Core Viewpoint - Rongchang Biopharma's innovative drug Telitacicept shows promising results in treating generalized Myasthenia Gravis (gMG), leading to a significant stock price increase [1][2] Company Summary - Rongchang Biopharma's stock rose by nearly 10%, reaching HKD 28.25 with a trading volume of HKD 188 million [1] - The company announced positive Phase III trial results for Telitacicept, with 98.1% of patients showing improvement in daily activity scores and 87% showing significant improvement in quantitative scores after 24 weeks of treatment [1] - The application for Telitacicept's market approval in China for gMG has been accepted by the CDE and is prioritized for review, with expectations for approval in Q2 of this year [1] Industry Summary - According to Jiao Yin International, Telitacicept's Phase III data outperforms existing competitors, indicating a clear commercialization strategy [2] - The commercialization strategy includes increasing specialized representatives in the neuroimmunology field, enhancing physician education, and encouraging clinical experts to explore more cases [2] - The bank is optimistic about the long-term sales growth potential of Telitacicept following its approval for gMG, supported by strong clinical data and a clear marketing strategy [2]

Core Viewpoint - The recent external environment has intensified, impacting the pharmaceutical sector, with the Hang Seng Healthcare Index experiencing significant fluctuations due to news of potential U.S. tariffs on drugs [1] Company Summary - Rongchang Biopharmaceuticals (09995) demonstrated resilience by surging over 15% within half an hour of trading despite initial market negativity, recovering from a maximum drop of 10.23% [2] - The stock's performance was driven by the announcement of promising results for Telitacicept (RC18) in treating generalized myasthenia gravis (gMG), showing significant clinical improvements compared to placebo [5][6] - Telitacicept treatment led to a 5.74-point reduction in MG-ADL scores and an 8.66-point reduction in QMG scores after 24 weeks, with 98.1% of patients showing significant improvement [5][7] - The safety profile of Telitacicept was comparable to placebo, with a lower incidence of infection-related adverse events [7] Industry Summary - The current market for gMG treatments is competitive, with existing therapies primarily developed by multinational corporations (MNCs) targeting B-cell pathways and complement C5 inhibitors [7] - The global market for gMG is projected to reach $7.24 billion by 2030, with approximately 1.2 million patients worldwide, including 220,000 in China [8] - Recent policy initiatives in China are favoring the development of innovative drugs, with a notable increase in the number of domestic innovative drugs approved from 51 in 2019 to 93 in 2024 [10] - Chinese companies are leading in antibody-drug conjugate (ADC) innovation, holding a significant share of the global pipeline and demonstrating a concentrated focus on key therapeutic targets [11] - The trend towards valuing "source innovation" and "true innovation" in drug development is expected to accelerate the revaluation of companies with strong innovative pipelines in the current market [12]

Summary of Rongchang Biologics Conference Call Company Overview - Rongchang Biologics is a well-established ADC biotech company that has shown strong performance in recent years, achieving over 1.7 billion in revenue for 2024, with a year-on-year growth rate of nearly 60% driven by increased productivity of the sales team and the clinical value of its products [3][4] Key Products and Market Performance - Rongchang Biologics has successfully launched two main self-developed products: - **2,418 Tadasip**: Used for treating systemic lupus erythematosus (SLE) and other autoimmune conditions. It has an SRI response rate of 83%, significantly higher than the 61% of Belimumab, with good tolerability. The domestic insurance price is slightly higher than Belimumab but remains acceptable to patients [4][6] - **RC48 Vidiqis**: The first HER2 ADC drug approved in China for treating gastric cancer and urothelial carcinoma. It has an ORR of 25% in third-line gastric cancer treatment, with a median PFS of 4.1 months and median OS of 7.9 months, outperforming PD-1. In urothelial carcinoma, it achieved a DCR of 95% and ORR of 26.3%, with median PFS of 15.5 months and median OS of 16.4 months [4][7] Clinical Value and Future Potential - Rongchang Biologics focuses on developing first-in-class and best-in-class biologics in the fields of autoimmune diseases, oncology, and ophthalmology. The company has several promising new pipelines with best-in-class and overseas potential, including RC88 mesothelin ADC, c-Met ADC, and PD-1/VEGF dual antibodies [4][8] - The PD-L1/VEGF fusion protein shows advantages in safety and overall survival, potentially outperforming existing therapies [8] Investment Considerations - Investors should monitor the sales performance of Tadasip and Vidiqis, the progress of domestic and international clinical trials, early-stage IND developments, and the company's business development efforts abroad, as these factors will significantly influence Rongchang Biologics' future growth potential [4][8]

