Gelonghui December 7th 丨Shiyao Group (01093.HK) announced that the SYH2055 (“Product”) developed by the Group has been approved by the China Drug Administration to conduct clinical research in China.

SYH2055 is an oral small molecule anti-coronavirus 3CL protease inhibitor with independent intellectual property rights worldwide developed for the Group. It is a globally innovative drug for Class 1 chemicals in China. This product inhibits the cleavage of virus precursor proteins by acting on the main protease of the coronavirus (mPRO/3clPro), thereby blocking the replication of the virus and acting as an anti-coronavirus. Preclinical studies have shown that the product has strong and broad-spectrum antiviral activity against current mainstream mutant strains, including Omicronba.4 and BA.5 variants. The product significantly reduced lung viral load and significantly improved lung inflammation in animal models infected with COVID-19, which is superior to the same dose of nematver. The pharmacokinetic properties of this product in vivo improved markedly compared to nematvir in rats and crab-eating monkeys. It is expected to overcome the defect that nimatvir must be used in combination with ritonavir, and expand the target group of the drug to patients that cannot be covered due to concomitant use with ritonavir. Preclinical safety evaluation data also fully proved the safety of this product.

The Group will make every effort to advance clinical research on this product, strive to launch the product as soon as possible, and contribute to the fight against the global COVID-19 pandemic.