Alzheimer’s, HIV/AIDS drugs get market approval in China

The pharmaceutical company added that current drugs on the market only target symptoms and have a hard time dealing with the root cause.


File photo of a prescription bottle with capsules spilled over. PHOTO: UNSPLASH

January 17, 2024

BEIJING – China’s medical regulators recently approved two foreign drugs, bringing new hope to patients with Alzheimer’s disease and groups at risk for HIV/AIDS.

The National Medical Products Administration announced last week that it had granted market approval for the injected drug Leqembi, developed by Tokyo-based pharmaceutical company Eisai, to treat minor dementia and cognitive dysfunction triggered by Alzheimer’s.

The Economic Observer, a Beijing-based news outlet, reported that China is the third country to approve the drug, after the United States in July and Japan in September.

The drug targets amyloid betaprotein, widely believed to be associated with neurotoxicity and Alzheimer’s.

The pharmaceutical company added that current drugs on the market only target symptoms and have a hard time dealing with the root cause. During a global clinical trial, taking the drug was shown to reverse the progression for about 60 percent of early-stage patients and help them improve cognitive impairments, the company said.

Eisai set the price at 2,508 yuan ($350) per 2-milliliter dose, or about 180,000 yuan annually for a patient weighing 60 kilograms.

According to the Economic Observer, the drug was priced at 3,328 yuan per dose during a trial in Boao Hope City, a pilot medical zone in Hainan province, which allows drugs approved elsewhere to be used for real-world clinical trials in China. The first batch of 200 doses has been used up, the report said.

China has 9.83 million people with Alzheimer’s, and the disease is the fifth-largest cause of death in the country, according to an annual report on the disease released last year.

Meanwhile, the diagnosis and treatment rate is low, and awareness among the general public is inefficient, the report said.

Separately, Descovy, a tablet developed by US-based pharmaceutical company Gilead, has been approved by the NMPA for pre-exposure prophylaxis, or PrEP, to lower the risk of HIV infection due to high-risk sexual activities. Previously, the drug had been approved to treat HIV infections in adults.

The NMPA said that clinical trials showed that Descovy had effectiveness as a PrEP drug no worse than Truvada, the first PrEP drug approved in China, and that it displayed very low side effects.

“Groups with a high risk of HIV exposure can take this drug regularly to help maintain a certain density of the drug in the blood to prevent HIV infections,” said Wang Hui, chief expert of the HIV/AIDS center at Shenzhen Third People’s Hospital, adding that the drug offers a new choice for those involved in high-risk sexual activities, such as those engaging in unprotected homosexual sex, sex with unfixed partners, or prostitution.

Sexual activity is a major means of HIV transmission among adults. As of late 2022, China has 1.2 million people living with HIV, according to the Chinese Center for Disease Control and Prevention.

The World Health Organization said oral PrEP is highly effective in preventing HIV when used as directed, and recommends people at substantial risk of HIV infection be offered PrEP drugs as an additional choice as part of comprehensive prevention.

However, awareness and prevalence of PrEP in China are relatively low compared with developed countries. Based on a study published in the Chinese Journal of Epidemiology in 2020, only 56 percent of some 600 interviewed men who have sex with men said they were aware of the method, and just 10.6 percent said they were absolutely willing to use it.

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