China Times (www.chinatimes.net.cn) reporter Sun Mengyuan Yu Na Beijing reported
Recently, CanSino announced its inhalation recombinant novel coronavirus vaccine (type 5 adenovirus vector). After the National Health Commission’s recommendation, National Drug Administration organized a demonstration and agreed to be included in emergency use as a strengthening injection. A reporter from " China Times " asked about vaccine-related matters through email, but no reply was received as of press time.
CanSino said that after the company's inhaled recombinant novel coronavirus vaccine (type 5 adenovirus vector) is approved for emergency use, if the relevant national departments subsequently purchase and use it, it will have a certain positive impact on the performance of the listed company.
Jiang Han, a senior researcher at Pangu Think Tank, told the reporter of the China Times that after obtaining emergency use, it actually means obtaining the birth certificate . The subsequent commercialization process can be promoted with the establishment of supply and sales channels, which will have very good support for the company's performance.
However, inclusion in emergency use does not mean that it will be approved for market launch soon. There is still a long way from approval and license to production and market launch. Whether CanSino can reverse its performance decline with the first inhaled COVID-19 vaccine remains to be seen.
The world's first inhaled new crown vaccine was approved
html On September 4, CanSino issued an announcement stating that the company developed the recombinant novel coronavirus vaccine for inhalation (type 5 adenovirus vector) Kevisa Wuyou, after the National Health Commission's recommendation, the State Food and Drug Administration organized a demonstration and agreed to be included in emergency use as a strengthening injection.Public information shows that in March 2021, the inhaled recombinant novel coronavirus vaccine (type 5 adenovirus vector) was approved by the National Drug Administration for Drug Clinical Trials, and the indication is to prevent diseases caused by novel coronavirus infection (COVID-19). The semi-annual report previously released showed that the project is expected to have a total investment of 300 million yuan and a cumulative investment of 955.02 million yuan. Phase 1 and 2 clinical trials have been completed, and sequential immunization clinical trials are being carried out.
According to CanSino, this product is the world's first new crown vaccine that uses atomized inhalation administration. It is based on the company's virus vector technology and is further developed in combination with the company's developed respiratory mucosal immunization technology. In terms of mechanism of action, the atomized inhalation administration method is used to atomize the vaccine into tiny particles, and enter the respiratory tract and lungs through oral inhalation, stimulating the mucosal immune response, thereby inhibiting viral replication more quickly and reducing viral transmission.
htmlOn September 6, CanSino revealed on the interactive platform that the company has conducted clinical trials of sequential immunization of the new crown vaccine for inhaled inhaled inhaled in the new crown vaccine for tens of thousands of people. The accumulated large amount of safety and immunogenicity data shows that the total adverse reactions in intramuscular inhaled vaccines, such as headache, fatigue and fever, have dropped significantly in the inhaled vaccine, and the decline is even greater among the elderly. Among them, the third-level adverse reactions, such as fever, have dropped to a few percent; 28 days after the sequential strengthening of the new crown vaccine for inhaled inhaled, the cross-neutralizing antibody titer against the live Omicron virus is 22.8 times that of the homologous strengthening of the inactivated vaccine for . In an interview with a reporter from the China Times, Tao Lina, an expert invaccine, said that injectable vaccines can produce IgG antibody , which can neutralize the virus, in the blood, but it is not usually believed that it will produce mucosal IgA antibodies that neutralize the virus. Inhalation/nasal spray vaccine is believed to be able to produce both antibodies at the same time, which can neutralize the mucosal IgA antibodies as soon as the virus adheres to the respiratory surface. At this time, the amount of viruses invading the human body is still very small, and it is very likely that only a small amount of mucosal IgA antibodies can completely neutralize the virus and achieve the desired preventive effect.
