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Domestic Oseltamivir First Received FDA Approval

【摘要】:
The official website of the US FDA shows that Sunshine Lake's abbreviated new drug application (ANDA, the US generic drug application) for the anti-flu drug oseltamivir phosphate capsules, including 30 mg, 45 mg and 75 mg doses, has been approved by the FDA on March 4. Strikingly, this is the first time domestic oseltamivir phosphate has been approved by the FDA for marketing in the United States.

The official website of the US FDA shows that Sunshine Lake's abbreviated new drug application (ANDA, the US generic drug application) for the anti-flu drug oseltamivir phosphate capsules, including 30 mg, 45 mg and 75 mg doses, has been approved by the FDA on March 4. Strikingly, this is the first time domestic oseltamivir phosphate has been approved by the FDA for marketing in the United States.

Influenza is an acute respiratory infection caused by the influenza virus, and is also a highly contagious and rapidly spreading disease. The typical clinical symptoms are: high fever, systemic pain, marked fatigue, and mild respiratory symptoms. The disease is self-limited, but it is easy to cause serious complications such as pneumonia and cause death in infants and young children, the elderly and patients with cardiopulmonary diseases. According to the WHO and Lancet studies, about 5-10% of adults and 20-30% of children worldwide suffer from seasonal influenza every year, and about 3-50 million develop into severe cases, as many as 300-646 thousand people die of respiratory diseases due to seasonal flu. The number of people infected with influenza in China each year can reach 65 to 200 million.

Oseltamivir is a neuraminidase inhibitor that prevents and treats influenza caused by H5N1, H9N2 and other influenza viruses. It was developed by Gilead and commercialized globally by Roche. The drug was first approved for sale in Sweden in October 1999, and subsequently entered the Canadian, European Union and United States markets, and was approved to enter China in 2002.

The main indications for oseltamivir include treatment of influenza A and B for adults and children aged 1 and over, and prevention of influenza A and B for adults and adolescents aged 13 and over. The overall safety of oseltamivir is good, and the resistance rate is low. In 2009, the WHO recommended oseltamivir as "Essential medicine", and the CDC in the United States and Europe successively recommended it as the main anti-influenza virus drug. Due to its high safety profile, oseltamivir is also the only FDA-approved drug to treat flu in newborns older than 14 days.

Oseltamivir phosphate

Chemical formula: C16H28N2O4·H3PO4

Chemical name: ethyl (3R,4R,5S)-4-acetylamino-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate

Structural formula:

Oseltamivir entered the Chinese market under the brand name Tamiflu in 2002. Roche authorized the production and sales of oseltamivir to a subsidiary of Shanghai Pharmaceuticals and Sunshine Lake in December 2005 and March 2006, respectively. Oseltamivir was marketed by the two companies under the trade names Olfie (奥尔菲) and Covey (可威), respectively. Since then, the localization of oseltamivir has been achieved.

Since obtaining the patent authorization, Sunshine Lake has invested in large-scale innovations in the production process of oseltamivir. Covey of Sunshine Lake currently has two dosage forms, capsules and granules. Among them, granules are exclusive formulations of Sunshine Lake, approved for marketing in 2008 and entered the new national medical insurance catalog in 2017. The core patent is CN1820744B, the patent protection period of which is up to 2026, and it has family patents in many countries and regions.

Since 2012, the rise of Covey of Sunshine Lake has led to the explosive growth of domestic sales of oseltamivir. In 2018, the sales of Covey granules and capsules increased by 60.4% to 2.247 billion yuan, becoming another domestically produced 2 billion-level large variety with a market share of nearly 90%. In the first half of 2019, Covey’s sales revenue reached 2.933 billion yuan, an increase of 116.5% year-on-year, while Sunshine Lake's total revenue in the first half of the year was 3.071 billion yuan, wherein Covey accounted for more than 95%. The company's 2019 annual performance announcement released on January 2, 2020 shows that the total annual turnover of Sunshine Lake was 6.22 billion yuan, a sharp increase of 145% year-on-year. This increase was mainly due to the continued increase in sales of core product Covey.

US FDA review criteria has always been the industry's benchmark. ANDA approval for Sunshine Lake's oseltamivir phosphate capsules will help the overseas development of the product. It is expected to open the overseas market of "anti-flu panacea" oseltamivir with its own high cost performance ratio, and also provide new support for the growth of Sunshine Lake.

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