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Jan. 6 Company Quick Takes: China approvals for AZ, Sanofi and Gene+; plus Apollomics-GlycoMimetics, Pfizer- Merck KGaA and more

January 7, 2020 12:05 AM UTC
Updated on Jan 11, 2020 at 2:20 AM UTC

Trio of approvals from China’s NMPA
China’s National Medical Products Administration approved NDAs for Lokelma sodium zirconium cyclosilicate from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat hyperkalemia and anti-PCSK9 mAb Praluent alirocumab from Sanofi (Euronext:SAN; NASDAQ:SNY) to prevent cardiovascular events in patients with atherosclerotic cardiovascular disease and to reduce low-density lipoprotein cholesterol levels in primary hypercholesterolemia and mixed dyslipidemia.

The agency also approved a molecular diagnostic kit from Beijing Gene+ Technology Co. Ltd. to guide targeted therapy of non-small cell lung cancer. The kit detects mutations in EGFR, K-Ras, ALK and 56 other genes including drug resistance-related genes. ...