BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors, two weeks after Novartis AG’s alpelisib, which aims at the same target, was also granted IND clearance in China.
BEIJING – After its masks and test kits were said to be sent back by Western countries due to complaints over poor quality, China this week required only NMPA-approved companies export their products and stepped up regulations to ensure quality.
BEIJING – After its masks and test kits were said to be sent back by Western countries due to complaints over poor quality, China this week required only NMPA-approved companies export their products and stepped up regulations to ensure quality.
The market for multinational medical device companies in China has largely been driven by use only in major public hospitals for patients who pay mostly or entirely out-of-pocket. But that’s continuing to change in ways that could offer a window onto medical device trends in the region over the coming decades.
HONG KONG – Chinese med-tech regulators said in December that conditional approvals are now available to medical devices after the government created speedy review channels for devices that the country needs.