Investment Rating - The report maintains a "Hold" rating for the company with a target price of HKD 26 for Hong Kong shares and RMB 35 for A-shares [1][2]. Core Insights - The company's revenue for Q2 2024 slightly exceeded expectations, primarily due to better-than-expected sales of Taihe Xip, but the net loss was significantly higher than anticipated due to increased R&D expenses and non-operating costs [1][2]. - The sales of Taihe Xip reached approximately RMB 380 million in the first half of the year, showing a growth of around 100% year-on-year, with significant contributions from rheumatology and nephrology departments [1][2]. - The company is expected to face challenges in maintaining R&D expenses at the same level as the first half of 2024, with predictions of an increase in the second half due to ongoing clinical trials and new patient enrollments [2][3]. Financial Performance Summary - For Q2 2024, the company reported revenues of RMB 409 million, a year-on-year increase of 63.1% and a quarter-on-quarter increase of 23.8% [1]. - The net loss for Q2 2024 was RMB 432 million, reflecting a year-on-year increase of 13.7% and a quarter-on-quarter increase of 23.7% [1]. - The gross margin for Q2 2024 was 76.8%, showing a slight decrease from the previous quarter but a significant increase compared to the same period last year [1][2]. Revenue and Profit Forecast - The projected revenue for 2024 is RMB 1.719 billion, representing a year-on-year growth of 59.8% [3][4]. - The forecasted net loss for 2024 is RMB 1.704 billion, with subsequent years showing a gradual decrease in losses [3][4]. - The company anticipates a significant increase in sales for Taihe Xip in the second half of 2024, potentially exceeding RMB 500 million [1][2]. Market Position and Future Catalysts - The company has expanded its commercial team to over 800 members, enhancing its market coverage and sales capabilities [1][2]. - Key upcoming catalysts include potential overseas licensing for RC18, regulatory submissions for various indications, and data readouts for ongoing clinical trials [2][3].

[ T able_StockInfo] 2024 年 08 月 19 日 证券研究报告•2024 年半年报点评 当前价：26.81 元 荣昌生物（688331）医药生物 目标价：——元（6 个月） 收入符合预期，核心品种适应症持续拓展 [Table_Summary 事件：公司发布] 2024 半年度报告，2024 年上半年实现营业收入 7.4 亿元 （+75.6%），公司上半年归母净亏损 7.8亿元，较去年同期亏损额增加 0.8亿元。 核心产品持续放量，准入医院数量再创新高。泰它西普和维迪西妥单抗纳入医 保目录后的可及性持续提升。截至 2024 年 6月 30日，自身免疫商业化团队超 过 800人，已准入超过 900家医院。肿瘤科商业化团队近 600人，已准入超过 700 家医院。 泰它西普类风湿性关节炎适应症获批上市，渐入收获期。泰它西普类风湿性关 节炎适应症获 NMPA 批准。中国治疗重症肌无力于 2024 年 8 月达到主要研究 终点，美国于 2024年 8月实现首例患者入组。干燥综合征的中国Ⅲ期临床研究 已完成患者入组，美国于 2024 年 4 月获得快速通道资格认定。免疫球蛋白 A 肾病（IgAN） ...

事件 2024 年 8 月 17 日，公司公告，2024 年上半年营收 7.42 亿元，同比 增长 75.59%，归母/扣非净亏损 7.80/7.94 亿元。2024 年二季度营收 4.11 亿，同比增长 61.8%，归母/扣非净亏损 4.32/4.48 亿元。业绩 符合预期。 点评 泰它西普与维迪西妥继续放量，营收同比高增 75.69%。（1）业绩： 公司的泰它西普（针对自身免疫疾病的双靶点融合蛋白）和维迪 西妥单抗（HER2 ADC，人表皮生长因子受体 2 的抗体偶联药物） 分别于 2021 年 3 月和 6 月在中国获批上市后，都于当年进入国家 医保目录。随着 2023 年院内诊疗修复，公司在 2023 全年和 2024 上半年分别取得了近 40%和 76%的同比高增长。（2）销售：目前， 公司已组建约 800 人的自身免疫商业化销售队伍。作为全球首个 SLE（系统性红斑狼疮）治疗创新双靶生物制剂，泰它西普已获准 入超过 900 家医院。公司已组建近 600 人的肿瘤科商业化销售队 伍，维迪西妥单抗已获准入超过 700 家医院。该产品已经有 2 项 适应症获批并都被纳入国家医保目录，一项是用于治疗 HE ...

