Enshide has not yet been approved by the CDE for marketing. It is currently only available in the Boao Lecheng Pilot Zone. Two injections cost tens of thousands of yuan, and it cannot be used for medical insurance settlement.

2024/06/2702:58:33 hotcomm 1488

Every reporter: Lin Zichen Chen Hao Every editor: Wenduo

Take two shots to prevent new crown - How attractive is this slogan to special groups of people? The consultation operators at Boao Super Hospital and Ruijin Hainan Hospital have the best experience.

Today (July 9), two hospitals welcomed recipients of the new coronavirus neutralizing antibody drug Evusheld (Enshide).

is currently the only COVID-19 preventive drug in the world. It is suitable for adults and teenagers (age ≥ 12 years old and weight ≥ 40kg). COVID-19 pre-exposure prophylaxis.

Enshide has not been approved for marketing by CDE (Center for Drug Evaluation of the State Drug Administration). It is currently only available in the Boao Lecheng Pilot Area. Two injections cost tens of thousands of yuan, and it cannot be used for medical insurance settlement.

From the perspective of the applicable population, this drug is preferentially suitable for the prevention of new coronavirus infection in people with compromised immune function or low immunity. It is also a good choice for people who frequently travel on business or plan to travel to countries/regions with high infection risks. Of course, those who can be vaccinated should do so first.

Potential vaccinators may still be hesitant about Enshid, but the market for new coronavirus preventive drugs has risen again. On July 8, Teng Sheng Bo Yao (HK02137, stock price 11 Hong Kong dollars, market value 7.95 billion Hong Kong dollars) also revealed plans to expand drug indications from treatment to prevention at the new coronavirus neutralizing antibody drug launch conference.

Enshide has not yet been approved by the CDE for marketing. It is currently only available in the Boao Lecheng Pilot Zone. Two injections cost tens of thousands of yuan, and it cannot be used for medical insurance settlement. - DayDayNews

Image source: Hainan Boao Lecheng International Medical Tourism Pilot Zone website screenshot

Among those who have completed their appointments for the first dose of vaccination, more people studying abroad

According to reports, Enshide is AstraZeneca (AZN, stock price 66.98 US dollars, market value A long-acting antibody combination developed by the US$207.6 billion), consisting of the new coronavirus neutralizing antibodies "tisagvirumab" (150mg) and "sigvirumab" (150mg), was first approved by the FDA in December last year. Use authorization for pre-exposure prophylaxis of COVID-19.

Since then, this antibody combination has been approved for use in some European countries, and its PROVENT Phase III trial reached the primary endpoint before March this year. Data showed that compared with placebo, the antibody combination drug reduced the relative risk of symptomatic new coronavirus infection by 77% and the absolute risk by 0.8%. The median follow-up time after treatment was 83 days; in subsequent analyses, follow-up At a median time of 6.5 months, the antibody combination reduced the relative risk of symptomatic COVID-19 by 83% compared with placebo, with an absolute risk reduction of 1.5%.

This means that the risk of symptomatic COVID-19 infection is significantly reduced for people who get the injection, and the drug's protective effect against the new coronavirus can last for at least six months.

However, it is worth noting that in the face of the ever-changing Omicron variant strains, the efficacy of Enshid needs to be maintained by increasing the dose.

On June 29, local time, the FDA official website issued an announcement on the dosage revision of Ensect, saying that non-clinical data and the pharmacokinetics model showed that the dosage of Ensect was changed to 300 mg tisagvirumab and 300 mg After sigavirimab, activity against these sub-variants was maintained at drug concentrations for 6 months.

Enshide has not yet been approved by the CDE for marketing. It is currently only available in the Boao Lecheng Pilot Zone. Two injections cost tens of thousands of yuan, and it cannot be used for medical insurance settlement. - DayDayNews

Image source: FDA official website screenshot

html On July 9, a reporter from " Daily Economic News " called the public hotline of Boao Super Hospital as a consultant. The staff who answered said that the dosage form of Enshid currently provided by the hospital is 150mg+150mg. , effective against the Omicron variant BA.4/5, and is open to people whose age and weight meet the vaccination requirements, that is, vaccinators who are over 12 years old and weigh more than 40 kilograms. Vaccine recipients need to receive two doses of the neutralizing antibody drug at one time, with a total price of 13,300 yuan.

