Core Viewpoint - CICC maintains the net loss forecast for Rongchang Biologics (09995) at RMB 915 million for 2025 and RMB 333 million for 2026, while raising the target price by 24.8% to HKD 95.34 due to positive clinical results of Taitasip and the approval of RC148 for Phase II trials in the U.S. [1] Group 1 - The positive results from the Phase III clinical trial of Taitasip for dry eye syndrome are expected to enhance its future value [1] - The approval of RC148 for Phase II clinical trials in the U.S. marks its entry into global clinical development, indicating its international clinical value and potential for overseas expansion [1] - The company plans to submit a marketing application for Taitasip to the National Medical Products Administration (NMPA) and will present detailed data at major international academic conferences [1]

智通财经APP获悉，中金发布研报称，基本维持荣昌生物(09995)2025及26年归母净亏损预测9.15亿元及 3.33亿元人民币不变。由于泰它西普干燥综合症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;维持公司"跑赢行业"评级，上调目标价 24.8%至95.34港元。 荣昌生物日前宣布将尽快就自主研发的BLyS/APRIL双靶点融合蛋白创新药泰它西普，向国家药品监督 管理局药品审评中心(CDE)递交上市申请，并在国际重大学术会议上公布详细数据。另外，公司的 RC148获得FDA批准在美国开展针对多种晚期恶性实体肿瘤的Ⅱ期临床研究，标志着RC148进入全球临 床研发阶段，为推动产品后续开发奠定基础;该行认为RC148具有国际化临床价值和出海潜力。 ...

消息面上，8月13日，荣昌生物宣布，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。 中金发布研报称，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。此 外，公司的RC148获得FDA批准在美国开展针对多种晚期恶性实体肿瘤的Ⅱ期临床研究，标志著RC148 进入全球临床研发阶段，为推动产品后续开发奠定基础；该行认为RC148具有国际化临床价值和出海潜 力。 荣昌生物(09995)再涨超5%，截至发稿，涨4.28%，报80.6港元，成交额5.36亿港元。 ...

智通财经APP获悉，荣昌生物(09995)再涨超5%，截至发稿，涨4.28%，报80.6港元，成交额5.36亿港 元。 消息面上，8月13日，荣昌生物宣布，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。 中金发布研报称，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。此 外，公司的RC148获得FDA批准在美国开展针对多种晚期恶性实体肿瘤的Ⅱ期临床研究，标志著RC148 进入全球临床研发阶段，为推动产品后续开发奠定基础；该行认为RC148具有国际化临床价值和出海潜 力。 ...

Core Viewpoint - Rongchang Biologics has announced plans to submit a listing application for its self-developed dual-target fusion protein innovative drug, Tai Ta Xi Pu, to the National Medical Products Administration (NMPA) and will present detailed data at major international academic conferences [1] Group 1: Product Development - The company's RC148 has received FDA approval to conduct Phase II clinical trials in the United States for various advanced malignant solid tumors, marking its entry into global clinical research [1] - The approval of RC148 is expected to enhance its international clinical value and potential for overseas expansion [1] Group 2: Financial Forecast - The company maintains its net loss forecasts for 2025 and 2026 at 915 million yuan and 333 million yuan, respectively [1] - Positive Phase III clinical results for Tai Ta Xi Pu in dry syndrome are anticipated to increase its future value potential [1] Group 3: Investment Rating - The firm maintains a "outperforming the industry" rating for Rongchang Biologics and raises the target price by 24.8% to 95.34 HKD [1]

Company Updates - The company announced on August 13 that its self-developed innovative drug, Taitasip, a global first BLyS/APRIL dual-target fusion protein, has achieved the primary endpoint in the Phase III clinical trial for treating primary Sjögren's syndrome (pSS) and will soon submit a marketing application to the National Medical Products Administration (NMPA) [1] - Taitasip has shown significant clinical efficacy, with Phase II clinical data indicating a reduction of 4.3 points in the ESSDAI score after 24 weeks of treatment with 160mg, outperforming the placebo [1] - The drug has received multiple authoritative guideline recommendations in China and has been granted Fast Track designation by the FDA for its pSS indication, allowing for a global multi-center Phase III clinical trial [1] Product Development - The company’s novel bispecific antibody, RC148, has received FDA approval for clinical trials in the U.S. for various advanced malignant solid tumors, marking its entry into global clinical development [2] - RC148 is expected to enhance tumor-killing responses through immune checkpoint blockade and tumor angiogenesis inhibition, indicating its international clinical value and potential for global expansion [2] - In China, RC148 is progressing smoothly in clinical research for single-agent and combination therapies for advanced solid tumors, with promising efficacy and safety observed in early trials [2] Financial Forecast and Valuation - The company maintains its net profit loss forecast for 2025 and 2026 at 915 million yuan and 333 million yuan, respectively [2] - Positive Phase III clinical results for Taitasip are expected to enhance its future value, while the FDA approval for RC148's Phase II trial is anticipated to boost its global value [2] - Based on a DCF model, the company has raised its target price by 24.8% to HKD 95.34, indicating a potential upside of 23.1% from the current stock price [2]

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 中金主要观点如下： RC148获得CDE拟纳入突破性疗法 RC148单药及联合治疗晚期实体瘤的中国临床研究正在顺利推进中，前期单药疗法在临床试验中已观察到良好的疗效和安全性。获得CDE拟纳入突破性疗法的适应症为联合多西他赛治疗经 PD-1/PD-L1 抑制剂和含铂化疗（联合或序贯）治疗失败的驱动基因阴性局部晚期或转移性非小细胞肺癌，该行认为后续RC148有望与ADC等联合用药，进一步拓宽潜在临床应用范围。 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。 责任编辑：史丽君 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 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 II期临床数据显示，使用泰它西普160mg治疗24周，可将干燥综合征疾病活 ...

Group 1 - The core viewpoint of the report is that the company maintains its profit forecast for Rongchang Biologics, predicting losses of 915 million yuan for 2025 and 333 million yuan for 2026, while highlighting the positive results of the Phase III clinical trial for Taitasip and the approval of RC148 for Phase II trials in the U.S. [1] - The company announced on August 13 that Taitasip, a dual-target fusion protein for treating primary Sjögren's syndrome (pSS), has met its primary endpoint in Phase III clinical trials and will soon submit a marketing application to the National Medical Products Administration (NMPA) [2] - Taitasip has shown significant potential in improving clinical symptoms for pSS patients, with Phase II data indicating a 4.3-point reduction in the ESSDAI score compared to baseline after 24 weeks of treatment, outperforming placebo [3] Group 2 - RC148, a novel PD-1/VEGF bispecific antibody, has received FDA approval for Phase II clinical trials in the U.S. for various advanced solid tumors, indicating its entry into global clinical development [4] - RC148 is also progressing smoothly in clinical studies in China, with good efficacy and safety observed in earlier trials, and has been proposed for inclusion as a breakthrough therapy by the CDE for specific indications [5]

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]