Results reinforce telitacicept’s potential across multiple autoimmune diseases Data anticipated to be presented at an upcoming medical conference CAMBRIDGE, Mass., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), achieved the primary endpoint in Stage A of a Phase 3 clinical study in China evaluating telitacicept in adults with I ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 IgAN是一種常見的原發性腎小球疾病，該病臨床表現多樣，如反覆發作的鏡下血 尿或肉眼血尿，伴有不同程度蛋白尿，部分患者可以出現嚴重高血壓或者腎功能 異常。IgA腎病也是中國慢性腎臟病和終末期腎病的主要原因之一，高達40%的 IgA腎病患者在診斷後20年內達到終末期腎病，產生對新型藥物迫切的未滿足醫 療需求。目前學術界認為，半乳糖缺乏型IgA1(Gd-IgA1)分泌過多是IgA腎病的發 病的核心及始動因素。 1 RemeGen Co., Ltd.* 榮 昌 生 物 製 藥（ 煙 台 ）股 份 有 限 公 司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：9995） 自願公告 泰它西普（商品名：泰愛®）治療IgA腎病 中國III期臨床研究A階段達到主要終點 本公告由榮昌生物製藥（煙台）股份有限公司（「本公司」）自願作出。 本公司董事會（「董事會」）欣然宣佈，本公司自主研發的全球首創BLyS/APR ...

Group 1 - The core point of the article is that Rongchang Biologics (09995) has achieved the primary endpoint in the Phase III clinical trial of its innovative drug Taitasip (brand name: Tai'ai) for the treatment of IgA nephropathy (IgAN) in China [1] - The Phase III trial was a multicenter, randomized, double-blind, placebo-controlled study involving 318 adult patients with IgAN who had received standard treatment [1] - Taitasip was administered at a dosage of 240mg via subcutaneous injection once a week, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the control group after 39 weeks (P<0.0001) [1] Group 2 - IgAN is a common primary glomerular disease that can lead to severe hypertension or renal dysfunction, with up to 40% of patients reaching end-stage renal disease within 20 years of diagnosis [2] - The pathogenesis of IgAN is believed to be linked to the excessive secretion of galactose-deficient IgA1 (Gd-IgA1), with BLyS and APRIL being key cytokines in promoting Gd-IgA1 and its antibodies [2] - Taitasip is a recombinant dual-target fusion protein that inhibits both BLyS and APRIL, preventing abnormal differentiation and maturation of B cells, thereby alleviating pathological immune responses [2]

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]

Group 1 - The company Rongchang Biologics (09995) announced that its self-developed innovative drug Tai'aisip (泰它西普) for treating IgA nephropathy (IgAN) has achieved the primary research endpoint in the Phase III clinical trial 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] - The A stage analysis showed that 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, and is a major cause of chronic kidney disease and end-stage renal disease in China, with up to 40% of patients reaching end-stage renal disease within 20 years of diagnosis [2] - The academic community believes that the excessive secretion of galactose-deficient IgA1 (Gd-IgA1) is a core factor in the pathogenesis of IgAN [2] - The drug Tai'aisip is a recombinant BLyS/APRIL dual-target fusion protein that inhibits the binding of BLyS and APRIL to B cell surface receptors, effectively reducing pathological immune responses [2]

格隆汇8月27日丨荣昌生物(09995.HK)宣布，公司自主研发的全球首创BLyS/APRIL双靶点融合蛋白创新 药泰它西普(商品名：泰爱®)用于治疗IgA肾病(IgAN)的中国III期临床研究，达到A阶段的主要研究终 点。公司将尽快向中国国家药品监督管理局(NMPA)药品审评中心(CDE)递交上市申请(BLA)。 ...