From a process perspective, vaccinators need to go through hospitalization procedures, but they can complete the vaccination in the day ward and arrive at the hospital in the morning and be discharged in the afternoon. During this period, four or five blood tests are required, and the results are expected to be obtained in one and a half hours. After that, neutralizing antibody drugs can be vaccinated. After the vaccination, observation will be required for 1 to 2 hours.

At around 5 pm, the reporter called the hospital again and the staff said that the first injection had begun.

However, if you have received the new crown vaccine in advance, you need to receive this neutralizing antibody drug two weeks apart.On the contrary, if you take the neutralizing antibody drug first, you can get the COVID-19 vaccine at any time later. The staff said: "The antibodies produced by (Enshid) can last for half a year, and you can use the medicine again after half a year."

Another staff member of the hospital said that if you are in the late stage of liver cancer or other cancers, or during uremia dialysis, , vaccination is not recommended; vaccination is not recommended for pregnant women. At present, many people who come to make appointments for medication are people studying abroad.

In addition, the reporter checked the information and found that AstraZeneca announced in December last year that people who have been infected with the new coronavirus, or those who have been in close contact with an infected person recently, should not receive the treatment (Enxide).

According to the official website of Hainan Boao Lecheng International Medical Tourism Pilot Zone, Enshide is preferred for the prevention of new coronavirus infection in people with impaired immune function or low immunity, including patients with malignant hematological tumors or other tumors who are receiving chemotherapy, and those who have undergone organ transplantation. Patients on medications, dialysis patients, patients with conditions such as multiple sclerosis and rheumatoid arthritis who are taking immunosuppressive drugs.

Can treatment and prevention be achieved at the same time? Domestic drugs are exploring preventive indications

As the only new coronavirus preventive drug in the world, Enshi is easily reminiscent of the new crown vaccine. But there are fundamental differences between the new coronavirus vaccine and neutralizing antibody drugs.

The new coronavirus vaccine is an inactivated virus or virus fragment. After injection, the body will have immune memory and can produce antibodies at the same time, which is active immunity; neutralizing antibody itself is an antibody and can be directly input into the human body, which is passive immunity .

Taking Enshid as an example, it can simulate the body's natural antibody defense mechanism, and by binding to different sites on the spike protein of the new coronavirus, it can reduce the ability of the virus to enter and infect healthy cells, and help clear the infected Cell.

Currently, there is only one domestically produced COVID-19 specific drug approved by the CDE for marketing, which is the combination therapy of the COVID-19 neutralizing antibodies "Ambavirimab" and "Romisivimab" from Tengsheng Biopharmaceuticals.

Enshide has not yet been approved by the CDE for marketing. It is currently only available in the Boao Lecheng Pilot Zone. Two injections cost tens of thousands of yuan, and it cannot be used for medical insurance settlement. - DayDayNews

Image source: screenshot of Tengsheng Boyao website

html On July 8, Yan Li, chief medical officer of Tengsheng Boyao, said at an online press conference that the main application scenarios of neutralizing antibody drugs are divided into prevention and treatment. Among them, the preventive effect is aimed at people who cannot be protected by vaccination, or high-risk occupational groups such as customs, airports, and cold chains.

Currently, domestically produced neutralizing antibody therapies are only approved for the treatment of eligible COVID-19 patients with mild to moderate symptoms, and Enshid is only approved for pre-exposure prophylaxis of COVID-19 for eligible people, but neither party intends to stop there.

According to news from AstraZeneca's official website in June, Insect was shown to be able to significantly prevent COVID-19 disease progression or death in the TACKLE Phase III clinical trial, which supports the benefit of the drug in the outpatient treatment of patients with mild to moderate COVID-19.

Specifically, in a prespecified analysis of subjects who were treated within 3 days of symptom onset, treatment with Enceta was associated with an increased risk of severe COVID-19 illness or death from any cause compared with placebo. The risk was reduced by 88%, and by 67% if treated with Ensad within 5 days of symptom onset.

Mene Pangalos, AstraZeneca's global executive vice president and head of biopharmaceuticals R&D, said the company is discussing the TACKLE trial data with regulatory agencies and continues to advance its submission for treatment and prevention indications.

Domestically, Teng Sheng Bo Yao Luo Yongqing said that the company's antibody therapy has been genetically engineered, has a long half-life , and is effective against the current Omicron variant. The company has plans to develop its indications for pre-exposure prophylaxis or post-exposure prophylaxis.

In addition, on the morning of July 9, Lu Hongzhou, leader of the first Shenzhen Public Health Expert Group on Epidemic Prevention and Control and director of Shenzhen Third People’s Hospital, told the Daily Economic News reporter via WeChat that several independent Experimental testing data for live viruses and chimeric viruses in the laboratory show that the combination therapy of ambavirumab and romisevir maintains neutralizing activity against the major new coronavirus variants of concern; currently, this combination therapy is confirmed Further experiments on the neutralizing activity of BA.4/5, including live virus analysis, are ongoing.

variant strain has catalyzed the popularity of new coronavirus drugs, and the stock prices of many companies in the sector have climbed

Two new coronavirus neutralizing antibody therapies at home and abroad have been launched into clinical trials, just at the time when the domestic new coronavirus strain is updated.

Recently, the Omicron BA.5 variant has appeared in some areas of the country, increasing the pressure for imported cases from outside.

Lu Hongzhou said that BA.5 is more transmissible and faster than the previous BA.1 and BA.2, and has a stronger immune escape ability, which can escape infection by BA.1 and BA.2 to a certain extent. Established immune protection.

"BA.5 has a higher infection efficiency in human lung tissue cells than BA.2, and is more pathogenic than BA.2 in animal models, but is still milder than the Delta strain."

Lu Hongzhou It is also said that there are currently local Omicron BA.2 and BA.4/5 mutant strains circulating in the country, and BA.5 has replaced BA.2 as the most dominant strain globally. "Due to the stronger transmission speed and immune evasion ability, more efficient and precise prevention and control measures are needed. Drawing on Shenzhen's prevention and control experience, I believe that good prevention and control effects can be achieved."

It is worth noting that laboratory research results show , the double-antibody combination therapy of Enshide and Tengshengboyao is both effective against BA.4/5, which also gives market investors a lot of confidence.

On July 7, shortly after the online press conference of Tengsheng Boyao's new coronavirus neutralizing antibody combination therapy, the company's stock price rose rapidly, up 11.45% as of the close. The company's stock price accumulated a large amount in the three trading days from July 6 to July 8. An increase of about 30%.

In addition, the share prices of Ruikang Pharmaceutical (SZ002589, stock price 5.18 yuan, market value 7.794 billion yuan) and Heavy Pharmaceutical Holdings (SZ000950, stock price 5.35, market value 9.327 billion yuan), which have a cooperative relationship with AstraZeneca, have risen significantly before.

Enshide has not yet been approved by the CDE for marketing. It is currently only available in the Boao Lecheng Pilot Zone. Two injections cost tens of thousands of yuan, and it cannot be used for medical insurance settlement. - DayDayNewsEnshide has not yet been approved by the CDE for marketing. It is currently only available in the Boao Lecheng Pilot Zone. Two injections cost tens of thousands of yuan, and it cannot be used for medical insurance settlement. - DayDayNews

However, Ruikang Pharmaceutical issued an announcement on July 8 stating that the company has long-term cooperation with AstraZeneca. However, as of the date of the announcement, the company has not signed any agency agreement with AstraZeneca regarding Ensida in mainland China.

Heavy Pharmaceutical Holdings also stated on the investor interaction platform on July 7 that "the company currently does not have the agency rights for this product (Enshide)."

At the same time, many domestic pharmaceutical companies are rushing to develop the first domestically produced oral COVID-19 drug, which has also attracted the attention of investors.

Take the real biological Azivudine as an example. Its currently announced entrusted processing manufacturers (or dealers) include 3, namely China Resources Shuanghe (SH600062, stock price 31.14 yuan, market value 32.486 billion yuan), Aoxiang Pharmaceutical (SH603229, stock price 49.51 yuan, market value 19.896 billion yuan), Xinhua Pharmaceutical (SZ000756, stock price 26.72 yuan, market value 17.892 billion yuan).

