Zai Lab partner Argenx announces US approval for new drug

Zai Lab, a Shanghai-based biopharmaceutical company, and its partner Argenx SE, a Europe-based immunology company, jointly announced that the United States Food and Drug Administration has approved Vyvgart for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive.

The injection, which provides an innovative treatment option for such patients -- who represent 85 percent of the total population suffering from this chronic neuromuscular disease characterized by debilitating and potentially life-threatening muscle weakness -- was developed by Argenx. Zai Lab has the exclusive rights to develop and commercialize it in China.

Zai Lab said it expects to file a new drug application in China by mid-2022.

The therapy, which was approved by the FDA on Friday, was a breakthrough after years of research and will bring novel treatment solutions for patients, especially those with drug-resistant or refractory conditions and those prone to develop into severe cases.

"With an estimated 200,000 patients living with the disease in China, we see a great need to bring the therapy to Chinese patients with this autoimmune disease as expeditiously as possible," said Samantha Du, founder, chairwoman and CEO of Zai Lab.

"We'll work closely with China's National Medical Products Administration to accelerate access for these patients with unmet medical needs. The drug has the potential to be the first-of-its-kind therapy in this disease area in China," Du said.

Zai Lab said it has also initiated Phase II confirmatory research for multiple new indications of the drug in China to accelerate the development of more autoimmune indications for the therapy on a global scale.