On its PDUFA date Thursday, the FDA cleared Xcopri (cenobamate) tablets from South Korea’s SK Biopharmaceuticals Co. Ltd. to treat partial-onset seizures in adults. The drug’s mechanism of action is not fully understood, but it's believed to work through two separate mechanisms: enhancing inhibitory currents through positive modulation of GABA-A receptors and decreasing excitatory currents by inhibiting the persistent sodium current. 

BEIJING – Beijing-based Chinese biotech giant Beigene Ltd. said Brukinsa (zanubrutinib) won accelerated FDA approval to treat adults with mantle cell lymphoma (MCL) who received at least one prior therapy. This is the first China-discovered innovative cancer drug to win FDA clearance. Beigene said Brukinsa is the only FDA-approved BTK inhibitor shown to deliver 100% median occupancy in peripheral blood cells. It is also the only BTK inhibitor that can be taken once or twice daily. Brukinsa is expected to be launched in the U.S. in the coming weeks.

BEIJING – Chinese biosimilar maker Bio-Thera Solutions Ltd., of Guangzhou, said its BAT-1406 became the first biosimilar referencing Abbvie Inc.'s blockbuster TNF-blocker, Humira (adalimumab), to win a marketing nod in China. It is Bio-Thera's first biosimilar and China's second homegrown biosimilar approved by the National Medical Products Administration (NMPA).

BEIJING – Chinese drug regulators granted conditional approval to Shanghai Green Valley (Group) Co. Ltd.'s marine-derived oligosaccharide, GV-971, to treat Alzheimer's disease (AD), but required further trials to prove the drug's efficacy after marketing.

HONG KONG – Daewon Pharmaceutical Co. Ltd., based in Seoul, South Korea, has received the approval from the country's Ministry of Food and Drug Safety (MFDS) to market Terrosa, a biosimilar teriparatide for osteoporosis treatment developed by Richter-Helm Biotec GmbH & Co. KG, of Hamburg, Germany.