Although the drug has not yet been approved for anti-new coronavirus indications, in the secondary market, the stock prices of the above three listed companies have experienced several roller coasters. Since the beginning of 2022 (as of July 8), the stock prices of China Resources Shuanghe, Xinhua Pharmaceutical, and Aoxiang Pharmaceutical have increased by 138.46%, 138.78%, and 90.67% respectively.

●This article does not involve any operational suggestions, and you enter the market at your own risk.

Daily Economic News

Daily Economic News

On the contrary, if you take the neutralizing antibody drug first, you can get the COVID-19 vaccine at any time later. The staff said: "The antibodies produced by (Enshid) can last for half a year, and you can use the medicine again after half a year."

Another staff member of the hospital said that if you are in the late stage of liver cancer or other cancers, or during uremia dialysis, , vaccination is not recommended; vaccination is not recommended for pregnant women. At present, many people who come to make appointments for medication are people studying abroad.

In addition, the reporter checked the information and found that AstraZeneca announced in December last year that people who have been infected with the new coronavirus, or those who have been in close contact with an infected person recently, should not receive the treatment (Enxide).

According to the official website of Hainan Boao Lecheng International Medical Tourism Pilot Zone, Enshide is preferred for the prevention of new coronavirus infection in people with impaired immune function or low immunity, including patients with malignant hematological tumors or other tumors who are receiving chemotherapy, and those who have undergone organ transplantation. Patients on medications, dialysis patients, patients with conditions such as multiple sclerosis and rheumatoid arthritis who are taking immunosuppressive drugs.

Can treatment and prevention be achieved at the same time? Domestic drugs are exploring preventive indications

As the only new coronavirus preventive drug in the world, Enshi is easily reminiscent of the new crown vaccine. But there are fundamental differences between the new coronavirus vaccine and neutralizing antibody drugs.

The new coronavirus vaccine is an inactivated virus or virus fragment. After injection, the body will have immune memory and can produce antibodies at the same time, which is active immunity; neutralizing antibody itself is an antibody and can be directly input into the human body, which is passive immunity .

Taking Enshid as an example, it can simulate the body's natural antibody defense mechanism, and by binding to different sites on the spike protein of the new coronavirus, it can reduce the ability of the virus to enter and infect healthy cells, and help clear the infected Cell.

Currently, there is only one domestically produced COVID-19 specific drug approved by the CDE for marketing, which is the combination therapy of the COVID-19 neutralizing antibodies "Ambavirimab" and "Romisivimab" from Tengsheng Biopharmaceuticals.

Enshide has not yet been approved by the CDE for marketing. It is currently only available in the Boao Lecheng Pilot Zone. Two injections cost tens of thousands of yuan, and it cannot be used for medical insurance settlement. - DayDayNews

Image source: screenshot of Tengsheng Boyao website

html On July 8, Yan Li, chief medical officer of Tengsheng Boyao, said at an online press conference that the main application scenarios of neutralizing antibody drugs are divided into prevention and treatment. Among them, the preventive effect is aimed at people who cannot be protected by vaccination, or high-risk occupational groups such as customs, airports, and cold chains.

Currently, domestically produced neutralizing antibody therapies are only approved for the treatment of eligible COVID-19 patients with mild to moderate symptoms, and Enshid is only approved for pre-exposure prophylaxis of COVID-19 for eligible people, but neither party intends to stop there.

According to news from AstraZeneca's official website in June, Insect was shown to be able to significantly prevent COVID-19 disease progression or death in the TACKLE Phase III clinical trial, which supports the benefit of the drug in the outpatient treatment of patients with mild to moderate COVID-19.

Specifically, in a prespecified analysis of subjects who were treated within 3 days of symptom onset, treatment with Enceta was associated with an increased risk of severe COVID-19 illness or death from any cause compared with placebo. The risk was reduced by 88%, and by 67% if treated with Ensad within 5 days of symptom onset.

Mene Pangalos, AstraZeneca's global executive vice president and head of biopharmaceuticals R&D, said the company is discussing the TACKLE trial data with regulatory agencies and continues to advance its submission for treatment and prevention indications.

Domestically, Teng Sheng Bo Yao Luo Yongqing said that the company's antibody therapy has been genetically engineered, has a long half-life , and is effective against the current Omicron variant. The company has plans to develop its indications for pre-exposure prophylaxis or post-exposure prophylaxis.

