Multinational companies still account for 80% of the hospital anti-AIDS market
On December 9, the news of the successful development of the first domestic new crown special drug was all over the streets.
China's specific drug is the only antibody in the world to conduct efficacy evaluation of mutant strains, and has obtained optimal data, but the leader behind this fruit is little known. He is an expert who has struggled in the field of AIDS treatment for nearly 35 years, zhang Linqi, a professor at Tsinghua University.
In January 1981, the UCLA Medical Center confirmed the world's first case of human immunodeficiency virus (HIV). During his phD at the University of Edinburgh in the United Kingdom, Zhang Linqi learned about AIDS for the first time and became one of the first HIV researchers in China.
According to the latest data released by China on "AIDS Day" on December 1 this year, as of the end of October, 1.14 million cases of HIV infection were reported nationwide, of which 111,000 were reported from January to October.
In June 1985, China discovered the first case of imported AIDS patients from abroad, and now the number of infected people has exceeded one million, and the number of patients has gradually increased, and the average annual growth rate of the incidence in the past 10 years has reached 18.1%. Worryingly, the number of HIV infections among young people is increasing. According to the Chinese Center for Disease Control and Prevention, about 3,000 cases of young students aged 15 to 24 infected with HIV/AIDS in China every year.
Since January this year, the General Administration of Customs has exempted anti-AIDS drugs from import tariffs, and in the medical insurance negotiations in November this year, three more anti-AIDS drugs have entered the medical insurance.
No one wants to see China's market for anti-AIDS drugs grow huge, but anti-AIDS drugs are inevitably being watched.
01 Once the state procurement, enterprises are not profitable
In the fight against AIDS, the internationally used "cocktail therapy".
Cocktail therapy was proposed in 1996 by Chinese-American scientist He Dayi to treat AIDS with a combination of antiviral drugs. Around 2000, the former Ministry of Health estimated that the per capita annual treatment cost was 80,000 to 100,000 yuan. Under China's economic conditions at that time, too many people could not afford it.
Northeast Pharmaceutical told the media in 2003 that there were nearly 100,000 patients in urgent need of medication in China, but only 200 patients received cocktail treatment at their own expense.
Since 2003, the state has launched the "four exemptions and one care" policy for AIDS patients, the core of which is: the basic treatment drugs for AIDS patients are free of charge by the state. These free drugs are mainly antiviral generic drugs purchased by the state, including nearly 10 varieties of stavudine, nevira ping, and the manufacturers are Northeast Pharmaceutical, Shanghai Sainuodi, Zhejiang Huahai and so on.
China Medical News has reported that around 2005, more than 90% of domestic anti-AIDS drugs were obtained through unified bidding and procurement by the national central government.
At that time, there were less than 20,000 AIDS patients in China, and the total market size of anti-AIDS drugs was less than 100 million yuan, and the state's single procurement, low-cost winning bids, and failure to win the lottery would die, which seriously hit the enthusiasm of domestic anti-AIDS generic drug enterprises. At that time, Northeast Pharmaceutical occupied 50% of the market share of domestic anti-AIDS drugs, and in 2005, the sales of anti-AIDS drugs were only 24 million yuan.
At that time, China's anti-AIDS strategy was to solve the problem of "whether there is medicine" and did not give much consideration to the economic interests of enterprises.
In 2006, the state no longer implemented unified procurement, but by local independent procurement, after the price liberalization, the national anti-AIDS procurement amount began to rise year by year. In 2018, according to the Data of the China Center for Disease Control and AIDS Prevention, the actual annual purchase amount of free drugs for AIDS patients nationwide has reached 1.493 billion yuan, mainly provided by generic drug companies.
However, in recent years, the situation of HIV infection has become more and more complex, and while the number of AIDS patients is increasing, the treatment demand is also changing, and the traditional generic drugs have been unable to meet the demand.
02 Self-funded drugs started, and medical insurance was opened to anti-AIDS drugs
The biggest problem with anti-AIDS generic drugs is the side effects.
Efaviren has always been a first-line anti-AIDS drug in the national free anti-AIDS drug, with accurate efficacy and good absorption. In 2018, the purchase amount of Ephesian in Hunan Province alone was close to 15 million yuan. However, the drug has serious side effects, and the user may feel dizzy, insomnia, and even hallucinate.
On the Internet medical platform, similar questions often appear: "Efaviren has too many side effects, can you stop the drug or take your own medicine?" ”
The Health Bureau learned from a chief physician of an infectious disease hospital that around 2019, AIDS patients can only use imported drugs at their own expense if they do not want to use free drugs provided by the state. The average monthly cost is more than 5,000 yuan, which is difficult for patients to bear for a long time.
In 2018, imported anti-AIDS drugs repivirine and emtrictabine nofovir tablets entered medical insurance for the first time, and the market for anti-AIDS drugs began to turn around. In 2019, Gilead's anti-AIDS star drug, Icoen propranio tablets, entered the national medical insurance directory, and the price of each tablet dropped from 99 yuan to 43 yuan.
At the same time, domestic anti-AIDS enterprises have also begun to exert efforts, frontier biological injection of Abbott was approved in 2018, the second year of listing to achieve sales revenue of 20 million, in 2020 into the national medical insurance.
