China'S First New Crown Vaccine Patent Approved

On August 14, the drug evaluation center of the State Drug Administration issued five guiding principles, including the technical guidelines for the research and development of new coronavirus vaccine for prevention (Trial Implementation). On August 16, the State Intellectual Property Office (SIPO) announced the approval of the patent application for new crown vaccine jointly applied by Chen Wei, academician team of Academy of military medicine, Academy of Military Sciences and kangxinuo biology.

In the view of experts in the industry, under the superimposed effect of the above guiding principles and approved news, the subsequent large-scale listing of new crown vaccines in China will further accelerate, which has also boosted the vaccine sector under adjustment to a certain extent.

The patent application for the new crown vaccine jointly applied by academician Chen Wei's team and kangxinuo biology has been granted the patent right. Visual China

The first patent of new crown vaccine in China

The patent application for new crown vaccine jointly applied by Chen Wei, academician team of Academy of military medicine, Academy of Military Sciences and kangxinuo biology has been granted patent right, which is the first new crown vaccine patent in China.

According to the notice of invention patent granted by the State Intellectual Property Office, the name of the patent is "a new recombinant coronavirus vaccine based on human replication defective adenovirus". The inventors include Chen Wei, Wu Shipo, Hou Lihua, etc.

According to the patent abstract, the invention provides a novel coronavirus vaccine based on human replication defective adenovirus type 5. The vaccine has good immunogenicity in mice and guinea pigs, and can induce strong cellular and humoral immune responses in a short time. In addition, the preparation of the vaccine is rapid and simple, and can be used in large-scale production in a short period of time to deal with sudden outbreaks.

There is a long history of cooperation between kangxinuo and the Institute of bioengineering of the Academy of Military Sciences. The first vaccine product on the market, Ad5 EBOV, was developed by kangsinol and the Institute of bioengineering of the Academy of Military Sciences. This cooperation is the second cooperation between the two sides.

The third phase of the trial will be announced on August. Prior to this, the phase I and phase II clinical trials of recombinant new crown vaccine (Ad5 ncov) jointly developed by kangxinuo biological and Chen Wei's team have been completed in China, and the approval document of military special drugs was obtained on June 25.

The development and production of vaccines are closely related to the whole epidemic situation. Hundreds of scientific research teams around the world are accelerating the research and development of new coronal vaccines on different technical routes.

According to the latest data released by who and China, up to now, seven vaccines have entered phase III clinical practice, of which 4 are from China (konsinobio, Kexing biological, and the Beijing Institute and Wuhan Institute of Zhongsheng group), 1 is from the United States, 1 is from the United Kingdom, and 1 is developed by the German biological company biontech and Pfizer.

According to a study published by Johnson & Johnson, the covid-19 vaccine produced an antibody response in primates, and a single injection could protect them. In April, GlaxoSmithKline and Sanofi, two of the four major vaccine giants, decided to jointly develop a new crown vaccine. GlaxoSmithKline's candidate vaccine uses Sanofi's technology for producing an influenza vaccine, as well as GlaxoSmithKline's own adjuvant technology, which the company says will be produced in European countries, including France, Belgium, Germany and Italy.

R & D and listing accelerated

On August 14, the drug evaluation center of the State Drug Administration issued five guiding principles, including the technical guidelines for the research and development of new coronavirus vaccine for prevention (Trial Implementation), which will be implemented from the date of promulgation. These guidelines provide reference national technical standards for clinical research and development of new coronal vaccine in China.

A professor of immunology pointed out that the release of the above guidelines will play an important role in promoting the follow-up standardization of the research and development, clinical trials and marketing of new coronal vaccines. Only with standardized standards can we better promote the research and development of new coronal vaccines, and ensure the safety, effectiveness and timeliness of vaccines.

At present, the research and development of new coronal vaccine mainly includes virus inactivated vaccine, genetic engineering recombinant vaccine, virus vector vaccine, nucleic acid vaccine (plasmid DNA, mRNA), etc.

According to the drug evaluation center, data show that all age groups are susceptible to the new coronavirus, and large-scale vaccination is needed to form a population immune barrier and block transmission. Therefore, the candidate vaccine should be suitable for all ages, including pregnant and lactating women.

According to the center for drug evaluation, the vaccine clinical research should be carried out step by step according to the safety consideration. Firstly, the preliminary safety data should be obtained from adults, and the elderly clinical trial should be started after reasonable interval; minors should conduct clinical trials independently based on the safety and effectiveness results of adults and the elderly; children under 6 years old should be comprehensively considered based on the research results of other populations.

