BIONET Therapeutics, a subsidiary of BIONET Corp., announced that it has received notification from the U.S. Food and Drug Administration (FDA) approving the Drug Master File (DMF) Type II registration for its proprietary umbilical cord mesenchymal stem cell (UCMSC) exosome drug substance.
The company stated that this DMF approval not only supports its new drug development efforts but also allows partner organizations intending to use UCMSC Exosomes as a drug substance to reference the file in regulatory submissions. These include Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), or veterinary drug registrations. This regulatory milestone is expected to significantly enhance the international commercialization of the product and provide stable material support for global partners advancing safer and more effective exosome (extracellular vesicle) therapies.
BIONET Corp. has identified “Exosomes” and “AI-driven drug design” as two core engines to drive both revenue growth and innovation. BIONET Gene Digital utilizes its AI drug design platform to support precise drug selection, protein structure modeling, and pathology mechanism simulations, playing a vital role in new drug discovery and drug repurposing. Meanwhile, BIONET Therapeutics leverages AI-integrated exosome research and manufacturing to revolutionize the field of traditional Chinese medicine, promoting industry transformation and opening up new market opportunities.
BIONET Therapeutics recently completed the construction of an exosome manufacturing facility featuring a PIC/S GMP-compliant pharmaceutical-grade automated system. The facility is capable of producing over 10,000 vials of highly active and consistently high-quality exosomes per day. It is staffed by a team of 200 professionals with master’s and doctoral degrees across the fields of pharmaceutical sciences, AI, and life sciences, providing customized services to meet diverse client needs.
In the first half of this year, BIONET Corp.'s broadly defined exosome R&D and manufacturing business saw year-over-year revenue growth exceeding 70%, with a substantial increase in its revenue contribution. The company has engaged in a number of strategic collaborations, including: co-developing functional herbal exosomes with the Chingguan Yihau (NRICM101) team; exploring the potential of turmeric-derived exosomes using AI in partnership with Datan Biotech; and jointly developing HanFang plant-based exosomes with Hanyitang Chinese Medicine Clinics, integrating traditional Chinese medical services and expanding to serve the Chinese community in Malaysia this year.
In addition, BIONET is working with Luo Lih-Fen Holding Co. to develop scientific-grade skincare products that combine unique Taiwanese plant extracts with BIONET’s mammalian stem cell-derived exosomes.
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