Text|Source Media, Author| Hu Qingmu, editor | Su Huai
Is the 100% effective anti-AIDS miracle drug coming to the sensational industry?
On June 21, Beijing time, Gilead Sciences (NASDAQ: GILD), an American biopharmaceutical company, announced on its official website that its research and development of the twice-a-year capsid inhibitor "Lenacapavir" (lenacapavir) has shown 100% effectiveness in preventing HIV.
The screenshot comes from Gilead's official website
It is reported that the clinical trial was carried out in South Africa and Uganda, and a total of about 5,300 female subjects between the ages of 16 and 25 were recruited. The participants were randomly assigned to three different HIV prevention drug treatment groups in a 2:2:1 ratio.
Of these, 2134 participants were using lenacamirvir; 2136 participants were treated with Descovy (trade name: Dacohua); 1068 subjects were treated with Truvada (trade name: Sufatech). It should be noted that Dakova and Sufatai are both previously marketed HIV prevention drugs under Gilead.
From the final results, it is striking that the number of people infected with HIV in the test group using lenacapavir was 0; In the test group using Dakova and Shufatai, there were 39 and 16 HIV infections, respectively, and the experimental infection rates were 1.83% and 1.50%, respectively, equivalent to 2.02% and 1.69% per 100 people per year, respectively.
Locally, the probability of natural HIV infection is about 2.41% per 100 women aged 16-25 per year per year. Although Dacovola and Sufatai have played a role in preventing HIV, they are still dwarfed by the 100% prevention efficiency of lenacapavir. Moreover, lenacapavir only needs to be injected once every six months, which greatly reduces the frequency of medication, and it is easier to adhere to it from the patient's perspective than other conventional drugs that need to be taken daily.
Gilead Sciences' Chief Medical Officer is also proud to say that with zero infection and 100% prevention in this trial, twice-yearly lenacapavir has proven its potential as an important new tool to help prevent HIV infection.
As soon as this announcement was released, it not only caused a sensation in the industry, but the share price of Gilead in the secondary market opened higher, closing up 8.46% on the day.
Since June 24, the stock price of A-share AIDS drug listed companies has continued to fall sharply, and as of the close of trading on June 26, Aidi Pharmaceutical (688488. SH) fell 14.94% for three consecutive days, closing at 10.70 yuan per share, with a total market value of only 4.502 billion yuan, down 73.03% from the peak at the beginning of the listing.
From "talking about Ai color change" to being preventable and controllable
AIDS, also known as acquired immunodeficiency syndrome (AIDS), is a disease caused by the human immunodeficiency virus (HIV) that severely affects the immune system.
In the 15 years from the discovery of AIDS in 1981 to 1996, the case fatality rate continued to increase due to the lack of a particularly effective treatment. Therefore, in that era when the speed of information dissemination was extremely slow, AIDS was labeled as a "super cancer" and "incurable". So much so that in that era, everyone "talked about Ai Sechang". Coupled with the lack of follow-up science popularization, the people's misconception of AIDS has lasted for many years.
From the discovery of the cause to the development of effective treatments, medical development has come a long way. HIV infection has gradually changed from a fatal disease to a preventable and controllable chronic infectious disease, and patients can effectively inhibit the replication of the HIV virus by insisting on taking relevant drugs every day, and then work, live and study like normal people.
According to the 2023 survey of the Joint United Nations Programme on HIV/AIDS, an estimated 39 million people living with HIV worldwide in 2022 are receiving treatment, of which 29.8 million are still receiving treatment, and about 9.2 million people still remain untreated.
Driven by the continuous use of drugs by infected patients, the market size of related drugs has begun to increase year by year. According to the Frost & Sullivan report, the global anti-HIV drug market size was $32.5 billion in 2017 and $38 billion in 2021, growing at a CAGR of 4.0%. It is expected to reach $47.9 billion in 2025.
The continuous expansion of the market scale has also attracted more and more pharmaceutical companies to enter the market.
Among foreign pharmaceutical companies, Gilead, as a major player in this market segment, has a number of anti-HIV drugs, among which Biktarvy (trade name: Biktarvy ®) has become a blockbuster product with annual sales of more than 10 billion US dollars due to its good efficacy, high safety and low drug resistance rate, with a global market share of nearly 50%.