The above guidelines are also clear. In order to speed up the development and marketing process of the new crown vaccine and allow the phase III clinical trial before determining the most appropriate immunization procedure and dosage, it is necessary to consider changing the immunization procedure during the phase III clinical trial (such as increasing the number of inoculants), or optimizing it after marketing.

The protective effect of new coronal vaccine should be evaluated by phase III clinical protective efficacy test. At the same time, the safety risk of vaccine products and the risk of vaccination should be evaluated.

In addition, we should continue to observe the safety and clinical protection effect of the vaccine under the condition of large-scale vaccination, and continue to study the protection persistence.

The primary end point of the disease prevention should be cod19. In the placebo-controlled trial, the protective effect of the target population should reach more than 70% (point estimate), at least 50% (point estimate), and the lower limit of 95% confidence interval should not be less than 30%.

Vaccine sector in adjustment

Under the catalysis of the huge market space of Xinguan vaccine, the biological vaccine sector has increased by 106% since the Spring Festival, but the recent correction has been large, and the decline has been more than 10% since August.

Among the listed companies that have disclosed their performance or performance forecast in the first half of the year, in addition to Kanghua biology, Guanhao biology, Changchun hi tech, Tibet pharmaceutical, etc., the net profits of Watson biological, Weiming pharmaceutical and kangxinuo have experienced a sharp decline.

On the evening of August 10, Hualan biology and Tibet Pharmaceutical Co., Ltd. released a semi annual report.

In the first half of the year, Tibet pharmaceutical industry achieved a revenue of 629 million yuan, a year-on-year increase of 1.57%. The net profit was 220 million yuan, with a year-on-year increase of 39.76%. Compared with the nearly 500% increase of the company's stock price in the year, the performance growth is not significant.

In mid June, Tibet pharmaceutical announced that it had concluded an exclusive strategic cooperation relationship with Sri Lanka microorganism, involving the cooperation consideration of new crown vaccine products of about 350 million yuan. Since then, the company's share price has started to take off. In less than two months, it has gained 14 limit boards, up nearly 200%, and its market value has exceeded 30 billion yuan.

However, with regard to the progress of the new crown vaccine, Tibet pharmaceutical industry responded in the semi annual report that the preventive vaccine products involved in the current cooperation are still in the pre clinical research stage in China, and they need to go through the main links such as clinical trial approval, clinical phase I, II and / or III trials, marketing approval, and production facility certification / verification (if applicable), and there is a risk of R & D failure Insurance. If the research and development fails, there is a risk that the funds and clinical expenses paid to Sri Lanka microorganism cannot be recovered.

According to the semi annual report of Hualan biology, the company realized an operating revenue of 1.387 billion yuan in the first half of the year, a year-on-year decrease of 1.15%, and the net profit attributable to shareholders of listed companies was 512 million yuan, a slight increase of 0.94% year-on-year. Recently, the company made a reply to the progress of the new coronavirus vaccine on the interactive platform, saying that the company's new type of coronavirus inactivated vaccine is in the preclinical research stage, and the progress is smooth. At present, the company is successively submitting the relevant data required for the clinical application of the new coronavirus vaccine.

Before that, Zhifei biology released its semi annual report, which showed that it realized 6.994 billion yuan of operating revenue in the first half of the year, with a year-on-year growth of 38.8%. The net profit attributable to the parent company was 1.505 billion yuan, with a year-on-year increase of 31.18%. In terms of research and development progress of new crown vaccine, the recombinant protein new crown vaccine cooperated by the company and microorganism is currently in the second stage of clinical practice, belonging to the first echelon in China.

Watson bio's performance forecast shows that in the first half of the year, the company is expected to achieve a net profit of 61 million yuan to 66 million yuan, a year-on-year decrease of 22% - 28%. At present, the new coronavirus mRNA vaccine jointly developed by the company and abbio has received the drug clinical trial approval issued by the State Food and drug administration. On June 26, Watson bio announced that China's first new coronavirus mRNA vaccine has entered the phase I clinical trial, and has been approved for three clinical groups with 56 samples in each group.

Many senior people in the pharmaceutical industry believe that the current public has a strong awareness of vaccination, which also keeps the market's continuous attention and enthusiasm for vaccines. On August 17, the vaccine sector rose 1.87%, of which konshino group rose 4.33% and Hualan bio rose 7.69%.

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