Performance Summary [Business Summary](index=1&type=section&id=Business%20Summary) The company achieved significant progress in commercialization, product pipeline, and operations, with strong sales of core products Telitacicept and Disitamab Vedotin driving a **76.5% year-on-year revenue increase**, alongside key clinical trial advancements including FDA Fast Track Designation Revenue Performance for H1 2024 | Metric | H1 2024 (RMB) | H1 2023 (RMB) | YoY Growth | | :--- | :--- | :--- | :--- | | Revenue from Product Sales & R&D Services | 739.7 million | 419.1 million | 76.5% | - Core product Telitacicept (RC18) received FDA Fast Track Designation (FTD) for the treatment of primary Sjögren's Syndrome (pSS)[3](index=3&type=chunk) - Core product Disitamab Vedotin (RC48) achieved its primary endpoint in a Phase III clinical study for HER2-positive advanced breast cancer[3](index=3&type=chunk) - Investigational drug RC88 received FDA FTD for the treatment of platinum-resistant recurrent epithelial ovarian cancer and other indications[4](index=4&type=chunk) [Financial Summary](index=3&type=section&id=Financial%20Summary) For the six months ended June 30, 2024, the Group's revenue reached **RMB 739.7 million** with a gross profit of **RMB 570.4 million**, but a **49.2% increase in R&D expenses to RMB 806.2 million** led to a **11.0% expansion in pre-tax loss to RMB 780.5 million**, with cash and bank balances at **RMB 673.3 million** Key Financial Data for H1 2024 | Financial Metric | Amount (RMB) | YoY Change | | :--- | :--- | :--- | | Revenue | 739.7 million | N/A | | Gross Profit | 570.4 million | N/A | | R&D Expenses | 806.2 million | +49.2% | | Loss Before Tax | 780.5 million | +11.0% | | Loss for the Period | 780.5 million | +11.0% | | Adjusted Net Loss | 743.4 million | +12.7% | | Period-end Bank Balances & Cash | 673.3 million | N/A | Management Discussion and Analysis [Company Overview](index=4&type=section&id=Company%20Overview) The company is a fully integrated biopharmaceutical firm focused on innovative biologics discovery, development, and commercialization in autoimmune, oncology, and ophthalmology, having successfully commercialized two products, Telitacicept and Disitamab Vedotin, and built an integrated platform with over ten drug candidates - The company is positioned as a fully integrated biopharmaceutical company, focusing on three major therapeutic areas: autoimmune diseases, oncology, and ophthalmology[6](index=6&type=chunk) - The company has successfully commercialized two products: Telitacicept (Tai'ai®) and Disitamab Vedotin (Aidexi®), and possesses a product pipeline of over ten drug candidates, with seven in clinical development[6](index=6&type=chunk) [Extensive Product Pipeline](index=5&type=section&id=Extensive%20Product%20Pipeline) As of June 30, 2024, the company's extensive product pipeline spans autoimmune, oncology, and ophthalmology, with core products Telitacicept and Disitamab Vedotin undergoing clinical development for over twenty indications, alongside other candidates like RC88 and RC28 in various clinical stages, demonstrating continuous innovation - The company has over ten drug candidates, with seven in clinical development, targeting more than twenty indications[6](index=6&type=chunk) Key Pipeline Products and Progress | Candidate Drug | Target | Indications (Partial) | Development Stage | | :--- | :--- | :--- | :--- | | Telitacicept (RC18) | BLyS/APRIL | Neuromyelitis Optica, IgG4-Related Disease, etc. | Pivotal/Phase III, Commercialized | | Disitamab Vedotin (RC48) | HER2 | Urothelial