Monkey acne breaking defense, Chinese companies have gone to sea!(A detailed list)
Author:Pharmaceutical economy Time:2022.09.21
On September 16, the Chongqing report found a case of diagnosis of acne, which is also the first case of monkey acne infection in mainland China. So far, China has accumulated 5 cases of acne cases: 1 case of Chongqing, 1 case of Hong Kong, and 3 cases in Taiwan.
Monkey acne is a viral disease caused by humans and animals caused by monkey acne virus (MPXV). This virus is a dual -chain DNA virus, which belongs to the genus acne virus as the acne virus virus, and the acne virus. In the past 4 months, the epidemic of the monkey acne has affected 105 countries and regions. According to WHO data, as of September 19, 2022, a total of 61,753 laboratory confirmed cases and 533 suspected cases were reported to WHO, of which 23 of them were killed.
Diagnosis speed
On September 19, the China CDC Weekly (CHINA CDC Weekly) released a on -site minutes to describe the first input monkey acne cases in mainland China.
The minutes pointed out that the infected person visited Germany from September 2nd to 8th. During the period, MSM high -risk behavior occurred, and then went to Spain and returned to Chongqing on September 14. He had symptoms such as dry and itchy, fever, and fever, red rash and pustules in his right ankle.
On September 14th, in the entrance of new crown pneumonia in Chongqing, the infected person described the clinical manifestations of monkey acne. Then, the Chongqing Disease Control Center was identified as a suspected case of monkey acne. On the same day, the Chongqing CDC collected clinical specimens, including blisters, nasopharyngeal and oral pharmaceuticals and blood samples for real -time PCR testing, showing it as positive monkey acne.
On September 16, the sample was sent to the China Disease Control Virus to conduct review and general genome sequencing. The sequencing results show that the strain belongs to the B.1 branch of West Africa LINAGE, which is the same as the strains collected from Germany on June 21, 2022.
It is worthy of special attention: within two days, my country has efficiently completed all the processes of "discovering suspected -diagnosis of review -virus traceability".
"Very normal speed." Industry people told reporters that now, the entire experimental time is about 70-120 minutes. Some new products developed by some companies can shorten the experiments to about 30 minutes. Although there are no monkey acne test kits in China, the relevant technical reserves are very sufficient. "
According to reports, it is more difficult for virus all -gene sequencing and traceability technology. The basic path is to perform general gene sequencing the virus, and then compare the sequencing result with the data in the database in homologous, which can be preliminarily judged by its regional source. This experimental process is longer, and special information analysts are required. But with the latest sequencing technology, the entire experimental process can also be completed in about 24 hours.
IVD exports surge
Since 2020, testing, prevention, and treatment constitute the main investment line related to epidemic conditions. According to data from Gaohe Investment Research Center, during the new crown epidemic, the value of exports of diagnostic reagents in my country increased from 34.9 billion yuan in 2020 to 84.6 billion yuan in 2021, a year -on -year increase of 143%. This data was only 3.5 billion yuan in 2019. Among them, the new crown -related testing agents have contributed a huge amount of exports of soaring.
According to the report of Guotai Junan Securities, as of the end of 2021, there were more than 70 companies in the country's new crown test agent who have obtained EU CE certification, and nearly 30 companies certified by the United States. With the repeated overseas epidemic, the surge demand has made the performance of many detection companies stand up. Data from the General Administration of Customs show that in February this year, the export value of the new crown virus (COVID-19) testing the kit reached a peak of 18.024 billion yuan. However, it began to decline significantly. From March to May, its export value was 14.591 billion yuan, 3.911 billion yuan, and 1.813 billion yuan, respectively; the month -on -month decrease reached 19.05%, 73.19%, and 53.64%.
"There are sufficient technical reserves and standard substances. Enterprises can develop the research and development of monkey acne testing kits very quickly, and international registration has long been familiar with the car." R & D people said.
Chinese Monkey Acne Testing Overseas Analysis
On May 7 this year, the British Health and Safety Administration reported on the first diagnostic case of monkey acne in Europe. In the following more than ten days, cases reported in Portuguese, Spain, and the United States. On May 20, local time, with more than 100 cases of suspected monkey acne cases, the World Health Organization confirmed to hold an emergency meeting on monkey acne.
On the evening of May 23, Zhijiang Bio announced that the company's independently developed monkey acne virus nucleic acid fixed kit has been certified by the EU CE. In the next few days, a number of listed companies have announced the announcement that the company's in vitro -related diagnostic products have passed the EU CE certification or expressed their own technical reserves in public channels.
"According to the relevant requirements of EC qualification certification in EU" IVDD (98/79/EEC) in Ventiral Diagnosis Device in Ventures, the clinical performance assessment data in the CE filing product technology documentation can References '. This means that if the appropriate institution is selected for cooperation, IVD products can complete the EU CE application at a very fast speed because it is not necessary to submit clinical trial data." A person engaged in international registration told reporters.
According to statistics from securities analysis agencies, as of mid -August, monkey acne diagnostic reagent products have passed EU CE certification. The reporter compiled the certification of 47 enterprises based on the public information of each company, and conducted statistical analysis of the product certification information it disclosed.
Monkey acne virus is divided into two branches: West African branch and Congo basin branch. The epidemic epidemic epidemic outbreak of this outbreak is the branch of West Africa. The types of monkey acne test agents developed by these enterprises are both common type of acne virus and exclusive to China -Africa / West Africa evolution. The types of reagents include nucleic acids, antigens, antibodies, etc. In terms of nucleic acids, there are many fluorescent PCR and PCR -fluorescent probes, and some companies also use new technologies such as digital PCR. The antigen antibody detection reagents are mainly collagen golden methods. The advantage is that the operation is simple, the price is appropriate, the speed is fast, but it cannot be quantitative.
So, will monkey acne nucleic acid detection agents sell as new crown nucleic acid detection agents? Judging from the past few months, the demand for monkey acne nucleic acid detection agents may be far less than that of new crowromytic acid test agents. On July 14, Zhijiang Bio announced on the investor interactive platform to obtain 17 consecutive orders from WHO. Nevertheless, Zhijiang Bio also said to the media that the current impact of monkey acne test kits on performance has little impact. Huada Gene also officially reported that the monkey acne test kit helped Saudi Arabia. In addition, hot -ora -view biology, Mole Biology, Kefu Medical, etc. have also publicly stated that the products have exported.
There are also securities analysis that with the development of the epidemic, the demand for border inspection and the screening needs of countries in severe epidemic conditions may be measured one after another.
Edit: Chen Shuwen
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