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, trade-named Botawei, for the treatment of breast cancer in premenopausal and perimenopausal women eligible for hormone therapy.
Botawei: A Pioneering Treatment for Breast Cancer
Botawei, the world’s first and currently only goserelin acetate in microsphere form, was initially approved to treat prostate cancer requiring androgen castration treatment in China in July 2023. A Phase III study in breast cancer demonstrated the drug’s good clinical efficacy and safety, reducing the incidence and severity of adverse reactions at the injection site. The drug’s improved injection needle, with a diameter of only 0.8 millimeters, effectively reduces the psychological burden related to treatment for patients, offering significant clinical advantages.
Partnership with BeiGene for Drug Development and Commercialization
Luye has struck a licensing agreement with compatriot firm BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), granting BeiGene exclusive development and commercialization rights to Botawei in mainland China. Luye will retain its role as the marketing authorization holder (MAH) and will supply and manufacture the drug based on BeiGene’s requirements.-Fineline Info & Tech
