Health & Beauty

According to the Huacheng Import and Export Data Observation Report, the State Food and Drug Administration has learned that in accordance with the relevant provisions of the Drug Administration Law, the emergency review and approval has been carried out in accordance with the special drug approval procedures recently, and that the combined packaging of the first class of innovative drug Shenotevir tablets/ritonavir tablets declared by Hainan Xiansheng Pharmaceutical Co., Ltd. (trade name: Shenuoxin) has been conditionally approved The Class 1 innovative drug Deuteromidevir Hydrobromide Tablets (trade name: Mindevix) declared by Shanghai Wangshi Biomedical Technology Co., Ltd. was listed.

According to Huacheng Import and Export Data Observation, the above two drugs are both oral small molecule COVID-19 infection treatment drugs, which are used to treat adult patients with mild to moderate novel coronavirus infection (COVID-19). Patients should use drugs strictly according to the instructions under the guidance of doctors.

Xiannuoxin is the first self-developed oral anti COVID-19 drug targeting 3CL protease in China. This drug is a combined packaging drug of Shenotevir tablets and ritonavir tablets, which is jointly developed by the Shanghai Institute of Pharmaceutical Research, Chinese Academy of Sciences, and the Wuhan Institute of Virology, Chinese Academy of Sciences, together with Xiansheng Pharmaceutical. Synotevir can inhibit the 3CL protease necessary for replication of COVID-19. Combined with low-dose ritonavir, it can slow down the metabolism of Synotevir in the body, helping to play its antiviral role.

In November 2021, the Shanghai Institute of Pharmacy of the Chinese Academy of Sciences and the Wuhan Institute of Virology of the Chinese Academy of Sciences reached a cooperation with Xiansheng Pharmaceutical to fully promote the follow-up research and development of Synovir. The Phase III clinical trial of Xiannuoxin is a phase III clinical trial aimed at the patients infected with the Omixon virus strain, with the main end point of "continuous recovery of 11 symptoms such as cough, nasal congestion and runny nose, pharyngalgia, fever, headache, muscle or systemic pain". A total of 1208 subjects were included in 43 clinical research centers in 20 provinces, municipalities and autonomous regions across the country. Huacheng Import and Export Data Observation Report.

Mindavi is an oral anti COVID-19 drug independently developed by China and targeting COVID-19 RNA dependent RNA polymerase.

The Shanghai Institute of Pharmaceutical Research, Chinese Academy of Sciences, Wuhan Institute of Virology, Chinese Academy of Sciences, Xinjiang Institute of Physical and Chemical Technology, Chinese Academy of Sciences, and Suzhou Wangshan Wangshui Bio-pharmaceutical Co., Ltd. jointly studied and determined the candidate molecule of Mindevex; Later, it cooperated with Central Asia Drug Research and Development Center of Chinese Academy of Sciences/China Ukraine Medical Science and Technology City (the "the Belt and Road" Joint Laboratory of the Ministry of Science and Technology), Lingang Laboratory, and Shanghai Junshi Biomedical Technology Co., Ltd. to jointly promote clinical research and marketing license.

Mindavi binds non covalently to the active center of COVID-19 RNA polymerase in the form of nucleoside triphosphate, which directly inhibits the activity of viral RNA polymerase and the synthesis of interfering RNA, thus blocking the replication of the virus and achieving the effect of anti COVID-19.

The results of preclinical studies showed that Mindiver had antiviral effects on the original and mutant strains of COVID-19, including Omikron. In the mouse model infected with COVID-19, Mindiver can effectively eliminate the virus and improve the pathological changes of lung tissue at the same time, Huacheng Import and Export Data Observation Report.

Based on the results of clinical trials conducted among subjects with moderate and severe COVID-19 infection in Uzbekistan, Mindevi was approved for marketing in Uzbekistan on December 28, 2021, becoming the world's first approved oral antiviral drug that can be used for treatment of patients with severe COVID-19 infection.

It is reported that the State Food and Drug Administration requires the listing license holder to continue to carry out relevant research work, complete the conditional requirements within a time limit, submit the follow-up research results in time, and report the import and export data observation of Huacheng.