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On September 13, Livzon Pharmaceutical issued an announcement stating that the company received the "Notice of Acceptance" (acceptance number: CXHS2101039 country) issued by the National Medical Products Administration.
The company's application for triptorelin acetate microspheres for injection The registration and marketing authorization of domestically produced drugs was accepted by the China Food and Drug Administration
.
After years of research and development, triptorelin acetate microspheres for injection are high-end long-acting microsphere preparations independently developed by the company
.
This product is a gonadotropin releasing hormone agonist injected intramuscularly once a month
A phase III clinical study of triptorelin acetate microspheres for injection evaluated the effectiveness and safety of this product in the treatment of patients with locally advanced or metastatic prostate cancer
.
Clinical research results show that compared with the long-acting sustained and controlled release formulations of triptorelin that have been marketed, this product has: (1) a higher rate of achievement and maintenance of castration; (2) a greater reduction in the incidence of common adverse reactions , Clinical safety tolerance has a greater advantage
As of the disclosure date of this announcement, the cumulative amount of direct investment in the research and development of triptorelin acetate microspheres for injection is RMB 50,191,200
.
According to the database on the website of the China Food and Drug Administration and the Drug Evaluation Center, as of the date of this announcement, a total of 3 domestic imported products of triptorelin long-acting sustained-release preparations are on the market (including Daphine® (triptorelin acetate for injection), Tabi Jia ® (triptorelin for injection), triptorelin pamoate for injection, currently no domestic manufacturer has obtained production approval, and 2 clinical trials have been approved
.
The company is the first domestic enterprise to complete the clinical trials of triptorelin long-acting sustained-release preparations and apply for marketing authorization
According to IQVIA's sample statistical estimation data, the domestic terminal sales of triptorelin preparations in 2020 will be approximately RMB 1.
