Behind the suspension of Wanfu Biological Kit: after going up 60%, crossing more than 20 places

Behind the suspension of Wanfu Biological Kit: after going up 60%, crossing more than 20 places
After the news that the new coronavirus detection kits of some companies in China were replaced, on April 28, Wanfu Biology and Livzon Group were all suspected of closing down.Eventually closed, Wanfu Biological dropped by 1.8%, Livzon Group’s decline was 0.53%.Sauna, Yewang noticed that as early as in early February of this year, Wanfu Bio said publicly that it has completed the development of new coronavirus (2019-nCoV) series of detection reagents and new products, and became the first batch of new coronavirus antibodies officially approved for marketing that month.On-site rapid testing reagents.Another listed company, Livzon Group, also obtained a domestic listing license in March this year.In the context of the global outbreak, many companies have already started overseas gold panning.Among them, Wanfu Bio-New Crown antibody products have covered more than 20 countries and regions including South Korea and Germany.Under “Qian Jing”, sustainability is also constantly gaining popularity.The data shows that since this year, the overall growth of Wanfu Biology and Livzon Group has increased by 60% and 22% respectively from the beginning of the year to April 28.Anti-epidemic products are sold to more than 20 places: Wanfu Bio: approved by India Wanfu Bio issued a statement on April 28, saying that the company’s new coronavirus antibody detection reagent (colloidal gold method) is one of the first batch of detection reagents to obtain India’s import license, And has passed the verification and approval of the National Institute of Virus Research (NIV) in India.The company is actively communicating the above opinions on Indian medical research indicators.At the same time, the Chinese Embassy in India responded to the weighing, the storage, transportation and use of the new crown antibody detection reagents were consistent with strict requirements, and any specific precautions were carried out in accordance with the specifications of the product instructions, which would lead to deviations in the detection accuracy.Indian medical research indicators also clearly indicate that rapid testing reagents are only used to monitor the epidemic situation, and cannot be used to confirm diagnosis and judgment, and cannot replace nucleic acid testing. States should strictly abide by the method and purpose of use.The reporter noted that Livzon reagent issued a statement on March 17 this year, stating that the new coronavirus IgM / IgG antibody detection kit (colloidal gold method) developed by the company is only used to supplement the suspected cases of negative detection of novel coronavirus nucleic acidThe detection index or the use of nucleic acid detection in the diagnosis of suspected cases cannot be used as the basis for the diagnosis and elimination of pneumonia caused by new coronavirus infection, rather than the screening of the general population. It is only used by medical institutions.As early as February of this year, Wanfu Bio said that it has completed the research and development of new coronavirus (2019-nCoV) series of detection reagents.The series of products include 2019-nCoV new coronavirus antigen detection reagent, antibody detection reagent based on colloidal gold immunochromatography, and 2019-nCoV new coronavirus nucleic acid detection kit based on fluorescent PCR platform.On February 24, Wanfu Bio announced once again that the company’s new coronavirus (2019-nCoV) antibody detection kit (colloidal gold method) passed the emergency approval of the State Food and Drug Administration and officially obtained the medical device registration certificate, becoming the first batch of officially approvedAdmitted to the market for rapid on-site detection of new coronavirus antibody reagents.The following month, Wanfu Bio also announced that its three new coronavirus detection products have obtained CE certification submitted by the European Union.Against the background of the global outbreak, Wanfu Bio’s overseas orders are also increasing.According to the report of the first quarter of 2020 disclosed by Wanfu Bio on April 21st, from late February to early March, the company’s new coronavirus antibody detection kit gave priority to ensuring the need to fight the epidemic in the country.And medical institutions as a synergy and supplement to the new crown accounting and testing reagents.”Since the beginning of March, the global epidemic prevention and control has entered a major new stage overseas. The company’s overseas orders have grown rapidly. At the end of the first quarter, the new crown antibody products have covered more than 20 countries including South Korea, Germany, Italy, Brazil, Venezuela, etc.And region.”The data shows that Wanfu Bio’s total operating income in the first quarter of 20205.500 million US dollars, an increase of 21 from the same period last year.9%, the net profit attributable to shareholders of the listed company was 97.84 million yuan, an