Core Viewpoint - Rongchang Biopharma disclosed its research reception announcement, indicating strong financial performance and significant progress in core pipeline development for 2024, with a focus on various therapeutic areas [1][2]. Financial Overview - The company reported a revenue of 1.717 billion yuan for 2024, representing a year-on-year growth of 58.5% [7]. - The sales expense ratio for 2024 was 55.3%, a decrease of 16.3 percentage points compared to the previous year [7]. - Research and development expenses increased to 1.54 billion yuan, up 17.9% year-on-year [7]. - The overall gross margin for 2024 was 80.4%, an increase of 3.0 percentage points from the previous year [7]. - As of the end of 2024, the company had approximately 1 billion yuan in cash and cash equivalents, with sufficient loan credit lines available [7]. Core Pipeline Development Progress 1. **RC18 in China** - Myasthenia Gravis (MG): BLA application has been accepted, with data presented at the AAN conference showing significant clinical efficacy [4]. - Primary Sjögren's Syndrome (pSS): Phase III enrollment is complete, with normal progress in medication and follow-up [4]. - IgA Nephropathy (IgAN): Phase III enrollment is complete, with normal progress in medication and follow-up [4]. 2. **RC18 Overseas** - Systemic Lupus Erythematosus (SLE): Phase III international multicenter clinical research is ready [5]. - Myasthenia Gravis (MG): Continuous enrollment in Phase III [5]. 3. **RC48 in China** - Urothelial Carcinoma (UC): Phase III for first-line combination therapy is complete, with normal progress in medication and follow-up [6]. - Gastric Cancer (GC): Phase III for first-line combination therapy has started, with patient enrollment underway [6]. 4. **Other Pipeline Developments** - RC88: Phase II clinical trial for advanced malignant solid tumors has completed enrollment [10]. - RC148: Observed good efficacy and safety in single-agent clinical exploration, with ongoing Phase II trials for advanced lung cancer [11]. - RC278: ADC drug using next-generation conjugation technology for various solid tumors [12]. - RC28: Phase III clinical trials for diabetic macular edema (DME) and wet age-related macular degeneration (wAMD) have completed enrollment [13].

Summary of Conference Call on Rongchang Biotech's Taizhisip Company and Industry - The conference call focused on Rongchang Biotech and its product Taizhisip, which is aimed at treating Myasthenia Gravis (MG) [1][2]. Core Points and Arguments - **Clinical Trial Results**: Taizhisip demonstrated significant efficacy in a Phase III clinical trial for MG, with treatment groups showing superior MG-ADL and QMG scores compared to control groups (P<0.001). The treatment group had a 98.1% improvement rate in MG-ADL scores exceeding 3 points, and 87% in QMG scores exceeding 5 points, compared to 12% and 16% in the control group respectively [3][4]. - **Mechanism of Action**: Taizhisip works by inhibiting B cell differentiation and proliferation, normalizing the immune system. This mechanism is considered more stable for long-term use compared to FcRn antagonists, which may pose risks of B cell immune response issues and infections [3][6]. - **Safety Profile**: The safety of Taizhisip was confirmed, showing good performance against respiratory infections, urinary infections, pneumonia, and colds. No significant adverse events were reported during the clinical trials, and a trend towards steroid reduction was noted [3][5][9]. - **Market Strategy**: Taizhisip is expected to launch in 2025, with a strategy focusing on physician education, high-frequency academic promotion, and market coverage expansion [3][13]. - **International Trials**: The international Phase III trials are progressing well, with some countries already starting patient enrollment. The overall progress aligns with expectations [3][14]. - **Comparison with Competitors**: Taizhisip shows advantages over Agamod and C5 inhibitors in terms of safety and efficacy, particularly in long-term use. It is positioned as a better option for MG patients compared to existing therapies [3][11][17]. Other Important but Possibly Overlooked Content - **Clinical Demand**: The clinical demand for MG treatments in China remains unmet, and Taizhisip is the first successful aptamer-based treatment for MG, which could provide better options for patients [3][17]. - **Data Consistency**: While the trial designs in China and the US are similar, slight differences may arise due to the complexity of international multi-center trials [3][7][8]. - **Future Research**: There is potential for future studies to observe the continued use of other medications post-launch, as the current trials excluded patients who had previously used HM drugs [3][16]. - **Long-term Observations**: The ongoing Phase B trials are expected to yield results soon, with preliminary data indicating a continued improvement trend [3][24]. This summary encapsulates the key findings and strategic insights from the conference call regarding Rongchang Biotech's Taizhisip and its implications for the treatment of Myasthenia Gravis.

