Triptoreline acetate sustained-release microspheres for green leaf pharmaceutical injection obtained clinical approval

LVYE Pharmaceutical Group Co., Ltd announced that triptoreline acetate sustained-release microspheres (ly01007) for injection, the group's product under development, have been approved by China food and drug administration to carry out clinical trials for the treatment of prostate cancer, precocious puberty, endometriosis (phase I to phase IV), female infertility and breast cancer, and the pretreatment of uterine fibroids before operation Triptorelin microsphere is a kind of sustained-release microsphere preparation of triptorelin acetate (a gonadotropin releasing hormone agonist), which is developed by the group with its own microsphere injection technology and injected intramuscularly once a month It is a product under development in oncology department, which can be used for the treatment of several cancers including breast cancer and prostate cancer Triptoreline microspheres were prepared by a unique formulation and preparation process Compared with the products already on the market, the microspheres prepared by triptorelin have higher drug loading, lower sudden release, less irritation at the injection site and more stable drug release The company has submitted a patent cooperation agreement (PCT) application for triptoreline microsphere pharmaceutical composition, which has entered China, the United States and Europe in 2014 According to IMS statistics, in 2015, the market value of GnRH agonist products in China was about 2.79 billion yuan, with a compound annual growth rate of 21.6% from 2013 to 2015 In 2015, the market value of triptorelin products in China was about 900 million yuan, with a compound annual growth rate of 6.3% from 2013 to 2015 The company believes that triptorelin microsphere has good market potential and will vigorously promote the development of the group in the field of tumor treatment In addition to the product, the company also registered another gonadotropin releasing hormone agonist goserellin acetate sustained-release microspheres in China and the United States, and has been approved for clinical trials in the two countries In addition to the above two tumor drugs, the company is developing a variety of innovative microsphere products in China and the United States at the same time, including risperidone sustained-release microspheres for injection (LY 03004) (which has been confirmed by the U.S Food and drug administration to be able to submit new drug applications in the United States without any further clinical trials) and rotigotine sustained-release microspheres for injection (LY 03003) (phase I clinical trial has been completed in the United States), etc