Who will be the first to apply for conformity assessment of 2 billion aspirin varieties?

Aspirin enteric coated tablet is a commonly used drug for the elderly It is widely used in clinic and has created a considerable market share It plays an important role in antithrombotic treatment and prevention But up to now, aspirin enteric coated tablets have not yet been applied for conformity evaluation of generic drugs by enterprises According to China cardiovascular report 2018, there are 290 million people with cardiovascular and cerebrovascular diseases in China, including 13 million stroke, 11 million coronary heart disease, 5 million pulmonary heart disease, 4.5 million heart failure, 2.5 million rheumatic heart disease, 2 million congenital heart disease and 245 million high blood pressure With the development of aging population and the high risk factors of hypertension, hyperlipidemia and hyperglycemia, a large market of antithrombotic drugs has been formed According to the data of minenet, in 2018, the market of terminal antithrombotic drugs in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) reached RMB 31.358 billion, an increase of 19.46% year on year In 2018, the terminal aspirin enteric coated tablets Market of public medical institutions in China reached 2.298 billion yuan, an increase of 12.28% year on year Aspirin belongs to NSAIDs It is widely used in clinic, and its dosage is also very large Aspirin has many mechanisms, such as antipyretic analgesia, anti rheumatism, inhibition of platelet aggregation and so on With the progress of medicine, at present, the market of antipyretic and analgesic compound preparation accounts for 90% of the market, so aspirin is mainly used to inhibit platelet aggregation Aspirin can inhibit platelet aggregation by inhibiting Cox, acetylating serine of Cox molecular active center, preventing TXA2 synthesis, acetylating platelet membrane protein and inhibiting platelet membrane enzyme It is commonly used in clinical treatment and prevention of cerebral infarction, myocardial infarction and other cardiovascular and cerebrovascular diseases, the amount is 75-100mg once a day In addition, foreign research on aspirin has also reduced the incidence of lung cancer in women, as well as the risk of dementia or disability According to the data of minenet, in 2018, the market of aspirin enteric coated tablets in public hospitals of key provinces and cities in China was 267 million yuan, an increase of 8.87% year on year In the first half of 2019, the market of aspirin enteric coated tablets was 127 million yuan, of which Bayer aspirin enteric coated tablets (100mg) accounted for 98.43% of the market share, while domestic drugs only accounted for 1.57% At present, there are 237 enterprises in China that have approved the production of aspirin enteric coated tablets, but the dosage forms and specifications used to inhibit platelet aggregation are not optimistic The author thinks that there are only five enterprises that can compare the imitated aspirin enteric coated tablets with the original aspirin enteric coated tablets (100mg), which are Ouyi pharmaceutical, Hebei Ruisen pharmaceutical, Shenyang ojina pharmaceutical, Shanxi orchid pharmaceutical and Chenxin pharmaceutical In addition, 75 mg aspirin enteric coated tablets used to inhibit platelet aggregation only have the production approval from three companies, i.e Ouyi pharmaceutical, Sichuan Defeng pharmaceutical and Hainan bikai pharmaceutical According to the consistency evaluation database of minenet, up to now, there are five varieties of antithrombotic drugs that have passed the consistency evaluation, including clopidogrel bisulfate, tegrilol, apixaban, rivaroxaban and warfarin sodium Zhengda Tianqing, Ouyi and Shenzhen xinlitai are in the leading position, with more than two products having been evaluated The stone medicine Ouyi has certain research and development foundation in antithrombotic and anticoagulant In particular, there are seven approval numbers for aspirin preparation, namely, aspirin enteric coated tablets (100mg, 75mg, 50mg, 25mg, 300mg and aspirin VEC enteric coated tablets), and compound aspirin tablets It has become one of the most approved pharmaceutical companies for aspirin preparation Whether it can open the breach of consistency evaluation of this variety has won great attention Attention Up to now, no companies have applied for conformity evaluation of generic drugs Aspirin is a century old drug After many years of clinical application, its efficacy and safety have not been questioned It has become a known product for more than 90% of the elderly in the market of antiplatelet aggregation.