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Industry insiders said that this is the only Chinese covid-19 vaccine with the third-generation technical route certified by who Eul, and it is also the most important approval of Cansino Biologics Inc(688185) covid-19 vaccine in history.
how strong is the third generation domestic covid-19 vaccine
Cansino Biologics Inc(688185) may 19 announced that the World Health Organization disclosed on its official website on May 19 that the recombinant novel coronavirus vaccine (type 5 adenovirus vector) "kvisar" of Cansino Biologics Inc(688185) Jinyu Bio-Technology Co.Ltd(600201) Jinyu Bio-Technology Co.Ltd(600201) company was included in the "emergency use listing" (hereinafter referred to as "Eul")
The announcement shows that the product is constructed by genetic engineering method and can express the S antigen of novel coronavirus with replication defective human type 5 adenovirus as the vector. It is intended to prevent diseases caused by novel coronavirus infection. At the same time, it does not contain preservatives, adjuvants and animal derived ingredients.
The Eul procedure assesses the suitability of new health products in public health emergencies. Its purpose is to provide drugs, vaccines and diagnostic methods as soon as possible in response to emergencies, while respecting strict safety, efficacy and quality standards. The assessment process should weigh the threat posed by the emergency, the benefits of using the product and any potential risks. At the same time, who Eul is a prerequisite for providing vaccines for covid-19 vaccine implementation plan (covax). The list also allows countries to accelerate their respective regulatory approvals to import and manage covid-19 vaccines. The decision to include kweisa in Eul is based on the review of the product's quality, safety, effectiveness data and risk management plan (RMP) by who prequalification (PQ) experts, including regulatory experts from around the world. The final risk benefit assessment is conducted by the Eul technical advisory group (tag).
Cansino Biologics Inc(688185) said that after the product was incorporated into who Eul, the company still needs to conduct commercial negotiations with the intended countries on the future sales of the product. If the subsequent overseas countries increase the purchase and use of the product, it will have a positive impact on the performance of the listed company
It is understood that Cansino Biologics Inc(688185) covid-19 vaccine, as one of the few third-generation technology covid-19 vaccines using single shot immunization procedure, was approved by the State Food and Drug Administration in February last year with conditions for listing. Abroad, it has also obtained emergency use approval from Mexico, Pakistan, Chile, Argentina, Ecuador, Hungary, Indonesia, Kyrgyzstan and other countries, and obtained GMP certification in the EU, which is highly praised all over the world.
Recently, the journal Nature Medicine published a randomized controlled clinical study of sequential immunization with covid-19 vaccine. The study showed that the level of immune response induced by heterologous enhancement of two doses of inactivated vaccine + Cansino Biologics Inc(688185) vaccine was higher than that induced by homologous enhancement of inactivated vaccine, and the safety was good. At present, China, the United Kingdom, the United States, Canada, Chile, Thailand, Brazil, the United Arab Emirates, Peru, Argentina and other countries and regions have adopted or recommended Cansino Biologics Inc(688185) covid-19 vaccine as a sequential immunization enhancement strategy.
It is worth mentioning that as the recombinant novel coronavirus vaccine (adenovirus type 5 vector) has obtained conditional marketing approval and emergency use authorization from many countries at home and abroad, the product has also become the core engine for performance growth of Cansino Biologics Inc(688185) . In 2021, Cansino Biologics Inc(688185) achieved an operating revenue of 4.3 billion yuan, a year-on-year increase of 1717482%, and a net profit of 1.914 billion yuan, turning losses into profits.
how important is the WHO emergency use list
The emergency use list (Eul) is a mechanism formed by who to evaluate the applicability of new health products in public health emergencies. The goal is to provide drugs, vaccines and diagnostic tools as soon as possible.
In the face of sudden outbreaks (such as covid-19 epidemic), the world often lacks ready-made drugs, vaccines, testing reagents and other medical products. In order to make medical products effective as soon as possible and reduce the impact of the epidemic, who launched Eul to simplify the approval process on the premise of ensuring safety and effectiveness, so that newly developed products can be put into practical use as soon as possible.
simply put, Eul is the purchasing list of covid-19 vaccines from all countries in the world. People who choose to vaccinate on this list mean that they have obtained a "global pass" and can freely travel to all countries. At present, the standards of entry policies implemented by various countries are different. Even if countries have access to country a, they may not be able to move forward freely to country B. the certification of who just breaks this deadlock, just like giving a "green pass"
Of course, it is not easy to obtain the "green pass" of the WHO emergency use list.
According to the official website of who, at present, the World Health Organization has approved the emergency use of 11 covid-19 vaccines. The Cansino Biologics Inc(688185) vaccine included in the global tight use list this time is also the world's first Chinese covid-19 vaccine of the third generation technology route
According to the reporter, Cansino Biologics Inc(688185) also developed a global innovative covid-19 vaccine for inhalation, which was approved for clinical use in March 2021. By the end of 2021, phase I / II clinical trials had been completed. This may become the world's first inhalable covid-19 vaccine.
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