Anti class a drugs are in short supply

"A stream" is a terrible disease for many people, but it means business opportunities and profits for drug manufacturers On November 24, Shanghai Sanwei Pharmaceutical Co., Ltd., a subsidiary of Shanghai Pharmaceutical Group, held a high-profile press conference at the 62nd national drug fair, and officially launched the commercial sale of "alpha" product "ORFI" (common name: oseltamivir phosphate) As the only enterprise authorized by Roche and authorized by oseltamivir phosphate, Shanghai Pharmaceutical Group has sold "ORFI" in more than 300 stores of Shanghai Huashi pharmacy in early November At this time, dongyangguang Industrial Development Co., Ltd., another domestic enterprise authorized by Roche to produce oseltamivir phosphate, has already included a large order of government procurement in the bag, which has been put into production in April this year, and the products are purchased by the government While the two companies have entered the "class a" drug field, many domestic and foreign drug companies are also looking for opportunities to take a share For these enterprises, "A-flow" is a marketing concept, which is a powerful driving force for the cold medicine market With the change of treatment from "A-flow" prevention and control to severe treatment, anti-a-flow drugs are in short supply It is understood that the current national purchase price of oseltamivir phosphate is 8 yuan per capsule, and dongyangguang's products are specially purchased for the government The ex factory price of Shangyao's products is 18 yuan (tax included), and the price of entering Huashi pharmacy is 20 yuan (the retail price of "Tamiflu" produced by Roche is 28 yuan) Why were the two enterprises authorized by Roche to produce oseltamivir phosphate and dongyangguang finally treated differently in terms of sales? It is understood that in 2005, SARS broke out in China, and then Chinese enterprises started negotiations with Roche, the manufacturer of "Tamiflu" recommended by the World Health Organization Finally Roche gave the production license of "Tamiflu" to two Chinese companies, dongyangguang and Shangyao group The former is a private enterprise, the latter is a state-owned enterprise According to the agreement at that time, the products produced by the two enterprises can only be supplied to the state for storage and government procurement, while Roche's original research products continue to be sold in commercial channels Cai Zhijun, manager of dongyangguang company, said that dongyangguang is now strictly in accordance with the authorized contract of Roche at that time Shangyao group, on the other hand, said in the media that obtaining commercial channel sales license was the result of late efforts to negotiate On December 3, our reporter called Shanghai Roche to verify the final authorization The head of the public affairs department of Roche said that all authorized enterprises should follow the authorization That is to say, through efforts, Shangyao obtained the permission of channel sales and obtained preferential treatment Someone has calculated an account for the drug "ORFI" After the cost and channel expenses are removed, a "ORFI" will make a net profit of 3 yuan, which is undoubtedly the most direct good news after the new drug restructuring According to the international practice of pharmaceutical industry, when authorizing production, the authorizer should pay certain "Royalty" and "production license fee" to the patent owner From Roche's initial authorization of drug production, sales channels are limited to government procurement, to the final commercialization of drug application, that is, to sell "ORFI" to distributors, hospitals and retail pharmacies, what kind of interest game and compromise have both sides made? How much is the charge that the upper medicine pays to Roche? The medicine has been vague In fact, Roche has its own deep-seated reasons for opening up its domestic sales right to Shangyao On the one hand, in the severe situation of global influenza outbreak, Roche can not ignore the compulsory patent licensing measures of "Doha Declaration" while protecting drug patents; on the other hand, in recent two years, many countries have accelerated the research on "Tamiflu", and China, a big country of generic drugs, is no exception According to the data, in November 2001, the Fourth Ministerial Conference of WTO held in Doha issued the Doha Declaration on trips and public health, which proposed the compulsory licensing system for patented drugs On August 30, 2003, after 20 months of arduous negotiations, the governments of WTO members unanimously passed the final document on the implementation of the compulsory licensing system for patented drugs, It makes it easier for poorer countries with insufficient or no production capacity in the field of drugs to import cheaper unregistered drugs produced under the compulsory licensing system (internationally, the production without patent authorization is called "unregistered production", whose product price is much lower than that of similar drugs produced under patent protection) China has also added the compulsory license to the newly revised Patent Law this year One industry source said oseltamivir phosphate's main role is antiviral After the SARS epidemic, the spread of avian influenza has also caused the shortage of Tamiflu However, although as early as the end of 2005 when the drug was applied, dongyangguang was authorized later, but only this year it just organized production This shows that authorized enterprises still have concerns about the market demand "No matter which