Shang Hai Zheng Quan Bao·2025-08-13 19:00Core Viewpoint - Rongchang Biopharmaceutical's innovative drug Tai'ta Xipu (RC18) has successfully met the primary endpoint in its Phase III clinical trial for treating primary Sjögren's syndrome, indicating its potential effectiveness and safety in addressing this chronic autoimmune disease [1][3]. Group 1: Clinical Research Overview - The Phase III clinical trial for Tai'ta Xipu is a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the drug's efficacy and safety in patients with primary Sjögren's syndrome [1][3]. - Primary Sjögren's syndrome is characterized by chronic inflammation and damage to exocrine glands, leading to symptoms such as dry mouth and dry eyes, with a prevalence rate in China estimated between 0.3% and 0.7% [1][2]. Group 2: Mechanism of Action - Tai'ta Xipu is a recombinant dual-target fusion protein that inhibits both B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which are crucial in the abnormal activation of B cells, thereby reducing pathological immune responses [2]. Group 3: Clinical Progress - The clinical trial results indicate that Tai'ta Xipu can sustainably and effectively improve the clinical symptoms of patients with primary Sjögren's syndrome, demonstrating good efficacy and safety [3]. - The company plans to submit a marketing application to the National Medical Products Administration (NMPA) and will present detailed data at major international academic conferences [3].