China’s Livzon Pharmaceutical Group Inc., (HKG: 1513, SHE: 000513) has announced that its leuprorelin acetate microspheres for injection have successfully passed the generic quality consistency evaluation (GQCE) in China.
Leuprolide, a gonadotropin-releasing hormone (GnRH) receptor agonist, is utilized in the treatment of prostate cancer and endometriosis. Originally developed by Japan’s Takeda and marketed as Leuplin, it received its first approval in China in March 2000. Livzon’s leuprorelin acetate microspheres for injection are administered subcutaneously every 4 weeks, offering a long onset time and low medication frequency, which can decrease patient discomfort, reduce the burden of medication, and enhance medication tolerance and accessibility. This product is the first and only domestically developed leuprorelin acetate microspheres to pass GQCE in China and is also the world’s first to be approved following bioequivalence studies in line with the US FDA guidelines.- Flcube.com