Among the domestic pharmaceutical companies, there are currently three domestic anti-AIDS oral drugs on the market, two of which are from Aidi Pharmaceutical, namely enovirine tablets (trade name: Aibond ®) and enomitinib tablets (trade name: Fubond), ® and the remaining one is Azvudine under Real Biotech.
Replacement of imported medicines
Tianyancha data shows that Aidi Pharmaceutical, founded in 2009 and located in Yangzhou City, Jiangsu Province, is a pharmaceutical manufacturing company, focusing on the field of anti-HIV and human protein.
Before 2021, AIDS patients on the mainland had no choice but to buy imported drugs because they had no other options. Before entering the medical insurance, Gilead's Bitarvy was initially priced at RMB 3,680 per box (30 tablets), or about 123 yuan per piece.
Since the current anti-HIV oral drugs on the market need to be taken daily, it is a huge expense for patients over the years.
At that time, in the absence of domestic anti-HIV drugs, Aidi Pharmaceutical identified this "pain point" of patients, devoted itself to research and development for many years, and approved the marketing of two new domestic anti-HIV drugs, enovirine tablets (Aibond ®) and enomitinib tablets (Fubond), ® in June 2021 and December 2022 respectively.
Source Media Exchange from JD.com (09618. HK, NASDAQ: JD) pharmacy found that the current price of enovirine tablets is 514 yuan/box (60 tablets), about 8.57 yuan/tablet; There are only two stores selling enomitinib tablets, and the prices are 747 yuan/box (30 tablets) and 765 yuan/box (30 tablets), respectively, and the price of each tablet is about 25 yuan. Gilead's popular imported drug Bitaxui is priced at 890-933 yuan/box (30 tablets) in Jingdong Pharmacy, which is about 30 yuan/tablet.
It can be seen that Aidi Pharmaceutical's domestic anti-HIV drugs still have certain advantages in terms of terminal price.
More importantly, the launch of enomitinib tablets has changed the situation that there are no compound preparations for domestic anti-moxa drugs. This means that people with AIDS do not need to take several pills at once. This not only helps to reduce the financial pressure on the patient, but also improves the patient's medication compliance.
In 2023, driven by the launch of new drugs, the total sales revenue of Aidi Pharmaceutical's two new anti-HIV drugs will be about 73.5788 million yuan, a year-on-year increase of 119.67%; In the first quarter of this year, the company achieved sales revenue of about 35.7112 million yuan for these two new anti-AIDS drugs, a year-on-year increase of 76.52%.
Stimulated by good performance, the share price of Aidi Pharmaceutical has also risen from a low of 9.76 yuan in early February this year to around 17 yuan in mid-May, an increase of 60%. However, driven by the entire market, the company's stock price also fell.
The screenshot comes from Oriental Fortune Software
Like an "ultimatum"
After Gilead released the latest announcement of a 100% effective HIV prevention trial, the stock price of Addison Pharmaceuticals has fallen by about 15% in the past three trading days.
In this regard, Eddy Pharmaceuticals said that Gilead Sciences provides pre-AIDS prevention for high-risk exposed groups, and the company provides drugs for clinical trials of patients infected with AIDS. According to the results of the current trial, although it can be used for some prevention, there are still a large number of patients who need to be treated.
In response to this response, there are generally two voices in the market, and some investors think: "When new drugs come out, they are expensive, and a few can afford to buy them." And who has nothing to do to buy such expensive preventive pills to eat. It's like having medicine to prevent colds, so don't you catch a cold? Who knows in advance that they are going to get sick."
However, some investors did not agree with Eddy Pharmaceutical's response: "If the prevention effect can really reach 100%, as time goes by, the stock of patients will become fewer and fewer, so who will these drugs be sold to in the future?" ”
Both of these views have their own logic, and the stock price performance of the secondary market reflects from the side, and there are currently more investors who hold the latter view - under the pessimistic expectation of the company's future, they have sold their chips, which has caused the stock price to fall sharply in recent trading days.
Gilead's new drug for 100% HIV prevention is certainly a good thing for humanity from the perspective of patients; But from the perspective of other companies in the industry, it looks like an "ultimatum".
The only good news is that Gilead's trial is not yet complete. After the completion of the clinical trial, it still needs to be approved by the relevant departments before it can be approved for marketing.
Still, there isn't much time left for Eddy Pharmaceutical.