| 证券代码：688331 | 证券简称：荣昌生物 | 公告编号：2024-050 | | --- | --- | --- | | 港股代码：09995 | 港股简称：榮昌生物 | | 关于独立董事辞职的公告 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。 鉴于马兰女士辞职将导致公司独立董事人数少于董事会成员的三分之一，根据《中 华人民共和国公司法》《上市公司独立董事管理办法》《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》以及《公 司章程》等相关规定，其辞职报告将在新的独立董事到任之日或者独立董事人数不少于 公司董事会人数的三分之一起生效，在此之前，马兰女士仍将按照有关法律法规和《公 司章程》的规定继续履行职责。公司将按照相关规定，尽快完成新任独立董事的补选工 作。 马兰女士在担任公司独立董事期间，勤勉尽责、客观独立，在促进公司规范运作等 方面发挥了积极有效的作用，公司及董事会对马兰女士任职期间为公司及董事会工作所 做出的贡献表示衷心感谢！ 特此公告。 荣昌生物制药（烟 ...

Investment Rating - The report maintains a "Buy" rating for the company [3] Core Insights - The company has achieved rapid revenue growth, with a total revenue of 1.209 billion yuan for the first three quarters of 2024, representing a year-on-year increase of 57.10%. The net profit attributable to the parent company was -1.071 billion yuan, a decrease of 3.96% year-on-year [6] - The company’s gross profit margin has significantly improved, reaching 79.75% for the first three quarters of 2024, up by 2.86 percentage points year-on-year. In Q3 alone, the gross profit margin was 82.11%, an increase of 5.86 percentage points year-on-year [6] - The company has a strong cash reserve of approximately 1.12 billion yuan and a loan credit limit of about 2.8 billion yuan, indicating solid financial health [6] Summary by Sections Revenue and Profitability - For Q3 2024, the company reported a revenue of 467 million yuan, a year-on-year increase of 34.60% and a quarter-on-quarter increase of 13.56%. The net profit attributable to the parent company for Q3 was -291 million yuan, showing an 11.08% increase year-on-year and a 32.57% increase quarter-on-quarter [6] - The company’s R&D expense ratio was 95.41% for the first three quarters of 2024, down by 16.09 percentage points year-on-year, while the selling expense ratio was 51.51%, down by 18.64 percentage points [6] Product Development - The NDA for the third indication of Taitasip has been accepted, with the drug now fully approved for SLE in China and undergoing Phase III clinical trials in the US. The drug has also received approval for rheumatoid arthritis in July 2024 and has a listing application for myasthenia gravis accepted in October 2024 [7] - The company is expanding the indications for Vidisizumab in ulcerative colitis (UC), gastric cancer (GC), and breast cancer (BC), with ongoing clinical trials showing positive signals [8] Future Projections - The company is expected to achieve revenues of 1.586 billion yuan, 2.175 billion yuan, and 2.952 billion yuan for 2024, 2025, and 2026 respectively. The net profit attributable to the parent company is projected to be -1.138 billion yuan, -987 million yuan, and -356 million yuan for the same years [8]

1 证券代码：688331 证券简称：荣昌生物 荣昌生物制药（烟台）股份有限公司 投资者关系活动记录表 | --- | --- | --- | |----------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | □ 特定对象调研 | 分析师会议 | | 投资者关系活动 | □ 媒体采访 | □ 业绩说明会 | | 类别 | □ 新闻发布会 | □路演活动 | | | □ 现场参观 | 其他 | | 参与单位名称 | | 华泰证券、海通证券、兴业证券、方正医药、上海博颐投资、东吴证 | | | | 券、东方证券、东海证券、中信资管、中金公司、固禾基金、国泰基 | | | | 金、国金医药、大家资产、摩旗投資、新华资管、景领投资、 ...

