The city's new coronavirus infection treatment drug deuterium hydrobromide rimivir tablets (VV116) with conditions approved for marketing

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Recently, in accordance with the relevant provisions of the Drug Administration Law, the State Drug Administration conducted an emergency review and approval in accordance with the special drug approval procedure and granted conditional approval for the marketing of the Class 1 innovative drug deuterium rimivir hydrobromide tablets (trade name: Mindvir) declared by Shanghai Wangshi Biomedical Technology Co.

The drug is an oral small molecule neo-coronavirus infection treatment drug for adult patients with mild to moderate novel coronavirus infection (COVID-19). Patients should use the drug strictly as directed under the guidance of a physician. For more information

This class 1 domestic innovative drug is jointly developed by Shanghai Institute of Chinese Academy of Sciences and Shanghai Junshi Biologicals, held by Shanghai Wangshi Biomedical Technology Co. Ltd. is a typical representative of “Zhangjiang R&D + Made in Shanghai”, which is another successful case of Shanghai’s pilot drug listing license system (MAH) and promoting the rapid listing of innovative R&D results.

It is reported that the State Drug Administration has requested the marketing license holder to continue the relevant research work, complete the requirements of the conditions attached to the deadline, and submit the follow-up research results in a timely manner.

The city’s drug regulatory bureau actively docked with the State Drug Administration drug review and verification department, and under the guidance of the State Drug Administration drug review and inspection of the Yangtze River Delta sub-center, take the initiative to serve across the front, with the Municipal Science and Technology Commission, the Municipal Economic and Information Commission, the Municipal Health Commission and other relevant departments to work together to empower enterprises to innovate R & D, to promote the speed of product listing. 2022, the city’s self-developed “global In 2022, the city’s independent research and development of “global” innovative drugs, such as doxorubicin tablets and other four class 1 domestic innovative drugs approved, the number of the first in the country; 59 new drug approval number, through the generic drug quality and efficacy of the consistency of the evaluation of 53 drug approval number.

The next step, the city’s drug regulatory department will continue to focus on innovative products, and continue to optimize innovative drug development and reporting services and processes, accelerate the drug regulatory system and regulatory capacity building, strengthen post-marketing product supervision, guard the bottom line of drug safety, and help promote the high-quality innovative development of Shanghai’s biopharmaceutical industry.