Gilead's Long-Acting HIV Therapy Gets Nod to Go to Market in China
Qian Tongxin
DATE:  Jan 03 2025
/ SOURCE:  Yicai
Gilead's Long-Acting HIV Therapy Gets Nod to Go to Market in China Gilead's Long-Acting HIV Therapy Gets Nod to Go to Market in China

(Yicai) Jan. 3 -- US pharmaceutical company Gilead Sciences has been given the greenlight by Chinese regulators to sell its long-acting treatment for the human immunodeficiency virus, which only needs to be administered twice a year, in the country.

Sunlenca, also known as Lenacapavir, has been approved for use in China in injection and tablet form to treat adult patients with multidrug-resistant HIV type 1 infection who cannot achieve virological suppression with current regimens, Gilead said yesterday. The drug only needs to be administered twice a year and can be used in combination with other medicines.

Gilead is also promoting the use of Lenacapavir in HIV pre-exposure prophylaxis. Lenacapavir can reduce the risk of HIV infection in subjects by 96 percent, outperforming control drugs that need to be taken daily, according to the Phase 3 clinical trial results released by the Foster City-based company in November.

Lenacapavir is a capsid inhibitor that blocks the invasion and replication of the HIV virus in the human body by interfering with the capsid that encapsulates its genetic material. The drug has already been approved for marketing in many countries, including the US and the EU.

HIV is mainly transmitted through body fluids and can cause acquired immunodeficiency syndrome, leading to a severe weakening of the body’s immunity and eventually to death from various complications. As antiviral therapies continue to advance, HIV has become a controllable chronic disease and is no longer a fatal disease. However, it remains a major infectious disease that endangers human health.

There were nearly 40 million AIDS patients in the world as of the end of 2023, according to data from the World Health Organization. Of these, 1.3 million were newly infected and 630,000 people died from AIDS-related diseases that year.

China already has a long-acting HIV drug, Cabenuva, and a HIV prophylaxis medicine, Apretude, on the market. Developed by the UK’s GlaxoSmithKline, they both use the same main ingredient cabotegravir. Apretude needs to be injected at least six times a year and was given the green light by China’s National Medical Products Administration in May last year.

Editors: Dou Shicong, Kim Taylor

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Keywords:   Gilead Sciences