China Welcomes New Twice-Yearly HIV Drug Lenacapavir with NDA Submitted

　　【Pharmaceutical Network Industry Dynamics】AIDS is a severe disease caused by HIV infection and has long become a significant public health issue. Currently, there is a vast unmet treatment demand among the large patient population. According to a report by灼识咨询, the anti-HIV drug market is projected to reach 467.5 billion US dollars by 2023, with an average annual compound growth rate of 6% from 2019 to 2023. To meet the clinical treatment needs of patients, China is continuously accelerating the review and approval process, with new drugs both domestically and internationally being approved for clinical trials and market launch. Recently, a new HIV drug has been introduced in China, which only needs to be administered twice a year.
 

On September 23, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Gilead Sciences had submitted a new drug application for Lenacapavir Tablets (Class 5.1), which has been accepted. Public information indicates that this is an HIV-1 capsid inhibitor, Lenacapavir, and represents a novel treatment regimen requiring administration only twice a year.
 

In August 2022, lenacapavir received its first global approval in the EU for use in combination with other antiretroviral drugs to treat adult patients with multidrug-resistant HIV infection. In December of the same year, the drug was also approved in the United States for the aforementioned indication. The approvals by the European Commission (EC) and the FDA were both supported by data from a Phase 2/3 clinical trial named CAPELLA.
 

With the approval and market launch of this new drug, the industry expects that it will provide long-acting treatment options for people living with HIV in China, benefiting patients. In fact, in addition to lenacapavir, in recent years, as China's drug approval process has continued to focus on the HIV field, multiple HIV treatment drugs have been approved, and many domestically produced and imported drugs have entered the market, offering more choices for patients.
 

In June this year, information from the National Medical Products Administration showed that GlaxoSmithKline's Dolutegravir Sodium Dispersible Tablets had been approved for marketing, with the indication this time being the treatment of pediatric HIV-1 infection. Dolutegravir (brand name: Tivicay) is an HIV integrase inhibitor developed by ViiV Healthcare, a subsidiary of GlaxoSmithKline. It can block HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells.
 

According to reports, Dolutegravir Sodium Tablets were launched in the United States in August 2013, in the European Union in January 2014, and entered the Chinese market in December 2015 for the treatment of adult and HIV patients over 12 years old. Dolutegravir Sodium Dispersible Tablets were launched in the United States in November 2020 and in the European Union in January 2021 for the treatment of pediatric HIV patients. The recent approval obtained by GlaxoSmithKline is for Dolutegravir Sodium Dispersible Tablets. Compared with ordinary tablets, dispersible tablets have the characteristics of convenient administration, rapid absorption, high bioavailability, and minimal adverse reactions.
 

On December 8, 2022, the National Medical Products Administration (NMPA) of China announced that the new drug application for "Efavirenz Tablets (I)" submitted by Viatris Pharmaceuticals had been officially approved. 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.
 

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.
 

In recent years, however, domestic pharmaceutical companies in China have been making continuous efforts in this market and have started to achieve new breakthroughs. For instance, Adray Pharmaceutical's once-daily anti-HIV new drug, Ainoimitide tablets, had already submitted a new drug marketing application in May 2021; On October 10, 2022, information on the CDE website showed that Real Biotechnology's CL-197 capsules received clinical trial approval for the treatment of adult patients with HIV-1 infection... The industry expects that in the future, as domestic pharmaceutical companies in China accelerate their layout and innovation in this field, a broader range of new treatment options will become available to patients.
 

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