Investment Rating - The report does not specify a clear investment rating for the company [1] Core Insights - The company reported a third-quarter revenue of 470 million yuan, representing a year-on-year increase of 34.6% [1] - For the first nine months of 2024, total revenue reached 1.21 billion yuan, up 57.1% compared to the same period last year [1] - The product sales expense ratio for the first nine months was 51.5%, a decrease of 18.6 percentage points year-on-year [1] - The gross profit margin for the first nine months improved to 79.8%, an increase of 2.9 percentage points year-on-year [1] - Research and development expenses in the third quarter amounted to 350 million yuan, a decrease of 26.9% from the second quarter [1] - The net loss for the third quarter was 290 million yuan, a reduction of 32.6% compared to the second quarter [1] Financial Performance - The company is expected to achieve revenues of 1.64 billion yuan, 2.15 billion yuan, and 3.17 billion yuan for the years 2024, 2025, and 2026, respectively [4] - The projected growth rates for revenue are 51.5% in 2024, 31.3% in 2025, and 47.2% in 2026 [4] - The net profit attributable to the parent company is forecasted to be -1.51 billion yuan in 2024, -1.35 billion yuan in 2025, and 561 million yuan in 2026 [4] - The earnings per share (EPS) is expected to be -2.78 yuan in 2024, -2.49 yuan in 2025, -1.00 yuan in 2026, and 1.03 yuan in 2026 [4] - The return on equity (ROE) is projected to improve from -64.94% in 2024 to 26.68% in 2026 [4] Clinical Development - The application for the listing of Taitasip for the treatment of myasthenia gravis was officially accepted in October 2024, following the achievement of primary research endpoints in August 2024 [2] - The company has completed patient enrollment for the phase III clinical trial of Taitasip for Sjögren's syndrome in China and received fast track designation in the U.S. in April 2024 [2] - The phase III clinical trial for IgA nephropathy (IgAN) has also completed patient enrollment [2] - The company is conducting a phase III international multicenter clinical study of Taitasip for systemic lupus erythematosus (SLE) in the U.S. [2] - The company is exploring the use of Vidisizumab for various indications, including HER2-positive breast cancer, with ongoing clinical trials [3]

第一表达在鲁县,在山西这个工作呢已经是目前进入到了数据的期末阶段那么预计呢大概在2025年的第一季度会有数据的特殊阶段的登出这个也就快到了最关键的这是这个2048国内的情况我们海湾呢这个跟辉烈合作那么这个丹药 三药四疗二线的上面的关键临床实验这个实验的辉瑞正在进行推进当中这个BMI的申报时间呢现在要根据现在这个辉瑞将根据一线的三期的进展最终与FDA沟通确认这个申报的时间这个是因为对FDA这些要求呢是对三期 它的进展有联系虽然这个三支的研究呢就是联合匹利物联合资料的一线的尿露双别的三支的研发实验归类有分为这个推举和指导中这个三支的进展呢就是要现在呢就是说说以前比那时明显加快了所以这个时也是一个就是说速度比以前快了 主要是入宿的病人家的意愿明显增加了然后还有一些辉瑞生物科技工作一个是联合突发基尼的资料晚期的颅腺癌和胃癌的二期针对入宿病例另外还有丹药的资料散投颈癌、肥皂细胞皮癌等多数时期有的二期的探测性的工作也针对入宿当中 归类给RC-48的推进方案还是有不少的工作得做那么这是两个商务产品的情况在这一桩实验然后其他的种类产品就是RC-88目前我们在联合RC-88体检秘书把下的AED所以说我们目前其中在联合PTV治疗 ...

Investment Rating - The report maintains a "Hold" rating for Rongchang Biologics with a target price of HKD 26.0 for the Hong Kong stock and RMB 35.0 for the A-share [11][18]. Core Insights - Rongchang Biologics' Q3 2024 revenue met expectations, with a significant improvement in net loss primarily due to effective control of R&D expenses. The company reported a revenue of RMB 470 million, a year-on-year increase of 34.6% and a quarter-on-quarter increase of 13.6% [11][12]. - The gross margin for Q3 2024 was 82.1%, showing a significant year-on-year and quarter-on-quarter improvement, attributed to the economic effect of increased revenue scale [11]. - The management indicated that the sales of Taitasip reached approximately RMB 270 million in Q3 2024, with a 43% year-on-year increase, driven by enhanced market access and recognition of product efficacy [12]. - R&D expenses for Q3 2024 were RMB 350 million, reflecting a 9.3% year-on-year increase but a 26.9% quarter-on-quarter decrease, indicating effective cost management [14]. Financial Summary - For 2024E, the company expects total revenue of RMB 1.769 billion, with a year-on-year growth of 64.4%. The net loss is projected to be RMB 1.34 billion [19]. - The report forecasts a gradual improvement in net loss over the next few years, with estimates of RMB 1.165 billion for 2025E and RMB 816 million for 2026E [18][19]. - The cash and cash equivalents as of September 30 were RMB 1.12 billion, with a loan credit line of RMB 2.8 billion, indicating a solid liquidity position [11].

