New crest virus detection reagents out of the tide: more than a dozen listed companies grab the EU

15 Jul by admin

New crest virus detection reagents out of the tide: more than a dozen listed companies grab the EU

New crest virus detection reagents out of the tide: more than a dozen listed companies grab the EU
“According to incomplete statistics, 14 new coronavirus detection reagents developed by 5 universities including Tsinghua University have obtained EU CE certification and officially obtained the qualification to enter the EU market.”On March 17, the State Council Joint Prevention and Control Mechanism Press Conference found that across the epidemic situation abroad, the demand for virus detection has increased significantly. On the basis of the need for virus detection, our detection reagents have gone abroad.In fact, in addition to the new coronavirus detection products that colleges and universities participate in research and development, domestic third-party detection institutions and research institutes also frequently publish news about the deployment of new coronavirus detection products in overseas markets.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.The domestic “certified” kits have a daily production capacity of more than 3 million copies and start overseas supply. On March 16, the State Food and Drug Administration announced the emergency approval situation again.Two new coronavirus (2019-nCoV) IgM / IgG antibody detection kits (colloidal gold method) from Bead Reagent Co., Ltd.This means that the domestic production capacity of “certified” new coronavirus detection reagents has further expanded.As of March 16, the State Food and Drug Administration’s emergency approval system has approved 19 new crown virus detection products.Relatively one day, the State Food and Drug Administration released news that as of March 11, the State Drug Administration had approved a total of 16 new coronavirus detection reagents, including 10 nucleic acid detection reagents and 6 antibody detection reagents; nucleic acid detectionThe daily production capacity of reagents is nearly 2.6 million, and the daily production capacity of antibody detection reagents is nearly 1 million.Basically, there are a large number of nucleic acid detection reagent products that have not yet passed emergency approval in China, which can be donated or sold to disease control centers and other alternative research.The domestic epidemic has eased, but the global epidemic has begun to begin.According to WHO statistics, as of 23:00 on the 17th, Beijing time, more than 180,000 cases have been diagnosed worldwide, and 159 countries and regions have reported cases.Behind this is a huge gap in the detection reagents for new coronary pneumonia.On the evening of March 17th, Beijing time, the US FDA urgently issued the latest new coronavirus detection guidance policy mentioning that the number of new coronavirus infections in the United States is increasing, and there is an urgent need to expand the detection of new coronavirus in the United States in public health emergencies.ability.On March 17, Lei Chaozi, director of the Science and Technology Department of the Ministry of Education, said that the new coronavirus detection products developed by Tsinghua University and other five universities have not been donated with alternative reagents, and have also been started in more than 10 countries such as Italy, the United Kingdom, and the Netherlands.Funding goods.Prior to this, some new coronavirus testing and production enterprises also received foreign orders.On February 27, in response to a regulatory inquiry letter, the listed company Orient Bio stated that the three new coronavirus diagnostic products developed by the company can be sold in the European Union, and it has already cooperated with Austria, Croatia, Italy, Greece and other EU countries.An emergency sales order for the new crown virus diagnostic series has been issued.In addition, on March 3, the Chengdu Science and Technology Bureau told the media that Mike Bio-new coronavirus supported by the Chengdu Emergency Science and Technology Research Project.The 2019-nCoV nucleic acid detection kit (fluorescence PCR method) has received overseas orders from Iran and other countries after obtaining the “Medical Device Registration Certificate” submitted by the State Food and Drug Administration.The EU market has low entry barriers and quasi-biologicals. It is not difficult to find out that the merged company is “rushing to the beach” and sorting out the public information. In this wave of kit kits, the EU has become the frontier for the Nuggets.On the evening of March 17, the listed company Kehua Biological announced that the company received the EU market free sales certificate for new coronavirus detection related products.Shortly after the opening on the morning of March 18, Kehua Bio stocks had a daily limit.According to the basic product information disclosed by Kehua Bio, the company’s new coronavirus nucleic acid reagent, IgM / IgG antibody detection kit, IgM antibody detection kit, IgG antibody detection kit 4 products have obtained the EU free sales certificate, and the EU has been completedThe competent authority has registered and has access to the EU market.This means that in addition to being marketable in the EU, these testing products must also be sold in other countries that have a recognized agreement with the European Economic Area.On March 18th, Sauna and Yewang called the Kehua Biological Securities Office. The staff said that the company’s national medical device product export sales certificate is still in the process.Some people in the IVD industry Song Yu (pseudonym) told reporters that some companies in the industry had already prepared for the export of virus detection products in January this year, “Some felt that they did not want to get (emergency approval), and they were deployed overseas in advance.”