Carcinoma, Breast Cancer, Gastric Cancer | Pivotal/Phase III, Commercialized | | RC88 | Mesothelin | Ovarian Cancer, Various Solid Tumors | Phase I/II | | RC28 | VEGF/FGF | Wet Age-related Macular Degeneration, Diabetic Macular Edema | Phase III | [Business Review](index=6&type=section&id=Business%20Review) During the reporting period, the company achieved significant business progress, with core products Telitacicept and Disitamab Vedotin showing positive clinical trial results and regulatory approvals across multiple indications, while ophthalmology drug RC28-E's Phase III study advanced steadily, and other early-stage pipeline products like RC88 demonstrated promising potential [Telitacicept (RC18, Tai'ai®)](index=6&type=section&id=Telitacicept%20(RC18,%20Tai%27ai%C2%AE)) Telitacicept (RC18) demonstrated rapid clinical development progress across multiple autoimmune diseases, with its rheumatoid arthritis (RA) indication approved in China post-period, and key advancements in Phase III trials for primary Sjögren's Syndrome (pSS) and generalized Myasthenia Gravis (gMG), securing FDA Fast Track or Orphan Drug Designations, highlighting its global market potential - In July 2024, Telitacicept was approved for the treatment of rheumatoid arthritis (RA) in China[11](index=11&type=chunk) - For primary Sjögren's Syndrome (pSS), patient enrollment for the Phase III clinical trial in China has been completed, and it received FDA Fast Track Designation (FTD) in March 2024[13](index=13&type=chunk) - For generalized Myasthenia Gravis (gMG), the Phase III clinical trial in China met its primary endpoint, and the first patient was enrolled in the global multi-center Phase III clinical study in the US[14](index=14&type=chunk) [Disitamab Vedotin (RC48, Aidexi®)](index=8&type=section&id=Disitamab%20Vedotin%20(RC48,%20Aidexi%C2%AE)) Disitamab Vedotin (RC48), China's first approved domestic ADC, continues to achieve breakthroughs in treating various HER2-expressing solid tumors, with its Phase III trial for HER2-positive advanced breast cancer with liver metastasis meeting its primary endpoint, and combination studies with PD-1 antibodies for urothelial and gastric cancers showing encouraging efficacy, while global collaboration with Seagen/Pfizer progresses with ongoing international clinical trials - The Phase III clinical trial for HER2-positive advanced breast cancer with liver metastasis achieved positive results, meeting its primary endpoint[20](index=20&type=chunk) - Patient enrollment for the Phase III clinical trial of Disitamab Vedotin combined with a PD-1 antibody as first-line treatment for advanced urothelial carcinoma has been completed[18](index=18&type=chunk) - Global collaboration with Seagen/Pfizer is progressing well, with Seagen conducting a pivotal Phase II clinical trial in the US evaluating Disitamab Vedotin for urothelial carcinoma[21](index=21&type=chunk)[22](index=22&type=chunk) [RC28-E](index=12&type=section&id=RC28-E) RC28-E, a novel VEGF and FGF-targeting fusion protein for ophthalmic diseases, has published positive Ib clinical data for wet Age-related Macular Degeneration (wAMD) in an international journal, demonstrating good safety and efficacy, with its Phase III study initiated in China, and patient recruitment completed for the Phase III trial in Diabetic Macular Edema (DME) - Ib clinical study results for wet Age-related Macular Degeneration (wAMD) were published in an international journal, showing good safety and efficacy, with its Phase III clinical study initiated in China[24](index=24&type=chunk) - Patient recruitment