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Livrein injection of leuprolide acetate microspheres approved clinical "shock" original drug
Medical Network March 19th Recently, Lijiang Pharmaceutical Group Co., Ltd.'s holding subsidiary Shanghai Lizhu Pharmaceutical Co., Ltd. (abbreviation: Shanghai Lizhu) received the "Clinical Trial Notice" issued by the State Food and Drug Administration.
Drug related information
"Linc piracetin microspheres for injection (11.25mg)" has been researched and developed for 4 years, and the application for production has been accepted on August 1, 2018 (acceptance number: CYHS1800206).
The leuprolide acetate microspheres for injection (11.25mg) is a long-acting sustained release preparation of leuprolide acetate, which has the same mechanism of action as the original drug enalapril (11.25mg), and is administered once every 12 weeks. Significantly reduce the frequency of administration, reduce the side effects of drugs, improve the compliance of patients, mainly used to treat prostate cancer and premenopausal breast cancer.
Sales of leuprolide injections in Chinese public medical institutions (unit: 10,000 yuan)
According to the data from the intranet, in recent years, in China's urban public hospitals , county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) terminal leuprolide injections have maintained double-digit growth rates, 2017 sales It is as high as 1.791 billion yuan.
2017 China's public medical institutions terminal liangruilin injection brand pattern
This product is a gonadotropin-releasing hormone (GnRH). Currently, the same GnRH preparations that have been marketed in China are divided into daily dosage form, one-month dosage form and three-month dosage form, in which the sustained-release 3-month dosage form is used for injection of silver acetate. Ruilin Microsphere has only one importer.
Up to now, there has not been a domestically produced product of leuprolide acetate microspheres for injection in China for 3 months. The clinically approved leuprolide acetate microspheres (11.25mg) for injection are only available in Shanghai Lizhu, but there is no Other manufacturers have declared that the product has been invested in research and development costs of approximately RMB 16.87 million.
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