In this year's medical insurance negotiations, three new anti-AIDS drugs have entered medical insurance, namely Eddie Pharmaceuticals' Ainovirine tablets, Gilead's Bickenpronol tablets, and GlaxoSmithKline's Lamivudine doritillavir tablets. The real creature Azfedine was approved in July this year, failing to catch up with this year's health care negotiations and can only look forward to the next year.
So far, 7 anti-AIDS drugs have entered the national medical insurance directory. Generic drugs are starting to take on more impact.
According to incomplete statistics from the Health Bureau, as of November 30, 2021, there were more than 40 domestic enterprises involved in the imitation of anti-AIDS drugs, and Northeast Pharmaceutical, which used to occupy half of the anti-AIDS generic drugs, no longer disclosed the sales revenue of anti-AIDS drugs. However, Northeast Pharmaceutical has not stopped the research of generic drugs, and in May this year, Northeast Pharmaceutical also introduced iveren tablets on the investor interactive platform that generic drugs have been approved and are developing Zidolami difurdine tablets.
In any case, the original research drug has squeezed the market space of generic drugs. Some domestic AIDS companies told the media that the domestic medical insurance and self-funded anti-AIDS drug market size in 2020 will be 700 million to 800 million yuan. It is estimated that the market share of anti-AIDS generic drugs in China has dropped to 60%.
03 Foreign capital accounts for 80% of the hospital market, gilead won the king of anti-AIDS
In the rapid growth of the original anti-AIDS drug market, although there are 3 new drugs in China, foreign varieties still occupy the mainstream.
According to data from Minnet, in the first half of 2021, five foreign companies, including Gilead, GSK, Merck and AbbVie, divided up 80% of the anti-AIDS drug market in China's public medical institutions. Among them, the two varieties with the largest sales volume, Gilead, have a share: tenofovir disoprofurate tablets account for 57%, and Icoen propitide tablets account for 27%.
According to the official website of the State Food and Drug Administration, there are 24 domestic manufacturers of tenofovir disoproxil tablets, the first imitation manufacturer is Chia Tai Tianqing, and the multinational enterprises only have GSK and Gilead; Icoen propitide tablets are the exclusive varieties of Gilead, and there are no registered generic drugs in China.
GSK has long been known as an anti-AIDS pioneer and developed the world's first anti-AIDS drug, zidovudine. GSK even released the harsh words "curing AIDS is the goal of GSK" this year, and set the timetable for 2030. But Gilead is clearly better at anti-AIDS drugs.
As of June 2021, Gilead has generated revenue from nine anti-AIDS drugs. Among them, "Pittwei" and "Jiefukang", which have entered China's national medical insurance directory, have global sales of more than 2.5 billion US dollars in 2020, and "Bitavi" has exceeded 5 billion US dollars.
Gilead replaced GSK as the "king of anti-AIDS" in multinational pharmaceutical companies.
According to the report of the China Association for the Promotion of Pharmaceutical Innovation, it is estimated that by 2025, the scale of China's anti-AIDS drug market will reach 6.35 billion yuan, of which the medical insurance and self-payment market will reach 3.02 billion yuan, accounting for nearly 50% of the total scale. The national free drug supply market has been further compressed.
Three domestic anti-AIDS original research drugs hope to further seize the space of free drugs. In July this year, the head of the real organism told the media that the current stage is mainly to solve the drug resistance problem of lamivudine and seize this part of the market. According to the estimates of real organisms, at least 380,000 people in the country have developed resistance to lamivudine, so real organisms have a chance
04 New Hope
GSK, who shouts "cure AIDS by 2030," may not be a rhapsody.
In November, Harvard University discovered the world's second case of "self-healing" AIDS patients. Yu Xu, one of the members of the research team, told the media that this case shows that AIDS self-healing is not an isolated case, and there may be more potential self-healing patients. If you can understand the mechanism behind it, you can find a cure for AIDS.
Professor Steven Deeks, an EXPERT on HIV in the United States, also said that the mRNA technology used to develop a new coronavirus vaccine can be used to develop possible self-healing T cells.
The application of these new technologies may change the current problem of insufficient penetration of cocktail therapy.
Patients who receive cocktail therapy have poor compliance. On the one hand, cocktail therapy has more side effects, and in addition, there are not many patients who insist on taking drugs because of fear of discrimination in daily medication.
China also faces a special situation: the elderly AIDS population is increasing. According to the latest data from the Chinese Center for Disease Control and Prevention, the number of new HIV cases in the elderly over the age of 60 in China rose from 7.41% in 2010 to 18.21% in 2020. Among the people who reported AIDS in 2020, 44% of the elderly over the age of 50 were over the age of 50.
Elderly people living with HIV are a scar on society. Their state of life, the spiritual world, is often not understood by most people. Elderly patients are also more likely to be unable to withstand social pressure, abandon treatment or even choose to live lightly.
Providing long-acting drugs may help patients be socially accepted. Frontier Biologics, a Chinese company, has developed an anti-AIDS drug that can be taken once a week; in November, GSK's long-acting anti-AIDS therapy, callipravir, has submitted a listing application in China, and patients can even use it once a month.
These long-acting drugs not only provide treatment, but also comfort from the perspective of caring for the mental health of AIDS patients. This may be the direction of China's anti-AIDS drug development.
Text | David
Operational | Yan Ning