REMEGEN (09995) surged nearly 14% in early trading, with the stock's year-to-date cumulative gain reaching as high as 6 times. As of press time, the stock was up 13.9% to HK$110.2, with trading volume of HK$494 million.

On the news front, on September 9, REMEGEN announced that the marketing application for its self-developed, world's first BLyS/APRIL dual-target fusion protein innovative drug telitacicept (brand name: Taiju®) for the treatment of Sjögren's syndrome has been officially accepted by China's National Medical Products Administration Drug Review Center (CDE), making it the world's first biological drug to apply for marketing approval in the Sjögren's syndrome field.

It is reported that currently no targeted drugs for treating Sjögren's syndrome have been approved globally for marketing. At present, telitacicept's Sjögren's syndrome indication has received Fast Track designation from the US FDA and has been approved to conduct Phase III clinical trials in the United States. The drug has already been approved for marketing in China for three indications: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG).