As the project partner, BLA congratulates Bendao Gene on receiving IND may proceed letter for BD111 project
Gaithersburg, MD (July 20, 2023) – BLA Regulatory, LLC, a full-service biopharma regulatory consultancy, congratulates Shanghai Bendao Gene Technology Co., Ltd. on receiving the “May Proceed Letter” for an IND from the US FDA to initiate its first-in-human Phase 1 clinical trial of BD111 injection, which is being developed for type 1 herpes simplex virus stromal keratitis. This is the world’s first FDA-approved CRISPR antiviral orphan drug [1].
About BD111
BD111 utilizes the original new gene therapy carrier of this guide gene—viroid VLP transduction CRISPR gene editing tool to directly target and cut the genome of herpes simplex virus to reduce or even eliminate the genome of HSV-1 virus to realize the treatment of herpes Treatment of viral keratitis. BD111 is the third in vivo gene editing therapy candidate in the world to enter the IND and clinical stages. In addition, important clinical breakthroughs have been made in the gene therapy of macular degeneration and thalassemia.
About BLA Regulatory, LLC
BLA Regulatory, LLC, is a full-service drug regulatory consultancy focusing on the US with global reach to other major markets. BLA provides comprehensive regulatory strategy and operation services from pre-IND strategic planning, IND preparation & submission, all the way to submission and approval of BLA/NDA. Our goal is to help move your product through the development cycle efficiently. With credits of 300+ INDs and 50+ NDAs/BLAs to our senior consultants, BLA brings clients a broad range of experiences from Big Pharma, CROs, and the FDA. Our services expand across regulatory, CMC, nonclinical, clinical, biostatistics, scientific writing, project management, eCTD publishing, and submission. We have extensive experience across therapeutic areas such as oncology, respiratory, addiction, autoimmune, inflammatory, metabolic, and cardiovascular diseases.
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Reference
[1] Bendao Gene “The world’s first gene-editing therapy BD111 injection of Benguo Gene VLP was approved by FDA” 09 July. 2023,