Hengrui‘s Paclitaxel for injection is approved in the United States

  Recently, Hengrui Medicine announced that its Paclitaxel for Injection (albumin-bound) was approved by the U.S. Food and Drug Administration (FDA), becoming the first manufacturer to obtain generic approval for this variety in the United States. Paclitaxel for injection was developed by Abraxis bioscience in the U.S. and was first approved by the FDA in 2005.

  Hengrui’s paclitaxel for injection (albumin-bound) was approved for marketing in China in 2018 for the treatment of metastatic breast cancer that has failed combination chemotherapy or recurred within six months after adjuvant chemotherapy, and a second indication was approved in 2024 for use in combination with gemcitabine as first-line treatment for metastatic pancreatic cancer.   The new pancreatic cancer indications will provide new treatment options for pancreatic cancer patients and enhance the accessibility and affordability of medication for patients.

  Paclitaxel as an important antitumor drug, domestic and foreign pharmacopoeias differ in the control of substances related to paclitaxel and its injections, but are basically the same, both requiring strict control of the limits of each known impurity, unknown impurity and total impurity.

  The study of paclitaxel impurities is of great significance to ensure the safety and efficacy of the drug. Through continuous technological innovation and strict quality control standards, the production quality of Paclitaxel and the effect of patient use can be further improved. Premier Pharma supplies a full set of Paclitaxel impurity products for researchers/companies, detailed information can be viewed at the official website, and some of its catalogs are as follows: