CHINA FOOD AND DRUG ADMINISTRATION APPROVES COMPLERA® FOR THE TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS-1(HIV-1) INFECTION

[Beijing],[14 January 2016] – Xian Janssen Pharmaceutical Ltd. announced today that the China Food and Drug Administration has granted regulatory approval for COMPLERA® as a complete single-tablet regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adult patients with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL in China.

COMPLERA® is a single-tablet regimen for the treatment of HIV-1 infection, incorporating three antiretroviral medications in a single daily tablet - a fixed dose combination of the two nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir disoproxil fumarate, and non-nucleoside reverse transcriptase inhibitor, rilpivirine.

The availability of single tablet regimens taken as one pill once daily represents a significant milestone for patients living with HIV. Previously, patients had little choice but to take six pills twice a day.

HIV is a major public health concern in China, where a total of 840,000 people were living with HIV at the end of 2013, accounting for about half of all cases in the Asia Pacific . In spite of significant efforts, the rate of HIV infection is still on the rise and new therapies are still needed.

Cesar Rodriguez, President of Xian Janssen noted, “The approval of COMPLERA® has once again confirmed our commitment and leadership in addressing the urgent unmet needs of people living with HIV.”