Core Viewpoint - Rongchang Biopharma (09995.HK) announced that its self-developed innovative drug, Tai Aixin (泰爱®), a world-first BLyS/APRIL dual-target fusion protein, has achieved the primary research endpoint in the Phase III clinical study for treating IgA nephropathy (IgAN) in China [1] Summary by Categories - **Clinical Development** - The Phase III clinical study for Tai Aixin has reached the primary research endpoint [1] - The company plans to submit a New Drug Application (BLA) to the National Medical Products Administration (NMPA) in China as soon as possible [1]

Group 1 - The company Rongchang Biologics (09995) announced that its self-developed innovative drug Tai'aisip (泰爱®), a first-in-class BLyS/APRIL dual-target fusion protein, has met the primary endpoint in the Phase III clinical trial for treating IgA nephropathy (IgAN) in China [1] - The clinical trial was a multi-center, randomized, double-blind, placebo-controlled study involving 318 adult patients with IgAN who had received standard treatment, with a dosage of 240mg administered subcutaneously once a week [1] - Results from the A stage analysis showed that patients in the Tai'aisip group had a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the control group at 39 weeks (P<0.0001), demonstrating good tolerability and safety [1] Group 2 - IgAN is a common primary glomerular disease with diverse clinical manifestations, including recurrent microscopic or macroscopic hematuria and varying degrees of proteinuria, and is a major cause of chronic kidney disease and end-stage renal disease in China [2] - Up to 40% of IgAN patients may reach end-stage renal disease within 20 years of diagnosis, indicating a pressing unmet medical need for new therapies [2] - The company’s Tai'aisip targets the underlying mechanisms of IgAN by inhibiting the production of Gd-IgA1 and its antibodies through the dual inhibition of BLyS and APRIL, which are key cytokines in the disease process [2]

Core Viewpoint - Rongchang Biologics (09995) has announced that its innovative BLyS/APRIL dual-target fusion protein drug, Taisip, has successfully met the primary endpoint of its Phase III clinical trial for treating primary Sjögren's syndrome (pSS) in China, marking it as the first of its kind globally to complete such a study [1][2] Group 1: Clinical Trial Details - The Phase III clinical trial was a multicenter, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of Taisip in patients with primary Sjögren's syndrome [1] - The primary endpoint was the change in ESSDAI score at week 24, which is the gold standard for measuring disease activity in Sjögren's syndrome [1] - Results indicated that Taisip can sustainably and effectively improve clinical symptoms in patients, demonstrating good efficacy and safety [1] Group 2: Disease Background and Market Potential - Primary Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocytic infiltration and damage to exocrine glands, leading to persistent dry mouth and dry eyes, and can affect multiple organ systems [1] - The prevalence of Sjögren's syndrome in China is estimated to be between 0.3% and 0.7%, with an increasing trend, indicating a significant unmet clinical need [1] Group 3: Drug Development and Recognition - Taisip is a novel dual-target fusion protein developed by the company, designed to simultaneously inhibit the overexpression of B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), effectively preventing abnormal differentiation and maturation of B cells [2] - In China, Taisip has received recommendations from several authoritative guidelines, including the "Chinese Clinical Practice Guidelines for Sjögren's Syndrome" and the "Expert Consensus on B Cell Targeted Therapy for Rheumatic and Immune Diseases" [2] - Internationally, Taisip has been granted Fast Track designation by the U.S. Food and Drug Administration and has been approved to conduct global multicenter Phase III clinical trials for its indication in Sjögren's syndrome [2]

Core Viewpoint - Rongchang Biopharmaceutical (09995) announced that its innovative BLyS/APRIL dual-target fusion protein drug, Tai'aisip (泰爱), has successfully completed the primary endpoint of a Phase III clinical trial for the treatment of primary Sjögren's syndrome (pSS) in China, and the company plans to submit a marketing application to the National Medical Products Administration (NMPA) soon [1][2] Group 1 - Tai'aisip is the first BLyS/APRIL dual-target fusion protein drug globally to complete Phase III research for the treatment of Sjögren's syndrome [1] - The Phase III clinical study is a multi-center, randomized, double-blind, placebo-controlled trial aimed at evaluating the efficacy and safety of Tai'aisip in pSS patients, with the primary endpoint being the change in ESSDAI score at week 24 [1] - The results indicate that Tai'aisip can sustainably and effectively improve clinical symptoms in pSS patients, demonstrating good efficacy and safety [1] Group 2 - Primary Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocyte infiltration and damage to exocrine glands, leading to persistent dry mouth and dry eyes, and can affect multiple organ systems [1] - The prevalence of Sjögren's syndrome in China is estimated to be between 0.3% and 0.7%, with an increasing trend, indicating a significant unmet clinical need [1] - The overactivation of autoreactive B cells is a key pathological basis for the onset of Sjögren's syndrome, and Tai'aisip effectively inhibits the overexpression of BLyS and APRIL, preventing abnormal differentiation and maturation of B cells [2] Group 3 - Tai'aisip has received multiple authoritative guideline recommendations in China, including the "Clinical Practice Guidelines for the Use of Super Drugs in Sjögren's Syndrome" and the "Expert Consensus on B Cell Targeted Therapy for Rheumatic and Immune Diseases" [2] - Internationally, Tai'aisip has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its indication in Sjögren's syndrome and has been approved to conduct global multi-center Phase III clinical trials [2]

荣昌生物公告，全球首创BLyS/APRIL双靶点融合蛋白药物泰它西普（商品名：泰爱 ）用于治疗原发性 干燥综合征(pSS)的中国III期临床研究，达到方案设计的临床试验主要研究终点。公司将尽快向国家药 品监督管理局药品审评中心(CDE)递交上市申请，并择机在国际重大学术会议上公布具体数据。 ...