Shanghai-created new coronavirus infection treatment drug approved for marketing with conditions

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The Shanghai Pharmaceutical Regulatory Bureau announced today (January 29) that the State Drug Administration (SDA) has granted conditional approval for the marketing of a Class 1 innovative drug, deuterated 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.

The State Drug Administration requires the holder of the marketing license to continue the relevant research work, complete the requirements of the attached conditions by the deadline, and submit the results of the follow-up study in a timely manner.

This class 1 domestic innovative drug developed by Shanghai is jointly developed by Shanghai Institute of Pharmaceutical 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 holder system (MAH) and promoting the rapid listing of innovative R&D results.

With the guidance and assistance of the Yangtze River Delta Sub-center of Drug Review and Inspection of the State Drug Administration (SDA), the Shanghai Municipal Drug Administration (SDA) has taken the initiative to provide services across the front, working together with the Municipal Science and Technology Commission, the Municipal Economic and Information Commission, the Municipal Health Commission and other relevant departments to empower enterprises to innovate and accelerate the market launch of their products.

In 2022, Shanghai’s independent research and development of “global new” 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 consistency evaluation of 53 drug approval number.

The Shanghai Drug Administration said it will continue to focus on innovative products, constantly optimize the innovative drug development and reporting services and processes, speed up 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.