Chinese regulator approves Bayer blood thinner asundexian

The Regulatory Affairs Professionals Society's Regulatory Recon briefing said Chinese regulators cleared Bayer's blood thinner asundexian.

The item ran in the briefing's international developments section and was based on reports from Reuters and Bloomberg.

The briefing gave no indication for asundexian, no patient numbers, no trial results, and no brand name. It also did not say whether the approval is conditional or which patients can receive the drug. The briefing did not name the Chinese regulator.

The same briefing listed other regulatory actions separately, such as the UK's approval of Johnson & Johnson's oral psoriasis pill and Japan's halt of new patient use of Tavneos. It also reported the US Food and Drug Administration's approval of Edwards' tricuspid valve repair device, a decision unrelated to the Bayer approval. The briefing did not say the two decisions were related. The briefing did not state the date of either approval. The briefing provided no other information about the Bayer approval.