（股份代號：9995） 自願公告 泰它西普（商品名：泰愛®）治療IgA腎病 中國III期臨床研究A階段達到主要終點 本公告由榮昌生物製藥（煙台）股份有限公司（「本公司」）自願作出。 本公司董事會（「董事會」）欣然宣佈，本公司自主研發的全球首創BLyS/APRIL雙 靶點融合蛋白創新藥泰它西普（商品名：泰愛®）用於治療IgA腎病(IgAN)的中國III 期臨床研究，達到A階段的主要研究終點。我們將盡快向中國國家藥品監督管理 局(NMPA)藥品審評中心(CDE)遞交上市申請(BLA)。 這是一項多中心、隨機、雙盲、安慰劑對照臨床試驗，納入了318例接受過標準 治療的IgAN成人患者，泰它西普的使用劑量為240mg，皮下注射，每週1次。A 階段分析結果顯示：與對照組相比，泰它西普組患者在治療39周時的24小時尿蛋 白肌酐比值(UPCR)降低了55%(P<0.0001)，且表現出良好的耐受性和安全性。詳 細數據將在國際重大學術會議上公佈。 IgAN是一種常見的原發性腎小球疾病，該病臨床表現多樣，如反覆發作的鏡下血 尿或肉眼血尿，伴有不同程度蛋白尿，部分患者可以出現嚴重高血壓或者腎功能 異常。IgA腎病也是中國慢性腎臟 ...

Group 1 - The company reported a significant revenue growth of 48.0% year-on-year, with 1H25 revenue reaching 1.098 billion yuan, and a reduction in net losses by 42.4% to 450 million yuan [1] - The company expects a revenue growth of over 30% for the full year, driven by steady sales of core products and the upcoming commercialization of RC28 [1][2] - The company has made progress in international expansion, with the successful authorization of Tai Tasi Pi and ongoing Phase III trials for Vidisizumab [3] Group 2 - The gross margin improved to 84.1%, an increase of 5.8 percentage points year-on-year, attributed to successful ramp-up of new facilities and process optimizations [4] - Operating cash flow significantly improved, with a 69% reduction in cash outflow in 2Q25, indicating a positive trend towards cash flow turning positive in the future [4] - The company is focusing its resources on potential pipeline and indication development, leading to a reduction in R&D expenses by 19.7% year-on-year [4] Group 3 - The company anticipates narrowing losses in 2025, approaching breakeven in 2026, and achieving profitability in 2027, with projected net profits of 346 million yuan in 2025 and 536 million yuan in 2027 [5] - The target prices based on DCF are set at 107.37 yuan for A-shares and 116.94 HKD for H-shares, with a WACC of 6.8% and a perpetual growth rate of 2.5% [5]

Investment Rating - The report maintains a "Buy" rating for the company [3][7]. Core Insights - The company continues to reduce losses in Q2 2025, with strong sales growth in core products and an improving expense ratio, leading to stable overall performance and cash reserves [2][7]. - The global peak sales estimate for the key product, Tai Tasi Pu, has been raised to $3.1 billion based on excellent clinical data [2]. - The target price has been adjusted upwards to HKD 103, reflecting the company's performance in the first half of 2025 and anticipated contributions from new business development collaborations [2][8]. Financial Performance Summary - Revenue for 1H25 increased by 47.6% year-on-year to RMB 1.09 billion, driven by strong sales of Tai Tasi Pu and Vidisizumab [7]. - The gross profit margin improved by 7.3 percentage points to 84.4%, with further optimization in expense ratios [7]. - The company has a robust cash reserve of RMB 1.48 billion and an additional bank credit line of RMB 2.7 billion [7]. Earnings Forecast Changes - Revenue forecasts for 2025 and 2026 have been increased by 25% and 3% respectively, while the 2027 revenue forecast has been decreased by 14% [6]. - The gross profit for 2025 is projected at RMB 2.602 billion, reflecting a 38% increase from previous estimates [6]. - The net profit for 2027 is expected to rise by 87% to RMB 742 million, indicating a significant turnaround [6]. Valuation Model - The DCF valuation model estimates the equity value at RMB 52.776 billion, translating to a per-share value of HKD 103 [8].