AIDS is an infectious disease endangering human health, and its treatment price is subsidized by the state policy and should not be regulated by the market. Recently, the domestic anti-AIDS drug market is very lively.
165438+1On October 22nd, GlaxoSmithKline (GSK), a global pharmaceutical giant and the largest foreign-funded pharmaceutical company in China, announced that it would officially launch its first and only antiretroviral therapy (cocktail therapy) triple drug-Sanxiewei in China at the end of June.
GlaxoSmithKline claims to bring the world's most advanced anti-AIDS drugs to China. At the same time, it was also announced that the application documents for the production of Shuanghuanglian A, an anti-HIV drug in China, were submitted to the State Administration of Pharmaceutical Products at 5438+00 this June. When the market demand reaches the minimum of mass production, that is, about 654.38+00000 tablets, the drug will be put into production in Tianjin GlaxoSmithKline production base.
Shuangtaizi A is the world's first dual-compound high-efficiency backbone drug for antiretroviral therapy (cocktail therapy). On September 16, Shanghai Disno Biomedical Co., Ltd. announced that the anti-AIDS generic new drug deoxyinosine and powder that had passed the patent protection period had obtained the new drug certificate and production approval from the State Pharmaceutical Administration and would be put into production in Zhangjiang High-tech Park soon.
In addition, the other three anti-AIDS drugs copied by the company-stavudine, zidovudine and nevirapine-have also entered the acceptance stage in the State Medical Products Administration.
It is reported that many domestic pharmaceutical companies have applied to the State Administration of Pharmaceutical Products for the production and sale of anti-AIDS drugs. For example, Tian Fang Pharmaceutical applied for Zidovudine and DDI, and Beijing Shuanglu Co., Ltd. applied for D4T. It is reported that at present, there are more than 10 enterprises queuing in SDA to apply for zidovudine. If there are no quality and safety problems, these drugs will be approved for marketing sooner or later.
It is reported that in June this year, UNAIDS published a 92-page special report "AIDS: China Titanic Crisis Report", saying that AIDS has "increased dramatically" in China. The article even appealed with red epigrams: Now is the time to act!
According to the latest report on AIDS prevention and control in China issued by the Ministry of Health, in the first half of 2002, the number of reported HIV-infected people in China increased by 16.7% and 5438+0 compared with the same period in 2006. Although the growth rate has declined, it is estimated that the total number of infected people has increased to nearly 1 10,000. According to Dr Shao from the Virology and Immunology Laboratory of the AIDS Prevention and Control Center of the Ministry of Health, the average incubation period of HIV is 8 years.
In this way, since China 1994 AIDS entered a period of rapid growth, China is now facing the first AIDS peak. According to experts' prediction, if active and effective measures are not taken, by 20 10, more than 100000 people will be infected with HIV in China.
On the issue of rapidly reducing the price of drugs, Dr. Lu Fan of AIDS Prevention and Control Center believes that compared with other methods, it is a truly effective method to realize the complete localization of drugs. And all domestic pharmaceutical companies with anti-AIDS drugs are playing the price card.
Although the drug price has not been officially disclosed so far, almost all domestic anti-AIDS pharmaceutical companies claim that their products are110 at the price of similar products of multinational pharmaceutical companies. Regardless of the final price, there is no doubt that domestic anti-AIDS drugs have a strong price advantage compared with imported drugs.
However, insiders pointed out that at present, AIDS treatment uses a combination of drugs, because with a single drug, HIV can easily develop drug resistance through mutation. According to the mechanism of action, the existing antiviral drugs can be divided into nucleoside reverse transcriptase inhibitors (such as zidovudine and lamivudine produced by GlaxoSmithKline, Huituozi and Slater produced by Bristol-Myers Squibb), non-nucleoside reverse transcriptase inhibitors (such as strychnine produced by Merck) and protease inhibitors (such as good patients of Merck).
Clinically, 1-2 reverse transcriptase inhibitors and 1 protease inhibitors are generally used, and the price reduction of a single drug cannot completely reduce the treatment cost. Experts also introduced that "Kedu" and deoxyinosine are only nucleoside and non-nucleoside drugs, but domestic manufacturers have not made achievements in the field of protease inhibitors for cocktail therapy.
There are considerable difficulties in the synthesis of protease inhibitors. At present, the protease inhibitors listed abroad have intellectual property rights problems in terms of compounds and preparation processes to varying degrees in China, and domestic manufacturers cannot copy them for the time being.
Antivirus requires combined treatment. If the price of only one drug is reduced, and other drugs, such as protease inhibitors, are not reduced, the overall cost may still be high, thus inhibiting users. In order to effectively control the serious AIDS epidemic in China, the government gave the green light to anti-AIDS drugs.
According to industry insiders, it is impossible for the government to allow enterprises to have more profit margins in product pricing. On the other hand, foreign companies are constantly introducing new drugs to make greater profits.
As we know, GlaxoSmithKline officially launched the first and only cocktail therapy triple compound drug-Sanxiewei in China. Bristol-Myers Squibb plans to apply to the FDA for registration and research on a new protease that inhibits Atazanavir; Before the end of this year;
Abbott's new-generation protease inhibitor Coolidge, which was listed in Europe and America two years ago, is applying for listing in China. Moreover, in the future, with the expiration of patents for other anti-AIDS drugs, domestic enterprises will compete for imitation, and the competition will be more intense.
By then, anti-AIDS drug enterprises will not only compete with imported drugs for the market, but also face competition from domestic enterprises. Therefore, at present, the prospects of anti-AIDS drug companies should be cautious and not blindly optimistic.