Core Viewpoint - The public fund industry achieved impressive performance in Q1 2025, driven by a structural market led by AI and robotics themes [1][2]. Group 1: Fund Performance - The fund performance leaderboard for Q1 2025 was dominated by robotics-themed funds, Beijing Stock Exchange funds, and Hong Kong stock funds [2]. - The top-performing fund, Penghua Carbon Neutral Theme A, managed by Yan Siqian, achieved a return of 60.26%, heavily investing in several robotics stocks [3][5]. - Other notable funds include Ping An Advanced Manufacturing Theme A and Yongying Advanced Manufacturing Smart Selection A, both exceeding 50% returns, also focusing on robotics [6]. Group 2: Robotics Theme Funds - Penghua Carbon Neutral Theme A's significant holdings included stocks like Beite Technology and Hechuan Technology, with Double Forest Co. seeing a year-to-date increase of 118.16% [3][6]. - Fund managers expressed optimism about the rapid production of humanoid robots and the investment opportunities in new materials and technologies [7]. - The focus on core components and AI perception in humanoid robots indicates a growing market potential, with significant room for technological advancement [7][8]. Group 3: Beijing Stock Exchange Funds - Beijing Stock Exchange funds also performed well, with notable returns from funds like CITIC Construction Investment and Huaxia, achieving returns of 38.98% and 37.45% respectively [9]. - These funds have successfully identified high-performing stocks within the Beijing Stock Exchange, such as Kelaite, which saw a remarkable increase of 136.01% [9]. Group 4: Hong Kong Stock Funds - Hong Kong stock funds regained attention, with funds like Huatai Hong Kong Advantage Selection and Zhongyin Hong Kong Medical achieving returns of 38.9% and 32.25% respectively [12]. - The performance of these funds was bolstered by significant gains in pharmaceutical stocks, with companies like Kelun Pharmaceutical and Rongchang Biological seeing increases of 78.08% and 64.58% [12]. - The manager of Huatai Hong Kong Advantage Selection highlighted the growing competitiveness of Chinese innovative drugs in the global market, projecting a significant increase in overseas licensing deals [12][13].

智通财经APP获悉，特朗普"对等关税"即将落地，港股三大指数早盘走高，恒科指数曾涨超2%，午后 涨幅显著收窄。截止收盘，恒生指数涨0.38%或87.26点，报23206.84点，全日成交额2502.31亿港元；恒 生国企指数涨0.24%，报8537.34点；恒生科技指数涨0.23%，报5407.38点。 交银国际表示，全球不确定性升温，港股以守待攻。该行指出，进入4月，后续消费、地产等各项基本 面的数据验证、以及关税等外生性影响将成为市场关注重点，也是4月底中央政治局会议会否释放更进 一步政策刺激信号的关键。 蓝筹股表现 2. 石油股普遍上扬。截至收盘，中海油(00883)涨2.7%，报19.02港元；中海油服(02883)涨2.5%，报6.57 港元；中石油(00857)涨2.07%，报6.42港元；中石化(00386)涨0.24%，报4.11港元。 美国总统特朗普周一表态，要求伊朗尽快达成核协议，并称考虑对俄罗斯能源出口实施新的制裁。这些 言论引发投资者对中东和东欧地缘冲突升温的担忧情绪，隔夜国际油价应声上涨。中信证券研报指出， 综合来看，考虑到近期美国对伊朗、委内瑞拉制裁及地缘扰动等多重因素影响，202 ...

Core Viewpoint - The Audit Committee of Rongchang Biopharmaceutical (Yantai) Co., Ltd. has diligently fulfilled its supervisory responsibilities for the year 2024, ensuring compliance with relevant regulations and maintaining effective internal controls [1][4]. Group 1: Audit Committee Overview - The Audit Committee consists of three members, including independent director Ma Lan and director Wang Liqiang, with accounting professional Hao Xianjing serving as the chairperson [1]. - During the reporting period, the Audit Committee held five meetings, with full attendance from all members [1]. Group 2: Key Activities of the Audit Committee - The committee supervised and evaluated the external audit firm, Ernst & Young, ensuring that it adhered to independent and objective auditing standards [1][3]. - The committee guided the internal audit work, reviewing the internal audit plan and confirming its feasibility, while ensuring compliance with the audit plan [2][3]. - The committee reviewed the company's financial reports, concluding that they were true, accurate, and complete, with no significant fraud or misstatements detected [3]. - The committee monitored and assessed the effectiveness of the company's risk management and internal control systems, confirming that there were no major deficiencies [3][4]. - The committee facilitated communication between management, internal audit, and external auditors, enhancing the efficiency of the audit process [4]. Group 3: Overall Evaluation - The Audit Committee has effectively fulfilled its responsibilities in accordance with relevant laws, regulations, and the company's articles of association, promoting sound operations and safeguarding the rights of shareholders [4].

Core Viewpoint - The company intends to reappoint Ernst & Young Hua Ming as the A-share audit firm and Ernst & Young as the Hong Kong audit firm for the year 2025, highlighting their compliance with legal and ethical standards in previous audits [1][2][6]. Group 1: A-share Audit Firm Information - Ernst & Young Hua Ming was established in September 1992 and transitioned to a special partnership in August 2012, with its headquarters in Beijing [2]. - The firm reported a total audited business revenue of RMB 5.955 billion for 2023, with audit service revenue of RMB 5.585 billion and securities service revenue of RMB 2.438 billion [2]. - Ernst & Young Hua Ming has audited 137 A-share listed companies in 2023, generating a total fee of RMB 905 million [2]. Group 2: Audit Firm's Compliance and Performance - The firm has a strong investor protection capability, with a cumulative compensation limit exceeding RMB 200 million from its professional risk fund and insurance [3]. - Over the past three years, Ernst & Young Hua Ming has not faced any civil lawsuits or criminal penalties related to its auditing practices [3][5]. - The project partner, Yang Jing, has been a registered accountant since 2015 and has experience in auditing listed companies in the specialized equipment manufacturing and pharmaceutical manufacturing sectors [4]. Group 3: Hong Kong Audit Firm Information - Ernst & Young Hong Kong is a partnership firm providing audit, tax, and consulting services to numerous Hong Kong-listed companies, including financial institutions [5][6]. - The firm has been engaged by the company since 2019 to provide audit services for financial statements submitted to the Hong Kong Stock Exchange [6]. Group 4: Approval Process for Reappointment - The Audit Committee approved the reappointment of the audit firms during its meeting on March 27, 2025, citing their adherence to legal and ethical standards [6][7]. - The Board of Directors also approved the reappointment and agreed to submit the proposal for shareholder approval [7].

