Luye Pharma Group has announced the completion of a U.S. human pharmacokinetic study for its independently developed innovative formulation, Goserelin Acetate Extended-release Microspheres for Injection (LY01005). Aside from being registered in the U.S. via part 505(b) (2) of the United States Federal Food, Drug and Cosmetic Act, LY01005 is currently undergoing pivotal clinical trials in China.
LY01005 is the company’s once monthly administered goserelin acetate extended-release microspheres for intramuscular injection, for the treatment of certain cancers and other indications, including prostate cancer, breast cancer and endometriosis. The clinical trials conducted by four U.S. clinical centers were designed to assess the pharmacokinetic (PK), pharmacodynamic (PD) and safety profiles of a single dose of LY01005 compared with Zoladex®.
The results of the study showed that there was no significant difference in efficacy between LY01005 and Zoladex®, while the release of LY01005 was more stable in the human body. In addition, the safety and tolerability of LY01005 were well controlled, with no serious adverse events leading to patient withdrawal or death. The company intends to discuss the further development of LY01005 in the U.S. with the FDA.
Prostate cancer and breast cancer are some of the most common cancers among males and females respectively worldwide, with incidence of the two cancers increasing rapidly. According to IQVIA data on drug demand, in 2018, the markets for gonadotropin-releasing hormone agonist products in the U.S. and China were valued at approximately RMB 7.24 billion and RMB 4.95 billion respectively. Between 2016 and 2018, the compound annual growth rate for the U.S. market and China market were 20.8% and 19.7% respectively.
“We believe that LY01005 will have good market prospects, providing better treatment options for patients in the U.S., China, and around the world,” said a Luye Pharma Group management representative. The company currently holds patents related to goserelin microsphere pharmaceutical composition in China, the U.S., Europe, Japan and Russia. Luye Pharma is working to hasten the development of LY01005 in the U.S., China and other markets around the world, meanwhile advancing its strategic participation in the field of oncology therapeutics. Constantly enriching its product development pipeline, the company aims to further strengthen its competitive position in this field and lay solid foundations for future global market expansion.
Oncology is one of Luye Pharma’s four core therapeutic areas, with the company engaged in the comprehensive planning of its global product development pipeline for this therapeutic area. In additional to the recent progress with LY01005, LY01013, an IDO/TDO dual-target inhibitor immuno-oncology drug independently developed by Luye Pharma, has entered into Phase I clinical trials in China. LY01008 (a biosimilar of Avastin®) for the treatment of colorectal cancer and non-small cell lung cancer is progressing smoothly with its Phase III trials in China. LY01011 (a biosimilar of Xgeva®) for the treatment of multiple myeloma and bone metastasis from solid tumors has entered into Phase I clinical trials in China. In addition to these, the company has launched a series of collaborative research and development projects to accelerate the enrichment of its product development pipelines, including collaborations with a Spanish biopharmaceutical company PharmaMar for co-development of an innovative anticancer drug, Zepsyre® (Lurbinectedin), as well as working with global leading biotech companies to jointly develop the next generation of therapeutic antibodies for use in immuno-oncology and CAR-T therapy. At present, Luye Pharma has more than ten innovative formulations and drugs in this therapeutic field in different stages of clinical development in China and overseas markets.
Luye Pharma Group has announced the completion of a U.S. human pharmacokinetic study for its independently developed innovative formulation, Goserelin Acetate Extended-release Microspheres for Injection (LY01005). Aside from being registered in the U.S. via part 505(b) (2) of the United States Federal Food, Drug and Cosmetic Act, LY01005 is currently undergoing pivotal clinical trials in China.
LY01005 is the company’s once monthly administered goserelin acetate extended-release microspheres for intramuscular injection, for the treatment of certain cancers and other indications, including prostate cancer, breast cancer and endometriosis. The clinical trials conducted by four U.S. clinical centers were designed to assess the pharmacokinetic (PK), pharmacodynamic (PD) and safety profiles of a single dose of LY01005 compared with Zoladex®.
The results of the study showed that there was no significant difference in efficacy between LY01005 and Zoladex®, while the release of LY01005 was more stable in the human body. In addition, the safety and tolerability of LY01005 were well controlled, with no serious adverse events leading to patient withdrawal or death. The company intends to discuss the further development of LY01005 in the U.S. with the FDA.
Prostate cancer and breast cancer are some of the most common cancers among males and females respectively worldwide, with incidence of the two cancers increasing rapidly. According to IQVIA data on drug demand, in 2018, the markets for gonadotropin-releasing hormone agonist products in the U.S. and China were valued at approximately RMB 7.24 billion and RMB 4.95 billion respectively. Between 2016 and 2018, the compound annual growth rate for the U.S. market and China market were 20.8% and 19.7% respectively.
“We believe that LY01005 will have good market prospects, providing better treatment options for patients in the U.S., China, and around the world,” said a Luye Pharma Group management representative. The company currently holds patents related to goserelin microsphere pharmaceutical composition in China, the U.S., Europe, Japan and Russia. Luye Pharma is working to hasten the development of LY01005 in the U.S., China and other markets around the world, meanwhile advancing its strategic participation in the field of oncology therapeutics. Constantly enriching its product development pipeline, the company aims to further strengthen its competitive position in this field and lay solid foundations for future global market expansion.
Oncology is one of Luye Pharma’s four core therapeutic areas, with the company engaged in the comprehensive planning of its global product development pipeline for this therapeutic area. In additional to the recent progress with LY01005, LY01013, an IDO/TDO dual-target inhibitor immuno-oncology drug independently developed by Luye Pharma, has entered into Phase I clinical trials in China. LY01008 (a biosimilar of Avastin®) for the treatment of colorectal cancer and non-small cell lung cancer is progressing smoothly with its Phase III trials in China. LY01011 (a biosimilar of Xgeva®) for the treatment of multiple myeloma and bone metastasis from solid tumors has entered into Phase I clinical trials in China. In addition to these, the company has launched a series of collaborative research and development projects to accelerate the enrichment of its product development pipelines, including collaborations with a Spanish biopharmaceutical company PharmaMar for co-development of an innovative anticancer drug, Zepsyre® (Lurbinectedin), as well as working with global leading biotech companies to jointly develop the next generation of therapeutic antibodies for use in immuno-oncology and CAR-T therapy. At present, Luye Pharma has more than ten innovative formulations and drugs in this therapeutic field in different stages of clinical development in China and overseas markets.
