(Yicai) Feb. 13 -- Chinese biopharmaceutical company Bio-Thera Solutions’ Gotenfia has received regulatory approval from the European Union for the treatment of several chronic inflammatory autoimmune diseases.

Bio-Thera received the marketing authorization notification for Gotenfia (golimumab injection) from the European Medicines Agency, the Guangzhou-based company announced yesterday.

Golimumab is an antibody drug that prevents the binding of free and cell surface tumor necrosis factor to its receptors, thereby blocking the abnormal inflammatory response triggered by TNF. The indications approved by the EMA include various types of arthritis, such as rheumatoid arthritis, and ulcerative colitis.

This approval is expected to enhance Bio-Thera’s product influence in the international market and positively impact its long-term operational performance, the firm said, without providing any financial forecast.

The EMA’s marketing authorization was Gotenfia’s first in the global market, Bio-Thera noted, adding that regulators from Brazil, China, and the United States have received applications for the drug’s commercialization.

In May 2024, Bio-Thera granted German pharmaceutical company Stada Arzneimittel exclusive commercialization rights for Gotenfia in the EU, Switzerland, the United Kingdom, and other European countries for a total of upfront and milestone payments of up to USD157.5 million, as well as a double-digit percentage on the drug’s net sales after launch.

Golimumab injection is already available in the EU with similar products on the market, including original drug Simponi from Johnson & Johnson’s subsidiary Janssen Pharmaceuticals and biosimilar Gobivaz, developed by European biopharmaceutical company Alvotech.

Bio-Thera’s shares [SHA: 688177] closed 0.4 percent down at CNY23.76 (USD3.43) in Shanghai today.

Editor: Futura Costaglione