People’s Daily Health Client
12-28 08:27
Simcere Pharmaceuticals has completed the enrollment of 1,208 patients in the phase III clinical trial of SIM0417, a new crown treatment drug, and the progress of this project ranks first among domestic 3CL target drugs.
According to “Jiangsu Drug Supervision”, Jiangsu Provincial Food and Drug Administration held a special scheduling meeting on the research progress of Simcere’s new crown treatment drug SIM0417.
According to the announcement, SIM0417 is an oral drug for the treatment of 3CL-targeted COVID-19 jointly developed by Simcere Pharmaceuticals, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and Wuhan Institute of Virology. , and was included in the key scientific research catalog of the State Council’s joint defense and joint control mechanism.
On December 16, all 1,208 patients had been enrolled in the phase III clinical trials of the project, and the progress ranks first among domestic 3CL target drugs. It is expected to be launched in February 2023 at the earliest.
According to the announcement, Jiang Wei, deputy director of the Jiangsu Provincial Food and Drug Administration, pointed out that SIM0417, as a major innovative drug for the treatment of new crowns with independent intellectual property rights of enterprises in Jiangsu Province, is of great significance to the current epidemic prevention and control in our province. Enterprises should step up the progress of research and development, further strengthen the management of the research process, ensure science and compliance, actively carry out communication and exchanges with the Drug Evaluation Center of the State Food and Drug Administration, plan in advance, and consider issues such as production capacity expansion after approval for listing.
Jiang Wei said that the Provincial Bureau will go all out for the matters proposed by Simcere Pharmaceuticals that require coordination and support, continue to increase communication with superiors and apply for assistance, and handle matters such as review and approval, verification and inspection at full speed, and help SIM0417 It will be approved for marketing as soon as possible, benefit patients earlier, and contribute Jiangsu’s strength to the prevention and control of the epidemic.
Source of this article: People’s Daily Health Client, original title: “Domestic oral drug for the treatment of new crown has completed Phase III clinical trials and is expected to be launched in February 2023 at the earliest”
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