Luye Pharma Group announced on December 29 that the marketing authorization application for Goserelin Acetate Extended-release Microspheres for Injection (LY01005), an innovative formulation for the treatment of prostate cancer, has been accepted by the Center for Drug Evaluation of China's National Medical Products Administration. The drug is expected to become the world's only Goserelin microsphere product. Leveraging its globally leading microsphere technology platform, Luye Pharma possesses a number of product portfolios in major therapeutic areas, including oncology and the central nervous system, with clinical trials on new products being conducted in China and other countries. Following the China launch of Rykindo®, the country’s first domestically created innovative microsphere injection, Luye Pharma’s line of microsphere products is being commercialized at an accelerated speed. LY01005, another microsphere product at the marketing authorization application stage, has demonstrated Luye Pharma's leading R&D capability and level of industrial production in this field.

Microspheres make it easier for Goserelin to demonstrate its efficacy, and with a better safety advantage

As an important systemic therapy for prostate cancer, Androgen Deprivation Therapy (ADT) serves as a "cornerstone" in treating different stages of this disease. The Gonadotropin-Releasing Hormone (GnRH) agonists represented by Goserelin are drugs most commonly used for ADT. They can effectively control testosterone to the castrate levels, slow down disease progression, and increase survival for patients. However, in clinical practice, the therapeutic effects of GnRH agonists, such as Goserelin, should be achieved by extended drug release. As a first-line treatment for prostate cancer, the only formulation of Goserelin available in the market is for subcutaneous implants. Administered once a month through intramuscular injection, LY01005 is released steadily and consistently during the dosing period through an innovative microsphere technique. The drug can reduce adverse reactions at the injection site, improve patient experience, reducing the difficulty of nursing, and increase patient tolerance and compliance. This use of Goserelin allows it to demonstrate its efficacy and significant clinical advantages.

LY01005 is expected to become the world's only Goserelin microsphere product

Prostate cancer is the second most common cancer and the fifth leading cause of cancer death in men. It is the most commonly diagnosed cancer among men in more than half of the countries across the world1. In 2020, there were about 1.41 million new cases of prostate cancer and about 375,000 deaths worldwide; there were more than 115,000 new cases of prostate cancer and over 50,000 deaths in China2. Due to the huge demand from numerous patients, the size of China’s market for GnRH agonists in 2020 was approximately RMB7.45 billion, with a 2018-2020 compound annual growth rate of 22.6%3. LY01005 is expected to become the world's only Goserelin microsphere product, providing a new treatment option for patients. In addition to prostate cancer, a Phase III clinical trial of LY01005 for the treatment of breast cancer is also underway in China.

The innovations from the company's microsphere technology platform are being commercialized at an accelerated speed

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, microspheres are complex formulations with high technical barriers, which are difficult to develop and manufacture. The technique is monopolized by several overseas companies. Luye Pharma has been developing innovative microsphere technology for many years, and has successfully achieved industrial scale production. Both the investigational LY01005 and the marketed Rykindo® have broken the overseas monopoly on microspheres, lowering the cost of medical expenses for patients and increasing access for them. Luye Pharma has built a strong product portfolio centering on patients’ needs with its microsphere platform. In addition to LY01005, the company also has a number of other investigational microsphere products, including LY03003 for treating Parkinson's disease and LY03009 for treating both Parkinson's disease and restless legs syndrome. Coming new drugs will produce a synergy with Rykindo®, showcasing the company's advantages in this field and providing new high-quality treatment options for patients.