for the Phase III clinical trial of RC28-E for Diabetic Macular Edema (DME) has been completed[25](index=25&type=chunk) [Other Clinical Stage Drug Candidates](index=13&type=section&id=Other%20Clinical%20Stage%20Drug%20Candidates) The company actively advances clinical development for other innovative drugs, with RC88 (mesothelin-targeting ADC) progressing well in Phase II trials for ovarian cancer and other solid tumors, and first patient enrollments achieved for multiple Phase I candidates including RC148 (PD-1/VEGF bispecific antibody), RC198 (IL-15/IL-15Rα fusion protein), and RC248 (DR5-targeting ADC), showcasing a rich early-stage R&D pipeline - RC88 (mesothelin-targeting ADC) is progressing well in its Phase II clinical trial for platinum-resistant recurrent ovarian cancer and other indications[26](index=26&type=chunk) - First patient enrollments have been achieved for Phase I clinical programs including RC148 (PD-1/VEGF bispecific antibody), RC198 (IL-15 fusion protein), and RC248 (DR5-targeting ADC)[27](index=27&type=chunk) [Commercialization Progress](index=15&type=section&id=Commercialization%20Progress) The company established two independent sales teams for autoimmune and oncology products, significantly enhancing market access as core products Telitacicept and Disitamab Vedotin were included in the National Medical Insurance Drug List, with Telitacicept gaining access to over **900 hospitals** and Disitamab Vedotin to over **700 hospitals** by June 30, 2024, demonstrating effective commercialization - The company has established two independent sales teams for autoimmune and oncology fields, responsible for product commercialization[28](index=28&type=chunk) Core Product Hospital Access (As of June 30, 2024) | Product | Number of Hospitals Accessed | | :--- | :--- | | Telitacicept | Over 900 | | Disitamab Vedotin | Over 700 | - Both core products have been included in the National Medical Insurance Drug List, significantly improving product accessibility[28](index=28&type=chunk) [Significant Events After Reporting Period](index=16&type=section&id=Significant%20Events%20After%20Reporting%20Period) Post-reporting period, the company achieved several key milestones, including Telitacicept's rheumatoid arthritis (RA) indication approval in China, its generalized Myasthenia Gravis (gMG) China Phase III trial meeting its primary endpoint, and the first patient enrolled in its global Phase III trial in the US, alongside Disitamab Vedotin's Phase III trial with PD-1 for advanced urothelial carcinoma completing patient enrollment, further solidifying the late-stage pipeline value - In July 2024, Telitacicept was approved for the treatment of rheumatoid arthritis (RA) in China[29](index=29&type=chunk) - In August 2024, Telitacicept's China Phase III clinical trial for generalized Myasthenia Gravis (gMG) met its primary endpoint, and the first patient was enrolled in its global Phase III clinical trial in the US[29](index=29&type=chunk) - In August 2024, patient enrollment for Disitamab Vedotin combined with PD-1 as first-line treatment for advanced urothelial carcinoma Phase III clinical trial was completed[29](index=29&type=chunk) [Future Development](index=16&type=section&id=Future%20Development) The company aims to become a world-class biopharmaceutical leader, continuing to advance the commercialization of Telitacicept and Disitamab Vedotin in China and accelerating other pipeline clinical trials in H2 2024, while internationally focusing on global clinical studies for core products, including multiple Telitacicept Phase III trials