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Recently, North China Pharmaceuticals 3 generic spree listing application (acceptance number: CYHS1700264) has been changed to "in approval", is expected to be approved for listing in the near future(Source: NMPA)heavy "star drug"oxiracetam is a brain metabolic improverOraxitan and its similar drugs promote phosphamide and phosphamide amine synthesis, promote brain metabolism, and stimulate specific central neural pathways through the blood-brain barrier, improving intelligence and memoryThe functional treatment is suitable for memory and intelligence disorders caused by mild and moderate vascular dementia, Alzheimer's disease and traumatic brain injuryBut in 1995, Oraxitam was not approved by the FDA because it failed a Phase II clinical trial, and the 2010 AD treatment guidelines issued by the European Union of Neurologic Societies also noted that there was currently insufficient evidence to support the use of sitanic drugs to prevent or treat ADOraxitan api was first synthesized in 1974 by the Italian company Skbichem (ISF), the oral preparation was first marketed in Italy in 1987, and the injection was first registered in Korea and Italy in 1990Capsules were first listed in China in 2003, the commodity is called Kinlang star, injection son in 2005 in the domestic first listing, the product is called Pying staronly Asia has Oraxitan sales worldwide, mainly in China and South KoreaCurrently, only Olastan injections and Olaxitan capsules are available in China, and are used as an auxiliary drug, and North China Pharmaceuticals will be the only Olastan tablet on the market after its launchassisted drug policy, sales declined significantly
According to Minet data show that Oraxitam sales in China is huge, according to PDB data, 2019 national sample hospital Sorasitam sales of 1.280 billion yuan, down 13.84 percent year-on-year, but the actual sales forecast is still 5 billion yuanThere are nearly 10 domestic Oraxitan production enterprises, of which the top 3 sales are Stone Pharmaceuticals O'Yi Pharmaceuticals (41.60%), Shixin Pharmaceuticals (22.35%), Sanlian Pharmaceuticals (20.49%), with sales accounting for a total of 84.44%the impact of the restricted assisted drug policy, oraxitan's share of neurological use in the sample hospital has fallen from 10% in 2012 to 6%(source: PDB)December 12, 2018, the General Office of the National Health and Reform Commission issued "Notice on the work of doing a good job in the clinical application management of complementary drugs", clearly will develop a national catalogue of auxiliary drugs, provincial organizations in the jurisdiction of secondary and above medical institutions, the annual use of the amount from more to less to form a directory Subsequently, various places have introduced measures to limit the use of assisted drugs, the future of the next oraxitan sales will continue to decline the market prospects of North China Pharmaceuticals Oraxitan Tablets are uncertain
North China Pharmaceuticals submitted its listing application for Oraxitan tablets in February 2018 and is on the NMPA's list of 192 newly received applications for registration of newly completed clinical trials for production or import (see annex) (Source: NMPA) affected by the larger environmental policy, the future prospects for the North China Pharmaceutical Sorasitam tablets are not optimistic : Hort, J.Brien, J.T., Gainotti, G., Piratila, T., Popatescu, B.O., Rektorova, I.,....S.S., P (2010) EFNSguidelines forthediagnosis and management of Alzheimer's disease European Journal of Neurology, 17 (10), 1236-1248 original title: Generic s - North China Pharmaceuticals 3 generic sistancing tablets are about to be approved