Luye Pharma's Goserelin Acetate Extended-release Microspheres Start Phase III Clinical Trials in China, Paralleling Smooth Progress with U.S. Regulators

SHANGHAI,Sept. 7,2018 -- On September 4,Luye Pharma announced that its independently developed drug,Goserelin Acetate Extended-release Microspheres for Injection (LY01005),has entered phase III clinical trials for prostate cancer in China. Meanwhile,LY01005 is currently under phase I clinical trials in the U.S. via part 505(b) (2) of the United States Federal Food,Drug and Cosmetic Act.

Luye Pharma is working to hasten the launch of LY01005 in China and in other markets around the world,meanwhile advancing its strategic participation in the field of oncology therapeutics. Constantly enriching its R&D pipeline,the company aims to further strengthen its leading position in this field and lay solid foundations for future global market expansion.

Developed by Luye Pharma through its long-acting and extended-release technology platform,LY01005 is a gonadotropin-releasing hormone agonist for the treatment of several conditions,such as prostate cancer,breast cancer and endometriosis. Designed for once-monthly intramuscular administration,LY01005 has similar bioavailability to that of currently marketed drugs,but with better patient compliance and more stable efficacy.

Prostate cancer is one of the most common cancers,with a rate of incidence among the most prevalent of all male cancers in Europe and the United States. In China,incidence of prostate cancer has increased rapidly over the last 10 years. According to IQVIA (formerly known as IMS) data on drug demand,in 2017,total sales revenue for gonadotropin-releasing hormone agonist products in China was about 4.05 billion RMB. Between 2015 and 2017,the compound annual growth rate for this market was 19%. Luye Pharma believes that LY01005 will have a good market prospect after its launch,providing better treatment options for patients in China and around the world. In addition to China and the United States,the company is also working on clinical trial approvals for the drug in Europe and Japan.

Luye Pharma Group acquired the patent for the goserelin microsphere pharmaceutical composition in China,filing a Patent Cooperation Treaty (PCT) application for it in 2014,with patent applications filed in the U.S.,Europe,Japan and a number of other countries and regions in 2015; the application for Japan was approved.

Oncology is one of Luye Pharma's four core therapeutic areas. In addition to the recent progress on LY01005,a number of positive results have been achieved in other pipeline products in the same therapeutic field. For example,LY01013,a IDO/TDO dual-target inhibitor,a new immune-oncology drug independently developed by Luye Pharma,has been approved for Phase I clinical trials in China. LY01008,a Bevacizumab analog indicated for colorectal cancer and non-small cell lung cancer,is progressing smoothly with its Phase III trials. In addition,the company has launched a series of collaborative research and development projects 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,which are in different stages of clinical development in China and overseas markets.

As an international pharmaceutical company dedicated to the R&D,manufacturing and sale of innovative drugs,Luye Pharma has built a rich pipeline across different therapeutic areas,such as central nervous system,metabolism,and cardiovascular diseases. Driven by a strategy of "Global R&D",the company has established a global R&D network with three R&D centers,located in China,the United States and Europe. Currently,30 drug candidates are being studied in China and more than 10 are being studied in overseas markets. Luye Pharma has reached advanced world level towards the research of new delivery technology,such as liposome,microsphere and transdermal drug delivery. Moreover,the company has been actively exploring opportunities for the development of innovative compounds and antibodies,cell & gene therapies and smart formulations.

To better leverage R&D results to benefit patients,Luye Pharma has established 7 production bases and more than 30 production lines around the world,as well as a GMP quality management and control systems with international standards. The company has more than 30 marketed products and has presence in more than 80 countries and regions around the world,including China,the United States,Japan,other major global pharmaceutical markets and high-growth emerging markets. By building high-standard global quality management systems and global operation capacity,Luye Pharma is committed to improving the lives of global patients with ever more high-quality and innovative drugs.

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