Generic Name of Drug: Oseltamivir Phosphate for Oral Suspension

English Name: Oseltamivir Phosphate for Oral Suspension

Dosage form: Dry suspension

Registration Category: Chemicals Category 5.2

Our company and HETERO LABS LIMITED of India reached cooperation on Oseltamivir Phosphate for Oral Suspension at the beginning of this year. We are solely responsible for the registration and commercialization of it in mainland China. The product was formally accepted by the Center for Drug Evaluation, NMPA on 12 December 2019, and has entered the review phase.

Oseltamivir is an influenza virus neuraminidase inhibitor of choice for anti-influenza virus treatment and prophylaxis, and is the first-line treatment regimen recommended by the National Health Commission for the treatment and prevention of acute, uncomplicated influenza A and B in adults and children above 2 weeks of age and older.

Oseltamivir has been marketed in China in capsules and granules, there is no dry suspension. The dried suspension applied by our company is a special dosage form for children. Compared with capsules, the dry suspension has obvious clinical value and advantages in special populations with dysphagia (e.g. children). Compared with granules, the dry suspension has unique advantages in taste masking and flavoring, and the compliance of pediatric patients is better.

Yichang HEC Yangtze River Pharmaceutical Co., Roche and Shanghai 3D Pharmacy have been listed in China. The vast majority of the market is occupied by HEC pharma Kewei, Kewei sales reached 2.247 billion yuan in 2018, of which 1618 billion yuan granules; Sales in the first half of 2019 amounted to 2.93 billion yuan, of which granules amounted to 2.135 billion yuan, and the total sales of 2019 are expected to reach about 7 billion yuan.

　　Shenzhen Beimei Pharmaceutical Co., Ltd.

　　12-Dec-2019