Domestic oseltamivir first approved by FDA

United StatesAccording to the FDA's official website,East Sunshine Medicine in the United StatesFDA Declared New Drug Brief Application for Anti-Influenza Drug Oseltamivir Phosphate Capsules (ANDA, I .e. US Generic Drug Application)in local time.March4day approved, including30 mg,45 mg,75 mgThree specifications.What is striking is thatThis is the first time that domestic oseltamivir phosphate preparations have been obtained.FDA approved for marketing in the United States.

Influenza is an acute respiratory infection caused by the influenza virus,It is also a highly contagious and fast-spreading disease. Typical clinical symptoms are: rapid onset of high fever, general pain, significant fatigue and mild respiratory symptoms. The disease is self-limiting, but in infants and young children, the elderly and patients with underlying heart and lung diseases are prone to severe complications such as pneumonia and lead to death.AccordingAccording to the WHO and Lancet studies, approximately5%-10%Adults and20%-30%of children suffering from seasonal influenza, about300-5000million developed into severe cases, up30-64.6Ten thousand people die of respiratory diseases caused by seasonal influenza, and the number of people infected with influenza in China can reach0.65-2Billions of people.

Oseltamivir is a pairByH5N1、H9N2Influenza caused by subtypes of influenza viruses have therapeutic and preventive effects.Neuraminidase inhibitor, developed by Gilead and commercialized globally by Roche. The drug in1999Year10It was first launched in Sweden in September and subsequently entered the Canadian, EU and US markets,2002year allowed to enter China. The main indications for oseltamivir include use in adults and1 year old and1Treatment of influenza A and B in children over the age13years and13Prevention of influenza A and B in adolescents over the age.The overall safety of oseltamivir is good and the resistance rate is low.2009YearWHOrecommend oseltamivir“Essential drugs (Essential medicine）”,United States and EuropeThe CDC has also recommend it as a major anti-influenza virus drug. Given the high safety profile, oseltamivir is stillFDAThe only one approved can be used for more14Day Neonatal Flu Treatment Drugs.

Oseltamivir phosphateChemical formula:C₁₆H₂₈N₂O₄·H₃PO₄

Chemical Name:(3R,4R,5S)-4-Acetamide-5-Amino-3-(1-Ethyl Proxy)-1-Cyclohexene-1-carboxylic acid ethyl ester phosphateStructural formula:

Oseltamivir inIn 2002 to enter the Chinese market under the trade name Tamiflu, Roche in2005Year12Monthand20063MonthAuthorized the production and sales of oseltamivir to Shanghai Pharmaceutical Subsidiaryand East Sunshine Medicine, two companies under the trade names Orffy and Kewei, respectively.Listed for sale,Since thenThe localization of oseltamivir was realized.

After obtaining the patent authorization, East Sunshine Medicinemake large-scale inputsOseltamivir production process innovation.At present, East Sunshine Medicine's Kewei has two dosage forms: capsules and granules, of which granulesYesExclusive Dosage Form of East Sunshine Medicine,InApproved for listing in 2008, and in2017 into the new version of the national health insurance directory;Its core patent isCN1820744B,Patent Protection Period2026, andOwn patents of the same family in many countries and regions.

2012Years later, the rise of East Sunshine Medicine, oseltamivir domestic sales to achieve explosive growth.2018Nian Kewei GranulesandSales growth of capsules60.4 percent22.47Billions of dollars, become anotherOneDomestic2 billion leveloflarge variety,Market share upNearly 90%.In the first half of 2019, Kewei salesIncomeupTo29.33Billion yuan, year-on-year growthIt's116.5%,AndEast Sunshine MedicineTotal revenue in the first half of the year3.071 billion yuan,Keweichanmore95%.2020Year1Month2 companies.Publishof2019YearDegreePerformance ForecastDisplay,East Sunshine Medicine Year-roundTotalTurnoverFor62.2Billion yuan, year-on-yearDramaIncrease145%，This growthMainStillDue to the continued growth in sales of the core product, Kewei.

United StatesFDA's review standards have always been the industry benchmark, this time.East Sunshine Medicine Oseltamivir Phosphate CapsulesGetANDA approvals will contribute to the overseas development of products and are expected to rely on their ownofHigh cost performance open"Flu medicine" oseltamivirOverseas markets, alsoEast Sunshine Medicine's performance growth provided newthe support.