In addition, on the morning of July 9, Lu Hongzhou, leader of the first Shenzhen Public Health Expert Group on Epidemic Prevention and Control and director of Shenzhen Third People’s Hospital, told the Daily Economic News reporter via WeChat that several independent Experimental testing data for live viruses and chimeric viruses in the laboratory show that the combination therapy of ambavirumab and romisevir maintains neutralizing activity against the major new coronavirus variants of concern; currently, this combination therapy is confirmed Further experiments on the neutralizing activity of BA.4/5, including live virus analysis, are ongoing.

variant strain has catalyzed the popularity of new coronavirus drugs, and the stock prices of many companies in the sector have climbed

Two new coronavirus neutralizing antibody therapies at home and abroad have been launched into clinical trials, just at the time when the domestic new coronavirus strain is updated.

Recently, the Omicron BA.5 variant has appeared in some areas of the country, increasing the pressure for imported cases from outside.

Lu Hongzhou said that BA.5 is more transmissible and faster than the previous BA.1 and BA.2, and has a stronger immune escape ability, which can escape infection by BA.1 and BA.2 to a certain extent. Established immune protection.

"BA.5 has a higher infection efficiency in human lung tissue cells than BA.2, and is more pathogenic than BA.2 in animal models, but is still milder than the Delta strain."

Lu Hongzhou It is also said that there are currently local Omicron BA.2 and BA.4/5 mutant strains circulating in the country, and BA.5 has replaced BA.2 as the most dominant strain globally. "Due to the stronger transmission speed and immune evasion ability, more efficient and precise prevention and control measures are needed. Drawing on Shenzhen's prevention and control experience, I believe that good prevention and control effects can be achieved."

It is worth noting that laboratory research results show , the double-antibody combination therapy of Enshide and Tengshengboyao is both effective against BA.4/5, which also gives market investors a lot of confidence.

On July 7, shortly after the online press conference of Tengsheng Boyao's new coronavirus neutralizing antibody combination therapy, the company's stock price rose rapidly, up 11.45% as of the close. The company's stock price accumulated a large amount in the three trading days from July 6 to July 8. An increase of about 30%.

In addition, the share prices of Ruikang Pharmaceutical (SZ002589, stock price 5.18 yuan, market value 7.794 billion yuan) and Heavy Pharmaceutical Holdings (SZ000950, stock price 5.35, market value 9.327 billion yuan), which have a cooperative relationship with AstraZeneca, have risen significantly before.

Enshide has not yet been approved by the CDE for marketing. It is currently only available in the Boao Lecheng Pilot Zone. Two injections cost tens of thousands of yuan, and it cannot be used for medical insurance settlement. - DayDayNewsEnshide has not yet been approved by the CDE for marketing. It is currently only available in the Boao Lecheng Pilot Zone. Two injections cost tens of thousands of yuan, and it cannot be used for medical insurance settlement. - DayDayNews

However, Ruikang Pharmaceutical issued an announcement on July 8 stating that the company has long-term cooperation with AstraZeneca. However, as of the date of the announcement, the company has not signed any agency agreement with AstraZeneca regarding Ensida in mainland China.

Heavy Pharmaceutical Holdings also stated on the investor interaction platform on July 7 that "the company currently does not have the agency rights for this product (Enshide)."

At the same time, many domestic pharmaceutical companies are rushing to develop the first domestically produced oral COVID-19 drug, which has also attracted the attention of investors.

Take the real biological Azivudine as an example. Its currently announced entrusted processing manufacturers (or dealers) include 3, namely China Resources Shuanghe (SH600062, stock price 31.14 yuan, market value 32.486 billion yuan), Aoxiang Pharmaceutical (SH603229, stock price 49.51 yuan, market value 19.896 billion yuan), Xinhua Pharmaceutical (SZ000756, stock price 26.72 yuan, market value 17.892 billion yuan).

Although the drug has not yet been approved for anti-new coronavirus indications, in the secondary market, the stock prices of the above three listed companies have experienced several roller coasters. Since the beginning of 2022 (as of July 8), the stock prices of China Resources Shuanghe, Xinhua Pharmaceutical, and Aoxiang Pharmaceutical have increased by 138.46%, 138.78%, and 90.67% respectively.

●This article does not involve any operational suggestions, and you enter the market at your own risk.

Daily Economic News

Daily Economic News

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