Qilu Pharmaceutical Secures Approval for 300 Million RMB Anti-Cancer Injection Azacitidine for Injection
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
Recently, according to the announcement on the NMPA official website,Qilu PharmaceuticalSubmitted Category 4 Generic Chemical DrugAzacitidine for InjectionThe marketing application has been approved and passed the consistency evaluation. Currently, Qilu Pharmaceutical has 154 varieties that have passed the evaluation, of which 53 are the first to pass.
Screenshot source:NMPA
AzacitidineIs a naturally occurring cytosine nucleoside analog, belonging to uridine kinase andDNA Demethyltransferase Inhibitors exert antitumor effects by inducing DNA demethylation and direct cytotoxic effects on abnormal hematopoietic cells in the bone marrow.According to the data statistics from Pharma Intelligence, in recent yearsAzacitidine for InjectionSales in hospitals across China have steadily increased,Sales in 2022 were nearly 3 billion yuan, representing a year-on-year increase of 11.56%. Sales in 2023 were nearly 2 billion yuan.
Screenshot source: PharmaCloud China Hospital Sales Database
According to the statistics from Pharma Data Cloud, in 2024, Qilu Pharmaceutical still hasMirabegron Sustained-Release Tablets, Levosimendan, Eltrombopag Ethanolamine TabletsThree varieties have been approved, this is the fourth approved variety, and also the first approved anti-tumor drug this year. Currently, Qilu Pharmaceutical has 154 varieties that have passed the evaluation, of which 53 are the first in their category.
Screenshot source:PharmCube Approved Drugs Summary Database
Apart from the original research and Qilu Pharmaceutical, which was approved this time, currently in China, there are 7 pharmaceutical companies that have production approval, including Shandong New Era Pharmaceutical, Yangtze River Pharmaceutical, Jiangsu Hengrui Pharmaceutical, and Zhengda Tianqing Pharmaceutical.
In addition, in the field of generic drug layout,Azacitidine for InjectionIn China onlyYesJianjin Pharmaceutical, Ruiyang PharmaceuticalTwo pharmaceutical companies have submitted generic applications, both of which are under review. This time, Qilu Pharmaceutical'sAzacitidine for InjectionApproved,Further enriches the company's oncology drug product pipeline and provides more domestically produced medication options for clinicians and patients in China.
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