[ 2T 0a 2b 4l 年e_S 0t 3o 月ckI 2n 8f 日o] 证券研究报告•2023年年报点评 当前价： 53.04元 荣昌生物（688331） 医药生物 目标价： ——元（6个月） 核心产品持续放量，期待海外进展 投资要点 西南证券研究发展中心 [T ab事le件_S：u公m司ma发ry布] 2023年度报告，2023年实现营业收入达10.8亿元（+40.3%）， [分Ta析bl师e_：Au杜th向or阳] 公司加大研发投入，2023年研发费用为13.1亿元（+33%）。 执业证号：S1250520030002 电话：021-68416017  核心产品持续放量，自免和肿瘤均准入超过 600 家医院。泰它西普和维迪西妥 邮箱：duxy@swsc.com.cn 单抗 2023年持续放量，纳入医保后以量换价明显。截至 2023年12月 31日， 自身免疫商业化团队超过 750人，已准入超过 800家医院。肿瘤科商业化团队 分析师：汤泰萌 近 600人，已准入超过650家医院。 执业证号：S1250522120001 电话：021-68416017  泰它西普多项适应症持续推进，渐入收获期 ...

公 司 研 究 [Table_Reportdate] 2024年03月29日 [Table_invest] [荣Tabl昌e_N生ewT物itle] （688331）： 核心产品持续放 买入（维持） 公 量，临床进展顺利推进 报告原因：业绩点评 司 简 ——公司简评报告 评 [table_main] [证Ta券b分le析_A师u thors] 投资要点 杜永宏 S0630522040001 dyh@longone.com.cn ➢ 收入端快速增长，利润端亏损扩大。2023年，公司实现收入10.83亿元（+40.26%），归母 医 证券分析师 净利润-15.11亿元（2022年为-9.99亿元），扣非净利润-15.43亿元（2022年为-11.17亿元）。 药 伍可心 S0630522120001 2023年公司两大核心商业化产品的销售持续放量，泰它西普和维迪西妥单抗收入规模均超 生 wkx@longone.com.cn 5亿元，收入端增长整体符合预期。由于公司新药研发管线持续推进，同时商业化团队扩 物 联系人 充以及学术推广力度加大，研发销售费用支出较大，导致利润端同比亏损进一步扩大。 付婷 futing@l ...

Financial Performance - The company reported no profit distribution or capital reserve transfer to increase share capital for the fiscal year 2023[5]. - The company reported a 20% increase in revenue year-over-year, reaching $1.5 billion for the fiscal year 2023[15]. - The net profit attributable to shareholders for 2023 was approximately -¥1.51 billion, a significant decrease compared to -¥998.83 million in 2022[22]. - The company's operating revenue for 2023 was approximately ¥1.08 billion, representing a year-over-year increase of 40.26% due to increased sales of Taitasip and Vidisilimab[22]. - The total assets decreased by 8.19% year-over-year to approximately ¥5.53 billion, while the net assets attributable to shareholders decreased by 30.98% to approximately ¥3.44 billion[23]. - The basic earnings per share for 2023 was -¥2.80, compared to -¥1.88 in 2022, indicating a decline in profitability[24]. - The company reported a quarterly operating revenue of ¥313.48 million in Q4 2023, with a net loss attributable to shareholders of -¥480.64 million[26]. - The company achieved operating revenue of 1.083 billion RMB in 2023, a 40.26% increase from 772 million RMB in the previous year, primarily driven by rapid growth in sales of core products Tai'ai® (Tai'ituximab) and Aidiqi® (Vidisizumab)[33]. - The company reported a significant increase in revenue, achieving a total of 1.2 billion in 2023, representing a 15% year-over-year growth[169]. Research and Development - The company is committed to maintaining significant R&D investments for ongoing product pipelines, which may lead to increased short-term losses[3]. - The total R&D investment for the year reached ¥1,306,306,793.92, an increase of 33.01% compared to the previous year's ¥982,080,423.23[78]. - R&D expenses accounted for 120.62% of operating revenue, a decrease of 6.57 percentage points from the previous year, primarily due to increased revenue[24]. - The company is focused on advancing multiple innovative drugs currently in critical trial phases, leading to increased R&D expenditures[24]. - The company has established three R&D centers in Yantai, Shanghai, and California, focusing on innovative biopharmaceutical development[60]. - The company has developed innovative biopharmaceutical technologies, including fusion proteins, ADCs, and bispecific antibodies, which have shown better targeting and affinity compared to traditional monoclonal antibodies[69]. - The company is actively expanding its product pipeline with several new drug candidates in various stages of clinical trials[123]. - The company is focusing on expanding its drug pipeline, particularly in the areas of autoimmune diseases and oncology[79]. Clinical Trials and Product Development - The company is actively developing innovative therapies across multiple disease treatment areas[3]. - The company submitted Investigational New Drug applications to the FDA for multiple new therapies, indicating a strong pipeline for future growth[13]. - The company has eight molecules currently in clinical development, with ongoing clinical trials for Tai'ai® and Aidiqi® in China and the United States[35]. - The company has initiated a Phase III clinical trial for Taitasip in China for the treatment of Myasthenia Gravis (MG), completing patient enrollment as of the report date[45]. - The company’s lead product, RC18 (brand name Tai'ai®), is the world's first dual-target fusion protein for treating autoimmune diseases, which received full approval in China in November 2023[43]. - The company is conducting a Phase III trial in China to evaluate Vidisicimab combined with other therapies for HER2-expressing urothelial carcinoma, with patient recruitment ongoing[50]. - The company is advancing clinical trials for several new products, including RC88, RC118, RC148, RC198, and RC248, to enhance the clinical value and potential of its pipeline[150]. Market Expansion and Strategy - The company is expanding its market presence in Asia, targeting a 30% increase in market share by 2025[15]. - The company is considering strategic acquisitions to enhance its product portfolio and market presence[164]. - The company plans to accelerate the commercialization of its core products, including Tai Tasi Pu (RC18) and Vidi Xi Tuo Monoclonal Antibody (RC48), which have been included in the national medical insurance directory[148]. - The company aims to enhance product sales through a collaborative marketing strategy that integrates medical, market, and sales efforts, focusing on academic promotion and real-world studies[64]. - The company is exploring potential acquisitions to enhance its product portfolio, with a target of completing at least one acquisition by the end of 2024[169]. Financial Risks and Challenges - The company’s future plans and development strategies are subject to investment risks and do not constitute substantial commitments to investors[6]. - The company faces risks related to non-profitability due to lengthy drug approval processes, which may delay product launches and impact revenue growth[88]. - The company relies on external financing for working capital, and insufficient funds could pressure its financial situation and delay R&D projects[92]. - The company faces risks related to the potential inability to include its drugs in the national medical insurance directory, which could impact future revenues[90]. Governance and Compliance - The company has received a standard unqualified audit report from Ernst & Young Hua Ming[4]. - The company’s board of directors and supervisory board members have confirmed the accuracy and completeness of the annual report[2]. - The company has not faced any significant issues regarding independence from its controlling shareholders or related parties[155]. - The company held five shareholder meetings during the reporting period, ensuring compliance with legal requirements and protecting shareholder rights[153]. - The company has established a cash dividend policy, prioritizing cash dividends when conditions are met, with a minimum cash distribution of 10% of the distributable profit for the year[192]. Employee and Management - The company has a total of 1,308 technical personnel, 1,185 sales personnel, and 684 production personnel, indicating a strong focus on technical and sales capabilities[189]. - The company emphasizes a performance management system to distinguish high and low performers, ensuring a cycle of rewarding excellence and addressing underperformance[190]. - The total remuneration for all directors, supervisors, and senior management personnel at the end of the reporting period amounted to 30.55 million RMB[173]. - The company has implemented a second phase of the H-share incentive trust plan, reflecting its commitment to employee motivation and retention strategies[186].