"As far as the evidence I have seen, I believe that inhaled vaccines can be approved for emergency use, and the safety is certainly no problem. The immune effect is better than the injection of vaccines, and the actual protective effect remains to be seen. However, oral inhalation has not been widely used before, and there may be a exploratory process in the implementation of vaccination. In addition, inhalation methods may inevitably lead to viral air leakage, which may have an immune enhancement effect on the surrounding population." Tao Lina further pointed out.In terms of price of
, CanSino said that the selling price and cost of inhaled COVID-19 vaccine are sensitive information that may have an impact on the company's stock price, and it is within the scope of confidentiality and cannot be further disclosed for the time being.
Regarding whether emergency use will be approved for listing, Deng Zhidong, general manager of Hainan Boao Medical Technology Co., Ltd., said in an interview with a reporter from the China Times that inclusion in emergency use is only an administrative licensing act, not a bidding act, but only represents temporary use authorization in emergency situations. It does not mean that the government will definitely purchase it. Government procurement also requires bidding procedures, and it does not mean that the drug will be launched soon. There is still a long way from approval and license to production and market.
market competition is fierce
reporters of the China Times found that 9 vaccines have been approved by the National Drug Administration for Market Regulation on conditional marketing or emergency use, 3 have been included in the list of emergency use of World Health Organization , and many are in the clinical trial stage.
"I think the prevention effect of injectable vaccines is likely to have reached the ceiling, and even mRNA vaccines are not good enough to prevent infection. I think vaccines that can produce mucosal immunity may make breakthroughs in preventing infection and bring new solutions to epidemic control." Tao Lina told a reporter from the China Times.
Just the day before, Lizhu Group issued an announcement stating that its controlling subsidiary Zhuhai Lizhu Mab Biotechnology Co., Ltd. (hereinafter referred to as "Lizhu Mab") and , the "recombinant novel coronavirus fusion protein vaccine" (hereinafter referred to as "V-01") jointly developed by Institute of Biophysics of the Chinese Academy of Sciences , and , the "V-01") was proposed by the National Health Commission, and , the National Medical Products Administration organized a demonstration and agreed to include the new coronavirus epidemic prevention and sequentially strengthening immunity emergency use.
According to the previously disclosed semi-annual report data, affected by the slowdown in vaccination rate, most COVID-19 vaccine companies' performance is lower than expected. Therefore, it is still unknown whether the subsequent COVID-19 vaccine can drive the company's performance growth.
Take CanSino as an example. In the first half of this year, the company achieved operating income of 630 million yuan, a year-on-year decrease of 69.45%; net profit attributable to shareholders was 12.238 million yuan, a year-on-year decrease of 98.69%; basic earnings per share 0.0495 yuan. Regarding the reasons for the decline in performance, CanSino admitted that it was mainly due to the slowdown in the global COVID-19 vaccination rate during the reporting period, the reduction in vaccine demand, the adjustment of vaccine product prices and the price of COVID-19 vaccine-related inventory set-ups with signs of impairment.
"Similar products are increasing. Even if these two products are included in the emergency use scope, they still face fierce market competition. At the same time, affected by multiple factors such as the development and changes of the epidemic at home and abroad and the domestic COVID-19 vaccination rate, the profit margin of the later selected products will be squeezed by a greater market." Deng Zhidong told a reporter from the China Times.
CanSino also reminded in the announcement that the vaccine needs to apply for clinical trials, conduct clinical trials, apply for production documents, and issue product batches before it is launched. The subsequent research and development and administrative approval of the company's recombinant novel coronavirus vaccine (type 5 adenovirus vector) for inhalation are still uncertain.
AVIC Securities research report pointed out that the new crown vaccine provides the company with clear performance support and financial guarantees in the short term, promoting the company's rapid growth. At the same time, as the uncertainty of the repeated outbreak of the epidemic is still very large, the protection of the third dose of vaccine has declined over time, and the demand for the fourth dose of vaccine in countries around the world is relatively certain, and the expectation of demand for COVID-19 vaccines has improved significantly compared with the previous one. The company's trend of increasing COVID-19 vaccines may continue in the short term.
Intern editor: Yan Yuan Editor-in-chief: Chen Yanpeng
