Sinomed: New drug-eluting stent system receives conditional approval from the US FDA.

Sinopharm Medical announced that in December 2021, the company submitted registration materials for a new drug eluting stent system to the US FDA, and recently received a notification from the FDA that the product has been conditionally approved. The FDA will issue a formal approval after the company completes the necessary improvements. This product is the first domestically developed product approved by the US FDA before market application in China, with a global patent layout, and has undergone clinical research in China, the US, Japan, Europe, and other countries and regions. The product is based on Sinopharm Medical's internationally pioneering theory of "time window for arterial vascular wound healing" and is aimed at improving the speed of wound healing in patients, accelerating endothelial functional recovery, and reducing the incidence of adverse events caused by traditional drug-coated stents. The company needs to complete the required improvements according to FDA requirements before obtaining formal approval and can start production and commercial sales of the product under FDA standards in the US. The specific timeline is not yet determined.