What's behind the NMPA's emergency approval of Pfizer's new coronavirus drug import?

Generations change, new and old emerge one after another
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On February 12, 2022, the State Food and Drug Administration announced that Pfizer's new coronavirus treatment drug nematevir tablet/ritonavir tablet combination package import registration has been approved with emergency conditions
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As a small-molecule oral drug, the drug is registered for the treatment of adults with mild to moderate new coronaviruses with high risk factors for progression to severe disease, such as the elderly, patients with chronic kidney disease, diabetes, cardiovascular disease, and chronic lung disease
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This may be complementary to some domestic drugs, and given the current degree of virus mutation, any drug may face the same outcome, and it is difficult to work alone
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In the process of medication, the virus will develop drug resistance, just like HIV, which requires a cocktail therapy; Helicobacter pylori requires a quadruple therapy
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They all use drugs to inhibit microorganisms at different stages, and strangle them layer by layer
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Some drugs may be concentration-dependent, while others may be time-dependent.
Combination therapy can maximize the use of the advantages of different drugs
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The drug's naimatevir tablet is a viral protease inhibitor, which can inhibit the SARS-CoV-2 protein and prevent virus replication; while ritonafil itself is a drug used for AIDS, and in this combination preparation, it is used to slow down the Matvir breaks down, allowing the drug to remain in high concentrations in the body for a longer period of time
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This strategy benefits 105 low- and middle-income countries compared to Merck's approval of many Chinese pharmaceutical companies to produce the COVID-19 antiviral drug Molnupiravir
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Pfizer has a similar policy for the drug, with a licensing agreement with the Medicines Patent Pool (MMP) covering 95 low- and middle-income countries
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Generally, such drugs are relatively expensive, so using the partial opening model can expand the scope of benefits and reduce the risk of the spread of the epidemic
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For the domestic prevention and control situation, reducing the social cost of epidemic prevention as soon as possible is the top priority
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To know that imported therapeutic drugs are much faster than imported new crown vaccines, we hope to cooperate with drug treatment to reduce the impact of the closure of the city
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However, this drug is not used for pre-exposure or post-exposure prophylaxis, so it is not a substitute for vaccines, and the use of drugs will not affect the normal use of vaccines
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Whether a drug is effective is one thing, and whether there are more serious adverse reactions is also related to the promotion and use of the drug
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Impaired taste, diarrhea, etc.
that may exist in the drug have a limited effect on the large-scale application of the drug
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In addition, ritonafil itself is metabolized and cleared by the liver, which can cause liver damage, which increases the risk of use in patients with poor liver function
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Of course, the existing domestic new crown drugs have been well promoted by the media in the early stage
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However, as the epidemic spreads and continues, it often falls into silence
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It is not clear whether this imported drug is a supplement to the domestic new crown drug or a substitute
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This import is expected to have an impact on the stock prices of some domestic pharmaceutical companies, especially stocks that have soared amid the new crown epidemic
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After all, it is generally only when the domestic product fails to meet expectations that it will take the risk of emergency and conditional import
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Some netizens also suggested that since the drug is imported in China, should the United States also open up the approval of a certain drug in China? Personally, I think this may only be a matter of time
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According to past experience, if the vaccine can be properly prevented, the pressure of treatment and medication will be reduced a lot, because the number of diseases can be limited
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However, when the vaccine has limited efficacy, especially when the virus mutates frequently, more requirements must be placed on the therapeutic drug
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It is not clear how Pfizer's production capacity of the drug will be able to meet the volume requirements
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If it is effective, it is best to build a factory in China and adopt the mode of cooperation.
On the one hand, it will speed up the application, on the other hand, reduce the cost of transportation and logistics, and also reduce the spread of the epidemic with the goods
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Merck's hepatitis B vaccine cooperation model should still be respected at this stage
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