HIV Field Welcomes a First-in-Class New Drug Requiring Only Two Doses Per Year

　　【Pharmaceutical Network Product Information】AIDS is a severe disease caused by HIV infection and has now become a significant public health issue. According to data from UNAIDS, there are currently 38 million people living with HIV globally. In China, as of the end of October 2021, reports indicate that there are approximately 1.14 million people living with HIV, an increase of about 90,000 compared to 2020, and this number is expected to continue rising. Some institutions predict that by 2027, the actual number of infections in China will exceed 2 million.
 

A large patient population has unmet treatment needs. According to a report by灼识咨询, it is predicted that the anti-HIV drug market will reach 46.75 billion US dollars by 2023, with an average annual compound growth rate of 6% from 2019 to 2023. To meet the treatment needs of clinical patients, many pharmaceutical companies both in China and abroad are targeting the HIV field for urgent solutions. Recent news indicates that the HIV field has welcomed a FIC new drug, which only needs to be used twice a year.
 

On December 23, Gilead Sciences announced that the FDA had approved the marketing authorization for its drug Sunlenca (lenacapavir) injection and tablets, to be used in combination with other antiretroviral drugs for the treatment of multidrug-resistant human immunodeficiency virus (HIV) infection in adult patients. Sunlenca is the first HIV treatment option based on a capsid inhibitor, and this FIC medication will offer HIV patients a new, twice-a-year treatment choice.
 

值得一提的是，此前，Sunlenca已于2019年5月获得FDA授予的突破性疗法认定(BTD)，并于今年8月获欧盟委员会(EC)全球初次批准，用于联合其他抗逆转录病毒药物治疗多重耐药HIV感染的成人患者。
 

With the approval and market launch of this new drug, the industry expects that it will provide long-acting treatment options for a wide range of AIDS patients, allowing them to benefit.
 

In addition to Sunlenca, multiple HIV treatment drugs have been approved since 2022. In China, the country's drug approval process has continuously focused on the HIV field over the past two years, with several domestically produced and imported drugs coming to market, providing patients with more options.
 

For example, on December 8, the China National Medical Products Administration announced that the new drug application for "Efavirenz Tablets (I)" submitted by Viatris Pharmaceuticals had been officially approved. It is reported that the approved indication for this product is: treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infection in adults and pediatric patients weighing at least 35 kg.
 

On October 21, the information disclosed by the National Medical Products Administration (NMPA) showed that the new drug application for the dual-drug HIV therapy — Dolutegravir and Rilpivirine Tablets — submitted by GlaxoSmithKline (GSK) has been approved. The indication approved this time is for the treatment of certain adult patients with Human Immunodeficiency Virus Type 1 (HIV-1) infection.
 

In addition, a batch of new drugs is on the way to being approved for marketing, such as the new indications for GSK/ViiV Healthcare’s HIV (human immunodeficiency virus) drug Cabotegravir Injection and Cabotegravir Sodium Tablets, which are expected to become the first complete long-acting HIV therapy to be launched in China, reducing the number of days patients need to take medication from 365 days to 6 or 12 days; CL-197 Capsules, a potential long-acting novel oral HIV candidate product by Real Biotechnology, which aims to achieve once-weekly dosing, has already been granted clinical trial approval.
 

Currently, the anti-HIV virus drug market is mainly dominated by multinational pharmaceutical companies such as Gilead Sciences, GSK, Bristol-Myers Squibb, Merck, AbbVie, and Johnson & Johnson. In China, the market is also predominantly held by foreign enterprises. As domestic pharmaceutical companies continue to make progress, more treatment options will be available for people living with HIV, helping to achieve the goal of "eliminating the AIDS epidemic by 2030" faster and more effectively.
 

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