Core Insights - The company reported a revenue of 1.72 billion yuan in 2024, representing a 58.5% increase, but incurred a net loss attributable to shareholders of 1.47 billion yuan, with a non-GAAP net loss of 1.51 billion yuan, aligning with expectations [1] - The company's core products continue to expand, with both the autoimmune and oncology teams gaining access to over 1,000 hospitals [1] - The drug Tai Taisip received NMPA approval in March 2021 and was included in the new national medical insurance for treating SLE in December of the same year [1] - The autoimmune commercialization team has grown to over 800 people, while the oncology team has nearly 600, both achieving access to over 1,000 hospitals [1] Clinical Data - Tai Taisip's Phase III clinical data for generalized Myasthenia Gravis (gMG) was presented at the AAN annual meeting, showing the highest MG-ADL response among peers [2] - The study included 114 gMG patients, with significant improvements in MG-ADL and QMG scores observed from week 4 [2] - At 24 weeks, the MG-ADL score decreased by 5.74 points in the Tai Taisip group compared to a 0.91 point decrease in the placebo group, with 98.1% of patients showing a ≥3 point improvement [2] - The QMG score decreased by 8.66 points in the Tai Taisip group versus a 2.27 point decrease in the placebo group, with 87% of patients showing a ≥5 point improvement [2] - The safety profile of Tai Taisip during treatment was reported to be acceptable [2] - The application for Tai Taisip's market approval for gMG was accepted in October 2024, with expectations for approval in Q2 2025 [2] Revenue Forecast - Revenue projections for the company are estimated at 2.27 billion yuan in 2025, 3.11 billion yuan in 2026, and 4.29 billion yuan in 2027, reflecting year-on-year growth rates of 32.5%, 36.8%, and 37.8% respectively [3] - The continued expansion of commercialized products, along with the potential international market entry for Tai Taisip, supports a "buy" rating [3]

消息面上，近日，荣昌生物宣布其自主研发的BLyS/APRIL双靶点融合蛋白创新药泰它西普 （telitacicept，RC18）用于治疗全身型重症肌无力（gMG）3期研究结果，以"最新突破性研究"口头报 告亮相美国神经病学学会（AAN）年会。数据显示，泰它西普治疗24周后，98.1%的患者重症肌无力日 常活动评分（MG-ADL）改善≥3分，87%的患者定量重症肌无力评分（QMG）改善≥5分，具有显著的 临床意义。目前，泰它西普用于治疗全身型重症肌无力的上市申请已于2024年10月获CDE受理，并被纳 入优先审评，预计于今年二季度在中国获批上市。 交银国际认为，泰它西普gMGIII期数据优于已上市竞品，且商业化推广策略清晰。在中国内地，泰它 西普的gMG适应症上市申请已于2024年10月获受理并纳入优先审评，公司对于该适应症的商业化策略 包括：1）增加神经免疫领域专线代表，覆盖更多目标市场（包括VYVGART的现有重点目标医院）； 2）加强医生教育，重点推广泰它西普相比VYVGART的核心竞争优势；3）鼓励临床专家探索更多病 例，收集医生反馈，建立专家分享平台。基于优异的临床数据和清晰的商业化推广策略，该行看好 ...

近期，外部环境震荡加剧，并蔓延至医药板块。4月9日，在传出"美国将对药品征收关税"的消息后，恒生医疗保健指数(800804)早盘跌幅一度超过7%，但随 后指数并未持续下探而是一路走高并于午后翻红。 并且研究结果还显示出来持续改善趋势，即随时间推移，泰它西普组MG-ADL和QMG评分持续下降，并在第24周改善幅度达峰值。 而从安全性来看，泰它西普治疗期间整体安全耐受，总体不良事件(AE)发生率与安慰剂组相当，感染类AE发生率低于安慰剂组(45.6%vs 59.6%)。 其中医药板块情绪的带动者之一，便是早盘半小时内拉升超15个点的荣昌生物(09995)。 智通财经APP观察到，虽然4月9日开盘时受到整个市场负面情绪影响，荣昌生物深水低开，开盘10分钟内两度探底，最大跌幅达到10.23%，但在触底后，荣 昌生物股价先于指数快速反弹，20分钟便将股价从深水拉至0轴，并在接下来10分钟后将股价强势拉升至最高5.33%。 虽然后续在市场震荡影响下，荣昌生物的场内筹码分歧扩大，股价再度走低，但午后荣昌生物股价再度于水下强势拉升，并在20分钟内再度将涨幅从0轴拉 升至最高11.19%。 荣昌生物之所以能逆市实现资金合力上攻 ...

荣昌生物4月9日龙虎榜 | 买入营业部名称 | 买入金额(万元) | | --- | --- | | 沪股通专用 | 7027.69 | | 机构专用 | 2349.73 | | 中国国际金融股份有限公司上海分公司 | 2144.56 | | 机构专用 | 1604.83 | | 机构专用 | 1364.31 | | 卖出营业部名称 | 卖出金额(万元) | | 沪股通专用 | 4939.74 | | 机构专用 | 2325.87 | | 机构专用 | 1745.22 | | 机构专用 | 1607.37 | | 中信证券股份有限公司北京安外大街证券营业部 | 740.41 | 注：本文系新闻报道，不构成投资建议，股市有风险，投资需谨慎。 （文章来源：证券时报网） 4月9日荣昌生物(688331)收盘价44.00元，收盘上涨8.70%，全天换手率6.44%，振幅34.98%，成交额4.21 亿元。科创板交易公开信息显示，当日该股因日价格振幅达30%等上榜。 证券时报·数据宝统计显示，上榜的前五大买卖营业部合计成交2.58亿元， 其中，买入成交额为1.45亿 元，卖出成交额为1.14亿元，合计净买入3132.5 ...

荣昌生物 20250402 摘要 Q&A 融创生物和荣昌生物作为老牌的 ADC biotech 企业，其业绩表现如何？ 荣昌生物近年来业绩持续超预期，2024 年公司全年实现了超过 17 亿的营收， 同比增速接近 60%。这一增长主要得益于销售团队的人均单产上升以及产品的 临床价值。公司坚持以临床价值为导向，致力于开发 first-in-class 和 best- in-class 的生物药，研发方向锁定在自身免疫、肿瘤科和眼科三大领域。 荣昌生物目前有哪些主要上市产品？其市场表现如何？ 荣昌生物目前已成功推出两款自主研发的主要产品：2,418 泰达西普和 RC48 维 迪西妥。2,418 泰达西普主要用于治疗系统性红斑狼疮（SLE）及其他自免适应 • 荣昌生物已上市两款自主研发产品：泰达西普（治疗系统性红斑狼疮等自 免适应症）和维迪西妥（中国首款 HER2 ADC 药物，治疗胃癌、尿路上皮癌 等）。 • 泰达西普作为双靶点药物，在系统性红斑狼疮治疗中 SRI 应答率达 83%， 显著高于贝利尤单抗，且耐受性良好，国内医保价格虽略高于贝利尤单抗， 但患者可接受。 • 维迪西妥在三线胃癌治疗中 ORR 达 25 ...

北京市金杜律师事务所 关于荣昌生物制药（烟台）股份有限公司 之法律意见书 致：荣昌生物制药（烟台）股份有限公司 北京市金杜律师事务所（以下简称本所）接受荣昌生物制药（烟台）股份有 限公司（以下简称公司）委托，根据《中华人民共和国证券法》（以下简称《证 券法》）、《中华人民共和国公司法》（以下简称《公司法》）、中国证券监督 管理委员会《上市公司股东会规则（2025 修订）》（以下简称《股东会规则》） 等中华人民共和国境内（以下简称中国境内，为本法律意见书之目的，不包括中 国香港特别行政区、中国澳门特别行政区和中国台湾地区）现行有效的法律、行 政法规、规章和规范性文件和现行有效的公司章程有关规定，指派律师出席了公 司于 2025 年 4月 2 日召开的 2025年第二次临时股东大会（以下简称本次股东大会）， 并就本次股东大会相关事项出具本法律意见书。 为出具本法律意见书，本所律师审查了公司提供的以下文件，包括但不限于： 限公司章程》； 《荣昌生物制药（烟台）股份有限公司关于补选公司执行董事的公告》； 《荣昌生物制药（烟台）股份有限公司关于召开 2025 年第二次临时股东大会的通 知》（以下简称《股东大会通知》）； ...

北京市金杜律师事务所 关于荣昌生物制药（烟台）股份有限公司 2025 年第二次临时股东大会 之法律意见书 致：荣昌生物制药（烟台）股份有限公司 北京市金杜律师事务所（以下简称本所）接受荣昌生物制药（烟台）股份有 限公司（以下简称公司）委托，根据《中华人民共和国证券法》（以下简称《证 券法》）、《中华人民共和国公司法》（以下简称《公司法》）、中国证券监督 管理委员会《上市公司股东会规则（2025 修订）》（以下简称《股东会规则》） 等中华人民共和国境内（以下简称中国境内，为本法律意见书之目的，不包括中 国香港特别行政区、中国澳门特别行政区和中国台湾地区）现行有效的法律、行 政法规、规章和规范性文件和现行有效的公司章程有关规定，指派律师出席了公 司于2025年4月2日召开的2025年第二次临时股东大会（以下简称本次股东大会）， 并就本次股东大会相关事项出具本法律意见书。 为出具本法律意见书，本所律师审查了公司提供的以下文件，包括但不限于： 1. 经公司 2023 年年度股东大会审议通过的《荣昌生物制药（烟台）股份有 限公司章程》； 2. 2025 年 3 月 15 日，公司刊登于上海证券交易所网站（www.sse ...

证券代码：688331 证券简称：荣昌生物 公告编号：2025-017 荣昌生物制药（烟台）股份有限公司 2025 年第二次临时股东大会决议公告 本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 （四） 表决方式是否符合《公司法》及公司章程的规定，大会主持情况等。 符合 重要内容提示： 本次会议是否有被否决议案：无 一、 会议召开和出席情况 （一） 股东大会召开的时间：2025 年 4 月 2 日 （二） 股东大会召开的地点：山东省烟台市经济技术开发区北京中路 58 号荣昌 生物三期 6134 会议室 （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况： | 1、出席会议的股东和代理人人数 | 101 | | --- | --- | | 普通股股东人数 | 101 | | 其中：A 股股东人数 | 100 | | 境外上市外资股股东人数 | 1 | | 2、出席会议的股东所持有的表决权数量 | 218,266,774 | | 普通股股东所持有表决权数量 | 218,266,774 | ...