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On the evening of May 11, Zhongsheng Pharmaceutical issued an announcement stating that the clinical trial registration application for the innovative drug RAY1216 tablets of oral anti-new coronavirus 3CL protease inhibitor, Zhongsheng Ruichuang, a holding subsidiary, was accepted by the National Medical Products Administration (NMP.
The announcement pointed out that the 3CL protease cleavage site is in the "highly conserved" region of the coronavirus, and it retains a high degree of activity against the mutant strain of the coronavirus, and the probability of drug resistance is l.
RAY1216 is a potent and broad-spectrum anti-new coronavirus 3CL protease inhibitor developed by Zhongsheng Ruichua.
At present, Zhongsheng Ruichuang has completed a series of IND-compliant preclinical research work in accordance with the regulations and guidelines related to the preclinical development of new crown drugs, and submitted an IND application to the State Drug Administrati.
Preclinical studies have shown that RAY1216 is a broad-spectrum and potent anti-COVID-19 clinical candidate compound, with significant inhibitory effect on 2019-nCoV 3CL protease, and against different 2019-nCoV variants (wild strain, Alpha, Beta, Delta, Omicron) Efficient in vitro inhibitory activity, the inhibitory effect is comparable to that of nelmatevir (PF-07321332) approved by the US and Chinese drug regulatory authorities for emergency use authorization (EUA) or conditionally approved for marketing; in K18-hACE2 infected with the new coronavirus Delta strain In the mouse model, RAY1216 can effectively protect mice, can significantly reduce the virus titer in lung tissue, improve lung lesions, and significantly improve tissue damage caused by the new coronavirus, showing a good dose-effect relationsh.
On May 12, the daily limit of Zhongsheng Pharmaceutical was reported at 157 yuan per share, with a total market value of 1125 billi.
