ANP Technologies (ANP) announced that its drug master file (DMF) on its novel, nano-encapsulating polymer-based drug excipient, ANP001B has been accepted and published by the U.S. Food & Drug Administration (FDA).

The DMF#36513 demonstrates ANP’s success in the development of its “Plug and Play” drug delivery platform that can be broadly applicable for many active pharmaceutical ingredients (API’s) – particularly those that are poorly soluble, need better pharmacokinetics, improved safety or tolerability, enhanced biodistribution or those requiring targeted delivery.

The novel nano-encapsulating polymer, ANP001B, is a proprietary polymer composition developed by ANP and has been successfully used in the chemotherapy drug, FID-007 during the clinical trial conducted by ANP and its Partner Fulgent Pharma for the treatment of solid tumors in pre-treated cancer patients. The clinical trial was performed at the University of Southern California (USC) Norris Comprehensive Cancer Center and the results were published in 2021 at the American Society of Clinical Oncology (ASCO) Annual Meeting.

“This is a significant validation and confirmation of ANP’s nano-encapsulating polymer drug delivery platform,” said Dr. Ray Yin, President, and CTO of ANP.

“Based on the data from the clinical trial, ANP001B is safe for intravenous (IV) injection in humans. In addition to FID-007, we are also working on a number of other drug candidates using the same nano-drug delivery platform with the goal to provide next generation formulation solutions by tackling age old problems associated with poor solubility, efficacy and tolerability. Our strong intellectual property (IP) position and low-cost manufacturing advantages have uniquely positioned ANP within the highly competitive drug development field, as it allows the rapid and vertical integration of our nano-drug delivery platform with various APIs seamlessly.”