Hanall Biopharma said Wednesday that Harbour BioMed, its Chinese partner, has started the first patient administration of HL161 (Ingredient: batoclimab), a new autoimmune disease treatment drug for treating thyroid-associated ophthalmopathy.

Harbour BioMed plans to evaluate the safety and efficacy of HL161 during the phase 2 clinical trial.

Thyroid-associated ophthalmopathy is a disease in which damage and inflammation of the fatty tissue around the eye appear and may occur as a complication of Graves' disease. The main symptoms include bulging eyes, eyelid edema, double vision, and visual impairment. Hospitals currently use steroids to treat patients with moderate to severe disease.

However, there is no other treatment method than surgery in severe cases, such as orbital decompression. Therefore, there has been a high unmet medical need for a new treatment.

Aside from treating thyroid-associated ophthalmopathy, Harbor BioMed also carries out clinical trials for three other autoimmune diseases -- myasthenia gravis, optic neuromyelitis, and thrombocytopenia.

Hanall said it expects that the development area of ​​HL161 will grow further.

In September, Harbor BioMed has received approval for its investigational new drug application from the Chinese National Medical Products Administration for sing HL161 in treating chronic inflammatory polyneuropathy.

“HL 161 is a fully human monoclonal antibody new drug that reduces pathogenic antibodies in the body and is in clinical trials for several autoimmune diseases caused by such antibodies," the company said. "Notably, the treatment is being developed as a subcutaneous injection formulation that allows direct administration to patients. Therefore, we expect the treatment to be highly convenient."

Hanall exported HL161 technology to Roivant in Switzerland and Harbor BioMed in China in 2017 for about 700 billion won ($594.1 million). In addition, Hanall will receive royalties based on sales if the company and its partners succeed in commercializing the treatment.