Zai Lab nabs speedy China regulatory review for PARP drug Zejula
January 28 , 2019
January 28, 2019 08:09 AM EST John Carroll
Chinese regulatory officials are signaling that they’re ready to whisk Zejula through the regulatory process.
Zai Lab $ZLAB said this morning that the Center for Drug Evaluation of China’s National Medical Products Administration has offered a priority review for this drug, the PARP therapy niraparib in-licensed from Tesaro. They’re looking for an OK in China to market the drug for ovarian cancer.
Zai Lab nabbed a fast OK for Zejula in Hong Kong at the end of 2018, allowing them to begin rolling it out in the huge Asian nation.
Chinese officials have been ramping up speedy drug approvals, looking to advantage companies like Zai Lab, homegrown outfits that have been snapping up late-stage and commercial products looking to build quick commercial portfolios. Priority reviews and the promise of swift action after lowering the bar on data requirements have shaken up the Asian market.
Once the $5 billion Tesaro buyout goes through at GSK, Zai Lab will be partnered with the pharma giant, which has large operations inside China and has had for years.
Chinese regulatory officials are signaling that they’re ready to whisk Zejula through the regulatory process.
Zai Lab $ZLAB said this morning that the Center for Drug Evaluation of China’s National Medical Products Administration has offered a priority review for this drug, the PARP therapy niraparib in-licensed from Tesaro. They’re looking for an OK in China to market the drug for ovarian cancer.
Zai Lab nabbed a fast OK for Zejula in Hong Kong at the end of 2018, allowing them to begin rolling it out in the huge Asian nation.
Chinese officials have been ramping up speedy drug approvals, looking to advantage companies like Zai Lab, homegrown outfits that have been snapping up late-stage and commercial products looking to build quick commercial portfolios. Priority reviews and the promise of swift action after lowering the bar on data requirements have shaken up the Asian market.
Once the $5 billion Tesaro buyout goes through at GSK, Zai Lab will be partnered with the pharma giant, which has large operations inside China and has had for years.