enterprise is authorized, it will definitely invest a lot of money However, if the products are limited to government procurement for drug reserves, it is difficult for enterprises to make profits If there is no large-scale influenza outbreak, the market prospect of the Chinese version of "Tamiflu" is uncertain But if the licensing fee of the authorized enterprise is linked to the drug sales, the Chinese version of "Tamiflu" is not much higher " The industry source said On December 3, China pharmaceutical, a listed company of General Motors Group, disclosed that it would timely carry out the distribution activities of antiviral drugs (oseltamivir phosphate capsules and granules) on the premise of ensuring the completion of the national reserve task To this end, the company's holding subsidiary general Meikang Pharmaceutical Co., Ltd has signed an exclusive distribution agreement with Yichang Changjiang Pharmaceutical Co., Ltd under Dongguang on December 1 Does this mean that dongyangguang has also started the marketing of domestic "Tamiflu"? Perhaps, Roche's authorization for East Sunshine has also changed The swarming nuggets are playing games around the authorization of oseltamivir phosphate, while the other nuggets are swarming in "Leganqing" produced by GlaxoSmithKline, a British company listed as an effective anti influenza drug together with oseltamivir, has been selected as a partner of Nanjing Xiansheng Pharmaceutical Co., Ltd Xiansheng pharmaceutical said that everything has been prepared and can be put into production as soon as the production approval is obtained Guangzhou Baiyunshan Pharmaceutical General Factory of Guangzhou Pharmaceutical Group has submitted the generic drug registration application report to the State Food and drug administration, hoping to start the green channel and approve the bioequivalence test in advance Shijiazhuang No.4 Pharmaceutical Co., Ltd under Lijun international, a Hong Kong listed company, also recently launched the anti influenza drug "enerxin" It is disclosed that "enerxin" capsule has been used in 200 clinical trials in Beijing Union Medical College Hospital, China Japan Friendship Hospital, etc The results show that its early use after the onset of influenza can significantly shorten the duration of the disease and reduce the relevant symptoms Are these "a stream" concept drugs really effective? Lin Jiangtao, director of respiratory department of China Japan Friendship Hospital, said that the active metabolites of Tamiflu can inhibit neuraminidase of influenza A and B viruses From the research point of view, the spread of influenza A virus is divided into four steps, "Tamiflu" inhibition of neuraminidase virus is only one of the effective means, do not exclude other drugs in different targets have inhibition "In the past, amantadine drugs were widely used in the treatment of influenza, but they are highly resistant and have some side effects, which are not good for the treatment of influenza." It is reported that "enerxin" is to prevent the fusion of virus and host cells to achieve the effect of influenza treatment "At present, Nissan has reached 1 million, which is still difficult to meet the market demand We are stepping up the construction of an oral agent production workshop with an investment of 30 million yuan, with a design annual production capacity of 1 billion tablets The process layout is all designed and constructed in accordance with the EU GMP standard, and can be put into production by the end of the year, which will greatly alleviate the market demand for "enerxin" Qu Jiguang, chairman and general manager of Shijiazhuang No.4 Pharmaceutical Co., Ltd It is understood that in addition to the western medicine "Tamiflu" and "leganqing", the TCM syndrome differentiation treatment scheme is also recommended in the four treatment schemes of "A H1N1 influenza diagnosis and treatment scheme" researched and formulated by the Ministry of health The main products involved include Shufeng Jiedu Capsule, Xiangju capsule, Yinqiao Jiedu, Shuanghuanglian oral preparation, Huoxiang Zhengqi, Lianhua Qingwen capsule, Yinhuang Preparations, lotus heat clearing preparations, etc Industry insiders believe that influenza has attracted increasing attention in recent years The new influenza has gradually faded the old cold medicine out of the market, leaving a great imagination space for the cold medicine market In the future, the market will not only be the gold mine of "Tamiflu", but also bring business opportunities to other products It is reported that the price of star anise has been greatly increased due to the use of "a-stream" Recently, the price of star anise in China has increased from less than 10000 yuan per ton to 12000 yuan per ton, and the export price has increased by more than 3000 yuan on the basis of 12000 yuan per ton The main reason is that octagonum can be used as the raw material for the production of "Tamiflu" It is understood that shikimic acid can be extracted from star anise, and shikimic acid is an essential raw material for the production of Tamiflu Shikimic acid has convulsive effect on human nerves and is often used as a specific drug for the treatment of influenza China's octagonal exports account for more than 80% of the world market The price rise of octagonal not only benefits the related Chinese medicine enterprises in China, but also benefits the listed companies that produce monopoly "Tamiflu" raw materials Guangxi is one of the largest provinces of plant resources in China except Yunnan, and two listed companies in Guangxi, LMZ and Rhine bio, are all affected by the favorable market of octagon.