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：2024-040 | | --- | --- | | 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 2024 年度向特定对象发行 A 股股票预案（修订稿） 披露的提示性公告 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。 荣昌生物制药（烟台）股份有限公司（以下简称"公司"）于 2024 年 7 月 24 日召开第二届董事会第十四次会议和第二届监事会第十一次会议，审议通过了《关 于调整公司向特定对象发行股票方案的议案》《关于公司向特定对象发行股票预 案（修订稿）的议案》等相关议案，对公司 2024 年度向特定对象发行 A 股股票预 案进行了修订，相关文件于 2024 年 7 月 25 日在上海证券交易所网站 （www.sse.com.cn）披露，敬请广大投资者注意查阅。 本次向特定对象发行股票预案（修订稿）披露事项不代表审批机关对本次向 特定对象发行股票相关事项的实质性判断、确认或批准，预案所述本次向特定对 象发行 A 股股 ...

证券代码：688331 证券简称：荣昌生物 公告编号：2024-042 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 2024 年度向特定对象发行 A 股股票 摊薄即期回报及填补措施与相关主体承诺 （修订稿）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。 荣昌生物制药（烟台）股份有限公司（以下简称"公司""上市公司"或"荣 昌生物"）拟向特定对象发行 A 股股票（以下简称"本次向特定对象发行股票" 或"本次发行"）。根据《国务院办公厅关于进一步加强资本市场中小投资者合法 权益保护工作的意见》（国办发[2013]110 号）《国务院关于进一步促进资本市场 健康发展的若干意见》（国发[2014]17 号）和《关于首发及再融资、重大资产重 组摊薄即期回报有关事项的指导意见》（证监会公告[2015]31 号）等法律、法规、 规章及其他规范性文件的要求，为保障中小投资者利益，公司就本次向特定对象 发行股票事项对即期回报摊薄的影响进行了分析，结合实际情况提出了具体的填 补回报措施，且相关主体对填 ...

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 RemeGen Co., Ltd. （中国（山东）自由贸易试验区烟台片区烟台开发区北京中路 58 号） 2024 年度向特定对象发行 A 股股票 募集资金使用的可行性分析报告 （修订稿） 二〇二四年七月 荣昌生物制药（烟台）股份有限公司 2024年度向特定对象发行A股股票 募集资金使用的可行性分析报告（修订稿） 一、本次募集资金使用计划 荣昌生物制药（烟台）股份有限公司（以下简称"荣昌生物"或"公司") 为 进一步增强公司综合竞争力，根据公司业务发展需要，拟向特定对象发行股票募 集资金总额不超过195,292.12万元（含本数），募集资金总额扣除相关发行费用后 的净额将用于投资以下项目： 单位：万元 1、项目基本情况 公司是一家具有全球化视野的创新型生物制药企业，为满足市场不断增长的 需求，推动公司创新药物的研发进程，巩固并进一步提高公司的核心竞争力，公 司及其全资子公司上海荣昌生物科技有限公司作为该项目的实施主体，拟使用募 集资金195,292.12万元用于创新药物的研究与开发，包括RC18、RC48、RC28、 RC88、RC1 ...

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 56.00, representing a potential upside of 86.7% from the current price of HKD 30.00 [9][10]. Core Insights - The company reported strong product sales in Q1 2024, with revenue reaching RMB 330 million, a year-on-year increase of 96.4% and a quarter-on-quarter growth of 5.4%. The net loss narrowed to RMB 350 million, down from RMB 480 million in Q4 2023, aided by a reduction in sales and R&D expenses [1][2]. - The management has guided for over 50% revenue growth for the full year 2024, with expectations of further declines in R&D and sales expense ratios. The company anticipates a funding requirement of approximately RMB 1.5 to 2 billion for the year [1][2]. - The upcoming ASCO conference will showcase 16 clinical study results, including the first human data for the mesothelin ADC RC88, which is being compared with other treatments [2]. - The company is progressing with its international expansion, with significant milestones expected in 2024, including the initiation of Phase III trials for its products [2][3]. Financial Summary - Revenue projections for the company are as follows: RMB 1.663 billion in 2024, RMB 2.503 billion in 2025, and RMB 3.728 billion in 2026, with net losses expected to gradually narrow [3][10]. - The company reported a cash balance of RMB 620 million as of Q1 2024, with an additional bank credit line of RMB 4 billion, ensuring operational sustainability until breakeven [1][2]. - The financial outlook includes a projected EBIT of RMB 821 million by 2027, indicating a path towards profitability [6][10].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 37.02, indicating a potential upside of 24.2% from the current price of HKD 29.80 [2][3]. Core Insights - The company is expected to achieve a revenue of CNY 1.08 billion in 2023, representing a year-on-year growth of 40.2%. However, it is projected to incur a net loss of CNY 1.51 billion, which is an increase of 51.3% compared to the previous year [1]. - The company has seen a recovery in Q1 2024, with revenues reaching CNY 330 million, a quarter-on-quarter increase of over 13%, and a reduction in net loss by 27.4% to CNY 349 million [1]. - The company plans to initiate an A-share private placement to raise CNY 2.55 billion, aimed at supporting innovative drug research and development [1]. Summary by Sections Financial Performance - The company reported a total revenue of CNY 1.08 billion for 2023, with a year-on-year growth of 40.2%. The net loss for the year is projected at CNY 1.51 billion, which is a 51.3% increase from the previous year [1]. - In Q1 2024, the company achieved revenues of CNY 330 million, with a quarter-on-quarter growth of over 13% and a net loss reduction of 27.4% to CNY 349 million [1]. Funding and Financial Strategy - As of the end of Q1 2024, the company had CNY 620 million in cash and equivalents. It is actively seeking various financing tools to increase cash reserves, in addition to a CNY 4.4 billion loan obtained in Q1 [1]. - The company announced plans for a private placement to raise CNY 2.55 billion, which will be fully allocated to support innovative drug development [1]. Product Pipeline and Market Potential - The company is advancing its product pipeline, with multiple candidates entering Phase III clinical trials, including indications for SLE, MG, pSS, and IgAN [2]. - The company is facing a strategic decision regarding the timing of data release for its product, which could impact potential overseas licensing agreements and FDA approval [2]. - The oncology pipeline is set to present up to 16 research data points at the upcoming ASCO conference, which could provide significant insights into the company's future growth [2].

Investment Rating - The report assigns an "Buy" rating for Rongchang Biopharma (9995.HK) [3][6] Core Insights - Rongchang Biopharma is positioned as a pioneer in the domestic autoimmune and oncology sectors, with a comprehensive capability from R&D to commercialization, and is advancing multiple clinical studies overseas [7][14] - The company has successfully launched two products: VidiXimab, the first domestic ADC, and Taitasip, the first domestic biological agent for systemic lupus erythematosus (SLE) [14][24] - The report anticipates significant revenue growth, projecting revenues of 16.1 billion, 21.7 billion, and 28.9 billion CNY for 2024, 2025, and 2026 respectively [6][8] Summary by Sections Company Overview - Rongchang Biopharma was established in 2008 and focuses on discovering, developing, and commercializing innovative biopharmaceuticals targeting major diseases such as autoimmune disorders and cancer [14][18] - The company has a strong executive team with extensive experience in the pharmaceutical industry, enhancing its strategic planning and operational capabilities [18][20] Product Pipeline - The company has eight products in clinical trials, with VidiXimab and Taitasip already approved for commercialization [14][15] - Taitasip is positioned as a potential global best-in-class (BIC) and first-in-class (FIC) product for SLE, with multiple ongoing clinical studies [35][40] - VidiXimab has been recognized as the first domestic ADC and has established a partnership with Seagen for global development [24][30] Financial Projections - The report estimates revenues for VidiXimab to be 7.6 billion, 8.5 billion, and 11.7 billion CNY for 2024, 2025, and 2026 respectively [8][6] - Taitasip is projected to generate revenues of 7.6 billion, 12.4 billion, and 15.9 billion CNY over the same period [8][6] Market Potential - The report highlights the significant market potential for VidiXimab in gastric cancer and urothelial carcinoma, with a large patient base and promising early clinical data [25][30] - The global market for ADCs is expected to grow, with VidiXimab leading the way in the domestic market [24][30] Conclusion - The report concludes with a total valuation of Rongchang Biopharma at 241 billion CNY, equivalent to 265 billion HKD, supporting the "Buy" rating [6][8]

