Edaravone sodium chloride injection class 3 generic listing application has been approved

Figure 1: Sales of edaravone in public medical institutions in China (unit: 10000 yuan) Source: the terminal competition pattern of Chinese public medical institutions in the Internet Edaravone is a kind of brain protective agent (free radical scavenger), which is used to improve the neurological symptoms, activities of daily life and dysfunction caused by acute cerebral infarction This product is the top 4 type of terminal neurosystemic drug in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions), with a peak sales of 5.33 billion yuan in 2016 In recent years, with the implementation of new policies such as medical insurance fee control and local key monitoring, the product has been under various pressures, and the sales growth has begun to slow down, even a negative growth in 2018 In 2019, the first batch of national key monitoring list of rational drug use was released, edaravone was listed in the list, and the 2019 version of national health insurance also excluded the variety, and it is expected that the market will again show negative growth Figure 2: enterprise structure of edaravone, the terminal of public medical institutions in China in 2018 Source: the terminal competition pattern of Chinese public medical institutions in the Internet At present, the main competitors of edaravone injection in China's public medical institutions are Nanjing Xiansheng Dongyuan pharmaceutical, Jilin Boda pharmaceutical and Guorui pharmaceutical, with a total share of more than 60% From the perspective of enterprises, edaravone accounts for 62.18% of the total sales of Nanjing xianshengdongyuan pharmaceutical, 100.00% of the total sales of Jilin Boda pharmaceutical, and 34.99% of the total sales of Guorui pharmaceutical Once the sales of products decline, the impact on enterprises will undoubtedly be huge In May 2019, CDE released the list of the second batch of overseas new drugs in urgent clinical need Edaravone sodium chloride injection of Tianbian Mitsubishi pharmaceutical was listed as the reason of urgent clinical need because of "rare disease medication", and the indication was "amyotrophic lateral sclerosis" It was included in the priority review in June 2019 and approved to enter the Chinese market in July Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease, is a rare disease Gradually frozen human disease is progressive degeneration of motor nerve cells, resulting in muscle weakness and atrophy of limbs, trunk, chest and abdomen, as well as decreased speech, swallowing and respiratory function, until death of respiratory failure At present, FDA has approved two "gradually frozen human disease" treatment drugs, one is the oral drug of riluzole developed by Sanofi approved in 1996; the second is edaravone of Japan's tambian Mitsubishi company approved in 2017, with the support of FDA, it is expected to improve the market position of edaravone On March 11, 2018, the drug "racemic-3-n-butylphthalide" (butylphthalide), which is used by stone Pharmaceutical Group to treat ALS, was awarded the qualification of orphan drug by FDA The most important significance of orphan drug qualification is to get more guidance from FDA, have the opportunity to communicate with FDA extensively, and in some cases, reduce part of clinical trials, and accelerate the speed of product marketing Orphan drugs in the United States can enjoy 7 years of market monopoly and up to 50% of the tax relief of R & D costs At present, the global prevalence of Cryogenics is 5.2/100000, and it is estimated that there are about 60000 patients in China With the rapid development of gradually frozen human disease, the survival period of most patients is only 3-5 years After suffering from this disease, the muscles of patients will gradually shrink and lose control until they completely lose their motor function In the later stage, patients will be unable to speak, swallow or even breathe, and eventually die Edaravone sodium chloride injection of Tianbian Mitsubishi pharmaceutical was approved to enter China, giving new hope to patients with gradually frozen human disease in China A bigger surprise appeared in 2020, the first domestic imitation of edaravone sodium chloride injection was approved! Edaravone sodium chloride injection class 3 generic listing application of Jiangsu zhengdafenghai pharmaceutical, affiliated to China biopharmaceutical, was undertaken in March 2018 With the approval of imported new drug "front and back foot", what kind of competition will come after entering the market? We'll see Table 1: 36 neurosystemic drugs that have been evaluated (or deemed to have been evaluated) earlier Source: medchina drug review database 2.0 According to the data of minenet, in 2018, the market scale of terminal chemical drugs in public medical institutions in China has exceeded 1030 billion yuan, and the market of nervous system drugs, as the sixth largest category, has reached the level of 100 billion since 2017 As of January 13, 2020, in addition to edaravone sodium chloride injection, which has just been approved and deemed to have passed the consistency evaluation, 36 products have passed or deemed to have passed the consistency evaluation, including 13 psychotropic drugs, 12 psychostimulants, 5 antiepileptics, 3 anesthetics, 2 painkillers, 1 anti Parkinson's disease drug, involving 37 manufacturers and 83 approvals 。 Table 2: the bid winning situation of the first batch of neurologic drugs Source: Shanghai Sunshine pharmaceutical purchasing network In the first batch of belt purchase, a total of 6 products of nervous system drugs were selected, accounting for 24% of the total It can be seen that the clinical value of this category has been highly recognized by the relevant departments of the state Through the centralized purchase and price reduction, patients have also been given a large discount Table 3: market share changes of winning varieties in 2018 and the first three quarters of 2019 Source: terminal competition pattern of public hospitals in key provinces and cities The first batch of pilot projects of "4 + 7" with volume procurement was the exclusive bid winner After the results of the pilot project were released on December 17, 2018, they gradually landed in the pilot city According to the market data, the market share of the six major product winning enterprises has increased significantly Although the price of the enterprises eating "first soup" has decreased significantly, they can quickly occupy the market The results of centralized mining and selection of 25 provinces and cities are released on September 25, 2019, and market feedback is expected to be reflected in 2020 Table 4: nervous system drugs involved in the second batch of belt purchase Source: Shanghai Sunshine medicine purchase network, minenet database The second batch of purchasing documents with quantity was released on December 29, 2019 There are two nervous system drugs involved in the 33 purchased varieties in this round Although the quantity is less than that in the first round, the two varieties are also valuable in clinical application Paracetamol is a painkiller, which is suitable for the fever caused by common cold or influenza It is also used to relieve mild to moderate pain such as headache, joint pain, migraine, toothache, muscle pain, neuralgia and dysmenorrhea In 2018, acetaminophen ranked seventh among the top 20 general names of terminal chemical oral painkillers in China's public medical institutions At present, the products that have been evaluated are acetaminophen tablets, and there are 5 domestic enterprises that have been evaluated Donepezil, a psychostimulant, is suitable for the treatment of mild or moderate Alzheimer's dementia In 2018, donepezil ranked ninth among the top 20 generic names of terminal chemical oral psychostimulants in public medical institutions in China Currently, donepezil hydrochloride is the product that has been evaluated, and there are two domestic enterprises that have been evaluated.