Luye Pharma : 3-month Long-acting Goserelin Microspheres Approved for Clinical Trials in China

- The company is accelerating the development of innovative products from its globally leading microsphere platform-

Shanghai, January 30, 2023 - Luye Pharma Group today announced that its 3-month long-acting Goserelin Acetate Extended-release Microspheres for Injection (LY01022), an innovative anticancer formulation developed by the company itself, has been approved by the Center for Drug Evaluation of China's National Medical Products Administration (NMPA) for clinical trials, intended for treating prostate cancer and breast cancer that can be treated with hormones.

The innovative microsphere technology improves the safety and patient compliance of Goserelin

Goserelin is a Gonadotropin-Releasing Hormone (GnRH) agonist for the treatment of a range of diseases such as prostate cancer, breast cancer, and endometriosis. In clinical application, this drug needs to produce its therapeutic effect through an extended-release mechanism. The currently available Goserelin formulation is a subcutaneous implant.

Goserelin Acetate Extended-release Microspheres for Injection (LY01005) administered monthly developed under Luye Pharma's innovative microspheres technology can be released steadily and consistently during the dosing period. At present, the new drug application for LY01005 is being reviewed in China for treating prostate cancer and breast cancer. Compared with subcutaneous implant, LY01005 can effectively reduce the adverse reactions at the injection site by applying the innovative microsphere technology, improve patient experience for its usage, reduce nursing difficulty and improve the patient's tolerance and compliance. LY01022, which was approved for clinical trial, is a 3-month long-acting dosage form of Goserelin Extended-release Microspheres for Injection. Compared with formulations administered monthly, LY01022 prolongs the dosing cycle and reduces the frequency of injections, which can further improve the patient's compliance.

Prostate cancer and breast cancer are among the most common cancers in men and women respectively. Data from the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO) shows that prostate cancer is the second most common cancer in men globally: In 2020, there were about 1.41 million new cases of prostate cancer worldwide, of which about 120,000 were in China; breast cancer is the No.1 malignancy worldwide: In 2020, there were about 2.26 million new cases of breast cancer worldwide, of which about 420,000 were in China. Driven by the huge patient demand, the size of the market for GnRH agonists in China was approximately RMB 8.97 billion in 2021, with a compound annual growth rate (CAGR) of 18.4% from 2019 to 2021, according to IQVIA.

LY01022 and LY01005 will form a differentiated product portfolio to serve the urgent needs of patients with the two diseases above.

The company keeps delivering innovative results from its globally leading microsphere platform

Microspheres as a new type of high-end formulation can be designed to release at different speeds, over different periods, for different clinical needs. They can release steadily and continuously for a period between one week and several months, improving efficacy, increasing safety and treatment compliance, and showing significant advantages in clinical practice.

However, as a kind of complex formulations, microspheres are difficult to develop and manufacture. The technique used to be monopolized by several overseas companies. Luye Pharma has been developing innovative microspheres for many years. All the key ingredients and formulations of the company's products are developed by itself. While putting an end to foreign monopoly, the company has also successfully achieved industrial production. Compared with the once-a-month formulation, LY01022 has a higher entrapment efficiency and allows the drug to release more steadily thanks to the innovative formulation design. As a result, the dosing frequency can be further reduced, and patient tolerance and compliance can be further improved.

Luye Pharma already has a strong portfolio of products developed on its microsphere platform to serve the needs of patients. In addition to LY01022 and LY01005, the company also has Rykindo® (risperidone for extended-release injectable suspension), which has been approved for marketing in the U.S. and China. The company's pipeline also includes multiple other microsphere products, such as Rotigotine Extended-release Microspheres for Injection (LY03003) and LY03009. Once launched, these new drugs will create a synergy with the existing ones, to demonstrate the company's strength in this field, and to provide clinically relevant innovative products for doctors and patients.