Lizhu and CanSino enhanced needles have been approved for emergency use, and the battle for the "upgraded" vaccine has arrived?

On September 3, Health Yuan and its holding subsidiary Lizhu Group issued an announcement that the recombinant novel coronavirus fusion protein vaccine (V-01) developed by its holding subsidiary Lizhumab in cooperation with the Institute of Biophysics of the Chinese Academy of Sciences was included in the Sequence Enhanced Immunization Emergency Use

Following V-01, on September 4, another vaccine research and development company, CanSino, also announced that its inhaled recombinant novel coronavirus vaccine (adenovirus vector type 5) (Ad5-nCoV for inhalation) was included in the sequence of emergency use of boosted immunization, becoming the first inhaled COVID-19 vaccine

Undoubtedly, livosumab V-01 and cansino inhaled COVID-19 vaccines have created two more accessible options for domestic heterologous vaccination (sequential strengthening), which will help continue to improve China's vaccination capacity and effectively expand the strength

01 Why was it approved at this time?

"It's not easy, and now I feel like the atmospheric pressure has been relieved

The V-01 vaccine, which began research and development in July 2020, is an innovative covid-19 recombinant protein vaccine with independent intellectual property rights developed by Livuzumab in cooperation with the Chinese Academy of Sciences, and was approved by the Food and Drug Administration for clinical trials in early 2021 for the prevention of diseases caused by novel coronavirus infection (COVID-19).

The inhaled COVID-19 vaccine, which was approved in March last year, took about the same

In February this year, with the approval of the joint prevention and control mechanism of the State Council, the National Health Commission began to deploy a sequential strengthening of immunization

Since June this year, the virus variant Omilton BA.

An industry insider in the vaccine industry told the E-drug manager: "At the end of the year, a new round of epidemic peak may come, and the continuous strengthening of vaccines is very critical

02 What are the characteristics of the two vaccines?

"One of the highlights of the V-01 is its safety and protection, and its protective advantages for the elderly and those with underlying medical conditions are obvious

It is understood that the sequential enhancement phase III clinical trial protocol of V-01 is the world's first randomized, double-blind phase III clinical trial in which the sequential enhancement of protection is studied

At the same time, the V-01 sequential strengthening group compared with the 2-needle inactivated seedling control group had an absolute protective force of 61.

In addition, more than 90% of the 110 primary endpoint cases were infected with Ami kerong, showing a good immune boost effect

According to Guosen Securities data, as of September 2, the cumulative number of new crown vaccines reported nationwide exceeded 3.

According to the CanSino announcement, inhaled Ad5-nCoV is an inhaled genetically engineered vaccine to prevent COVID-19 disease, which trains the body's immune memory function by imitating the natural infection of the virus, can efficiently stimulate the triple protection of mucosal immunity, humoral immunity and cellular immunity, has the advantages of good immunity, painlessness and higher accessibility, and can also meet the needs of large-scale, rapid and flexible vaccination of

Source: Vaccine R&D and Production Forum

On September 2, Xie Xiaoliang, academician of the Chinese Academy of Sciences and Chair Professor Li Shau Kee of Peking University, said at the 2022 Health and Industrial Science and Technology Innovation Service Conference - Vaccine Research and Development and Production Forum that in the future development direction of the new crown immunization vaccine, nasal vaccination can effectively activate mucosal immunity and promote IgA antibody production, and as a strengthening needle, it can activate a higher level of humoral immunity and cellular immunity, which has the potential to make the virus cleared in a shorter period of time and increase the protective efficacy of the vaccine

As the world's first COVID-19 vaccine using aerosol inhalation administration, CanSino's vaccine has enriched the commercial layout
of the new crown vaccine.

In addition, the inhaled vaccine also has the advantage of stable storage and transportation under conditions of 2 to 8 °C, which can be deployed on a large scale more efficiently and improve the accessibility
of the vaccine.

In general, based on the comprehensive consideration of covering more age-old vaccinators, production and transportation costs, applicability, etc.
, the two vaccines have certain advantages
.

03 How much market margin is there?

Along the five major vaccine design routes of inactivated vaccines, viral vector vaccines, recombinant protein vaccines, nucleic acid vaccines and live attenuated vaccines, there are currently 170 new coronavirus vaccines that have entered the clinical trial stage in the world, while a total of 45 new crown vaccines in China have carried out clinical trials, of which 5 have been approved for marketing, 4 have been used urgently, and 3 have been included in the World Health Organization's emergency use list
.

As of 2 September, the total number of vaccinated people nationwide reached 1.
314 billion, and 822 million people were
immunized intensively.
The above-mentioned industry insiders told the manager of E-drug: "More than 60% of the people in China have actually taken the third injection, and at best there are more than 300 million doses of
margin.
" Some countries abroad have gradually opened up the second dose to strengthen the use of the needle, and there are data showing that the safety of the fourth dose is good after vaccination, and the protective effect on symptomatic infection is obviously superior to that of the three-shot vaccine
.
If the fourth dose is approved domestically, the two vaccines can be in the market of 1 billion to 1.
2 billion doses, but in any case, the two vaccines may face competition
for vaccines with mutant strains.
”

CanSino also said that even if the product is included in emergency use, its future market sales will still face a fierce competitive situation, and at the same time affected by the development and changes of the epidemic situation at home and abroad, the domestic new crown vaccination rate and other factors
.

Indeed, due to the "changeable" of the Omiljung virus, the new crown vaccines and booster needles on the market are only for the original new crown virus, which is a "monovalent" vaccine, but the inhibition effect on BA.
4 and BA.
5 has weakened, and vaccine manufacturers around the world are constantly launching new "bivalent" vaccines
.

Source: Vaccine R&D and Production Forum

It is understood that the "divalent seedling" of Livzon Group is the first new crown divalent vaccine in China to publish the results of the Opichron neutralization experiment, and the results show that the neutralization titer of the V-01-351/V-01D divalent seedling on the Omicron variant strain is comparable to the neutralizing titer of the prototype V-01 di-free on the wild-type strain, which is stronger than the sum of the neutralizing titers of the V-01-351 and V-01D variants of the vaccine on the Omicron variant strains alone
.

However, it is worth noting that the variant of Omilon has now developed rapidly to Omilon BA.
4 and BA.
5, so whether the subsequent V-01 vaccine has more neutralization trial results against different variants such as BA.
5, or based on the bivalent vaccine developed by Omilon, is crucial
.

In addition, domestic COVID-19 vaccine companies have successively launched the research and development
of new coronavirus vaccines for the Aomi Kerong variant.
On April 26 this year, Sinopharm China Bio-Omikejong Mutant Strain Inactivated Covid-19 Vaccine was clinically approved by the State Food and Drug Administration, becoming the world's first inactivated vaccine for the Aomi Kerong variant to enter clinical trials; Not long ago, the State Food and Drug Administration officially approved the inactivated vaccine of the new coronavirus developed by SINOVAC Kexing based on the Aomi Kerong variant into clinical research to evaluate the safety and immunogenicity of the new coronavirus variant vaccine in various populations
.
In this way, the competition for vaccines with mutant strains has begun to take shape
.