Financial Performance - The company's product sales revenue for the year ended December 31, 2023, was approximately RMB 1,049.2 million, representing a 42.1% increase from RMB 738.2 million in the same period last year[2]. - For the year ended December 31, 2023, the company's revenue was RMB 1,076.1 million, an increase from RMB 823.0 million[6]. - Revenue increased from RMB 767.8 million in 2022 to RMB 1,076.1 million in 2023, driven by strong sales of the autoimmune product TaiTasi and the oncology product Vidisic[31]. - The net loss increased from RMB 998.8 million in 2022 to RMB 1,511.2 million in 2023[40]. - The company reported a net loss attributable to ordinary equity holders of RMB 1,511,229,000 for 2023, compared to a loss of RMB 998,830,000 in 2022[79]. - Other income and gains decreased from RMB 232.5 million in 2022 to RMB 110.6 million in 2023, primarily due to a reduction in government subsidies by RMB 75.6 million[32]. - The company incurred a net loss of RMB 1,511.2 million for the year, compared to a net loss of RMB 998.8 million in 2022, leading to a basic loss per share of RMB 2.80, up from RMB 1.88[48]. Research and Development - The company has a robust pipeline with over ten candidate drugs in various stages of clinical development targeting multiple indications[8]. - The company initiated a Phase III clinical trial for RC28-E injection for wet age-related macular degeneration (wAMD) in China in January 2023[4]. - The company is currently conducting late-stage clinical trials for RC18 to explore its potential in treating various autoimmune diseases[9]. - The company completed a Phase III clinical trial for systemic lupus erythematosus (SLE) in China, achieving positive results and receiving full NMPA approval in November 2023[10]. - The company is conducting a Phase III trial comparing RC48 combined with chemotherapy for treating HER2-expressing locally advanced or metastatic urothelial carcinoma, with progress reported as smooth[18]. - The company has successfully renewed the inclusion of its drug in the national medical insurance catalog by the end of 2023[17]. - The company is actively assessing the potential of RC18 for treating other autoimmune diseases, although success cannot be guaranteed[15]. Regulatory Approvals - Tai'taixip received FDA approval for a Phase III clinical trial for the treatment of generalized myasthenia gravis (gMG) in January 2023, and was granted Fast Track Designation[3]. - Vidi's monoclonal antibody received NMPA approval for multiple clinical trials, including treatment for HER2-positive breast cancer and advanced solid tumors throughout 2023[4]. - RC88 received FDA approval for a Phase II IND for treating gynecological tumors in December 2023[5]. - The company received FDA approval for a global Phase III trial of the treatment for primary Sjögren's syndrome (pSS) in December 2023[13]. - The company received CDE approval in April 2023 for the Phase II IND of Vidisicimab combined with Trastuzumab injection (brand name: Tuoyi®) for HR-positive, HER2-low expressing breast cancer patients[20]. Commercialization and Market Strategy - The company has commercialized two products, RC18 (brand name: 泰愛®) and RC48 (brand name: 愛地希®), and is conducting clinical trials for over 20 indications in China and the United States[7]. - The company has established a sales and marketing department focused on the commercialization of pipeline products, with independent sales teams for autoimmune and oncology fields[28]. - The company is focused on commercializing TaiTasi and Vidisic in China while accelerating clinical trials and regulatory submissions for pipeline products[30]. - The company is expanding its market presence through targeted marketing strategies and direct interactions with key opinion leaders and physicians[28]. Financial Position and Assets - The company's bank balance and cash as of December 31, 2023, amounted to RMB 726.6 million[6]. - Total non-current assets increased to RMB 3,299.3 million as of December 31, 2023, from RMB 2,809.1 million in 2022, driven by growth in property, plant, and equipment[50]. - Current assets decreased to RMB 2,228.9 million in 2023 from RMB 3,212.1 million in 2022, with cash and cash equivalents significantly dropping to RMB 726.6 million from RMB 2,069.2 million[50]. - The company's total liabilities increased to RMB 1,137.5 million in 2023 from RMB 892.3 million in 2022, with interest-bearing bank borrowings of RMB 286.3 million reported for the first time[51]. Corporate Governance - The company has adopted corporate governance principles and has complied with all applicable codes during the fiscal year[44]. - The audit committee reviewed the financial statements and confirmed that the annual performance complies with applicable accounting standards and regulations[45]. - The financial statements are prepared in accordance with the International Financial Reporting Standards and presented in RMB[55]. Employee and Compensation - The total number of employees as of December 31, 2023, is 3,615, with total compensation costs amounting to RMB 1,152.3 million, an increase from RMB 810.7 million in 2022, primarily due to an increase in employee count and salary levels[43].

