07 June 2023 | Wednesday | News
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The FDA Orphan Drug Designation program grants orphan status to promising investigation drugs or biological products designed to treat, prevent or diagnose rare diseases or conditions affecting fewer than 200,000 individuals in the U.S. Orphan drug designation qualifies sponsors for several incentives to the subsequent development, registration and commercialization including FDA support for clinical studies, tax credits for qualified clinical trials, exemption from user fees and potential seven years of market exclusivity after approval.
Prior to this designation granted by U.S. FDA, Biosyngen's BRG01 IND application has been approved by U.S. FDA (Feb. 16th,2023) and China CDE (Dec. 14th, 2022) respectively. With this approval of ODD for BRG01, it reinforces Biosyngen's advances in technology and capability to develop first-in-class biological products addressing unmet needs for patients across the world.
Moving forward, the company will continue to live up to its mission to address unmet clinical needs and bring superior treatments to patients. From this milestone, a follow-up application for Fast Tract Designation Request of BRG01 is being planned, together with other products in Biosyngen's portfolio projected to enter IIT/Phase I in 2023, across Singapore, China and the US. The indications targeted include hepatocellular cancer, gastric cancer and digestive track cancers.