Pioneering HIV/AIDS prevention drug launched in Hainan

A pioneering medicine in the field of HIV/AIDS prevention and control was officially launched in the Hainan Bo'ao Lecheng International Medical Tourism Pilot Zone in Hainan province on Friday. The twice-yearly pre-exposure prophylaxis (PrEP) medicine lenacapaviris is expected to accelerate the development of China's HIV prevention and control system.

Pre-exposure prophylaxis (PrEP), as an effective means to reduce new HIV infections in high-risk populations, is listed as one of the important intervention strategies for high-risk populations in the China AIDS Treatment Guidelines (2024 edition), and provides a crucial tool for HIV prevention and control.

The introduction of this innovative solution is expected to enable diversity and personalization in the rapid development of China's HIV prevention and control system, and is a boost for the country in its bid to achieve the goal of "ending the HIV epidemic by 2030".

Under the guidance of central government and thanks to the concerted efforts of medical institutions, community organizations and various sectors of society, China's prevention and treatment efforts for HIV have achieved remarkable results, but the number of new infections remains high.

Professor Cai Weiping from the Guangzhou Eighth People's Hospital, affiliated to Guangzhou Medical University, said at Friday's launch that to truly end the HIV epidemic, it is necessary to realize the shift from a treatment-centered "reactive response" to prevention-centered "proactive prevention". With new infections in China still at a high level, accelerating the implementation and application of more efficient prevention measures has become a priority in HIV prevention and control.

China's PrEP model has been expanding in recent times, with the options of daily and twice-yearly dosing both available for people to choose from in the interests of prevention and control.

Cai Lin from Chengdu's Public Health Clinical Center said: "Lenacapavir's uniqueness lies first and foremost in its unique multi-stage mechanism of action, which directly binds to the HIV capsid protein to modulate capsid stability and transport and interrupt key viral replication cycles such as the nuclear uptake, virus assembly and release, and capsid core formation to achieve the prevention of HIV infection.

"The unique mechanism of action sets lenacapavir apart from other currently approved antiretroviral medicines, and is free of known cross-resistance with other currently available medicines."

Results of the Phase 3 Purpose 1 and Purpose 2 trials published by the leading New England Journal of Medicine show that, under the twice-yearly scheme, over 99.9 percent of respondents have retained a HIV-1–negative status, demonstrating its superior efficacy.

Based on this breakthrough, the Science journal last year named lenacapavir as its 2024 Breakthrough of the Year. It has also been recognized by the WHO.

According to management, the rapid introduction of lenacapavir at Bo'ao Lecheng demonstrates the synergistic effect of the zone's "pioneer-and-pilot" policy advantages and its distinctive medical-service ecosystem.

Liao Jingle, deputy director of Bo'ao Lecheng, said: "As the only 'special medical zone' in China, the Lecheng Pilot Zone has been granted specific policies and has been committed to accelerating the introduction of the world's leading innovative medicines and cutting-edge therapies, to meet the diversified health needs.

"Currently, LeCheng has introduced 501 innovative drugs and devices that have been FDA licensed or CE marked but that are not yet available in China, allowing Chinese patients to access cutting-edge global therapies without having to travel overseas.

"Lenacapavir's simultaneous access in Lecheng is the result of the zone's continuous innovations in institutional integration and its unwavering efforts to ensure drug accessibility. As the island-wide customs operation in the Hainan Free Trade Port is about to be launched, we will continue to deepen the reform and give full play to the advantages of 'Lecheng Speed', so that more people can access the world's latest medical innovations in real time."

Leveraging the policy advantages of Lecheng, Bo'ao Super Hospital seeks to take the lead in providing international cutting-edge quality medical services to domestic patients.

Liu Xitong, vice-president of Bo'ao Super Hospital, said: "Thanks to Lecheng's unique 'licensed access' policy, it took only eight working days for lenacapavir to be approved in Lecheng after it was approved by the US FDA, creating the remarkable Lecheng speed."

As the first medical institution to use lenacapavir clinically in Asia, Bo'ao Super Hospital has launched a "full-process, full-privacy, full-lifecycle" healthcare service package, which combines multidisciplinary team consultation, provides full privacy protection services, establishes personalized healthcare, and manages the whole process of diagnosis and treatment in a streamlined manner to ensure that every user receives safe, effective and comprehensive care.

Liu added that the hospital intends to "continue to serve as a spearhead of pilot policies, [be] a leader in technology breakthrough and also stick to the gold standard of service to help Chinese patients to share the world's top medical achievements with zero time gap, and to usher in a new era of HIV prevention and control".

Hainan Yiling Lifecare Center has, as part of its mission statement, the promotion of international advanced medical technology to benefit the health of Chinese people, and has accumulated rich experience in the clinical application of licensed medicines and devices, real-world clinical research and health management.

Yiling Hospital Management Group Chairman Wei Li said: "PrEP medicines are the key measures to control the HIV epidemic, and the landing and application of lenacapavir provides new possibilities for realizing the transition from 'controllable' to 'preventable' AIDS.

"Hainan Yiling will carry out the clinical application of lenacapavir with high standard and high efficiency, strengthen international cooperation and exchange and, based on Lecheng's research platform, push forward real world clinical studies, and accelerate the official approval of lenacapavir in China."

Zhang Fujie, director of the Clinical and Research Center of Infectious Diseases at Beijing Ditan Hospital, affiliated with the Capital Medical University, said PrEP is part of an effective HIV/AIDS intervention which requires multiple tools for prevention, including raising awareness and the promotion of safe sex.

Jin Fangqian, vice-president and China general manager of Gilead Sciences, said: "With the strong support from the Hainan Provincial Medical Care and Drugs Administration, Administrative Bureau at Bo'ao Lecheng International Medical Tourism Pilot Zone, Lecheng Medical Regulatory Bureau and Bo'ao Super Hospital, it is very encouraging that we have achieved zero time gap in introducing lenacapavir to the Lecheng Pilot Zone and that it is ready to be put into the clinical use quickly."

When Bo'ao Lecheng opens the appointment channel for lenacapavir, those in need will be able to make enquiries or book through the hotlines of Bo'ao Super Hospital, Bo'ao Yiling Life Care Center and other designated organizations to obtain standardized PrEP services and full-lifecycle health management support.