A preparation, two possible 11 swine flu vaccine manufacturers also prefer to worry about the first production in July

Source: Internet
Author: User
Keywords Hualan Biology influenza vaccine vaccine production batch issue
CFP for illustration June 8, the state Food and Drug Administration (SFD A) convened a press conference, announced the launch of special approval procedures for drugs, scientific and efficient 1N 1 influenza vaccine emergency approval.  That night, Beijing Branch Hing Biological Products Co., Ltd. announced the launch of the United States C D C of the 1N 1 influenza vaccine production strains, and initiated the preparation of the seed batch of the virus, which marks the official launch of the swine flu vaccine production, and is expected to produce the first vaccine by the end of July.  Prior to June 3 and June 5, Hualan Bioengineering Co., Ltd. and Dalian ya Li Feng Bio-Pharmaceutical Co., Ltd have also received the British biological product accreditation vaccine strains.  According to SFD A's conservative estimate, if our country 11 influenza vaccine production enterprises all put into production, the first batch production can reach 3 million doses, the annual output can reach 360 million doses.  This is undoubtedly an opportunity for the 11 flu vaccine manufacturers to contain temptations and challenges.  Swine flu vaccine Go "green channel" state Food and Drug Administration spokesman Yijiang said that the Bureau will be through the Declaration and on-site assessment synchronization, production and strains of the record synchronization, enterprise inspection and the application of batch issue synchronization, such as the rapid approval channel for a H 1N 1 influenza vaccine opened "green channel." It is reported that this week, 11 enterprises will be acquired a 1N 1 influenza vaccine production of strains, and then, enterprises should establish a poison seed library, according to the provisions of the test of the strain, and as soon as possible to carry out the adaptability of the strain; seasonal influenza vaccine production is nearing its end, Influenza vaccine manufacturers should continue to ensure the supply of raw materials needed for the production of vaccines, maintain production equipment, and prepare for the production of a 1N 1 influenza vaccine. SFD A Drug Registration Division biological Products Department Yun Hongzhang Commitment, "must be produced before the national Day vaccine, and let some people use." "The nature of the flu is still on standby." According to Yun Hongzhang, China has 11 seasonal influenza vaccine manufacturers, including Beijing Branch Hing 1 companies with pandemic Influenza vaccine production qualification. However, whether or not a pandemic influenza vaccine production qualification, can apply for the development and production of H. 1N 1 Influenza vaccine. "In the emergency situation, the state Food and Drug Administration will also establish a linkage mechanism to organize coordinated production of other vaccine production enterprises."  Beijing Branch Hing 8th Night also said that because of the large demand for pandemic influenza vaccine, its capacity is difficult to fully meet the needs of the country and the public, decided to work with several seasonal influenza vaccine manufacturers allied to production.  In addition, Yun Hongzhang said, "A total of 32 influenza vaccine production enterprises around the world, our country accounted for 11", "now formally to the international commitment, we not only bear our country's affairs, may be within a certain range also to perform the duties of W H o assigned." However, the Bohai Securities Research Institute believes that, because the World Health Organization has not yet on the H. 1N 1 Influenza belonging to the seasonSeasonal flu or pandemic flu. Therefore, China's vaccine production enterprises in the acquisition of strains at present only to carry out the adaptive study of strains and improve the technical route of the vaccine, as well as to continue to the H. 1N 1 Influenza vaccine immunization procedures and dosage forms, dosage options, such as in-depth research, validation and other related work, such as large-scale production  It will also await the WHO's classification of influenza and the unified arrangement of our health sector.  Virus mutation in the early stage of investment or skipping although the outlook seems tempting, but for companies, the production of influenza vaccine is still a big "danger."  The danger is that the flu virus is fickle. At present, the production of a H 1N 1 influenza vaccine is still a while, "in case of the virus mutation, then some of the early stage of the enterprise research is very likely to water drift."  "The Beijing Temple of Heaven Bio-dong Zhang Yi admits that the development of a swine flu" is more to reflect social responsibility. But he also said that if the epidemic develops more seriously, mass production of vaccines may lead to more lucrative profits. "There are two possibilities for the business, but in any case, what the company needs to do is actively prepare for it." "For this Yun Hongzhang said, generally speaking, influenza virus in the process of transmission between people is constantly changing, there is a quantitative change to qualitative process." Now the development of a H 1N 1 influenza vaccine is effective to see when the mutation of the virus and its current strains of the cross protection between the high.  In addition, departments such as the Ministry of Science and Technology have previously built a joint working mechanism for the scientific research of vaccines, and one of its research work is to say how we respond to the constant mutation of the virus, including our means of prevention and treatment, including the development and production of vaccines.  A senior industry personage said, even if the virus did not have a large mutation, because the vaccine out, the state will be based on the prevention and control situation to unify the distribution of vaccines, and according to the Convention should be the government procurement, so the expected price will not be high, the impact on the profits of enterprises is difficult to  However, Shen Wan Ban analyst Lou Rui in the study of Hualan Biology, pointed out that if the State of stockpiling, as one of the major influenza vaccine manufacturers, will assume the production task and obtain a reasonable profit, the annual performance may exceed expectations.  No hype in the capital market according to the national Centers for Disease Control and Prevention, the country's H 1N 1 influenza vaccine needs to reserve 13 million doses at a minimum of 20 yuan per purchase price (common influenza vaccine price in 20 yuan/above), then the purchase amount of the project is more than 260 million yuan.  However, from the capital market, the recent policy has not brought the stock market similar to the early stage of the outbreak of influenza speculation phenomenon. Hualan 8th morning rose more than 8%, but then closed with 1 34%, 9th fell by 5.94%. The Temple of Heaven 8th plunged 4.08%, 9th fell 0.99%.  Sea King Biology 8th slightly rose 1.27%, but may be related to another joint venture case. Analysis of Guotai MedicineDivision Yi-Ming and Bohai Securities analyst Ma Drizzling all believe that, in view of the future of the 1N 1 influenza epidemic development uncertainty, so each company H 1N 1 Influenza Vaccine production scale, sales can not be expected, short-term impact on the future performance of listed companies there are significant uncertainties. The number 360 million agent in China 11 vaccine enterprises to obtain the corresponding strains, the conservative estimate, the first 1N 1 influenza vaccine production can reach 3 million doses, annual output will reach 360 million doses 7 steps in general, a single batch of vaccine production needs to undergo viral inoculation, virus culture, virus inactivation, purification, proportion, At least 7 steps, such as subcontracting and batch issuing, can be finally put into use HK $700 million Hong Kong SAR will provide free of charge of an H 1N 1 influenza vaccine to about 2 million people in Hong Kong, the scheme cost HK $700 million for 30 yuan the head of the national influenza pandemic vaccine preparation Company, the domestic independent research and development of the 1N 1 influenza vaccine price will not be high At 30 yuan or so the ordinary influenza vaccine price newspaper reporter Li Yifi
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