Revenue and Profitability - Revenue for Q3 2024 reached ¥467,117,500.34, representing a year-on-year increase of 34.60%[3] - Net profit attributable to shareholders was -¥290,966,871.21, with a cumulative net profit of -¥1,071,426,638.90 year-to-date[3] - Total operating revenue for the first three quarters of 2024 reached ¥1,208,874,280.23, a significant increase from ¥769,470,314.65 in the same period of 2023, representing a growth of approximately 56.9%[16] - Net profit for the third quarter of 2024 was a loss of ¥1,071,426,638.90, slightly worse than the loss of ¥1,030,585,859.60 in the same quarter of 2023[19] - The company reported a basic and diluted earnings per share of ¥-1.99 for the third quarter of 2024, compared to ¥-1.91 in the same quarter of 2023[19] Research and Development - Research and development expenses totaled ¥347,174,784.03, accounting for 74.32% of revenue, a decrease of 17.17 percentage points compared to the previous year[4] - Research and development expenses for the first three quarters of 2024 amounted to ¥1,153,407,440.34, up from ¥857,977,852.40 in 2023, reflecting a growth of approximately 34.4%[18] - The company experienced a decline in equity attributable to shareholders, down 31.09% due to increased losses from R&D investments[7] - Future outlook includes continued focus on research and development of new products and technologies to drive growth[12] Assets and Liabilities - Total assets at the end of the reporting period were ¥5,712,713,413.00, an increase of 3.34% from the previous year[4] - The company's current assets totaled RMB 2,524,007,322.36, up from RMB 2,228,931,955.16 at the end of 2023, indicating a growth of approximately 13.2%[13] - Total liabilities as of the end of the third quarter of 2024 were ¥3,344,032,874.19, compared to ¥2,090,972,550.70 in 2023, showing an increase of about 60.0%[18] - The total equity attributable to shareholders of the parent company was ¥2,368,680,538.81, down from ¥3,437,268,153.89 in the previous year, indicating a decrease of approximately 30.9%[18] Cash Flow - Cash flow from operating activities was not applicable for the current period, with a cumulative negative cash flow of -¥835,103,066.88 year-to-date[3] - Cash inflow from operating activities totaled ¥1,222,172,614.37 for the first three quarters of 2024, compared to ¥718,145,797.69 in 2023, marking an increase of about 70.0%[20] - Cash flow from operating activities for the first three quarters of 2024 was negative at ¥-835,103,066.88, an improvement compared to ¥-1,114,762,180.68 in the same period of 2023[20] - Net cash flow from investment activities was -¥425.81 million, an improvement from -¥920.37 million year-over-year[21] - Total cash inflow from financing activities reached ¥1,316.63 million, up from ¥659.28 million, representing a 99.5% increase[21] - Net cash flow from financing activities was ¥1,202.06 million, compared to ¥511.63 million in the previous period, showing a significant increase of 134%[21] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 7,618[8] - The company reported a total of 7,594 A-share common stockholders and 24 H-share common stockholders as of the report date[11] - The top 10 shareholders held a total of 189,566,728 shares, representing 34.83% of the total shares outstanding[9] Market Position and Strategy - The company reported a significant increase in sales of injectable drugs, specifically TaiTasi and VidiXimab, contributing to revenue growth[7] - The company has engaged in strategic partnerships and investments to enhance its market position and expand its product offerings[12] Government Support - Government subsidies recognized in the current period amounted to ¥17,816,478.70, impacting the overall financial performance positively[5]

荣昌生物制药（烟台）股份有限公司（以下简称"公司"）第二届监事会第 十三次会议，于 2024 年 10 月 29 日在公司会议室以现场方式召开，会议已于 2024 年 10 月 15 日以邮件方式发出会议通知。会议应出席监事 3 名，实际出席 监事 3 名，会议由任广科先生主持，会议的召集、召开、表决程序符合《中华人 民共和国公司法》和《荣昌生物制药（烟台）股份有限公司章程》（以下简称"《公 司章程》"）的相关规定，所作决议合法有效。经与会监事表决，会议形成如下 决议： 二、监事会会议审议情况 1、审议通过《关于公司<2024 年第三季度报告>的议案》 监事会认为：公司《2024 年第三季度报告》的编制及审议程序均符合法律、 法规、规范性文件和《公司章程》的要求，格式和内容符合上海证券交易所的各 项规定，报告内容真实、准确、完整地反映了公司本报告期经营管理和财务状况， 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 年第 三季度报告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。 | 证券代码：688331 | 证券简称：荣昌生物 公告编号：2024-049 | | --- | - ...

