Take stock of the . . The latest global list of approved medicines and devices in August 2020

In August 2020, the number of new drugs approved by the United States and the European Union increased, and the domestic Fuhong Hanxuan independently developed and produced injection quercetoju single resistance was approved, becoming the first domestic single anti-biosynamic drug in China and Europe.
the largest number of domestic medical devices approved is still the epidemic-related protective medical devices, accounting for 35.7%.
Global Drug Approvals 01 FDA Approvals Figure 1 Changes in FDA Drug Approvals 2010-2020 Source: Firestone Creation Database Figure 1, as of September 7, 2020, the FDA's official website discloses that in August 2020 the FDA completed a total of 72 drug first approvals (not including provisional approvals), of which 14 fda/BLA approvals (not including provisional drugs).
five of the drugs were designated as orphan drugs and six drugs were declared at 505 (b) (2), accounting for 35.7 per cent and 42.9 per cent, respectively.
and 505 (b) (2) remain the focus of the declaration.
Table 1 FDA Approval NDA/BLA Drug List Data Source: Firestone Creation Database 02 EUEMA Approval As of September 7, 2020 EMA Official Website Disclosure, August 2020 A total of five drugs were approved for sale this month, including one new active substance (NEW active substance, NAS) and a heavy-bomb-grade biosynthic drug, beva bead monoantigen, which had sales of $7 billion in 2018.
approvals for 2010-2020 are shown in figure 2.
2 2010-2020 EMA drug approval data source: Firestone Creation Database Table 2 August 2020 EMA approved drug list 03NMPA approval status as of September 7, 2020 NMPA disclosed, in August 2020 a total of 46 domestic first-registered drugs approved.
weighted by dosage form, a total of 29 drug varieties, including 1 biological drug.
The drug for Fuhong Hanxuan independently developed and produced injection of quercetone single resistance (Hanquyou), has been approved by the European Commission and the State Drug Administration for listing, becoming the first central European double batch of domestic single anti-biosynamic drugs.
At present, there are 7 qutozhu single resistance in Phase III clinical stage, including Shanghai Institute of Biological Products, Jiahe Biology, Zhengda Tianqing, Hualan Gene, Haizheng Pharmaceuticals, Anke Biology and Samsung Biology.
Table 3 List of New Drugs Approved by the NMPA in August 2020 Source: Firestone Creation Database Global Medical Device Approval Status 01 FDA Approval As of September 7, 2020, the FDA approved a total of 218 510 (k) pathway products, of which 10 are class I devices, 201 are Class II devices, and 7 are not classified.
2020, there will be nine initial public listings through pre- LISTING approval (PMA).
by classifying 510(k) pre-market notified devices according to the use of the U.S. medical profession, it was found that the most approved types of products in August were orthopaedic surgery, radiology and cardiovascular, as shown in Figure 3.
3 Data on the distribution of approved product types through the FDA 510 (k) channel in August 2020 Source: Firestone Creation Database Table 4 Device Data first approved by the PMA in August 2020 Source: Firestone Creation Database 02 domestic approval as of September 7, 2020, august 2020, the State Bureau approved the first registration of three types of medical device products 32, of which 22 domestic and imported 10.
based on the continuous resumption of work and re-production throughout the country, provincial drug regulatory departments approved a total of 576 registrations of the second category of medical devices in China in August, and 893 medical devices for the record.
Affected by the materials required for the epidemic at home and abroad, medical device approval is still concentrated in injection, nursing and protective equipment, a total of 552 items were approved this month, accounting for 35.7%, the approval of the main category of medical personnel protective supplies, operating room infection control supplies and other medical devices to control the spread of the virus.
addition to infusion, nursing and protective equipment, other medical devices related to the outbreak, such as in-body diagnostic reagents, physiotherapy equipment, clinical testing equipment, etc.
Table 5 Data on the distribution of the number of approved registration categories for domestic and imported medical devices in August 2020: Firestone Creation Database from the geographical distribution, and the largest number of approvals for two or three types of registered products in August were in Hunan Province, Guangdong Province and Zhejiang Province.
see Figure 4.
4 Regional distribution of approved devices: Firestone Creation Database Sketch The number of new drugs approved by the United States and the European Union increased in August 2020.
the FDA has completed 72 drug first approvals (without provisional approval) and the EMA has approved a total of five drugs on the market, including a heavy-duty bomb-grade biosynthic drug, beva bead monoantigen, which was originally developed by Avivitin.
approved by the PMA for the first time in August.
Domestic Fuhong Hanxuan independently developed and produced injection of quercetone single resistance (Hanquyou), has been approved by the European Commission and the State Drug Administration to list, becoming the first central European double-batch of domestic single anti-biological similar drugs.
affected by the materials needed for the domestic and foreign outbreaks, medical device approvals this month remained concentrated in infusion, nursing and protective equipment, accounting for 35.7%.