Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its injectable goserelin acetate in microsphere form, a treatment for prostate cancer requiring androgen castration therapy. This innovative formulation is designed to provide a smoother drug release during the dosing cycle, enhancing the stability of testosterone control and ensuring treatment effectiveness and safety.
Partnership with BeiGene for Commercialization Rights
In conjunction with the approval, Luye Pharma has entered into a licensing agreement with BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), granting the latter exclusive development and commercialization rights to the drug in mainland China. Luye will retain the role of marketing authorization holder (MAH) and will be responsible for supplying and manufacturing the drug according to BeiGene’s requirements.
Enhanced Patient Experience with Microsphere Technology
The goserelin acetate microspheres leverage innovative microsphere technology, which allows for a more stable release of the drug, leading to a more consistent control of testosterone levels. The product is administered through an improved injection needle with a diameter of only 0.8 millimeters, significantly enhancing the patient’s injection experience.
Clinical Efficacy and Safety Demonstrated in Phase III Study
The results of a Phase III clinical study for goserelin acetate in prostate cancer have shown the molecule to be both clinically effective and safe, with comparable outcomes to the control drug. The product has also demonstrated a significant reduction in the incidence and severity of adverse reactions at the injection site, leading to improved patient tolerance and compliance, and offering significant clinical advantages.
Broadening Indications for Goserelin Acetate
Beyond prostate cancer, Luye Pharma is also awaiting regulatory decisions for the use of goserelin acetate in treating breast cancer in China, indicating the potential for this product to address a broader range of therapeutic needs.-Fineline Info & Tech
