South Korean biopharmaceutical company Celltrion said Monday that its first-ever chemical combination drug for use by patients with HIV-1 infection has been approved by the US Food and drug Administration.

Developed by Celltrion, Temixys is a tablet-type drug that targets HIV-1, short for Human Immunodeficiency Virus Type 1. It is a next-generation modified drug combining the properties of GSK’s Zeffix (lamivudine) and Gilead Sciences’ Viread (tenofovir disoproxil fumarate).

The newly-approved tablet drug will be manufactured by Celltrion Pharm, a company under the Celltrion Group. 

With the FDA approval, Celltrion plans to begin selling Temixys in the US from early next year, where it is expected to compete head-on with Gilead Sciences Truvada, another chemical drug that combines emtricitabine with tenofovir disoproxil fumarate.

Right now, Truvada accounts for around 3.3 trillion won ($2.9 billion) out of the US HIV treatment market estimated at 24 trillion won, according to Celltrion.

The Korean drugmaker plans to position Temixys as an affordable, high-quality alternative drug to combination drugs for HIV such as Truvada, and work to secure supply contracts with major purchasers of HIV treatments including the Global Fund, USAID and UNDP.

The US launch of Temixys comes around three years after Celltrion first announced plans in 2015 to embark on the development of chemical drugs, with aims to expand company’s drug portfolio beyond biosimilars referencing blockbuster biologics.

As of now, Celltrion’s Remicade-referencing biosimilar, Remsima, is being sold in the US and Europe. The firm’s other biosimilars, Truxima and Herzuma, referencing Rituxan and Herceptin respectively, have been launched in Europe.

In October this year, Truxima won the endorsement of the US FDA’s drug advisory committee, while Herzuma is still under review. Celltrion has previously cited expectations for both drugs to secure FDA approval before the year’s end.

By Sohn Ji-young (jys@heraldcorp.com)