公司近况 8月13日，公司宣布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用于治疗原发性干 燥综合征(pSS)的Ⅲ期临床研究，达到方案设计的临床试验主要研究终点，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，详细数据将在国际重大学术会议上公布。 泰它西普可持续有效改善干燥综合征患者的临床症状，具有全球市场发展潜力 智通财经APP获悉，中金发布研报称，基本维持荣昌生物(09995)2025年/2026年归母净利润预测亏损 9.15亿元/亏损3.33亿元不变。由于泰它西普干燥综合征III期临床结果积极，有望提升泰它西普未来价值 空间，且RC148美国II期临床获批有望提升其出海潜力和全球价值空间，基于DCF模型，该行维持公司 跑赢行业评级，上调目标价24.8%至95.34港币，相比当前股价有23.1%上行空间。 中金主要观点如下： 公司原研双特异性抗体RC148获得美国FDA新药临床试验许可 风险提示：研发失败的风险，行业竞争加剧的风险，国际合作推进不及预期的风险。 RC148为新型PD-1/VEGF双特异性抗体，该行认为RC148有望通过免疫检查点阻断和抑制肿瘤血管生成 ...

Group 1: Core Insights - Rongchang Biologics (09995.HK) announced that its innovative drug Taitasip (brand name: Tai Ai®) for treating primary Sjögren's syndrome has met the primary endpoint in a Phase III clinical trial in China [1] - Taitasip is the first BLyS/APRIL dual-target fusion protein drug to complete Phase III research in the field of Sjögren's syndrome globally [1] - The clinical trial was a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of Taitasip, with the primary endpoint being the change in ESSDAI score at week 24 compared to baseline [1] Group 2: Disease Background and Drug Mechanism - 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 [2] - 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 [2] - Taitasip is a novel dual-target fusion protein developed by the company that simultaneously inhibits the overexpression of BLyS and APRIL, effectively preventing abnormal differentiation and maturation of B cells [2] Group 3: Regulatory and Clinical Recognition - Taitasip has received multiple authoritative guideline recommendations in China, including the "Clinical Practice Guidelines for Sjögren's Syndrome" and the "Expert Consensus on B-cell Targeted Therapy for Rheumatic and Immune Diseases" [2] - Internationally, Taitasip has been granted Fast Track designation by the U.S. FDA for its indication in Sjögren's syndrome and has been approved to conduct global multi-center Phase III clinical trials [2]

Core Insights - Rongchang Biopharmaceutical (09995.HK) announced that its dual-target fusion protein drug, Taitasip (brand name: Tai'ai®), has successfully completed Phase III clinical trials for the treatment of primary Sjögren's syndrome (pSS) in China, achieving the primary endpoint of the study [1] - 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 [1] - Taitasip is the first dual-target fusion protein drug to complete Phase III trials in the field of Sjögren's syndrome treatment [1] Clinical Study Details - The Phase III clinical study was a multicenter, randomized, double-blind, placebo-controlled trial aimed at evaluating the efficacy and safety of Taitasip in patients with primary Sjögren's syndrome [2] - 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 Taitasip significantly and sustainably improved clinical symptoms in patients, demonstrating good efficacy and safety [1] Disease Background and Market Potential - Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocytic infiltration and damage to exocrine glands, leading to persistent dryness of the mouth and eyes, and potentially affecting 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] Mechanism of Action - Research indicates that the overactivation of autoreactive B cells is a key pathological basis for the onset of Sjögren's syndrome [2] - Taitasip is a novel dual-target fusion protein developed by the company that simultaneously inhibits the overexpression of B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), effectively preventing abnormal differentiation and maturation of B cells [2] - Taitasip has received multiple authoritative guideline recommendations in China, including the "Clinical Practice Guidelines for Sjögren's Syndrome" and the "Expert Consensus on B Cell Targeted Therapy for Rheumatic and Immune Diseases" [2]

干燥综合征是一种慢性炎症性自身免疫性疾病，以淋巴细胞浸润和外分泌腺体损伤为主要特征。除唾液 腺和泪腺功能障碍导致的持续口干、眼干外，还可累及多系统器官。中国干燥综合征的患病率为 0.3%-0.7%，且呈上升趋势，存在巨大尚未被满足的临床需求。 这是一项多中心、随机、双盲、安慰剂对照的III期临床研究，旨在评价泰它西普用于治疗原发性干燥综 合征患者的有效性和安全性。主要终点是治疗第24周ESSDAI评分(衡量干燥综合征疾病活动的金标准) 较基线的变化。临床研究结果显示，泰它西普可持续有效改善干燥综合征患者的临床症状，显示出良好 的疗效和安全性。 研究表明，自身反应性的B细胞过度活化是干燥综合征发病的重要病理基础。泰它西普是由公司自主研 发的新型双靶融合蛋白，可同时靶向抑制B淋巴细胞刺激因子(BLyS)及增殖诱导配体(APRIL)的过度表 达，有效阻止B细胞异常分化与成熟，在临床和真实世界研究中展现出良好的疗效和安全性。 荣昌生物(09995)发布公告，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 ...