Financial Performance - The company's operating revenue for Q3 2024 was ¥467,117,500.34, representing a year-on-year increase of 34.60%[2] - The net profit attributable to shareholders was -¥290,966,871.21, with a year-to-date net profit of -¥1,071,426,638.90[2] - Total operating revenue for the first three quarters of 2024 reached ¥1,208,874,280.23, a significant increase from ¥769,470,314.65 in the same period of 2023, representing a growth of approximately 56.9%[14] - The net loss for the first three quarters of 2024 was ¥1,071,426,638.90, compared to a net loss of ¥1,030,585,859.60 in the same period of 2023, showing a slight increase in losses[16] - The basic and diluted earnings per share were both -¥0.54 for Q3 2024, with a year-to-date figure of -¥1.99[3] - The basic and diluted earnings per share for the first three quarters of 2024 were both -¥1.99, compared to -¥1.91 in 2023, indicating a slight deterioration in per-share performance[17] Research and Development - Research and development expenses totaled ¥347,174,784.03 in Q3 2024, accounting for 74.32% of operating revenue, a decrease of 17.17 percentage points compared to the same period last year[3] - Research and development expenses surged to ¥1,153,407,440.34 in the first three quarters of 2024, compared to ¥857,977,852.40 in 2023, reflecting a rise of approximately 34.4%[14] - The total equity attributable to shareholders decreased by 31.09% year-on-year, primarily due to increased losses from higher R&D expenditures[6] Assets and Liabilities - The total assets at the end of the reporting period were ¥5,712,713,413.00, an increase of 3.34% from the end of the previous year[3] - The total liabilities increased to ¥3,344,032,874.19 in 2024 from ¥2,090,972,550.70 in 2023, marking an increase of approximately 60.0%[13] - The total equity attributable to shareholders decreased to ¥2,368,680,538.81 in 2024 from ¥3,437,268,153.89 in 2023, a decline of about 30.9%[13] Cash Flow - The cash flow from operating activities was not applicable for the current period, with a year-to-date net cash flow of -¥835,103,066.88[2] - In the first three quarters of 2024, the company generated cash inflows from operating activities totaling approximately ¥1.22 billion, compared to ¥718.15 million in the same period of 2023, representing a year-over-year increase of 70%[18] - The net cash flow from operating activities for the first three quarters of 2024 was approximately -¥835.10 million, an improvement from -¥1.11 billion in the same period of 2023[18] - The total cash outflow from operating activities was approximately ¥2.06 billion in 2024, compared to ¥1.83 billion in 2023, indicating an increase of about 12%[18] Shareholder Information - The company reported a total of 7,618 shareholders, with 7,594 being A-share holders and 24 being H-share holders[9] - The top 10 shareholders include HKSCC NOMINEES LIMITED holding 189,566,728 shares, representing 34.83% of total shares[9] Government Support - The company received government subsidies amounting to ¥17,816,478.70 during the reporting period, contributing to its other income[4] Interest and Other Income - The company reported a significant increase in interest expenses, which rose to ¥55,598,761.08 in 2024 from ¥13,656,827.51 in 2023[16] - Other comprehensive income after tax for the first three quarters of 2024 was negative at -¥42,366,321.69, compared to -¥7,908,770.97 in 2023, indicating a worsening position[17] Product Development - The company reported a significant increase in sales revenue due to higher sales volumes of its injectable products, specifically TaiTasi and VidiXimab[6] - The company is actively involved in the development of new products and technologies, focusing on market expansion strategies[10]

