{"id":19258,"date":"2023-04-26T23:29:00","date_gmt":"2023-04-26T15:29:00","guid":{"rendered":"https:\/\/flcube.com\/?p=19258"},"modified":"2024-12-21T23:33:01","modified_gmt":"2024-12-21T15:33:01","slug":"junshi-biosciences-submits-market-filings-for-pcsk9-mab-ongericimab-to-nmpa","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=19258","title":{"rendered":"Junshi Biosciences Submits Market Filings for PCSK9 mAb Ongericimab to NMPA"},"content":{"rendered":"\n

China\u2019s Junshi Biosciences (HKG: 1877<\/a>, SHA: 688180<\/a>) has announced the submission of two market filings for its PCSK9 monoclonal antibody (mAb) ongericimab (JS002) for the treatment of primary hypercholesterolemia and mixed hyperlipidemia to the National Medical Products Administration (NMPA).<\/p>\n\n\n\n

Phase III and II Clinical Studies Support Filings<\/strong>
Ongericimab is currently in a Phase III clinical study for heterozygous familial hypercholesterolemia, having successfully concluded a Phase III study in primary hypercholesterolemia and mixed hyperlipidemia, as well as a Phase II study in homozygous familial hypercholesterolemia. The market filings are supported by data from two randomized, double-blind, placebo-controlled, multi-center Phase III clinical studies and one single-arm, open-label Phase II clinical study.<\/p>\n\n\n\n

Competition in the PCSK9 mAb Market<\/strong>
Amgen\u2019s Repatha (evolocumab) and Sanofi\u2019s Praluent (alirocumab) are already marketed PCSK9 mAbs in China. Junshi Biosciences is poised to become the first domestic firm to develop a PCSK9 mAb in the country, although it faces competition from other domestic candidates such as Innovent Bio\u2019s IBI306 and Akeso Bio\u2019s AK102, which are also under development.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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