The first new crown vaccine approved in China has come, and how big is the market left to it

03.09.2022

Number of this text: 2027, reading time for about 4 minutes

Introduction: Prior to this, 7 new crown vaccines in China were approved for listing or emergency use. Most of these vaccines could also be used to enhance needle use, but when they were approved for the first time, they were obtained through basic immune methods.

Author | First Finance Lin Zhiyin

The first new crown vaccine in China was approved by reinforcement.

On the evening of September 2nd, Lizhu Group (000513.SZ, 01513.HK) announced that the company's holding affiliated company Zhuhai Lizabi Biotechnology Co., Ltd. (hereinafter referred to as "Lizumab") and Biological Physics Research on the Chinese Academy of Sciences The "reorganized new coronary virus fusion protein vaccine" (hereinafter referred to as "V-01") of the "reorganized new coronary virus fusion protein vaccine" made suggestions that the State Drug Administration organized a demonstration and agreed to be included in the new coronary virus epidemic prevention order to strengthen immune urgent use.

Prior to this, 7 new crown vaccines in China were approved for listing or emergency use. Most of these vaccines could also be used to enhance needle use, but when they were approved for the first time, they were obtained through basic immunity.

Nowadays, the domestic new crown vaccine market is fiercely competitive. How big is the market left to the V-01?

Clinical data shows that it has good protection for Omikon

V-01 has been developing research and development since July 2020. It is an innovative new crown restructuring protein vaccine developed by Lizab's cooperation with the Institute of Biology of the Chinese Academy of Sciences. V-01 was approved by the China National Drug Administration for clinical trials in early 2021. The adaptation certificate was caused by the prevention of new coronary virus infection (COVID-19).

In February of this year, Lizhu Group announced the key data of the third phase of clinical trials in V-01 sequence. This sequential enhancement plan is based on the order -enhancing design on the basis of the two -needle activity vaccine. It adopts the relatively strong and strong effects standards, which is different from the traditional gapper scheme.

The data shows that after the V-01 sequence is enhanced, compared with the two-shot activity vaccine, the annual incidence of the V-01 sequence enhancement group and the two-shot activity vaccine group is 6.73%and 12.80%, respectively, with significant differences (P. = 0.0012); The absolute protection after the enhancement of the V-01 sequence is 61.35%, which has significant strong advantages. V-01 sequence strengthening absolute protection has met the WHO standard. All the first-generation sequencing of the new coronal virus genes in the test specimen in this test are Omikon (the rest are still undergoing second-generation sequencing), indicating that the V-01 sequencing enhances the infection caused by the Omikon infection. COVID-19 can produce good protection. At the same time, no security issues worthy of attention were found.

It is worth noting that the V-01 sequencing to strengthen the third phase of the clinical trial plan is also the world's first clinical trial of random and double-blind phase of Omikon's research preface to strengthen protection.

"The absolute protection data of 61.35%this time is based on the effectiveness of the protection of the live vaccine and the data generated under the popularity of Omikon. This data also meets the WHO standard." In February this year, Health Yuan Pharmaceutical Industry The group's chief scientist Jin Fang said in an interview with the First Financial Reporter.

Lizhu Group also stated in the announcement that V-01 is in the third phase of the clinical trial phase (the clinical preset end point has been reached), and the main analysis is completed). According to the clinical trial scheme, the subject must continue to be completed.

Since the beginning of this year, there have been many places in China that have encountered the Omiroko epidemic attack. According to incomplete statistics, domestic reports have also discovered at least 11 types of Ormico's strain subtypes, including BA.2.12.1, BA.2.38, BA. 5, BA.5.1, BA.5.2, etc.

And is V-01 effective for different strains of Omikon? It still needs to be tested in the real world.

How big is the market left for it?

Prior to the approval of V-01, 7 new crown vaccines in China were approved for listing or urgently used, namely the inactivation of the Chinese Medicine Beijing, the activated vaccine of Wuhan in Wuhan, the Konaco vaccine, and Kangshino Gonadic virus vectors vaccine, Kangtai biochemical vaccine, Zhifei biological recombination vaccine, and the inactivated vaccine of the Chinese Academy of Medical Sciences. Most of these vaccines can also be used for enhanced use on the basis of two -needle activity vaccine. After V-01 was approved, is there a big reinforcement market for it?

According to data from the National Health and Health Commission, as of July 23, 2022, the basic immune vaccination rate in China was 89.7%, and the immune vaccination rate was 71.7%. Among them, at least 1 dose of vaccination rate for the elderly over 60 years of age is 89.6%, the entire vaccination rate is 84.7%, and the immunization vaccination rate is 67.3%.

Judging from the recent interim reports released by some vaccine companies, its new crown vaccine has slowed sales.

For example, in the first half of this year, Kangsano achieved operating income of 630 million yuan, a year -on -year decrease of 69.45%; the net profit attributable to shareholders belonging to the parent company was 12.238 million yuan, a decrease of 98.69%year -on -year. The reduction of vaccine demand and product price adjustment.

Another example is Zhifei Bio. In the first half of this year, the net profit attributable to the owner of the parent company was 3.729 billion yuan, a decrease of 32.08%over the same period last year. The decline in performance is also related to the decline in sales of the new crown vaccine. The company said that with the widespread vaccination of my country's new crown vaccine, basic immunity has been accelerated. According to the public information in July this year, the entire vaccination rate of the new crown vaccine in my country has reached nearly 90 %, but the epidemic prevention and control still faces the mutant strain belt that is continuously iterated and updated. The new threat to the new crown vaccine has also ushered in new changes. During the reporting period, the company's sales of Miao Zhikhis were significantly reduced compared with the same period last year. At present, Lizhu Group stated in the announcement that the sales of the new crown vaccine after the listing of the new crown vaccine have been affected by many factors such as the development of epidemic conditions, market environment, and sales channels. The subsequent market sales of the vaccine have uncertainty.

At the recent national vaccine and health conference, Yin Zundong, a researcher at the China Centers for Disease Control and Prevention, said that there are some problems to be resolved in the future prevention and control strategy and vaccine immunity in my country. Second, how to enhance the needle in the basic immune people; the third is how to strengthen the second needle among people who have strengthened immunity, and how to choose the timing of strengthening, the type of vaccine; It is how the new crown vaccine is incorporated into conventional vaccination and the approval strategy of new vaccines.

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