Investment Rating - The report maintains a "Hold" rating for Rongchang Biologics (9995.HK) with a target price of HKD 33 [2][4]. Core Views - The net loss for Q1 2024 was in line with expectations, with revenue reaching RMB 330 million, representing a year-on-year increase of 96.41% and a quarter-on-quarter increase of 6.6%. The net loss was RMB 349 million, up 7.8% year-on-year but down 27.4% quarter-on-quarter, primarily due to better-than-expected gross margin and lower operating expenses [2]. - The company maintains its revenue guidance for 2024, projecting a 50% year-on-year increase, driven by sales from two listed products, RC18 and RC48, both expected to grow by over 50% [2]. - The A-share private placement of RMB 2.55 billion is still pending regulatory approval, with no clear timeline for issuance. The funds will support innovative drug development [2]. - Key catalysts for 2024 include potential overseas licensing for RC18, approval for RA indications in China, and data readouts for RC48 and RC88 at the 2024 ASCO conference [2]. Financial Summary - Q1 2024 revenue was RMB 330 million, with a gross margin of 77.5%, slightly down from 4Q23 [2]. - The company expects total revenue of RMB 1.6 billion in 2024, with a projected net loss of RMB 1.39 billion [6][8]. - The financial outlook includes a significant increase in revenue from RMB 1.08 billion in 2023 to RMB 1.61 billion in 2024, with continued losses expected to decrease over the following years [6][8].

Financial Performance - The company's revenue for Q1 2024 was CNY 330,434,802.62, representing a 96.41% increase compared to the same period last year[5]. - Total operating revenue for Q1 2024 was CNY 330,434,802.62, a significant increase from CNY 168,238,991.99 in Q1 2023, representing a growth of approximately 96.5%[18]. - Total operating costs for Q1 2024 reached CNY 682,453,542.19, compared to CNY 506,546,573.98 in Q1 2023, indicating an increase of about 34.7%[18]. - Net loss for Q1 2024 was CNY 348,921,696.49, compared to a net loss of CNY 323,774,631.80 in Q1 2023, showing an increase in loss of about 7.8%[19]. - The total comprehensive loss for Q1 2024 was CNY -372,204,285.59, compared to CNY -326,630,103.58 in Q1 2023, reflecting an increase in comprehensive loss of about 13.9%[19]. Cash Flow - The net cash flow from operating activities was a negative CNY 426,289,929.83[5]. - Cash flow from operating activities resulted in a net outflow of CNY -426,289,929.83 in Q1 2024, worsening from CNY -349,845,397.38 in Q1 2023[20]. - Cash flow from investing activities showed a net outflow of CNY -81,362,490.71 in Q1 2024, compared to CNY -584,089,411.54 in Q1 2023, indicating a reduction in outflow[21]. - Cash flow from financing activities generated a net inflow of CNY 401,987,661.35 in Q1 2024, contrasting with an outflow of CNY -47,838,016.27 in Q1 2023[21]. - The ending cash and cash equivalents balance as of Q1 2024 was CNY 619,732,575.42, down from CNY 1,086,332,437.19 at the end of Q1 2023[21]. Shareholder Information - The company reported a total of 5,422 common shareholders at the end of the reporting period[10]. - The top shareholder, HKSCC NOMINEES LIMITED, held 189,566,728 shares, accounting for 34.83% of total shares[10]. - The company had a total of 5,422 shareholders as of the reporting date, with 5,397 being A-share holders and 25 being H-share holders[12]. - The top 10 shareholders held a total of 189,566,728 shares, representing a significant portion of the company's equity[12]. Assets and Liabilities - Total assets at the end of the reporting period were CNY 5,478,656,892.82, a decrease of 0.90% from the previous year[6]. - The total liabilities as of March 31, 2024, were RMB 2,400,104,697.08, compared to RMB 2,090,972,550.70 at the end of 2023, indicating an increase in liabilities[16]. - The total equity attributable to shareholders decreased to RMB 3,078,552,195.74 from RMB 3,437,268,153.89[17]. - The company reported a net loss of RMB 3,202,432,084.51 in retained earnings as of March 31, 2024, compared to a loss of RMB 2,853,510,388.02 at the end of 2023[17]. - The inventory increased to RMB 751,473,242.66 from RMB 741,559,576.19, reflecting a rise in stock levels[16]. - The company’s short-term borrowings rose significantly to RMB 574,000,648.97 from RMB 284,276,638.87, indicating increased leverage[16]. Research and Development - Research and development expenses totaled CNY 331,178,800.01, an increase of 32.62% year-on-year[6]. - The ratio of R&D expenses to revenue was 100.23%, a decrease of 48.20 percentage points due to the significant increase in revenue[6][9]. - Research and development expenses amounted to CNY 331,178,800.01 in Q1 2024, up from CNY 249,722,218.25 in Q1 2023, reflecting a rise of approximately 32.5%[18]. Earnings Per Share - Basic and diluted earnings per share were both -CNY 0.65[6]. - The company reported a basic and diluted earnings per share of CNY -0.65 for Q1 2024, compared to CNY -0.60 in Q1 2023[19].