China-based Luye Pharma Group (HKG: 2186) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its goserelin acetate sustained-release microspheres for injection (LY01022, three-month long-acting dosage form). The drug will be evaluated for treating prostate and breast cancers that are suitable for hormonal therapy.
LY01022: Mechanism and Advantages
LY01022 is a gonadotropin-releasing hormone (GnRH) agonist designed to treat prostate cancer, breast cancer, and endometriosis, among other conditions. Unlike the currently available subcutaneous implant form of goserelin, LY01022 is formulated as an injectable microsphere. This formulation can effectively reduce adverse reactions at the injection site, improve patients’ medication experience, and enhance treatment compliance by simplifying the dosing regimen.
Development Pipeline and Future Outlook
In addition to LY01022, Luye Pharma is also developing LY01005, a one-month injectable formulation of goserelin acetate. LY01005 is currently under marketing review in China for use in prostate and breast cancers. The approval for LY01022 marks a significant step forward in Luye Pharma’s efforts to expand its portfolio of long-acting treatments for hormone-sensitive cancers.-Fineline Info & Tech
