August 15, 2022 - Luye Pharma Group today announced that the New Drug Application (NDA) for its Goserelin Acetate Extended-release Microspheres for Injection (LY01005) for the treatment of breast cancer has been accepted by the Center for Drug Evaluation of China's National Medical Products Administration. The NDA of this drug for the treatment of prostate cancer is also under review in China.
Leveraging its globally leading microsphere platform, Luye Pharma is accelerating the commercialization of its microsphere products. Last year, Rykindo® (Risperidone Microspheres for Injection (II)), China’s first innovative microsphere formulation, was launched in the country. LY01005 is expected to become the world's only Goserelin microsphere formulation approved for launch. This again attests to Luye Pharma’s strength in research and commercialization when it comes to microspheres.
LY01005 represents a breakthrough to the existing Goserelin formulation with a significant clinical advantage
Goserelin is a Gonadotropin-Releasing Hormone (GnRH) agonist for the treatment of a range of diseases such as prostate cancer, breast cancer, and endometriosis. Such drugs produce sustained therapeutic effects through an extended-release mechanism. The only Goserelin formulation currently available on the market comes in the form of a subcutaneous implant.
LY01005 is developed by Luye Pharma on its globally leading microsphere platform. In the form of innovative microspheres, LY01005 is administered intramuscularly once a month to have the drug released steadily and consistently. In addition, it can reduce adverse reactions around the injection site, to improve patient experience, to make nursing easier, and to increase patient tolerance and compliance.
The NDA for LY01005 is based on its Phase III clinical trial. The study showed that, when LY01005 was administered intramuscularly at a dose of 3.6 mg once every 28 days, blood estradiol could be effectively controlled to the postmenopausal levels, making LY01005 comparable to the reference drug in terms of efficacy. LY01005 was also similar to the reference drug in terms of safety. Besides, there was no adverse reaction to LY01005 around the injection site, resulting in better patient compliance. Overall, LY01005 was found to be safe and well tolerated.
GnRH agonists like Goserelin are products of choice for their ability to improve survival and fertility
Data from the online database GLOBOCAN shows that there were 2.26 million new cases of breast cancer worldwide in 2020, making breast cancer the most common cancer for the first time1. In China, breast cancer among young people is clearly on the rise: in 2021, the median age of diagnosis was 48 to 50 years old, and about 60% of the patients were in the premenopausal stage upon diagnosis2.
The release of estrogen induced by GnRH secreted from the hypothalamus in premenopausal women stimulates the growth of breast cancer. For decades, breast cancer has been treated through ovarian function suppression (OFS) to inhibit the release of estrogen. GnRH agonists represented by Goserelin are the most common castration agents used for OFS treatment2.
According to the Expert Consensus on Clinical Application of Ovarian Function Suppression in Early Stage Breast Cancer Treatment in China (the 2021 Edition), using OFS drugs alone can reduce the risk of recurrence and improve survival in breast cancer patients under 50 years of age, and GnRH agonists are recommended as the primary choice for OFS treatment in premenopausal patients with early stage breast cancer who are hormone receptor-positive2. The Consensus also recommends the use of OFS drugs for premenopausal patients with breast cancer before and during neoadjuvant chemotherapy to protect their ovarian function and preserve fertility, regardless of their hormone receptor status2.
Driven by patient needs, the size of the market for GnRH agonist products in China was approximately RMB 8.97 billion in 2021, with a compound annual growth rate of 18.4% from 2019 to 2021, according to IQVIA.
The company keeps delivering innovative results from its globally leading microsphere platform
Microspheres can be designed to release at different speeds, over different periods, for different clinical needs. The drug can be released steadily and continuously for a period from one week to several months, to improve efficacy and safety as well as patient compliance. Therefore, they have significant advantages in clinical practice. However, microspheres are complex formulations that are difficult to develop and manufacture. This technology was monopolized by several foreign drug makers in the past. After years of exploration in this field, Luye Pharma has been able to produce microspheres commercially, putting an end to the monopoly by foreign companies.
Leveraging its microsphere platform, Luye Pharma has built a strong product portfolio targeting major therapeutic areas including oncology and the central nervous system to address patient needs. In addition to LY01005 and Rykindo, the company has a number of other investigational microsphere products under clinical trials in China and abroad, including Rotigotine Extended-release Microspheres for Injection (LY03003) for treating Parkinson's disease and LY03009 for treating both Parkinson's disease and restless legs syndrome. Once launched, these new drugs will create a synergy with the existing products to provide new treatment options for patients.
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