REGEN-αGEEK's DASEA Regencarrier® Biomimetic Microcarrier Successfully Obtain Dual CBER & CDER Filings from US FDA

Recently, the DASEA Regencarrier^® Biomimetic Microcarrier, independently developed by REGEN-αGEEK, have successively obtained Drug Master File (DMF) filings with both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) under the US Food and Drug Administration (FDA). This achievement marks them as China's first* biomimetic microcarrier specifically optimized for 3D exosome cultivation (*Source: CDER publicly listed DMF registry, data as of Q3 2024).

DASEA Regencarrier^® Biomimetic Microcarrier are gelatin-based microcarriers for cells (for injection) independently developed by REGEN-αGEEK. They had previously passed registration as a pharmaceutical excipient with the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) on January 19, 2023 (Registration No.: F20220000380), becoming the country's first* pharmaceutical excipient microcarriers specifically designed for cell therapy drug development and intended for injection (*Source: Public database of NMPA's CDE, queried on October 31, 2024).

To date, the product portfolio of REGEN-αGEEK's DASEA Bio-manufacturing Platform has obtained:

• 16 US FDA DMF registrations

• 2 NMPA CDE pharmaceutical excipient registrations

• 3 medical device product filings

• 2 medical device production filings

• 2 stem cell quality testing reports from the National Institutes for Food and Drug Control (NIFDC)