证券代码：688331 证券简称：荣昌生物 公告编号：2025-011 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 年度利润分配方案的公告 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： ? 荣昌生物制药（烟台）股份有限公司（以下简称"公司"）2024 年度利 润分配方案为：不派发现金股利，不送红股，不进行资本公积金转增股本。 ? 本次利润分配预案的实施不会触及《上海证券交易所科创板股票上市 规则（2024 年 4 月修订）》第 12.9.1 条第一款第（八）项规定的可能被实施其他 风险警示的情形。 ? 2024 年年度利润分配预案已经公司第二届董事会第二十一次会议和 第二届监事会第十五次会议审议通过，尚需提交公司 2024 年年度股东大会审议。 一、利润分配方案内容 公司于 2025 年 3 月 27 日召开第二届董事会第二十一次会议，审议通过了 《关于公司<2024 年度利润分配预案>的议案》，同意公司 2024 年度不进行利润 分配，也不进行资本公积金 ...

Group 1 - The company held its 21st meeting of the second board of directors, with all 8 directors present, ensuring compliance with relevant laws and regulations [1][2] - The board approved the 2024 General Manager's Work Report, emphasizing the importance of scientific decision-making and operational compliance [2][3] - The board also approved the 2024 Board of Directors' Work Report, focusing on maintaining company interests and enhancing governance [2][3] Group 2 - The board approved the 2024 Independent Directors' Work Report, highlighting the independent directors' commitment to their duties and company governance [2][3] - A special opinion on the independence assessment of independent directors was approved, confirming their compliance with relevant regulations [3][4] - The 2024 Financial Settlement Report was approved, with financial statements audited by Ernst & Young, showing no reservations [4][5] Group 3 - The board approved the 2024 Annual Report and its summary, ensuring compliance with stock exchange regulations [4][5] - The 2024 Internal Control Evaluation Report was approved, indicating no significant deficiencies in the internal control system [5][6] - The board decided not to distribute profits for 2024, reporting a net loss of 146.84 million yuan [6][7] Group 4 - The board confirmed the remuneration of senior management for 2024 and proposed adjustments for 2025 based on various factors [6][7] - The board approved the remuneration of directors for 2024, with proposals for 2025 to be based on similar considerations [7][8] - An ESG report for 2024 was approved, reflecting the company's commitment to social responsibility [8][9] Group 5 - The board approved the annual performance report of the Audit Committee, confirming its effective operation [8][9] - A general authorization for share issuance was proposed, allowing the board to issue up to 20% of the total shares [9][10] - The board approved the 2025 "Quality Improvement and Efficiency Enhancement" action plan, aimed at optimizing operations and governance [10][11] Group 6 - The board approved a report on the use of raised funds, ensuring compliance with relevant regulations [11][12] - The board agreed to renew the appointment of Ernst & Young as the auditing firm for 2025 [12][13] - A proposal for a comprehensive credit facility of up to 5.5 billion yuan was approved [13][14] Group 7 - The company plans to use up to 500 million yuan for cash management through safe and liquid financial products [14][15] - The board approved the use of idle raised funds for cash management, with a limit of 140 million yuan [15][16] - The board reviewed the risk management and internal control systems for 2024, confirming their effectiveness [16][17] Group 8 - The board confirmed compliance with the Corporate Governance Code and related rules [17][18] - The board approved the evaluation report on the performance of the auditing firm for 2024, affirming its adherence to auditing standards [18]