.Song Yu said that the EU implements a filing system, and it is relatively simple to obtain EU market access qualification, as long as it is CE certified, but the United States is special and requires FDA certification.The reporter noticed that at the end of February, Oriental Bioscience disclosed the process of obtaining EU access qualification in detail in response to the inquiry letter of the Shanghai Stock Exchange-the CE certification of the new coronavirus diagnostic series products, made a declaration of conformity and submitted it to the EU competent authorityAfter completion, you can affix the CE mark on the product.Orient Bio began to provide the corresponding materials as required on January 28, and completed the CE certification in February.With the rapid spread of the epidemic around the world, intensive officials of listed companies have announced the EU market in recent years.On March 2, BGI announced that its wholly-owned subsidiary, European Medicine, has obtained a free sales certificate for EU in vitro diagnostic medical devices submitted by the Danish Medical Administration.On March 6, Wanfu Bio said that the company’s three new coronavirus detection products obtained the CE certification entrusted by the European Union, which has become an entry condition for the EU market.About 10 days later, Sanuo Bio and Sinbon Pharmaceuticals disclosed to the public that relevant products have submitted CE product notifications to the EU competent authorities, becoming EU market access conditions.Lepu Medical, Da’an Gene claims to obtain EU CE access or certification, and obtain EU market access qualification.Initially, at present, no domestic listed company has announced that a new coronavirus test product has obtained US FDA certification.The most recent news is that on March 18th, Shanghai Mindi Biomedical Technology Co., Ltd. announced that a new coronavirus nucleic acid detection system has submitted an application to the FDA and has officially entered the stage of review and approval.The current status of kit manufacturing companies: Only more companies are waiting for emergency approval to pass multiple listed companies to sprint the overseas new coronavirus testing market, but there are companies that are waiting for emergency approval from SINOPHARM regulators.For example, Kehua Biology, which has passed the preliminary CE certification, has not yet passed the registration approval of the State Food and Drug Administration.Air Force Kehua Bio said publicly that the company’s new coronavirus nucleic acid detection reagents are being supplied to disease control centers around the world, but are in the process of registration approval.On March 18th, Sauna and Yewang asked Kehua Bio to understand the progress of the company’s internal registration and approval of virus detection products and whether clinical trials have been completed. The staff said that they did not know the details.Song Yu Air Force told the sauna and Yewang that according to the requirements of the State Food and Drug Administration, new coronavirus detection reagents that have not passed the registration approval cannot be directly sold to the hospital.”Many listed companies supply CDCs without a registration certificate.”But if you supply it to the hospital for clinical use, it needs to be sold to the hospital.”Song Yu told reporters that under normal circumstances, a nucleic acid detection kit needs to be carried out in various local laboratories, after identification, to the hospital for clinical comparison, follow-up on-site verification and other work.”The approval time is more than 18 months, and two years is relatively normal.”” On March 18th, Sauna and Yewang learned from the relevant staff of the State Food and Drug Administration that the latest submission of new coronary pneumonia virus testing and approval can only be reviewed in accordance with the normal process, and you can take the “priority channel”, but you have no way”Emergency Approval”.At present, there are still many new crest virus detection reagent products in China awaiting emergency approval.As early as February 13, Fosun Pharma stated on the investor interaction platform that the new coronavirus nucleic acid detection kit developed by the holding subsidiary Fosun Long March is actively applying for emergency approval by the State Food and Drug Administration in accordance with relevant national regulations.In addition, Mike Bio and Livzon Group both said in February that related products entered the national emergency approval channel.In March, Yangpu Medical, Meikang Biology and ST East Ocean have successively revealed the progress of the registration-related work.On March 18, Sauna and Yewang learned from the listed company Runda Medical that the accounting reagents jointly developed by the existing company and its partners are still under review and approval and are “already in the clinical summary stage”.Sauna, Ye Wang Li Yunqi editor Wang Jinyu proofreading Li Ming