On September 8, 2023, SDLY announced:
The innovative preparation developed by the company, Goserelin Microspheres for Injection, has been approved by the National Drug Administration of China (NMPA) for use in premenopausal and perimenopausal women with breast cancer who can be treated with hormone.
The microsphere workshop has passed GMP certification in the United States and the European Union.
Since June 30, 2023, when Goserelin microspheres were approved for the treatment of prostate cancer in China, SDLV has quickly started the overall process of benefiting patients with this product and has been put into clinical use as soon as possible. The approval of this new indication means that the patient population covered by Goserelin microspheres will further expand.
Breast cancer is the largest malignant tumor threatening women's health in the world, and it is also a high incidence of cancer among Chinese women. In 2020, the number of confirmed breast cancer cases in China has reached 420000, and the incidence rate of breast cancer in different age groups continues to rise;
At the same time, the onset age of breast cancer in China is younger than that in Europe and the United States, and the proportion of premenopausal cancer patients accounts for about 1/2;
In addition, compared with older breast cancer patients, premenopausal breast cancer patients have a higher risk of recurrence and poor overall survival.
The upgraded microsphere dosage form and improved injection method of goserelin microsphere can give consideration to efficacy, safety and patient experience, provide women with higher quality treatment, reduce treatment related psychological pressure, improve treatment confidence and compliance, and help breast cancer patients overcome psychological barriers and return to normal life as soon as possible. "
Goserelin microspheres are the world's first and currently the only approved formulation of Goserelin microspheres. Through innovative microsphere technology, they significantly improve the patient's medication experience while ensuring treatment efficacy and safety.
The results of the Phase III clinical trial of this product for the treatment of breast cancer show that its clinical efficacy is equivalent to that of the control drug, its safety is similar to that of the control drug, and it can reduce the incidence and severity of adverse reactions at the injection site. Its improved injection needle has a diameter of only 0.8 millimeters, effectively reducing the psychological burden related to treatment for patients, and has significant clinical advantages.