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]

在中国，泰它西普获得《乾燥综合征超药品说明书用药中国临床实践指南》《B细胞靶向药物治疗风湿 免疫病中国专家共识》《原发性乾燥综合征多学科诊疗专家共识》等多项权威指南推荐。在国际上，泰 它西普的乾燥综合征适应症已获美国食品药物监督管理局授予的快速通道资格并获准开展全球多中心III 期临床试验。 格隆汇8月14日丨荣昌生物(09995.HK)公布，全球首创BLyS/APRIL双靶点融合蛋白药物泰它西普（商品 名：泰爱®)用于治疗原发性乾燥综合征(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，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。泰它西普成为治疗乾燥综合征领域全球首个完成III期研究的BLyS/APRIL双靶点融合蛋 白药物。 乾燥综合征是一种慢性炎症性自身免疫性疾病，以淋巴细胞浸润和外分泌腺体损伤为主要特征。除唾液 腺和泪腺功能障碍导致的持续口乾、眼乾外，还可累及多系统器官。中国乾燥综合征的患病率为 0.3%-0.7%，且呈上升趋势，存在巨大尚未被满足的临床需求。 这是一项多中心、随机、双盲、安慰剂对照的III期临床研究，旨 ...

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。 ...

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。 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®）治療原發性乾燥綜合徵 中國III期臨床研究達到主要終點 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，全球首創BLyS/APRIL雙靶點融合蛋白藥物 泰它西普（商品名：泰愛®)用於治療原發性乾燥綜合徵(pSS)的中國III期臨床研 究，達到方案設計的臨床試驗主要研究終點，將盡快向國家藥品監督管理局藥品 審評中心(CDE)遞交上市申請，並擇機在國際重大學術會議上公佈具體數據。泰 它西普成為治療乾燥綜合徵領域全球首個完成III期研究的BLyS/APRIL雙靶點融 合蛋白藥物。 1 在中國，泰它西普獲得《乾燥綜合徵超藥品說明書用藥中國臨床實踐指南》《B細 ...

前不久，荣昌生物一则配售公告悄然出现在港交所公告栏。这家"A+H"两地上市的生物科技公司计划以每股42.44港元配售1900万股新 H股，预计净筹资7.96亿港元。 去年25.5亿元的A股定增搁浅，现在转向H股市场筹资，公司现金流紧张程度可见一斑。 翻开荣昌生物2025年一季度报告，表面光鲜的数字令人振奋：营收5.26亿元，同比增长59.2%；毛利率提升至83.3%，同比增加5.8个百 分点。但往下细看，盈利栏赫然写着-2.54亿元的归母净亏损。 荣昌生物近期在资本市场动作频频，这家横跨A股与H股的生物科技公司正试图通过H股配售筹措资金。表面上看，公司营收保持着高 速增长的态势，核心产品市场覆盖也在持续扩大，但这份亮眼的成绩单背后，却难掩其多年来未能扭转的亏损困局。 持续的研发投入与市场竞争压力，让荣昌生物陷入了"增收不增利"的循环。尽管两款核心产品贡献了绝大多数收入，但高昂的销售费 用与管理成本不断吞噬利润，叠加应收账款攀升导致现金流承压，公司不得不在股权融资的路上反复尝试。从A股定增搁浅到转向H 股市场，频繁的"补血"动作折射出其日益紧张的资金链。 面对负债高企、货币资金难以覆盖短期债务的现状，荣昌生物的 ...

其他蓝筹股方面，中国人寿（601628）(02628)涨3.6%，报23.62港元，贡献恒指9.58点；康师傅控股 (00322)涨3.06%，报11.46港元，贡献恒指1.1点；比亚迪（002594）电子(00285)跌5.04%，报38.8港元， 拖累恒指2.58点；领展房产基金(00823)跌4.08%，报42.78港元，拖累恒指7.42点。 港股未能延续昨日强劲走势，三大指数集体高开低走。其中，恒科指表现最弱，午后一度挫逾1%。截 止收盘，恒生指数跌0.37%或94.35点，报25519.32点，全日成交额为2701.21亿港元；恒生国企指数跌 0.23%，报9128.93点；恒生科技指数跌0.97%，报5576.03点。 招商证券指出，在当前经济弱复苏/稳定复苏的环境下，流动性驱动仍然是股票市场的一个主要特点， 市场风险偏好的变化主导市场节奏，短期市场对国内政策预期有所降温；未来阶段市场将通过 7月和8 月的通胀数据、8月就业数据、8月下旬的Jackson Hole年会等对美联储降息预期进行修正，这可能导致 未来阶段美元指数的波动增大。同时考虑到当前港股市场情绪处于较高水平，在外部环境波动增大情况 ...