Sino Biopharmaceutical Ltd. said the Chinese Food and Drug Administration approved its generic version of Gilead Sciences Inc.'s chronic hepatitis B treatment, Viread.
The company said its medicine was the first generic drug in China to complete the bioequivalence study under the new approval guidelines issued by the Chinese State Council.
The drug also passed a head-to-head control clinical trial comparing it with the original drug, which is also known as tenofovir disoproxil fumarate.
In 2013, China's State Intellectual Property Office invalidated one of the patents on Viread, which is also listed in World Health Organisation's list of essential medicines.
Viread, which is also used for treating HIV, brought in $1.19 billion in annual sales in 2016 for Gilead.
