BDGene Therapeutics is a Chinese biotech company based in Shanghai. BDgene now has approval to run Phase 3 trials (held in China) on their gene therapy cure for HSV-1 keratitis.
The gene editing treatment for viral keratitis (BD111), developed based on BDmRNA delivery patent technology, has completed 3 human clinical trials of IIT. It is the only technology of Cas9 mRNA delivery by lentivirus in the world, and also the second human clinical research project of CRISPR-Cas9 gene editing treatment in human body in the world. BDgene are currently advancing pre-clinical research in gene therapy for HSV-2.
BD111 was previously approved as an orphan drug by the US FDA in June 2022. BDGene representatives have now entered pre-IND meetings with the FDA and are in final submission stages. This implies to me that they will start trials in the US in the near future.
After IND approval, BDgene will start Phase 3 clinical trials in three Chinese hospitals.