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On July 23, the official website of NMPA showed that the listing application of oseltamivir phosphate capsules of Xintai Pharmaceutical, a subsidiary of Borui Pharmaceuticals, had been reviewed and submitted to NMPA for administrative approval
.
Oseltamivir (Oseltamivir) is a specific inhibitor that acts on neuraminidase, which can inhibit the mature influenza virus from detaching from the host cell, thereby inhibiting the spread of influenza virus in the human body to play a role in the treatment of influenza
.
The original manufacturer of oseltamivir was Roche, and its trade name was Tamiflu.
Oseltamivir capsules were approved in China in 2001; Roche’s dry suspension was declared for marketing in China in November 2005, but it was not approved
.
In 2005 and 2006, Roche licensed oseltamivir to Shanghai Zhongxi Sanwei Pharmaceutical Co.
Currently, according to the Insight database, Dongyang Sunshine has two dosage forms of oseltamivir capsules and granules, and has also submitted an application for the marketing of oseltamivir dry suspension, which is currently under review and approval; at the same time, it has also applied for sustained-release tablets.
The dosage form has been approved for clinical use
.
The four formulations of oseltamivir are conducive to strengthening Dongyang's control over this market share
Dongyang Sunshine's 2020 financial report shows that the sales of Kewei granules and capsules totaled 2.
068 billion yuan, which was 65.
13% lower than 2019 due to the impact of the epidemic
.
Kewei accounted for 88.
From the Insight database (http://db.
dxy.
cn/v5/home/)
However, the current granular formulation is Dongyang Sun's exclusive formulation, and only Dongyang Sunshine has obtained production approval, and the patent protection period is until 2026
.
Yangzijiang initiated two BE trials of oseltamivir particles in July 2020 and April 2021, and one of them has been completed
From the Insight database (http://db.