increase of 34% every year.Another listed company, Livzon Group, also obtained a domestic listing license in March this year.On April 28, the Livzon Group stated in its investor relations activities that its affiliated company’s Livzon reagent’s new coronavirus IgM / IgG antibody detection kit (the colloidal gold method has also obtained EU CE certification and has become the EU market access conditionAnd apply for import registration in multiple countries.”From the perspective of orders, domestic orders were limited due to the fact that the domestic market epidemic situation was basically restored when it was approved, and the overseas epidemic situation was in an outbreak period.Servings.”In the first quarter of this year, Livzon Group’s operating income was 2.5 billion US dollars, and the net profit attributable to shareholders of listed companies was 3.9.9 billion yuan.A variety of reasons can lead to the failure of reagent testing. The export control of epidemic prevention materials has been tightened. At present, the domestic epidemic has eased, but the global epidemic has begun to enter the outbreak period. Behind this is a huge gap in the detection of new coronary pneumonia.According to incomplete statistics of sauna and Yewang, currently more than ten listed companies with kit products are supplied with Kehua Bio, Lepu Medical, Sanuo Bio, Wanfu Bio, Oriental Bio, Huada Gene, Xinbang Pharmaceutical, Daan Gene, etc.In the plan to deploy overseas, some of the companies have obtained EU market access conditions, and some companies have already received export orders.However, there are many listed companies sprinting to the overseas new crown virus detection market, but some of them are awaiting emergency approval from SINOPHARM.Xu Min (pseudonym), a researcher and developer of new coronavirus nucleic acid detection reagents, once interviewed at Sauna and Yeewang. There are many reasons for the false positive or false negative detection results of nucleic acid reagents.Since January this year, Xu Min has been involved in the development of new coronavirus detection reagents. The team completed the development of new coronavirus nucleic acid detection reagents in less than a week.It tells Sauna, Yewang that nucleic acid reagents are a major method of pathogen detection. From the design of the reagents to the raw materials, the entire production process is relatively simple, so many manufacturers will quickly complete the development of nucleic acid reagents.Xu Min said that if a certain nucleic acid detection kit itself does not have good quality control, it is easy to lead to inaccurate final results.”Any method used to detect products has its own sensitivity and limitations. When the virus does not reach a certain load, it may not be detected by this method (virus).”A staff member of another Guangzhou testing agency told reporters that in the sampling process of accounting virus detection products, many grassroots sampling methods are not uniform, and non-standard sample storage and transportation will also lead to inaccurate test results.In fact, since April this year, China’s defense epidemic materials export policy has been significantly tightened.On the evening of March 31, the Ministry of Commerce, the General Administration of Customs and the State Administration of Drug Administration issued an announcement stating that the export of medical materials should be carried out in an orderly manner. From April 1, new coronavirus detection reagents and medical masks will be exported.Enterprises in medical protective clothing, ventilators, and infrared thermometers must declare to the Customs that they have obtained an in vivo medical device product registration certificate when they declare to the customs.As of April 24, there were 30 registration certificates for new coronavirus detection reagents across the country, which meant that export biology is already high.On April 26, the State Council released a press conference on the joint defense and control mechanism. According to the business statistics of the Ministry of Commerce, on April 25, 74 countries and regions and 6 international organizations signed 192 commercial procurement contracts for medical materials.Cumulative amount 14.100 million US dollars.In 72 countries and regions, 8 international organizations are carrying out commercial procurement negotiations with our company for 129 purposes.China ‘s 31 provinces, autonomous regions and municipalities have exported anti-epidemic materials to 191 countries and regions through market-based procurement.At the same time, Wang Shucai, deputy director of the Medical Device Supervision Department of the State Food and Drug Administration, said on April 26 that since the outbreak, the State Food and Drug Administration took measures to comprehensively strengthen the quality control of medical devices for epidemic prevention and control.In the list, if there is evidence that there is a problem with the quality of the exported product, the production shall be stopped immediately for rectification.Sauna, Ye Wang Li Yunqi editor Wang Jinyu proofreading Li Shihui