Pfizer oral medicine written into the new version of the diagnosis and treatment plan Domestic hospitals are waiting for supply

On the evening of March 15, the National Health Commission issued the > of the Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Trial Version 9). In the latest version of the COVID-19 protocol, two antiviral therapies have been added, including the oral COVID-19 drug Paxlovid and the monoclonal antibody amphavulonumab/romizumab injection.

These two drugs are specially developed for the new crown virus and are regarded as special drugs for the new crown, and domestic hospitals are still waiting for the supply of drugs.

Prevents the transformation of the ordinary type into severe disease

After the opening of the market on March 16, the stock prices of related pharmaceutical companies rose sharply. As of midday, Tengsheng Bo Pharmaceutical's share price in Hong Kong stocks surged nearly 18%, and the shares of Ritonavir producer Golee Pharmaceuticals, a component of Paxlovid drugs, surged more than 16%. Golee pharmaceuticals recently announced that it has further expanded the annual production capacity of ritonavir oral tablets to about 530 million tablets.

In view of the treatment for covid-19 patients in the latest version of the diagnosis and treatment plan, Professor Lu Hongzhou, president of the National Clinical Research Center for Infectious Diseases and the Third People's Hospital of Shenzhen, interpreted it. Lu Hongzhou told the first financial reporter: "The new crown oral drugs Paxlovid and monoclonal antibodies written into the diagnosis and treatment plan are mainly used in the early stage to prevent the transformation of ordinary patients into severe diseases, thereby reducing virus replication and transmission, shortening the time of isolation and hospitalization." ”

Lu Hongzhou said that elderly patients and unvaccinated patients should be considered to prioritize the use of these new crown drugs. Specifically, Paxlovid is taken every 12 hours for 5 consecutive days; monoclonal antibody treatment is 1000mg each for ambavir monoclonal antibody and romidavir maclizumab, and Lu Hongzhou said that monoclonal antibodies can be injected multiple times as needed.

The basic mechanism of antiviral drugs is to reduce the replication ability of viruses by blocking or mutagenesis. For example, Pfizer's COVID-19 antiviral is an enzyme needed to stop the new coronavirus from replicating, while Merck's antiviral drugs directly destroy the new coronavirus gene.

At present, the efficacy of domestic anti-covid-19 neutralizing antibody drugs on the Omiljung variant has not been published in public clinical data. WHO experts also noted that the effectiveness of neutralizing antibodies against the Omiljung variant remains uncertain, and said guidelines for such drugs will be updated as more data become available. Previous clinical trials of neutralizing antibodies of Eli Lilly and Regenerator have shown a large degree of antibody escape against the Opichron variant.

In this regard, Lu Hongzhou believes that antibody cocktail therapy and the development of new neutralizing antibodies will become solutions to deal with the new crown variant in the future. He revealed that a small molecule drug that has the potential to work with Pfizer's Paxlovid is being developed and hopes to get clinically validated green channel approval as soon as possible.

China's drug supply has been initiated

The first financial reporter learned that the current supply of Paxlovid and monoclonal antibody amphavir monoclonal antibody / romizumab is still tight. Professor Yan Xuebing, director of the Department of Infectious Diseases of the Affiliated Hospital of Xuzhou Medical University, told the first financial reporter that there are no two drugs in the hospital at present, and he expects that it may take a while to get these drugs.

On March 9, China Pharmaceutical signed a supply agreement with Pfizer to be responsible for Paxlovid's commercial operations in the Chinese mainland market. The approval of Pfizer Paxlovid for listing has also driven the stock price performance of CDMO companies such as Gloria Ying, Boteng Shares, and Yaben Chemical.

Andrew Hill, a senior researcher at the University of Liverpool in the United Kingdom, has previously said that one potential challenge in making Paxlovid is obtaining raw materials. According to research firm Airfinity, the drug production process requires a large procurement of 38 different raw materials and reagents from global suppliers. While there are no known shortages yet, there may be bottlenecks in the future.

Ma Dawei, an academician of the Chinese Academy of Sciences and the Shanghai Institute of Organic Chemistry of the Chinese Academy of Sciences, believes that it is not difficult for pharmaceutical companies to sign production authorization agreements with Chinese suppliers to increase drug production. "The production capacity of domestic enterprises is very strong, and once the agreement is signed, supply will not be a big problem." Ma Dawei told the first financial reporter. At the same time, he said that the big channels still need to go through a lot of procedures, and the small channels should have already begun to supply.

Ma Dawei believes that Paxlovid will certainly sell for less than the United States in China, and he advocates that if the effect is confirmed, the drug should be made available as a prescription drug to most people in need. "At present, this drug is written into the diagnosis and treatment plan, that is, it is used after diagnosis in the hospital, in fact, most patients with mild diseases still do not need to use it, and if there are more obvious symptoms, it should still be too late to use it." He told the first financial reporter, "Oral medicine is of great significance for further opening up in the future. ”

At present, the relevant departments have not disclosed the pricing of new crown oral drugs in China. In the United States, Pfizer oral covid-19 drugs are priced at $530 per course of treatment. Globally, Pfizer is actively engaged in discussions with more than 100 countries about paxlovid procurement.

Last November, Pfizer reached an agreement with MPP to authorize generic drug plants to produce and sell cheap versions of Paxlovid to 95 low- and middle-income countries and regions without licensing fees, significantly reducing the price of the drug in some regions.

Brad Loncar, founder of bio-funded loncar Investments, told first financial reporters that Paxlovid is now very easy to buy in pharmacies in the United States, but it still needs to rely on a doctor's prescription to go to pharmacies to buy. "The U.S. government has begun to make changes, which means that in the future, as long as patients who test positive for covid-19 can go to pharmacies to buy." Lomka told the first financial reporter.

In its latest earnings report, Pfizer predicted that it is expected to provide up to 120 million courses of Paplovid oral covid-19 drugs this year, and sales will grow to $22 billion.