2024 年，公司将持续专注于主营业务的发展，不断提高自身竞争 力，具体包括一下几个方面： 1、加大在研产品管线的研发进度。公司将积极推动泰它西普、 维迪西妥单抗、RC28、RC88、RC108、 RC118 等分子的临床研究，持 续拓展现有管线的临床价值和潜力，并将探索其联合用药的治疗方案。 2、强化早期药物发现丰富管线。公司将持续健全发展包括抗体 和融合蛋白平台、抗体药物偶联物（ADC）平台和双特异性抗体平台 等核心技术平台，利用三大核心技术平台设计并创造具有创新机制的 生物新分子，不断充实产品管线，持续推出具有国际竞争力的重磅产 品。 荣昌生物制药（烟台）股份有限公司 2024 年度"提质增效重回报"行动方案 荣昌生物制药（烟台）股份有限公司（简称"公司"）为践行以 "投资者为本"的上市公司发展理念，维护公司全体股东利益，且基 于对公司未来发展前景的信心及价值的认可，经本公司董事会审议通 过，本公司将采取以下有效措施切实"提质增效重回报"，树立公司 良好的市场形象。主要措施如下： 一、聚焦经营主业，提升核心竞争力 公司是一家具有全球化视野的创新型生物制药企业，自成立以来 一直专注于抗体药物偶联物(ADC ...

| 证券代码：688331 | 证券简称：荣昌生物 | 公告编号： | 2024-013 | | --- | --- | --- | --- | | 港股代码：09995 | 港股简称：榮昌生物 | | | 荣昌生物制药（烟台）股份有限公司 关于使用闲置募集资金进行现金管理的公告 本公司董事会及全体董事保证本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。 重要内容提示： 现金管理受托方：银行、证券等金融机构 本次现金管理金额：投资额度不超过 2 亿元人民币，在上述额度内公司 可循环进行投资，滚动使用。 现金管理产品名称：保本型结构性存款、协议定期存款 履行的审议程序：荣昌生物制药（烟台）股份有限公司（以下简称"公 司"）于 2024 年 3 月 27 日召开了第二届董事会第十一次会议和第二届监事会第 八次会议，审议通过了《关于使用闲置募集资金进行现金管理的议案》，同意公 司使用不超过人民币 2 亿元的闲置募集资金购买安全性高、流动性好、购买机构 不限于银行、证券等金融机构的理财产品进行现金管理，本事项无需提交公司股 东大会审议。上述额度自公司董事会审 ...

荣昌生物制药（烟台）股份有限公司 已审财务报表 2023年度 荣昌生物制药（烟台）股份有限公司 页 次 审计报告 1 - 6 已审财务报表 合并资产负债表 7 - 8 合并利润表 9 - 10 合并股东权益变动表 11 合并现金流量表 12 - 13 公司资产负债表 14 - 15 公司利润表 16 公司股东权益变动表 17 公司现金流量表 18 - 19 财务报表附注 20 - 114 补充资料 1.非经常性损益明细表 1 2.净资产收益率和每股收益 1 目 录 3.中国企业会计准则与国际财务报告准则编报差异调节表 1 审计报告 安永华明（2024）审字第70051338_J01号 荣昌生物制药（烟台）股份有限公司 荣昌生物制药（烟台）股份有限公司全体股东： 一、审计意见 我们审计了荣昌生物制药（烟台）股份有限公司的财务报表，包括2023年12月31 日的合并及公司资产负债表，2023年度的合并及公司利润表、股东权益变动表和现金 流量表以及相关财务报表附注。 我们认为，后附的荣昌生物制药（烟台）股份有限公司的财务报表在所有重大方 面按照企业会计准则的规定编制，公允反映了荣昌生物制药（烟台）股份有限公司 20 ...

