less vibrant JP Morgan conference in the United States, biotech companies that had endured three harsh winters under capital scarcity not only failed to see a thaw in funding but instead faced a wave of successive layoffs, company closures, and asset sales: Aristea in the large-molecule space shut down, while Goldfinch and Xenikos initiated liquidation proceedings; in the cell and gene therapy sector, Editas and Century carried out workforce reductions, and Rubius closed its doors.

2023-03-27

He Yousheng

27

2023-03

Now that Funo Biotech is also entering the cell and gene CDMO space, could it be following the same path as the antibody industry?

Following the spin-off of CMC and manufacturing teams from antibody biopharmaceutical companies to establish independent CDMO firms, there is now a growing trend among cell and gene therapy R&D companies to carve out CGT CDMOs as well. For instance, JiaYin Bio, an AAV drug developer, established CoJourney Biotech in 2022 as an AAV CDMO service provider, while FunoGene Biotech, a oncolytic virus drug developer, recently founded FRASERNA to offer a one-stop CRDMO platform for viral vector and nucleic acid therapeutics—covering everything from concept development through IND filing to commercialization. Since its founding in 2019, JiaYin Bio has been focused on the R&D of AAV viral vector–based gene therapies.

2023-03-27

He Yousheng
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