
Understanding the Market | RemeGen rises over 6% as Tislelizumab becomes the world's first biologic drug to apply for listing in the field of Sjögren's syndrome

RemeGen opened more than 7% lower in the morning, but after the opening, it rose higher, and as of the time of writing, it has increased by 5.13%, trading at HKD 106.6, with a transaction volume of HKD 805 million. In terms of news, on September 9, RemeGen announced that the company's self-developed globally first BLyS/APRIL dual-target fusion protein innovative drug, Taitasip, has had its marketing application for the treatment of Sjögren's syndrome officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. As the world's first biologic to submit a marketing application in this therapeutic area, Taitasip is expected to be the first to provide a targeted treatment option for patients with Sjögren's syndrome. It is reported that Taitasip's indication for Sjögren's syndrome has been granted Fast Track designation by the U.S. FDA and has been approved to conduct Phase III clinical trials in the United States. The indications for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG) have been successively approved for marketing in China. Notably, the company previously entered into a licensing agreement with U.S. Vor Bio, granting Vor Bio exclusive rights to develop and commercialize Taitasip globally, excluding Greater China
According to Zhitong Finance APP, RemeGen (09995) opened more than 7% lower in the morning, but after the opening, it rose, and as of the time of writing, it has increased by 5.13%, trading at HKD 106.6, with a transaction volume of HKD 805 million.
In terms of news, on September 9, RemeGen announced that its self-developed globally innovative BLyS/APRIL dual-target fusion protein innovative drug, Taitasip, has officially been accepted for listing application by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of Sjögren's syndrome. As the world's first biopharmaceutical to submit a listing application in this therapeutic area, Taitasip is expected to be the first to provide a targeted treatment solution for patients with Sjögren's syndrome.
It is reported that Taitasip's indication for Sjögren's syndrome has been granted Fast Track designation by the U.S. FDA and has been approved to conduct Phase III clinical trials in the United States. The indications for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG) have been successively approved for marketing in China. Notably, the company previously entered into a licensing agreement with U.S. Vor Bio, granting Vor Bio exclusive rights to develop and commercialize Taitasip globally, excluding Greater China
