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Luye Pharma’s Goserelin Microsphere Formulation Meets Preset Endpoints in Phase III Clinical Trial in China

2021 / 09 / 09 Publisher:Luye Life Sciences Group

Luye Pharma Group announced today that a Phase III clinical trial of its innovative formulation for the treatment of prostate cancer, Goserelin Acetate Extended-release Microspheres for Injection (LY01005), has been completed in China, and has met the preset endpoints. 

For years, Luye Pharma has been leveraging its globally leading microsphere technology platform to address major diseases in the therapeutic areas of oncology and the central nervous system (CNS) and service the needs of patients. The company has a range of long-acting investigational microsphere products for injection, and has been seeking registration and conducting clinical trials in China and in international pharmaceutical markets such as the U.S. Europe and Japan. LY01005 is another innovative formulation developed by Luye Pharma on its microsphere platform following Rykindo®, a Risperidone microsphere for injection (II). LY01005 can be applied to the treatment of multiple diseases including prostate cancer, breast cancer, and endometriosis.

LY01005 is expected to become the world's only Goserelin microsphere, benefiting over 1 million patients 

According to the latest global cancer burden data from the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, prostate cancer is the world's second most common malignant tumor of males. There were approximately 1.41 million new cases of prostate cancer worldwide in 2020, of which approximately 120,000 new cases of prostate cancer were in China. It is estimated that by 2040 there will be 2.3 million new cases of prostate cancer worldwide with 740,000 deaths. In China, there will be 200,000 new cases of prostate cancer with 120,000 deaths. 

Androgen deprivation therapy (ADT) is an important systemic therapy, fundamental in the treatment of different stages of prostate cancer. The Gonadotropin-releasing hormone (GnRH) agonists represented by Goserelin are a category of the most commonly used drugs for ADT treatment. Goserelin can effectively control testosterone to the castrate levels, slow down disease progression, and increase the survival expectation. 

However, in clinical practice, GnRH drugs such as Goserelin can only produce effective therapeutic results through extended release. Currently, the only Goserelin available in the market is a formulation for intramuscular implantation, which is also a first-line treatment for prostate cancer today.

The use of the innovative LY01005 microsphere techniques, while ensuring equivalent efficacy with the reference drug, reduces the adverse reactions at the injection site, improves patient experience, reduces the difficulty of nursing, and improves patient tolerance and compliance. This drug is administered once a month through intramuscular injection, and can be smoothly released during the administration cycle. It is particularly worthy of attention that LY01005 has been entirely developed in China from key ingredients to formulation. While breaking the technological monopoly, this also helps to reduce medical expenses for patients and make the drug more accessible. 

LY01005 is expected to be the world's only Goserelin microsphere for the treatment of prostate cancer, and patients around the world will benefit from it. According to statistics from IQVIA, the market size for gonadotropin-releasing hormone agonist products in China in 2020 was approximately RMB7.45 billion, and grew at a compound annual growth rate of 22.6% from 2018 to 2020.

LY01005 is equivalent to the reference drug in terms of efficacy, but is significantly better in terms of safety

The phase III clinical trial of LY01005 was a randomized, open, positive drug-controlled clinical study, to evaluate the effectiveness and safety of LY01005 for treating prostate cancer patients through continuous intramuscular injection. During the trial, the patients received treatment with LY01005 or the reference drug randomly at a ratio of 1:1, and the drug was injected 3 times at a dose of 3.6 mg and an interval of 28 days. 

Based on results from this phase III clinical trial, LY01005 was injected intramuscularly at a dose of 3.6 mg every 28 days to treat prostate cancer, which could effectively control testosterone to castrate levels. The clinical efficacy was equivalent to reference drug. The adverse reactions at the injection site were significantly controlled, the patient compliance was better, other incidence of adverse events was similar, the safety characteristics were similar, and the overall clinical trial was safe and well tolerated.

In addition to treating prostate cancer, a Phase III clinical trial of LY01005 for the treatment of breast cancer is also under way in China. 

Luye Pharma has a strong portfolio of microspheres: In addition to LY01005, Rykindo for treating schizophrenia has been approved in China, and the clinical trials of other products including LY03010 (Paliperidone Palmitate Injectable Suspension) for treating schizophrenia and bipolar disorder, and LY03009, a microsphere injection for treating Parkinson's disease and moderate to severe Restless legs syndrome, are under way. 

These microsphere products have an administration cycle ranging from one week to three months. They have clear clinical advantages as well as being safer and more effective, and can increase patient compliance and meet the unmet clinical needs of many more patients. The new drugs to be launched in the future will form a strong portfolio with those that have already been available, to reinforce Luye's leading edge in this market segment. 

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