Biosyngen's First-in-class Cell Therapy BRG01 Receives FDA Fast Track Designation

12 July 2023 | Wednesday | News

On July 6, 2023, Biosyngen received an official notification from the U.S. Food and Drug Administration (FDA) granting Fast Track Designation (FTD) to its revolutionary first-in-class immunotherapy, BRG01, for the treatment of relapsed/metastatic nasopharyngeal carcinoma.
Image Source : Public Domain

Image Source : Public Domain


Fast Track Designation (FTD) aims to facilitate the development of drugs targeting severe or life-threatening diseases that have the potential to address unmet clinical needs. This designation enables expedited approval processes and streamlined market access for the drug.

BRG01, an immunotherapy drug developed by Biosyngen, has received regulatory approvals from both the China National Medical Products Administration (NMPA) on December 14, 2022, and the U.S. Food and Drug Administration (FDA) on February 16, 2023 respectively; as an Investigational New Drug (IND) for the treatment of relapsed/metastatic nasopharyngeal carcinoma. Further to that, it was granted Orphan Drug Designation (ODD) by the FDA on June 1, 2023. With this latest news, FDA's granting of Fast Track Designation to BRG01 signifies a significant acknowledgment of Biosyngen's advanced technology and product, demonstrating Biosyngen's strong commitment to developing groundbreaking products with a global market focus. This achievement marks another noteworthy milestone for Biosyngen.

Biosyngen remains steadfast in its commitment to addressing unmet clinical needs and advancing its product pipeline through rigorous and high-quality development. In line with this dedication, the company is on track in Investigational New Drug (IND) applications for innovative therapies targeting lung cancer and liver cancer indications in both China and the United States.

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