LUYE PHARMA(02186): Paclitaxel (injection of docetaxel microparticles) for the treatment of breast cancer has been approved in China.

Luye Pharma (02186) announced that its independently developed innovative formulation injection of goserelin microspheres, branded as "Baituwei" in Chinese, has received approval from the China National Medical Products Administration (NMPA) for use in the treatment of breast cancer in premenopausal and perimenopausal women who are undergoing hormone therapy. According to the company, this product is the world's first and currently the only approved long-acting goserelin microsphere formulation. Previously, this product had received NMPA approval on June 30, 2023, for the treatment of prostate cancer patients who require androgen deprivation therapy. Currently, the company is collaborating with BeiGene Limited (06160) for the commercialization of this product in mainland China. Breast cancer is the leading malignant tumor threatening women's health globally and is also a highly prevalent cancer among Chinese women. In 2020, the reported number of diagnosed breast cancer cases in China reached 420,000, and the incidence of breast cancer in different age groups continues to rise. Additionally, the age of breast cancer onset in China is younger compared to European and American countries, with premenopausal cancer accounting for about half of all cases. Furthermore, premenopausal breast cancer patients have a higher risk of recurrence and overall poorer survival compared to older breast cancer patients. According to the company, Baituwei is the world's first and currently the only approved goserelin microsphere formulation, which significantly improves the patient medication experience while ensuring treatment effectiveness and safety through innovative microsphere technology. The results of Phase III clinical trials for the treatment of breast cancer with this product showed comparable clinical efficacy to the control drug and similar safety characteristics, with a reduced incidence and severity of injection site adverse reactions. The improved needle diameter of only 0.8 millimeters effectively reduces the psychological burden associated with treatment for patients, enhances their confidence and compliance, and has significant clinical advantages. IQVIA data shows that the market value of GnRH agonist products in China in 2022 is approximately RMB 9.5 billion, with a compound annual growth rate of 17.7% from 2018 to 2022. The company believes that Baituwei has the potential to address current clinical needs and has good market potential in China. The approval of this new indication means that the patient population benefiting from Baituwei will be further expanded. With the clinical advantages of this product in the treatment of prostate and breast cancer, the company will continue to broaden the scope of commercial collaboration with BeiGene, accelerating the transformation of the product's social and commercial value.