Our core business strategy for our pharmaceuticals business is to exploit our unique drug delivery technology to develop and obtain FDA approval for the marketing and sale of branded generic pharmaceutical products. We intend to seek regulatory approval for our drug candidates by filing “505(b)(2)” applications, an appealing regulatory pathway alternative that permits companies to obtain FDA approval of new drug applications (NDAs) by relying, in part, on the agency’s findings for a previously approved drug. Created in 1984 as part of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act, the 505(b) (2) application is intended to encourage sponsors to develop innovative medicines using currently available products. According to Section 505(b) (2) guidelines, an NDA approval can be obtained for a new drug without conducting the full complement of safety and efficacy trials and without a “right of reference” from the original applicant. For intravenous injection products, such as a Sugar-Lipid Taxane, does not change the drug profile; therefore no clinical trial is required for the regulatory approvals. In addition, our pipeline also includes high valued oral products which currently have no true solution dosage forms available, especially for those of APIs are not soluble in any clinical acceptable solvents. All our oral products is based on an ODT (orally disintegrating tablets) and PFS (a powder for solution) or a combination of ODT and PFS which provides patients more options, take a tablet directly without water or make a true solution for children or patients who can't swallow or dislike tablets/capsules. Our near-term oral drugs will be filed as identical pharmacokinetic profile to a reference listed drug (RLD) and demonstrate a bioequivalence (BE) instead of a "BE better" product.

Selected (Intravenous) Product Candidate Portfolio