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 739.66 million, a significant increase of 76.5% compared to RMB 419.07 million for the same period in 2023[6]. - Gross profit for the first half of 2024 was RMB 570.39 million, up from RMB 316.42 million in the same period last year, reflecting a gross margin improvement[6]. - The company reported a pre-tax loss of RMB 780.46 million for the first half of 2024, compared to a pre-tax loss of RMB 703.36 million in the same period of 2023[6]. - The company reported a net loss of RMB 780.5 million for the six months ended June 30, 2024, compared to a net loss of RMB 703.4 million for the same period in 2023[43]. - The total comprehensive loss for the period was RMB 806,453 thousand, compared to RMB 709,024 thousand in the same period of 2023[153]. - The basic loss per share for the period was calculated based on a weighted average number of shares of 537,631,657, slightly down from 539,347,672 in the previous year[178]. Assets and Liabilities - Total assets as of June 30, 2024, reached RMB 5,754.54 million, an increase from RMB 5,528.24 million as of December 31, 2023[6]. - Total liabilities as of June 30, 2024, were RMB 3,089.93 million, compared to RMB 2,090.97 million as of December 31, 2023, indicating increased leverage[6]. - Total equity decreased to RMB 2,664.61 million as of June 30, 2024, from RMB 3,437.27 million as of December 31, 2023[6]. - The debt-to-asset ratio increased to 53.7% as of June 30, 2024, compared to 37.8% as of December 31, 2023[45]. - Cash and cash equivalents decreased to RMB 673,322 thousand from RMB 726,552 thousand, indicating a reduction in liquidity[155]. Research and Development - Research and development expenses increased to RMB 806.23 million in the first half of 2024, compared to RMB 540.45 million in the same period of 2023, indicating a focus on innovation[6]. - The company has a robust pipeline with over ten drug candidates, seven of which are in clinical development targeting more than twenty indications[7]. - The company is exploring Taitasip's potential for treating other autoimmune diseases, including antiphospholipid syndrome and thrombocytopenia[14]. - The company has received breakthrough therapy designation for Taitasip in gMG from the FDA in the U.S.[13]. Clinical Trials and Approvals - Taitasip (RC18) received full NMPA approval for systemic lupus erythematosus (SLE) in China in November 2023, with successful inclusion in the national medical insurance catalog by the end of 2023[11]. - A Phase III clinical trial for Taitasip in rheumatoid arthritis (RA) yielded positive results in Q2 2023, with a BLA submitted to NMPA in August 2023 and approval expected in July 2024[12]. - The company initiated a Phase III clinical trial for generalized myasthenia gravis (gMG) in China in H1 2023, with primary endpoints expected to be met by August 2024[13]. - The global Phase III trial for SLE is ongoing, addressing significant unmet medical needs[11]. Market Presence and Products - RemeGen has commercialized two products, RC18 (brand name: Tai'ai®) and RC48 (brand name: Aidiqi®), which are undergoing clinical trials in China and the United States[7]. - The company aims to become a leading player in the global biopharmaceutical industry by addressing unmet medical needs in autoimmune, oncology, and ophthalmology diseases[7]. - The company is actively expanding its market presence for TaiTasi and Vidisizumab in China while accelerating the clinical trial processes for pipeline products[33]. Shareholder Structure and Incentives - As of June 30, 2024, the total number of shares outstanding is 544,332,083, comprising 354,750,844 A shares and 189,581,239 H shares[59]. - The company has established partnerships with several limited partnerships for employee incentive plans, holding a total of 102,381,891 A shares among them[59]. - The company has implemented a restricted stock incentive plan for its executives, which includes performance-based conditions[60]. - Major shareholders include RongChang Holding Group LTD. with 53.25% of A shares and 11.47% of H shares, and Wang Xudong holding 54.41% of A shares and 13.31% of H shares[63][64]. Financial Management and Cash Flow - The net cash used in operating activities was RMB 826.3 million for the six months ended June 30, 2024, with cash and cash equivalents decreasing from RMB 726.6 million as of December 31, 2023, to RMB 673.3 million as of June 30, 2024[44]. - The company reported a decrease in cash and cash equivalents of RMB (55,065) thousand for the first half of 2024, compared to a decrease of RMB (968,393) thousand in the same period of 2023[160]. - The net cash flow from financing activities for the first half of 2024 was RMB 1,099,497 thousand, a significant increase from RMB 481,741 thousand in the same period of 2023[160]. Corporate Governance - The company has complied with all applicable corporate governance codes during the reporting period[141]. - The independent auditor, Ernst & Young, reviewed the interim financial information for the six months ending June 30, 2024[143]. - The company has adopted a standard code for securities trading by directors and supervisors, confirming compliance during the reporting period[142].