The board of directors of Luye Pharma Group Ltd. announced that the Group's innovative formulation, Goserelin Microspheres for Injection, has been approved by the National Medical Products Administration of the People's Republic of China for the treatment of breast cancer in premenopausal and perimenopausal women that can be treated with hormones. As far as the Company is aware, this product is the world's first and only formulation of goserelin long-acting microspheres approved for launch. Previously, this product has been approved by NMPA for the treatment of prostate cancer for patients requiring androgen deprivation therapy on 30 June 2023.

Currently, the Group collaborates with BeiGene Ltd. to commercialize this product in Mainland China. Breast cancer is the number one malignant tumor threatening women's health worldwide and is also a highly prevalent cancer in the Chinese female population. In 2020, China was reported to have 420,000 new cases of breast cancer, and the incidence was growing in different age groups.

In China, breast cancer tends to have an earlier onset than in Europe and the United States, which premenopausal breast cancer patients in China account for approximately half of all the patients. The premenopausal patients also have a higher risk of relapse and a lower overall survival rate compared with the elder ones. Baituowei is the world's first and Only approved microsphere formulation of Goserelin, as far as the Company is aware.

With its innovative microsphere formulation, Baituowei is able to ensure efficacy and safety while significantly improving patient experience. In a Phase III clinical trial of Baituowei for the treatment of breast cancer, its efficacy and safety profile were found to be comparable to those of the reference drug. In addition, Baituowei could reduce the incidence and severity of adverse reactions at the injection site.

Its modified needle has a diameter of only 0.8 millimeters to effectively reduce patients' psychological burden associated with the treatment, and to improve patient confidence and compliance. It was found to be clearly superior over the reference drug. Data from IQVIA shows the total size of the market for gonadotropin-releasing hormone (Goserelin) agonists in China was approximately RMB 9.5 billion in 2022, with a compound annual growth rate (CAGR) of 17.7% from 2018 to 2022.

The Company believes that Baituowei has the potential to address the prevailing clinical demands and has good market potential in China. The approval of the new indication will further expand the patient groups that can benefit from Baituowei. Meanwhile, the Group and BeiGene intend to continue to expand commercial collaboration to unleash the product's social value and commercial value faster by leveraging its superiority in treating prostate cancer and breast cancer.