The first Chinese generic drug of kabalatin for Alzheimer's disease has been approved for market

Source: Yigu 2018-06-11 Recently, Beijing New Pharmaceutical Co., Ltd announced that the company has received the approval document for the registration of kabaratin heavy tartrate capsule (specification: 1.5mg and 3.0mg) approved and issued by the State Food and drug administration The approval document numbers are Guoyao Zhun Zi h20183124 and Guoyao Zhun Zi h20183125, respectively The registration is classified as the sixth category of the original chemical drugs, and the approval document number is valid until May 22, 2023, which means that it is resistant to drugs The first imitation of the Alzheimer's drug kabalatin in China will be officially launched soon With the aging of the population, as a chronic neurodegenerative disease, Alzheimer's disease is affecting more and more people's health In high-income countries, Alzheimer's disease is the fifth leading cause of death, but it is the most expensive disease Some scholars even think that it is more terrible than cancer, and this terrible disease The incidence of Alzheimer's disease is on the rise at an unprecedented rate, according to Alzheimer's disease The latest data released by International show that approximately 1 AD patients are diagnosed every 3 seconds in the world In 2015, the number of AD patients in the world is about 46 million 800 thousand In 2050, the number of AD patients worldwide will reach 131 million 500 thousand The incidence rate of AD in China's elderly people aged 65 or above is 4% to 6% At present, about 60% of all dementia patients are in the category, and the number of cases will double every 20 years The huge patient group brings a huge drug market Due to the huge market prospect of therapeutic drugs, companies including Lilly, Merck, Biogen, etc are making great efforts to delay Alzheimer's disease at present However, this road is not smooth, and many clinical researches fail repeatedly, such as Lilly's "big bet" phase III clinical drugs used to treat mild AD Solanezumab failed to reach the main clinical end point and ended in failure In addition, verubercestat, Merck's bace inhibitor, failed to bring any positive clinical effect to AD patients, which also declared failure in clinical trials However, pharmaceutical companies did not stop the pace of research because of continuous setbacks According to the statistics of all clinical trials registered in clinical.gov in January 2017, as of May 1, 2017, a total of 105 new drugs in research for Alzheimer's disease were in clinical trials, of which 28 drugs in phase 3 were in 42 trials, 52 drugs in phase 2 were in 68 trials There are 29 trials of 25 drugs in phase 1 Up to now, there are only four recommended first-line drugs for ad in Europe and the United States, namely, donepezil, kabaratin, galanthamine, and memantine hydrochloride, NMDA receptor antagonist of glutamate Among them, kabaratin (trade name is asneng) is a pseudoirreversible acetylcholinesterase inhibitor approved by the US FDA for the treatment of Alzheimer's disease It is understood that kabaratin, developed by Novartis, is a first-line drug for the treatment of mild and moderate Alzheimer's dementia It has been on the market for many years in China Compared with similar drugs, kabaratin is used for the treatment of Alzheimer's dementia The index is high, and the use of antipsychotic drugs and auxiliary diazepam drugs can be significantly reduced during the treatment The clinical effect is significant, and the tolerance is good Prior to the approval of Beijing New Pharmaceutical Co., Ltd.'s kabaratin heavy tartrate capsule, kabaratin was the exclusive product in the domestic ad market According to the data, the sales volume of domestic city sample hospital esneng in 2016 was 31.26 million yuan, an increase of 22.25% over the previous year The average annual growth rate from 2012 to 2016 was 35.50%, and the sales volume in 2017 is expected to be close to 200 million yuan Jingxin pharmaceutical said that the approval of cabalatine heavy tartrate capsule further enriched the company's mental and neurological varieties As the first domestic imitation of cabalatine, its approved listing will have a positive impact on the company's business Everbright Securities estimated that the product might grow into a hundred million class variety.