Shanghai, July 24, 2022 — Luye Pharma Group announced today that its investigational drug Goserelin Acetate Extended-Release Microspheres for Injection (LY01005) for the treatment of breast cancer has met expected endpoints in a phase III clinical trial in China. The new drug application for LY01005 for prostate cancer indication is under review in China.
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 practice, the therapeutic effects of using GnRH agonists are best achieved by extended drug release. The only formulation of Goserelin currently available on the market comes in the form of subcutaneous implants.
LY01005 was developed by Luye Pharma on its global-leading microsphere technology platform. Administered once a month via intramuscular injection, the drug is released steadily and consistently for the duration of the dosing period by means of innovative microsphere technology. LY01005 can reduce adverse reactions at the injection site, improve the patient experience, reduce the difficulty of nursing, and increase patient tolerance and compliance, facilitating the therapeutic effect of the drug while providing significant clinical advantages.
The phase III study is a randomized, open-label, active-controlled, non-inferiority clinical study to evaluate the efficacy and safety of LY01005 after continuous intramuscular injections as compared with the reference drug in breast cancer patients. Results of the study showed that, at a dose of 3.6 mg intramuscular injection every 28 days, the serum estradiol (E2) was effectively controlled to postmenopausal levels in the group injected with LY1005, which was similar to the effects of the reference drug, reaching the non-inferiority standard. Generally, the safety profile of LY01005 is also similar to the reference drug. Furthermore, the study indicated that there was no adverse reaction to LY01005 at the injection site, which improved patient compliance. Overall, LY01005 was found to be safe and well tolerated.
Prostate cancer and breast cancer are among the most common malignancies in men and women, respectively. According to the 2020 global cancer burden data released by the World Health Organization’s International Agency for Research on Cancer (IARC), prostate cancer was the world’s second most common malignant tumor among males1. There were approximately 1.41 million new cases of prostate cancer worldwide in 20202, around 120,000 of which were in China . Breast cancer was the type of malignant tumor with highest incidence in the world in 2020, with approximately 2.26 million new cases globally2, of which approximately 420,000 were in China3. Driven by large patient needs, the size of the GnRH agonist product market in China reached approximately RMB 8.97 billion in 2021, with a compound annual growth rate of 18.4% for the period from 2019 to 2021, according to IQVIA.
Luye Pharma believes that LY01005 can provide a new treatment option for patients with prostate cancer and breast cancer, with the product expected to have good market potential following its launch. Furthermore, LY01005 will enrich the company’s oncology product portfolio, strengthen existing resources and advantages, and accelerate the company’s growth of coverage and development in this therapeutic field.
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Shanghai, July 24, 2022 — Luye Pharma Group announced today that its investigational drug Goserelin Acetate Extended-Release Microspheres for Injection (LY01005) for the treatment of breast cancer has met expected endpoints in a phase III clinical trial in China. The new drug application for LY01005 for prostate cancer indication is under review in China.
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 practice, the therapeutic effects of using GnRH agonists are best achieved by extended drug release. The only formulation of Goserelin currently available on the market comes in the form of subcutaneous implants.
LY01005 was developed by Luye Pharma on its global-leading microsphere technology platform. Administered once a month via intramuscular injection, the drug is released steadily and consistently for the duration of the dosing period by means of innovative microsphere technology. LY01005 can reduce adverse reactions at the injection site, improve the patient experience, reduce the difficulty of nursing, and increase patient tolerance and compliance, facilitating the therapeutic effect of the drug while providing significant clinical advantages.
The phase III study is a randomized, open-label, active-controlled, non-inferiority clinical study to evaluate the efficacy and safety of LY01005 after continuous intramuscular injections as compared with the reference drug in breast cancer patients. Results of the study showed that, at a dose of 3.6 mg intramuscular injection every 28 days, the serum estradiol (E2) was effectively controlled to postmenopausal levels in the group injected with LY1005, which was similar to the effects of the reference drug, reaching the non-inferiority standard. Generally, the safety profile of LY01005 is also similar to the reference drug. Furthermore, the study indicated that there was no adverse reaction to LY01005 at the injection site, which improved patient compliance. Overall, LY01005 was found to be safe and well tolerated.
Prostate cancer and breast cancer are among the most common malignancies in men and women, respectively. According to the 2020 global cancer burden data released by the World Health Organization’s International Agency for Research on Cancer (IARC), prostate cancer was the world’s second most common malignant tumor among males1. There were approximately 1.41 million new cases of prostate cancer worldwide in 20202, around 120,000 of which were in China . Breast cancer was the type of malignant tumor with highest incidence in the world in 2020, with approximately 2.26 million new cases globally2, of which approximately 420,000 were in China3. Driven by large patient needs, the size of the GnRH agonist product market in China reached approximately RMB 8.97 billion in 2021, with a compound annual growth rate of 18.4% for the period from 2019 to 2021, according to IQVIA.
Luye Pharma believes that LY01005 can provide a new treatment option for patients with prostate cancer and breast cancer, with the product expected to have good market potential following its launch. Furthermore, LY01005 will enrich the company’s oncology product portfolio, strengthen existing resources and advantages, and accelerate the company’s growth of coverage and development in this therapeutic field.
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