荣昌生物制药（烟台）股份有限公司 章 程 荣昌生物制药（烟台）股份有限公司 2024 年 3 月 | 第一章 | 总则 | 4 | | --- | --- | --- | | 第二章 | 经营宗旨和范围 | 6 | | 第三章 | 股份 | 6 | | 第一节 | 股份发行 | 6 | | 第二节 | 股份增减和回购 | 11 | | 第三节 | 股份转让 | 13 | | 第四节 | 购买公司股份的财务资助 | 15 | | 第五节 | 股票和股东名册 | 16 | | 第四章 | 股东和股东大会 | 19 | | 第一节 | 股东 | 19 | | 第二节 | 股东大会的一般规定 | 23 | | 第三节 | 股东大会的召集 | 27 | | 第四节 | 股东大会的提案与通知 | 28 | | 第五节 | 股东大会的召开 | 30 | | 第六节 | 股东大会的表决和决议 | 34 | | 第七节 | 类别股东表决的特别程序 | 39 | | 第五章 | 董事会 | 41 | | 第一节 | 董事 | 41 | | 第二节 | 董事会 | 44 | | 第三节 | 董事会专门委员会 | 49 | | 第六 ...

荣昌生物制药（烟台）股份有限公司 内部控制审计报告 2023年12月31日 内部控制审计报告 安永华明（2024）专字第70051338_J04号 荣昌生物制药（烟台）股份有限公司 荣昌生物制药（烟台）股份有限公司全体股东： 按照《企业内部控制审计指引》及中国注册会计师执业准则的相关要求，我们审 计了荣昌生物制药（烟台）股份有限公司2023年12月31日的财务报告内部控制的有效 性。 一、企业对内部控制的责任 按照《企业内部控制基本规范》、《企业内部控制应用指引》、《企业内部控制 评价指引》的规定，建立健全和有效实施内部控制，并评价其有效性是荣昌生物制药 （烟台）股份有限公司董事会的责任。 二、注册会计师的责任 我们的责任是在实施审计工作的基础上，对财务报告内部控制的有效性发表审计 意见，并对注意到的非财务报告内部控制的重大缺陷进行披露。 三、内部控制的固有局限性 内部控制具有固有局限性，存在不能防止和发现错报的可能性。此外，由于情况 的变化可能导致内部控制变得不恰当，或对控制政策和程序遵循的程度降低，根据内 部控制审计结果推测未来内部控制的有效性具有一定风险。 四、财务报告内部控制审计意见 我们认为，荣昌生 ...

荣昌生物制药（烟台）股份有限公司 2023 年度独立董事述职报告 2023 年度，本人作为荣昌生物制药（烟台）股份有限公司（以下简称"公 司"）的独立董事，根据《中华人民共和国公司法》（以下简称"《公司法》"）《中 华人民共和国证券法》（以下简称"《证券法》"）《上市公司治理准则》《上海证券 交易所科创板股票上市规则》《香港联合交易所有限公司证券上市规则》《荣昌生 物制药（烟台）股份有限公司章程》（以下简称"《公司章程》"）等法律、法规、 规范性文件的要求，勤勉尽责地履行了独立董事的职责，充分发挥了独立董事的 作用，维护了公司整体利益及全体股东的合法权益。现将 2023 年度担任独立董 事的履职情况报告如下： 一、基本情况 （一）个人工作履历、专业背景以及兼职情况 马兰，1958 年 9 月出生，女，中国国籍，无境外永久居留权，博士。于 1990 年获美国北卡罗来纳大学博士学位，并于 1991 年至 1993 年期间在美国北卡罗来 纳大学开展博士后研究， 1993 年至 1995 年期间在美国拜耳公司制药部研究中 心开展博士后研究； 1995 年 12 月至今担任复旦大学上海医学院教授，2003 年 11 月 ...