华泰联合证券有限责任公司 关于荣昌生物制药（烟台）股份有限公司 2025 年半年度持续督导跟踪报告 | 保荐机构名称：华泰联合证券有限责任公司 | 被保荐公司简称：荣昌生物 | | --- | --- | | 保荐代表人姓名：刘兆明 | 联系电话：025-56839300 | | 保荐代表人姓名：高元 | 联系电话：025-83387686 | 根据《中华人民共和国证券法》《证券发行上市保荐业务管理办法》和《上 海证券交易所科创板股票上市规则》（以下简称"《上市规则》"）等有关法律、 法规的规定，华泰联合证券有限责任公司（以下简称"华泰联合证券"或"保荐 机构"）作为荣昌生物制药（烟台）股份有限公司（以下简称"荣昌生物"、"公 司"或"发行人"）首次公开发行股票的保荐机构，对荣昌生物进行持续督导， 并出具本持续督导跟踪报告： 一、保荐机构和保荐代表人发现的问题及整改情况 （一）发现的问题 2025年上半年，公司实现营业收入10.98亿元，较去年同期的7.42亿元增加 48.02%，主要是因为两个核心产品泰爱®（泰它西普）、爱地希®（维迪西妥单抗） 销售收入及销量同比快速增长。归属于上市公司股东的净亏损4.50 ...

Core Viewpoint - Rongchang Biopharmaceuticals has seen a significant stock price increase, reaching over 100 yuan, driven by the approval of its drug for treating Sjögren's syndrome, marking a milestone in the biopharmaceutical industry [1][4][5]. Company Overview - Rongchang Biopharmaceuticals (688331.SH) is an innovative pharmaceutical company focused on developing treatments for autoimmune diseases, tumors, and ocular diseases, with key products including Taitasip and Vidisizumab [2][4]. - The company has several drugs in development, including RC28, RC88, RC148, and RC278, targeting major diseases [2]. Recent Developments - On September 9, the company announced that its application for Taitasip to treat Sjögren's syndrome was accepted by the National Medical Products Administration (NMPA), making it the first biopharmaceutical to apply for this indication globally [4][5]. - The stock price closed at 104.09 yuan per share on the same day, reflecting an 11.92% increase, with a trading volume of 20.79 million shares [4]. Market Context - The prevalence of Sjögren's syndrome in China is estimated to be between 0.3% and 0.7%, affecting approximately 4.2 to 9.8 million people, indicating a growing market for effective treatments [4]. - Currently, there are no approved targeted therapies for Sjögren's syndrome globally, positioning Taitasip as a potential first-line treatment [5]. Financial Performance - Rongchang Biopharmaceuticals has experienced revenue growth but has not yet achieved profitability, with projected revenues of 772 million yuan in 2022, increasing to 1.717 billion yuan by 2024, while net losses are expected to decrease from 999 million yuan in 2022 to 468 million yuan in 2024 [8]. - In the first half of 2025, the company reported a revenue of 1.098 billion yuan, a 48.02% year-on-year increase, and a reduced net loss of 450 million yuan compared to 780 million yuan in the previous year [8]. Strategic Partnerships - The company has secured significant partnerships, including a collaboration with Vor Bio for Taitasip, which could yield up to 4.105 billion USD in milestone payments [9]. - Additionally, a licensing agreement with Santen Pharmaceutical could bring over 1.2 billion yuan in milestone payments and sales revenue [9]. Industry Outlook - The innovative drug sector is expected to maintain a positive outlook, with ongoing support from policies and a focus on "innovation + internationalization" as core trends in the pharmaceutical industry [7].

Core Viewpoint - Rongchang Biopharma (09995) has seen a significant stock movement following the acceptance of its innovative drug, Taitasip, for the treatment of Sjögren's syndrome by the National Medical Products Administration (NMPA) in China, marking a potential breakthrough in the field [1] Company Developments - Rongchang Biopharma's stock opened down over 7% but later rose by 5.13%, reaching HKD 106.6 with a trading volume of HKD 805 million [1] - The company announced that Taitasip, a dual-target fusion protein drug, is the first of its kind globally to submit a marketing application for Sjögren's syndrome [1] - Taitasip has received Fast Track designation from the FDA in the United States and has been approved for Phase III clinical trials for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG) in China [1] Licensing Agreements - Rongchang Biopharma has entered into a licensing agreement with Vor Bio, granting Vor Bio exclusive rights to develop and commercialize Taitasip globally, excluding Greater China [1]

Core Viewpoint - Rongchang Biopharma (09995) has seen a significant stock movement following the acceptance of its innovative drug, Tai Tasi Pi, for the treatment of Sjögren's syndrome by the National Medical Products Administration (NMPA) in China, marking a potential breakthrough in the field [1] Company Summary - Rongchang Biopharma's stock opened down over 7% but later rebounded to a 5.13% increase, trading at 106.6 HKD with a transaction volume of 805 million HKD [1] - The company announced that Tai Tasi Pi, a dual-target fusion protein drug, is the first of its kind globally to submit a marketing application for Sjögren's syndrome [1] - The drug has received Fast Track designation from the FDA in the United States and has been approved for Phase III clinical trials for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG) in China [1] - Rongchang Biopharma has entered into a licensing agreement with Vor Bio, granting Vor Bio exclusive rights to develop and commercialize Tai Tasi Pi outside of Greater China [1]

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected investment return that exceeds the market benchmark by over 20% in the next 6-12 months [6][11]. Core Insights - The company reported a revenue of 1.098 billion yuan in H1 2025, representing a year-on-year increase of 48.02%. The net loss attributable to the parent company was 450 million yuan, with a significant reduction in losses compared to the previous year [1][6]. - The commercialization of core products is progressing as expected, with the self-immune commercialization team for Taitasip reaching approximately 900 people and over 1,000 hospitals approved for access [1][6]. - The company has successfully obtained domestic approval for Taitasip for generalized Myasthenia Gravis (gMG) and has entered into a licensing agreement with Vor Bio for global commercialization outside Greater China [2][3]. Financial Projections - Revenue projections for 2025-2027 are estimated at 2.37 billion yuan, 3.13 billion yuan, and 4.23 billion yuan, respectively, with year-on-year growth rates of 37.8%, 32.1%, and 35.2% [3][4]. - The company anticipates a significant reduction in net losses, with projections of -876.86 million yuan in 2025, -467.97 million yuan in 2026, and a return to profitability with a net profit of 221.48 million yuan in 2027 [4][10]. - The gross margin is expected to improve, reaching 84.0% in 2025 and 87.0% by 2027 [10]. Commercialization and Licensing - The company has successfully licensed RC28 to Santen Pharmaceutical for exclusive development and commercialization rights in several Asian markets, securing an upfront payment of 250 million yuan and potential milestone payments totaling up to 5.25 billion yuan [3][10]. - The commercialization efforts for Taitasip and Vidisicimab are expected to continue to expand, with both products achieving significant hospital access [1][2]. Market Position - The company is positioned to benefit from ongoing commercialization and potential international expansion, with a strong pipeline of products and strategic partnerships enhancing its market presence [2][3].

9月9日，荣昌生物（688331.SH）股价突破100元，盘中最高价达111.6元，较年内股价最低点24.11元大涨363%。目前，其已成为山东第四只股价超过百元 的股票。 治疗干燥综合征的新药申请获批 荣昌生物是一家创新药企，主要产品包括泰它西普（自身免疫领域）、维迪西妥单抗（抗肿瘤领域），以及在研药品RC28、RC88、RC148、RC278等， 为自身免疫疾病、肿瘤疾病、眼科疾病等重大疾病领域提供临床解决方案。 在股价突破百元的当日（9日），该公司宣布泰它西普治疗干燥综合征的上市申请获国家药品监督管理局药品审评中心（CDE）受理，成为干燥综合征领 域全球首个申请上市的生物药。 截至9月9日收盘，荣昌生物涨幅为11.92%，报收104.09元/股，全天换手率12.82%，成交量2079万股。据悉，在山东A股公司中，目前荣昌生物股价仅次于 中际旭创（300308.SZ）、惠城环保（300779.SZ）、云路股份（688190.SH）。 干燥综合征是一种慢性炎症性自身免疫疾病，并发症较多，除了外分泌腺受损的症状，还会有关节炎、肌痛、皮疹等腺体外表现，以及多系统内脏损害， 长期影响患者生活质量。我国干燥综合征的 ...

