智通财经网·2025-09-09 01:54Core Viewpoint - Rongchang Biopharma (09995) experienced a significant stock price increase of nearly 14%, with a year-to-date gain of 600% [1] Group 1: Stock Performance - As of the report, the stock price reached 110.2 HKD, with a trading volume of 494 million HKD [1] Group 2: Product Development - The company announced that its self-developed innovative drug, Tai'aisip (泰它西普), targeting both BLyS and APRIL, has received formal acceptance for market application from the National Medical Products Administration (NMPA) for the treatment of Sjogren's syndrome [1] - This marks the first application for a biological drug in the global market for Sjogren's syndrome, as there are currently no approved targeted therapies for this condition [1] Group 3: Regulatory Approvals - Tai'aisip has been granted Fast Track designation by the U.S. FDA and is approved to conduct Phase III clinical trials in the U.S. [1] - The drug has also received approvals for treating systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG) in China [1]