Accelerate approval of new anti-influenza drugs

As of April 8, a total of 24 people were diagnosed with H7N9 bird flu. Among them, 11 were in Shanghai (5 deaths), 8 in Jiangsu, 2 in Anhui, and 3 in Zhejiang (2 deaths). At present, a total of 621 close contacts have been investigated and no abnormalities have been found.

Shu Yuelong, deputy director of the Chinese Center for Disease Control and Prevention, also said that the institute has completed the analysis of all 8 gene segments of the H7N9 influenza virus and confirmed that the H7N9 that caused the outbreak is a reassortant new virus that belongs to avian origin.

On April 5, the State Food and Drug Administration (CFDA) approved the new anti-influenza paramalavir sodium chloride injection, which is the third neuraminidase inhibitor drug marketed in China. Effective for this epidemic. As a result, the status of the domestic hospital antiviral drugs oseltamivir, zanamivir, and rimantadine could be broken.

Very fast

The reporter learned that H7N9, which has recently received the attention of the whole society, is a virus subtype of influenza A. Peramivir is a new potent neuraminidase inhibitor, and it has been marketed in the United States, Japan and other countries. And domestic clinical trials confirmed that it is effective against HXNX influenza virus. The research team led by Li Song, a researcher of the Institute of Poison Drugs of the Academy of Military Medical Sciences, analyzed the genome sequence of the H7N9 virus and concluded that the neuraminidase structure of the virus is stable and the homology of N9 is greater than 98%, suggesting that neuraminidase inhibitors The outbreak was effective.

After SARS, bird flu, and a stream occur, the state pays close attention to drug development that may trigger major public health emergencies. For the R & D and application of anti-viral drugs, AIDS drugs and anti-drug resistant tuberculosis drugs, the review and appraisal departments of the drug industry also attach great importance to actively track international research progress; review early intervention and establish communication with applicants. Mechanisms; reviewing resource leanings, establishing corresponding working teams; timely coordination of sample inspections and production site inspections. The drug review and approval departments adopted the above measures and accelerated the review and approval of salamivir sodium chloride injection based on full scientific demonstration to meet clinical needs.

Expansion needs medical insurance

At this stage, an effective and effective means of influenza prevention and control is the injection of vaccines, but there is currently no vaccine for the H7N9 subtype. It is reported that the test kit for H7N9 has recently been sent to various provinces and cities in China, and patients can be quickly diagnosed.

For the Influenza A virus, the main domestic antiviral drugs are rimantadine, oseltamivir, zanamivir, and the newly approved and marketed palamivir. The latter three belong to neuraminidase inhibitors. Among them, oseltamivir is "Tamiflu". The product was listed in Switzerland in 1999, and subsequently obtained access in the United States, Argentina, Brazil, Canada and other countries. In July 2004, it was listed in China. With the outbreak of flu in recent years, more than 40 countries around the world have consciously stored antiviral drugs including Tamiflu. Data show that in 2004, Duffy’s global sales amounted to 330 million Swiss francs, reaching an unprecedented 3.2 billion Swiss francs in 2009.

At present, the drug is still in the patent protection period. In China, Hisun Pharmaceutical was approved by the Development and Reform Commission in 2010 to produce Tamiflu intermediates, but did not obtain Tamiflu's production and sales rights; Tatsuma's authorized production and sales of Tamiflu are still only Shanghai Pharmaceutical and Guangdong East Sunshine Group.

In fact, Zanamivir is the world's first neuraminidase inhibitor-like influenza virus treatment drug, and it is also the first approved flu treatment drug since the market of rimantadine in 1993. Oseltamivir is an anti-influenza drug originally researched by Australian biotech company Biota, which was later licensed to GSK for global development.

Judging from the reaction of the market in recent years, the global recognition of post-listed oseltamivir is relatively high. Relatively speaking, the market of zanamivir is not as good as oseltamivir, but in 2007, the global market of zanamivir. Sales have reached 524 million U.S. dollars. In 2009, H1N1 flu outbreaks also earned annual sales of 1.1 billion U.S. dollars.

It is reported that in 2006, GSK authorized domestic siphonic pharmaceutical production and sales of Zanamivir. In February 2010, Xiansheng Pharmaceutical was approved to be approved by the former State Food and Drug Administration to be marketed as anti-flu drug zanamivir inhalation powder. Fog (trade name "also blue"). The listed paramyvir, the clinical trial conducted by oseltamivir as a control drug, the test results show that its efficacy and adverse reactions were not significantly different with oseltamivir.

According to another research and development staff, paraamivir is suitable for patients who are resistant to oseltamivir; in addition, because of the injection of peramivir, clinical use is characterized by rapid onset and long duration.

The antiviral drug use data from the sample hospital in the key domestic cities of the Institute of Pharmacy and Economics of the South China University of Medicine shows that the current domestic hospital antiviral drugs are mainly oseltamivir, zanamivir and rimantadine. The listing of paramivir will undoubtedly make the The market for the sector is more "excited."

Analysts believe that since most of the previous countries' influenza drug storage is close to saturation, coupled with the fact that no influenza pandemic has been established in the world so far, it is not easy for Palamidi to make much sense in the short term. In addition, rimantadine and oseltamivir are currently national medical insurance reimbursement of Class B drugs, and Palamidi and Zanamivir want to further expand the market, but also need to open up medical insurance.