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君实生物(688180.SH):昂戈瑞西单抗注射液新药上市申请获得批准

junshi bio (688180.SH): The new drug application for Angoriximab injection was approved.

Gelonghui Finance ·  Oct 11 18:53

格隆汇 October 11th | Junshi Bio (688180.SH) announced that the company obtained information from the website of the National Medical Products Administration, indicating that the National Medical Products Administration approved the company's application for listing the Recombinant Humanized Anti-PCSK9 Monoclonal Antibody Injection (recombinant humanized anti-PCSK9 monoclonal antibody injection, trade name: Jushida), used for the treatment of primary hypercholesterolemia (non-familial) and mixed dyslipidemia in adults. This is the company's 5th approved commercial product.

Indications: On the basis of controlling diet, in combination with statins, or in combination with statins and ezetimibe, used for the treatment of primary hypercholesterolemia (non-familial) and mixed dyslipidemia in adults who still cannot achieve the target low-density lipoprotein cholesterol (LDL-C) level with moderate doses or higher doses of statins.

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