Group 1 - Rongchang Bio's stock price increased by 5.91%, reaching 98.5 yuan per share, marking a new high [1] - The company's total market capitalization surpassed 555.15 billion yuan [1] - The trading volume amounted to 1.88 billion yuan [1]

9月9日，荣昌生物（688331.SH，股价107.10元，市值603.62亿元）开盘大涨，截至发稿涨幅超15%。 今日，公司宣布泰它西普（商品名：泰爱）用于治疗干燥综合征的上市申请，已获国家药品监督管理局药品审评中心（CDE）正式受理，这意味着泰它西普成为干燥综合征领域全球首个申请上市 作为一种双靶点融合蛋白药物，泰它西普是荣昌生物首款商业化产品，最早于2021年在国内获批。截至目前，泰它西普已有治疗系统性红斑狼疮（SLE）、类风湿关节炎（RA）、全身型重症肌 值得一提的是，干燥综合征也是一种慢性炎症性自身免疫疾病，并发症较多，除了外分泌腺受损的症状，还会有关节炎、肌痛、皮疹等腺体外表现，以及多系统内脏损害，在中国的患病率为0.3 根据荣昌生物8月13日发布的公告，泰它西普治疗原发性干燥综合征的Ⅲ期临床研究已达到主要研究终点，可以持续有效改善干燥综合征患者的临床症状，显示良好的有效性和安全性。 值得注意的是，在全球范围内，还没有治疗干燥综合征的靶向药物获批上市，所以泰它西普有望成为该领域内首个对因治疗的有效手段——2023年12月，其用于干燥综合征的Ⅲ期临床试验已获得 封面图片来源：视觉中国-VCG41N1 ...

Core Viewpoint - Rongchang Biopharmaceutical (688331) experienced a significant stock price increase, reaching a peak of 16.37% on September 9, following the announcement of its innovative drug application for the treatment of Sjögren's syndrome [1] Company Summary - Rongchang Biopharmaceutical announced that its self-developed innovative drug, Tai Ta Xi Pu, which targets both BLyS and APRIL, has received formal acceptance from the National Medical Products Administration (NMPA) for its market application [1] - This drug is noted to be the first biopharmaceutical in the world to apply for market approval in the field of Sjögren's syndrome [1]

周二（9月9日）早盘，AH创新药再度异动。A股创新药龙头股领涨，百济神州大涨超6%，重仓创新药 的药ETF（562050）盘中续涨逾1%创上市新高！ 港股方面，荣昌生物一度暴拉逾15%创历史新高，乐普生物-B、君实生物大涨超7%，创新药纯度100% 的港股通创新药ETF（520880）开盘后快速探底回升，直线冲高逾1%，开盘不到30分钟成交额超2亿 元。 消息面上，荣昌生物最新宣布，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 用于治疗干燥综合征的上市申请，已获国家药品监督管理局药品审评中心（CDE）正式受理，成为干燥 综合征领域全球首个申请上市的生物药。 值得关注的是，昨日港股通创新药ETF（520880）标的指数"提纯"修订生效，正式成为一只不含 CXO、纯度100%的创新药指数，当日近8200万元大举涌入，至此，520880连续5日获资金加码，金额 合计近1.8亿元。 与此同时，场外投资利器火线上新！港股通创新药ETF（520880）联接基金（A类：025220 / C类： 025221）今日起开放日常申赎，场外投资者也能一键投资纯正创新药。 提醒：近期市场波动可能较大，短期涨 ...