in the US, and collaborating with Pfizer/Seagen on Disitamab Vedotin's global development - Domestic Strategy: Continuously advance the commercialization of Telitacicept and Disitamab Vedotin, and accelerate clinical trials for other investigational products[30](index=30&type=chunk) - International Strategy: Accelerate international clinical research for core products, especially Telitacicept's Phase III clinical trials in the US, and collaborate with Pfizer/Seagen to advance the global development of Disitamab Vedotin[30](index=30&type=chunk) Financial Review [Operating Performance Analysis](index=17&type=section&id=Operating%20Performance%20Analysis) In H1 2024, the company's revenue grew **76.5% year-on-year to RMB 739.7 million** due to strong core product sales, but total expenses significantly increased, with R&D expenses rising **49.2% to RMB 806.2 million** and sales and distribution expenses increasing **11.3% to RMB 389.7 million**, alongside higher finance costs, resulting in a **loss for the period expanding from RMB 703.4 million to RMB 780.5 million** Key Income Statement Item Changes for H1 2024 | Item | H1 2024 (RMB) | H1 2023 (RMB) | Reason for Change | | :--- | :--- | :--- | :--- | | Revenue | 739.7 million | 419.1 million | Strong growth in core product sales | | Sales and Distribution Expenses | 389.7 million | 350.2 million | Increased team building and promotional investment | | Administrative Expenses | 155.2 million | 168.6 million | Slight decrease | | R&D Expenses | 806.2 million | 540.5 million | Increased clinical trial expenses (especially overseas) | | Finance Costs | 31.9 million | 6.0 million | Increased interest on bank borrowings and bill discounts | | Loss for the Period | 780.5 million | 703.4 million | R&D and other expenses grew faster than revenue | - The increase in R&D expenses was primarily driven by clinical trial expenses (an increase of **RMB 120.2 million**), raw material expenses (an increase of **RMB 62.2 million**), and employee benefit expenses (an increase of **RMB 33.5 million**)[34](index=34&type=chunk)[35](index=35&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2024, the company's cash and cash equivalents decreased to **RMB 673.3 million** from **RMB 726.6 million** at year-end 2023, primarily used for daily operations, while total interest-bearing bank and other borrowings reached **RMB 2.2745 billion**, and the debt-to-asset ratio rose from **37.8% to 53.7%**, reflecting increased debt financing to support R&D and operations Key Financial Position Indicators | Indicator | June 30, 2024 (RMB) | December 31, 2023 (RMB) | | :--- | :--- | :--- | | Cash and Cash Equivalents | 673.3 million | 726.6 million | | Interest-bearing Bank and Other Borrowings | 2.2745 billion | N/A | | Debt-to-Asset Ratio | 53.7% | 37.8% | - Net cash used in operating activities during the reporting period was **RMB 826.3 million**, primarily funding R&D expenses[40](index=40&type=chunk) Financial Statements [Interim Condensed Consolidated Statement of Profit or Loss](index=23&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Profit%20or%20Loss) For the six months ended June 30, 2024, the company reported revenue of **RMB 739.7 million**, a **76.5% increase** from **RMB 419.1 million** in the prior year, with gross profit at **RMB 570.4 million**, but high R&D costs (**RMB 806.2 million**) and sales and distribution expenses (**RMB 389.7 million**) led to a pre-tax loss of **RMB 780.5 million**, expanding from **RMB 703.4 million** in the previous period H1 2024 Statement of Profit or Loss Summary | Item (Thousand RMB) | H1 2024 (Unaudited) | H1 2023 (Unaudited) | | :--- | :--- | :--- | | Revenue | 739,656 | 419,073 | | Gross Profit | 570,385 | 316,418 | | R&D Costs | (806,233) | (540,453) | | Loss Before Tax | (780,460) | (703,362) | | Loss for the Period | (780,460) | (703,362) | [Interim Condensed Consolidated Statement of Financial Position](index=25&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2024, the company's total assets were **RMB 5.7545 billion**, total liabilities **RMB 3.0899 billion**, and net assets **RMB 2.6646 billion**, with total assets slightly decreasing and total liabilities significantly increasing from year-end 2023, primarily due to interest-bearing bank and other borrowings rising from **RMB 1.127 billion to RMB 2.2745 billion**, and net current assets decreasing from **RMB 1.0914 billion to RMB 845.5 million** Statement of Financial Position Summary (As of June 30, 2024) | Item (Thousand RMB) | June 30, 2024 (Unaudited) | December 31, 2023 (Audited) | | :--- | :--- | :--- | | Total Non-current Assets | 3,260,658 | 3,299,310 | | Total Current Assets | 2,493,879 | 2,228,933 | | **Total Assets** | **5,754,537** | **5,528,243** | | Total Current Liabilities | 1,648,428 | 1,137,541 | | Total Non-current Liabilities | 1,441,499 | 953,433 | | **Total Liabilities** | **3,089,927** | **2,090,974** | | **Net Assets** | **2,664,610** | **3,437,269** | Other Information [Corporate Governance and Compliance](index=22&type=section&id=Corporate%20Governance%20and%20Compliance) During the reporting period, the company adopted and complied with all applicable provisions of the Corporate Governance Code, with directors and supervisors confirming adherence to the standard code for securities transactions, and interim financial results reviewed by independent auditor Ernst & Young and confirmed by the audit committee to comply with accounting standards and regulations - The company complied with all applicable provisions of the Corporate Governance Code during the reporting period[46](index=46&type=chunk) - The interim financial information has been reviewed by independent auditor Ernst & Young in accordance with Hong Kong Standard on Review Engagements 2410[47](index=47&type=chunk) [Interim Dividend](index=22&type=section&id=Interim%20Dividend) The Board of Directors does not recommend the payment of an interim dividend for the six months ended June 30, 2024 - The Board of Directors does not recommend the payment of an interim dividend for 2024[48](index=48&type=chunk)

| 证券代码：688331 | 证券简称：荣昌生物 | 公告编号：2024-047 | | --- | --- | --- | | 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 2024年半年度募集资金存放与实际使用情况的专项报告 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。 根据中国证券监督管理委员会发布的《上市公司监管指引第 2 号——上市公 司募集资金管理和使用的监管要求》和上海证券交易所颁布的《上海证券交易所 科创板上市公司自律监管指引第 1 号——规范运作》等的相关规定，荣昌生物制 药（烟台）股份有限公司（以下简称"公司"）将 2024 年上半年募集资金存放 与使用情况报告如下： 一、募集资金基本情况 （一）实际募集资金金额及资金到账情况 经中国证券监督管理委员会《关于同意荣昌生物制药（烟台）股份有限公司 首次公开发行股票注册的批复》（证监许可[2022]62 号）核准，公司首次公开 发行人民币普通股（A 股）股票 5,442.6301 万股，发行价格为每股 48 元。 ...

本公司监事会及全体监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、准确性和完整性承担法律责任。 一、监事会会议召开情况 证券代码：688331 证券简称：荣昌生物 公告编号： 2024-046 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 第二届监事会第十二次会议决议公告 监事会认为：公司 2024 年半年度报告的编制和审议程序符合法律、法规和 《公司章程》等各项规定，内容与格式符合中国证券监督管理委员会和上海证券 交易所、香港联合交易所的各项规定，所包含的信息真实、准确、完整地反映出 公司报告期内的经营情况和财务状况等事项；不存在任何虚假记载、误导性陈述 或者重大遗漏；也未发现参与公司 2024 年半年度报告及其摘要编制和审议的人 员有违反保密规定及损害公司利益的行为。 表决结果：有效表决票共 3 票，其中同意票为 3 票，反对票为 0 票，弃权票 为 0 票。 2. 审议通过 《关于<2024 年半年度募集资金存放与实际使用情况的专项报 告>的议案》 监事会认为：公司 2024 年半年度募集资金的存放与使用符合《上市公司监 管指引第 2 号 ...

