Suzhou's three new crown prevention and control-related medical devices were approved for marketing

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Since January 2023, three medical devices related to the prevention and control of Neoplasm have been approved and marketed in Suzhou, which has strongly improved the capacity of Suzhou in differential diagnosis and medical treatment.

Jiangsu’s first “new crown + A and B influenza” virus nucleic acid detection reagent was approved for marketing

Ltd. independently developed the new coronavirus (2019-nCoV), influenza A virus and influenza B virus nucleic acid test kit (fluorescent PCR method) approved by the State Drug Administration, which is the first nucleic acid triple test reagent for new coronavirus and influenza A and B virus approved for marketing in Jiangsu.

Both the new coronavirus and influenza virus are transmitted through contact, droplets and pollutants, causing respiratory diseases with similar symptoms, which cause a lot of clinical problems to doctors and patients. The triple test developed by Transcend has high sensitivity and high coverage, which can identify three viral nucleic acids of New Coronavirus (ORFlab and N gene), Influenza A (FluA) and Influenza B (FluB) at the same time in one test, which is helpful for accurate clinical diagnosis and treatment. In addition, its unique lyophilization process enables room temperature transportation and preservation, reducing storage and transportation costs while shortening operation time.

After the outbreak of the epidemic in 2020, Tranlan Biologicals quickly organized its R&D team to start the development of the product. 2021, the Suzhou market supervision department attached great importance to the product after it entered the registration filing, and sent special personnel to visit the company several times to provide services and guidance to speed up the product registration process. After the product was registered at the end of 2021, Suzhou market supervision department attached great importance to the product and sent its staff to visit the company several times to provide services and guidance to accelerate the registration process.

The first new coronavirus nucleic acid test kit approved for marketing in Suzhou

On January 17, the new coronavirus (2019-nCoV) nucleic acid test kit (fluorescent PCR method) developed by Suzhou Tianlong Biotechnology Co., Ltd. was approved for marketing by the State Drug Administration, which is the first new coronavirus nucleic acid test kit approved for marketing in Suzhou.

Suzhou Tianlong, established in 2009, is a medical device manufacturer specializing in genetic testing, molecular diagnostic field instruments and in vitro diagnostic reagents. After the outbreak, Suzhou Tianlong quickly organized a team to research and develop a new coronavirus (2019-nCoV) nucleic acid test reagent. The Suzhou market supervision department, after the company determined that the product had completed its R&D and was ready to declare registration for listing, sent staff to visit the company for several times to provide services, guide the company to improve the quality management system of internal production and quality control, pay close attention to the progress of product registration, and promote the rapid listing of the product.

The only domestic product for inhalable new crown vaccine is approved for marketing

On January 17, the micro-net nebulizer independently developed by Suzhou Weiqi Biotechnology Co., Ltd. was approved by Jiangsu Provincial Drug Administration for marketing. The product is used to nebulize liquid drugs and is dedicated to the nebulized inhalable recombinant Neocrown vaccine (adenovirus vector) developed by Chen Wei’s team and KangXinuo Bio, and is the only domestic nebulized delivery device. Compared with the existing nebulizer, this product realizes the separation of man and machine during nebulization, and adds a liquid addition control unit and a fog storage cup in the structure to realize one-key automatic liquid addition nebulization with a minimum single liquid addition of 0.1 ml, which can realize precise quantitative nebulization drug delivery.

In August 2021, the Suzhou market supervision department learned that Weiqi Biologicals had developed the first nebulized inhalation device for recombinant novel coronavirus vaccine for inhalation, and took the initiative to help the company contact the relevant departments of the Provincial Drug Administration and the Provincial Medical Device Inspection Institute, etc. In September 2021, the Suzhou market supervision department took the lead in organizing the above approval and testing agencies and Weiqi Biologicals, Kangxino Biologicals, Military Medical Research Institute of the Academy of Military Sciences and other development units We will hold a special registration and approval guidance meeting and continue to help track the inspection and testing, clinical trials and other processes of this variety.