Financial Performance - For the fiscal year ending December 31, 2024, the company's product sales revenue was approximately RMB 1,699.1 million, representing a 61.9% increase from RMB 1,049.2 million in the same period last year[4]. - The total revenue for the fiscal year was RMB 1,710.2 million, with a gross profit of RMB 1,367.4 million[9]. - Revenue increased from RMB 1,076.1 million in 2023 to RMB 1,710.2 million in 2024, driven by strong sales of the autoimmune product TaiTasi and the oncology product VidiSita[38]. - For the year ended December 31, 2024, the company's revenue increased to RMB 1,710,152 thousand, up from RMB 1,076,130 thousand in 2023, representing a growth of approximately 58.8%[63]. - The company reported a net loss of RMB 1,468,362,000 for the year ended December 31, 2024, compared to a net loss of RMB 1,511,229,000 in 2023, indicating a reduction in losses of approximately 2.8%[64]. - Total comprehensive loss for the year was RMB 1,499,240,000, down from RMB 1,570,147,000 in the previous year, reflecting a decrease of about 4.5%[64]. - The net loss for the year decreased to RMB 1,468.36 million in 2024 from RMB 1,511.23 million in 2023, showing a slight improvement in financial performance[48]. Research and Development - Research and development expenses increased by RMB 233.5 million or 17.9% to RMB 1,539.8 million for the fiscal year[9]. - The company has a comprehensive pipeline with over ten candidate drugs, seven of which are in clinical development targeting more than twenty indications[10]. - The company is actively exploring Taisai for other autoimmune diseases, including plans for a Phase III clinical study for membranous nephropathy[20]. - The company is conducting a Phase II clinical trial for RC148 in advanced lung cancer, progressing smoothly as of December 31, 2024[34]. - The company is focused on drug development and has received approval for the comprehensive marketing application of its drug, TaiTasiPu, in November 2023[69]. - The company is committed to adhering to corporate governance codes as outlined in the listing rules[106]. Clinical Trials and Approvals - The company received FDA Fast Track Designation for its product RC18 (Taitai) for the treatment of primary Sjögren's syndrome in March 2024[5]. - RC48 (Widi) showed positive results in a Phase III clinical trial for HER2-positive metastatic breast cancer, achieving the primary endpoint[6]. - Taisai (RC18) received full NMPA approval in China in November 2023 and was successfully included in the national medical insurance drug catalog by the end of 2023[14]. - The company initiated a Phase III clinical trial for Taisai in China for the treatment of IgA nephropathy in the first half of 2023, with patient recruitment completed by May 2024[16]. - The company submitted a Biologics License Application (BLA) for Taisai for rheumatoid arthritis in August 2023, with approval from NMPA expected in July 2024[15]. - The company has completed a Phase II clinical trial for Vidisicimab in HER2-overexpressing urinary tract cancer patients, leading to a multi-center Phase II registration trial[21]. - A Phase III clinical trial comparing Vidisicimab combined with chemotherapy for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC) is ongoing in China, with patient enrollment completed in August 2024[23]. Financial Position and Liabilities - The company's total liabilities to assets ratio increased to 63.9% as of December 31, 2024, compared to 37.8% in 2023, indicating a higher leverage position[51]. - The company's total liabilities increased significantly to RMB 3,512,318,000 in 2024 from RMB 2,091,074,000 in 2023, marking an increase of approximately 68%[66]. - The net asset value decreased to RMB 1,986,201,000 in 2024 from RMB 3,437,269,000 in 2023, a decline of about 42.3%[66]. - The company has cumulative losses of RMB 4,321,871,000 as of December 31, 2024, indicating ongoing financial challenges[69]. - The company maintains that its available funds and unused bank credit are sufficient to support its normal operations, research, and production activities for at least the next 12 months[69]. Market and Strategic Focus - The company aims to become a leading player in the global biopharmaceutical industry, focusing on unmet medical needs in autoimmune, oncology, and ophthalmology diseases[10]. - The company is one of the few Chinese biotech firms that have commercialized two products, RC18 and RC48[10]. - The company is actively pursuing new drug applications and clinical trials to expand its product pipeline[108]. - The core products include RC18 (brand name: 泰愛®), RC48 (brand name: 愛地希®), and RC28-E[107]. - The company is focused on developing antibody-drug conjugates (ADCs) for targeted cancer therapies[106]. Governance and Compliance - The company is subject to regulatory oversight by the National Medical Products Administration (NMPA) in China[108]. - The board of directors includes both executive and non-executive members, ensuring a diverse governance structure[109]. - The group has adopted revised international financial reporting standards, including IFRS 16 and IAS 1, with no impact on its financial position or performance[73]. - The company emphasizes the uncertainty in successfully developing and selling its core products, advising shareholders to act cautiously[105].