一、"聚焦经营主业，提升核心竞争力"相关措施的实施情况 报告期内，公司持续专注于主营业务的发展，不断提高自身竞争 力，并取得了一定的成效。 1、临床研发方面：公司积极推动泰它西普、维迪西妥单抗、RC88 等分子的临床研究，取得了一系列成果： （1）2024 年 7 月，泰它西普(商品名：泰爱®)新适应症上市申请 获得中国国家药品监督管理局（NMPA）批准，具体为：泰它西普与甲 氨蝶呤联合，用于对甲氨蝶呤疗效不佳的中、重度活动性类风湿关节 炎（RA）成人患者。这是泰它西普在中国获批的第 2 项适应症，其系 统性红斑狼疮适应症（SLE）已于 2021 年 3 月获批国内上市。 （2）2024 年 6 月，维迪西妥单抗(商品名：爱地希®)治疗 HER2 阳性存在肝转移的晚期乳腺癌患者的Ⅲ期临床取得阳性结果，达到主 要研究终点。 （3）2024 年 6 月，2024 年 ASCO 大会公布了 RC88 在铂耐药卵巢 癌中的临床数据，其客观缓解率取得了明显高出标准疗法的惊艳结果。 （4）2024 年 5 月，泰它西普治疗原发性干燥综合征（pSS）的国 内Ⅲ期临床试验已完成全部患者入组。 荣昌生物制药（烟台）股份有限公司 ...

R&D Investment and Product Development - The company is committed to maintaining a significant scale of R&D investment for ongoing product clinical research and global trials, which may lead to increased short-term losses[4]. - The company is actively developing a pipeline of innovative therapies across multiple disease treatment areas[4]. - The company is focused on developing innovative biopharmaceuticals, particularly in the field of antibody drugs, to meet unmet clinical needs[25]. - The company reported a total R&D investment of ¥806,232,656.31, representing a 49.18% increase compared to the previous year[50]. - The company has established three core technology platforms with independent intellectual property rights, enhancing its drug discovery and development capabilities[42]. - The company is actively preparing for clinical trials for several dual/multi-specific antibodies targeting various diseases, including tumors and autoimmune conditions[43]. - The company is focused on increasing research and development investment to enhance its competitive edge in the market[123]. Financial Performance - The company's operating revenue for the first half of the year reached ¥741,756,779.89, a 75.59% increase compared to ¥422,427,546.05 in the same period last year[17]. - The net profit attributable to shareholders was -¥780,459,767.69, compared to -¥703,360,797.19 in the previous year, indicating a continued loss[17]. - The total assets increased by 4.09% to ¥5,754,539,046.77 from ¥5,528,240,704.59 at the end of the previous year[18]. - The basic earnings per share for the first half of the year was -¥1.45, a decrease from -¥1.30 in the same period last year[19]. - The company's R&D investment accounted for 108.69% of operating revenue, down from 127.94% year-on-year, reflecting a 19.25% decrease[19]. - The company reported a weighted average return on equity of -25.62%, a decrease of 10.52 percentage points from -15.10% in the previous year[19]. - The company achieved a revenue of 742 million yuan in the reporting period, representing a 75.59% increase compared to 422 million yuan in the same period last year[61]. Market Position and Strategy - The company is actively pursuing market expansion strategies and new product development to enhance its competitive position in the biopharmaceutical sector[12]. - The company is exploring Taitasib for additional autoimmune diseases, including antiphospholipid syndrome and thrombocytopenia[31]. - The company plans to expand its market presence in Southeast Asia, targeting a 30% increase in market share by the end of 2025[119]. - The company is committed to maintaining a stable dividend policy, with a proposed dividend payout ratio of 40% for the fiscal year[119]. - The company is focused on expanding its commercialization efforts for multiple indications and products, aiming to improve its financial performance and achieve profitability[68]. Clinical Trials and Approvals - The product "Taitasip" (RC18) received full approval in China for the treatment of systemic lupus erythematosus, following conditional approval in November 2023[26]. - The company is involved in clinical trial management through Site Management Organizations (SMOs) to enhance