ST SC Pharmaceuticals: Injectable Paclitaxel (Albumin-Bound) ANDA approved for market by the U.S. FDA
ST SC Pharmaceuticals recently announced that the company has received approval from the U.S. FDA for the abbreviated new drug application (ANDA) for injectable paclitaxel (albumin-bound). This product has undergone comprehensive technical review, confirming its bioequivalence and therapeutic equivalence to the original drug. Injectable paclitaxel (albumin-bound) forms nanoparticles by encapsulating paclitaxel in albumin, significantly reducing cytotoxic side effects, enhancing anti-tumor effects, and providing targeting capabilities to direct release to tumor cells
According to the Zhitong Finance APP, *ST Pharmaceuticals (002693.SZ) announced that the company recently received notification from the U.S. Food and Drug Administration (referred to as "FDA") that its abbreviated new drug application (ANDA) for injectable paclitaxel (albumin-bound) submitted to the U.S. FDA has been approved for marketing. The U.S. FDA conducted a comprehensive technical review of the ANDA submission for injectable paclitaxel (albumin-bound) and determined that the company's product is bioequivalent and therapeutically equivalent to the original drug.
The announcement indicates that injectable paclitaxel (albumin-bound) is a nanoparticle formulation formed by wrapping paclitaxel in albumin. After being combined with albumin to form nanoparticles, injectable paclitaxel (albumin-bound) significantly reduces cytotoxic side effects compared to other paclitaxel drugs, allows for increased dosage, and enhances anti-tumor effects. In addition, injectable paclitaxel (albumin-bound) can accumulate in tumors and be released directionally to tumor cells, providing targeting capabilities that further improve the drug's efficacy
