On September 12 local time, the results disclosed by GILD. NASDAQ showed that Lenacapavir, a new drug for pre exposure prevention of AIDS virus (HIV) (PrEP), showed high effectiveness again. Among the 2180 participants in the Lenacapavir group, there were only 2 new cases, and 99.9% of the participants were not infected with HIV, resulting in a relative risk reduction of 96%; There were 9 new cases among the 1087 subjects in the control group. As of the close of the day, Gilead Science closed up 2.74%, approaching a historical high.
Under the influence of Lenacapavir's amazing clinical data, on September 13, the stock price of Aidi Pharmaceutical (688488. SH), a Chinese manufacturer of AIDS drugs, plummeted. As of press release, Aidi Pharmaceutical had dropped by more than 15%.
As for the news of Gilead AIDS prevention drugs and stock price fluctuations, the investor relations department of Aidi Pharmaceutical said that Gilead had also released the stage results in June this year, and said that "some people may think that if the drug is completely effective, it will not completely curb the HIV patient population, and the number of new patients will decrease a lot."
However, according to the above-mentioned individuals, there are currently oral medications available in China for this indication, which have been on the market for several years. However, the number of new HIV patients in China has not changed significantly. According to public information, there are currently four domestically produced new HIV drugs on the market, among which Eddie Pharmaceutical has two, namely Ainoviline tablets (trade name: iBond) and Ainomitinib tablets (trade name: Fubond).
Gilead is the dominant force in the field of anti HIV drugs. At present, Gilead's AIDS treatment related drug products include Biktarvy, Complex/Eviplera, Descovy, Genvoya, Odefsey, Stribild, Truvada, etc. Biktarvy is the world's best-selling AIDS treatment drug.
The new anti HIV drug Lenacapavir is an HIV-1 capsid inhibitor that mainly inhibits HIV-1 replication by stabilizing the HIV genetic material and the conical shell of essential enzymes, thereby preventing the breakdown of the capsid in infected cells. Lenacapavir is unique in that at present, most anti HIV drugs only act at one stage to prevent virus replication, but Lenacapavir can play an inhibitory role in the whole life cycle of HIV. According to Gilead's information, Lenacapavir has no known cross resistance with other existing drug categories and only needs to be administered twice a year.
Linda Gal Bekker, director of Desmond Tutu HIV Center at the University of Cape Town, South Africa and former president of the International Society for AIDS, said: "Although we know that traditional HIV prevention programs are very effective when taken by prescription, Lenacapavir, which only needs to be administered twice a year, can not only improve drug compliance, but also help solve the stigma and discrimination that some people may face when taking or storing oral PrEP drugs."
The above data comes from the mid-term analysis results of a key phase 3 trial called PURPOSSE 2. This is a randomized, double-blind, multicenter phase 3 study to evaluate the safety and effectiveness of twice yearly subcutaneous injection of lenacapavir as a pre exposure prophylaxis (PrEP) therapy, compared with the background incidence rate of HIV (bHIV) and once daily oral therapy Truvada. Truvada is an antiviral drug developed by Gilead and has been approved by the US FDA for PrEP for over ten years.
Gilead introduced that the PURPOSSE project is the most comprehensive and diverse HIV prevention trial project in history, including five global HIV prevention trials. In June this year, Gilead also disclosed the interim results of a PURPOSE trial. The data showed that Lenacapavir's effective rate of prevention before female HIV exposure (PrEP) reached 100%. Gilead said at that time that it was expected that another key trial, PURPOSE 2, would obtain results by the end of 2024 or the beginning of 2025.
Gilead expects to submit a listing application for Lenacapavir to global regulatory authorities by the end of 2024 to support its launch in 2025, becoming the first twice yearly HIV prevention option.
(Li Aohua, a reporter from Time Finance, is integrated from Wuming Kant's official WeChat official account, the Associated Press of Finance, Time Finance, and 21 Finance)