trial quality and compliance with regulations[11]. - The company’s ADC drug, RC48, has received dual breakthrough therapy designation from both the FDA and China's regulatory authority, highlighting its clinical significance[31]. - Taitasib's clinical trial for treating severe myasthenia gravis in China completed patient enrollment in 2023, with results published in a top international journal[27]. - The company plans to submit new drug applications for Taitasib in various indications, reflecting its commitment to expanding its product pipeline[31]. Financial Management and Governance - The board of directors has confirmed the authenticity, accuracy, and completeness of the semi-annual report[5]. - The company maintains transparency in its financial disclosures, with reports available on multiple financial news platforms and its official website[15]. - The company has established a dedicated EHS department to manage pollutant emissions and ensure compliance with environmental regulations[101]. - The company has committed to improving its governance structure to enhance operational efficiency and risk management[125]. - The company will utilize funds from its stock issuance to bolster its main business and capitalize on growth opportunities in the seed industry[123]. Risks and Challenges - The company has outlined various risk factors that may impact its operations and financial status in the report[4]. - The company faces risks related to market competition and potential delays in drug approval processes, which could impact future revenues[70]. - The company reported a net cash flow from operating activities of -820 million yuan, indicating reliance on external financing for working capital[72]. - The company’s financial expenses increased significantly due to higher bank loans and interest costs, with a total of 32 million yuan in financial expenses reported[75]. Shareholder and Equity Information - The company has commitments related to share lock-up periods and restrictions on share transfers, effective from March 31, 2022, until March 31, 2026[110]. - The company will automatically extend the lock-up period by six months if the closing price of A-shares falls below the issue price for a continuous period of twenty trading days[111]. - The company has established a policy to ensure that any share reductions post-lock-up will not be below the IPO price[117]. - The company reported a total of RMB 32,344,000 in related party transactions during the reporting period, with RMB 12,292,070 being the amount incurred[143]. - The company’s registered capital is CNY 544,263,003.00, with a total of 54,426,301 shares issued at a price of CNY 48.00 per share during the IPO[188].

| 证券代码：688331 | 证券简称：荣昌生物 | 公告编号：2024-045 | | --- | --- | --- | | 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 荣昌生物制药（烟台）有限公司（以下简称"公司"或"荣昌生物"）自主研发的 BLyS/APRIL 双靶点融合蛋白创新药泰它西普（RC18，商品名：泰爱®）用于治疗全身型 重症肌无力（gMG）的Ⅲ期临床研究，达到方案设计的临床试验主要研究终点。现将情 况公告如下： 一、 基本情况介绍 本研究是一项多中心、随机、双盲、安慰剂对照的Ⅲ期临床研究。旨在评价泰它西 普用于治疗全身型重症肌无力患者的有效性和安全性。 重症肌无力（MG）是一种罕见的、慢性自身免疫性疾病，由针对突触后膜上乙酰胆 碱受体、肌肉特异性激酶或其他乙酰胆碱受体相关蛋白的自身抗体引起，可不同程度影 响眼球运动、吞咽、言语、活动和呼吸功能，约 85%的患者会出现眼肌以外的症状，发 展为全身型重症肌无力，已被纳入我国《第一批罕见病目录》。根据弗若斯特沙利文报 告，全球重症肌无力患者人数预计 2025 年达到 114.60 万，中国患者人数约为 ...

| 证券代码：688331 | 证券简称：荣昌生物 | 公告编号：2024-044 | | --- | --- | --- | | 港股代码：09995 | 港股简称：榮昌生物 | | 关于变更部分高级管理人员的公告 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、准确性和完整性承担法律责任。 截至本公告披露日，何如意先生持有 A 股持股 4,840 股，H 股持股 1,771,951 股， 共计 1,776,791 股。何如意先生承诺将继续遵守《上海证券交易所科创板股票上市规则》 《上海证券交易所上市公司股东及董事、监事、高级管理人员减持股份实施细则》等相 关法律法规对股份转让的规定及公司首次公开发行股票时所作的相关承诺。 荣昌生物制药（烟台）股份有限公司（以下简称"公司"）于近日任命何如意先生 为公司首席战略官，何如意先生将继续担任公司董事且为核心技术人员，将不再担任公 司首席医学官及高级管理人员。根据《上海证券交易所科创板股票上市规则》《上海证 券交易所科创板上市公司自律监管指引第 1 号——规范运作》《公司章程》等有关规定， 何如意先生的职务调整于 ...