Group 1 - The core objective of the "Implementation Plan for the Digital and Intelligent Transformation of the Pharmaceutical Industry (2025-2030)" is to achieve significant progress in digital transformation by 2027, enhancing the competitiveness of the pharmaceutical industry and quality management throughout the product lifecycle [1] - The integration of new information technologies with the pharmaceutical industry is expected to drive high-quality and innovative development, with listed companies in the Shenzhen market actively participating in this transformation [1][2] - The rapid development of artificial intelligence is reshaping the pharmaceutical industry, providing unprecedented opportunities for transformation from drug development to health management [2] Group 2 - Companies are focusing on enhancing their research and development capabilities by integrating AI with medical technology, which requires overcoming various interdisciplinary barriers [2][3] - The digital transformation of the pharmaceutical industry involves automating manufacturing processes, unlocking the value of pharmaceutical data, enhancing cybersecurity, and promoting AI across the entire industry chain [3] - Capital markets play a crucial role in supporting the pharmaceutical industry through various funding channels, enabling companies to invest in high-cost areas such as innovative drug development and high-end medical device manufacturing [4][5] Group 3 - The establishment of a transparent corporate governance structure through public listing helps pharmaceutical companies improve internal decision-making processes and risk management capabilities [5] - As of April 29, 2024, 256 companies in the Shenzhen pharmaceutical and biotechnology sector reported a total revenue of 1.13 trillion yuan and a net profit of 67.63 billion yuan, with 37 companies experiencing over 50% net profit growth [5] - Companies plan to continue leveraging capital market support to drive further upgrades in the pharmaceutical industry, focusing on innovation and expanding research boundaries [6]

中信证券股份有限公司 关于贝达药业股份有限公司 2024 年度募集资金存放与使用情况的核查意见 中信证券股份有限公司（以下简称"中信证券"或"保荐机构"）作为贝达 药业股份有限公司（以下简称"贝达药业"或"公司"）2020 年度向特定对象发 行股票持续督导阶段的保荐机构，根据《深圳证券交易所创业板股票上市规则》、 《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》等相 关规定履行持续督导职责，对贝达药业 2024 年度募集资金存放与使用情况进行 了核查，现将核查情况及核查意见发表如下： 一、募集资金基本情况 （一）实际募集资金金额、资金到位情况 经中国证券监督管理委员会以证监许可[2020]2213 号《关于同意贝达药业股 份有限公司向特定对象发行股票注册的批复》同意注册，贝达药业股份有限公司 向特定对象发行股票 10,138,621 股，每股发行价格为 98.83 元，募集资金总额为 人民币 1,001,999,913.43 元，扣除保荐及承销费用人民币 5,000,000.00 元(含税)后 的余额人民币 996,999,913.43 元已全部划转至本公司银行账户。公司本次募集资 金总 ...

关于贝达药业股份有限公司 使用暂时闲置募集资金进行现金管理的核查意见 中信证券股份有限公司（以下简称"中信证券"或"保荐机构"）作为贝达药 业股份有限公司（以下简称"贝达药业"或"公司"）的保荐机构，根据《深圳证 券交易所创业板股票上市规则》、《深圳证券交易所上市公司自律监管指引第2号—— 创业板上市公司规范运作》、《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》等相关规定履行持续督导职责，对贝达药业使用暂时闲置募集资 金进行现金管理事项进行了核查，现将核查情况及核查意见发表如下： 一、募集资金基本情况 经中国证券监督管理委员会（以下简称"中国证监会"）《关于同意贝达药业 股份有限公司向特定对象发行股票注册的批复》（证监许可[2020]2213号）同意， 公司向14名特定对象发行人民币普通股（A股）10,138,621股，发行价格为98.83元/ 股，实际募集资金总额为人民币1,001,999,913.43元（大写：人民币壹拾亿零壹佰玖 拾玖万玖仟玖佰壹拾叁元肆角叁分），扣除本次发行费用（不含税）人民币 6,594,538.73元后，实际募集资金净额为人民币995,405,374.70元。 ...

Group 1 - The core viewpoint of the articles highlights the advancements in the field of medical innovation, particularly focusing on the development of stem cell therapies for diabetes by RuiPu ChenChuang Technology Co., Ltd. [1] - The launch of the innovation ecosystem alliance at the Wanwu Shengzhang Conference signifies a commitment to empowering more projects within the ecosystem, as stated by the chairman of Betta Pharmaceuticals, Ding Lieming [1] - Betta Pharmaceuticals has established itself as a representative of domestic innovative drugs, having developed China's first small molecule targeted anti-cancer drug, demonstrating the potential of China's biopharmaceutical industry [2] Group 2 - The biopharmaceutical industry in China is undergoing profound changes, with over 200 early-stage innovative drug projects being acquired by multinational companies in the past two years, amounting to nearly $100 billion [2] - Betta's innovation ecosystem has set up four funds and incubated nearly 30 projects, aiming to gather more resources for high-quality early-stage projects [2] - The company emphasizes the importance of collaboration across various sectors to address challenges in the overall pharmaceutical innovation ecosystem [2]

Group 1 - The company achieved a record high quarterly revenue of 918 million yuan in Q1 2025, representing a year-over-year increase of 24.71%, with a net profit attributable to shareholders of 100 million yuan, up 1.99% year-over-year, and a non-GAAP net profit of 164 million yuan, up 83.59% year-over-year [3] - The non-GAAP net profit margin reached 17.86%, an increase of 5.64 percentage points year-over-year, indicating strong operational performance [3] - The company is expected to enter a multi-product commercialization phase in 2025, with core products like Ensartinib and others anticipated to drive significant revenue and profit growth from 2025 to 2027 [3] Group 2 - Ensartinib has been approved in the U.S. and is under EMA review, with expectations for increased performance due to internationalization [4] - The company is advancing its EYP-1901 clinical trials, with promising data expected in 2024 and 2025, indicating potential for further international success [4] - The company signed a regional distribution agreement with He Yuan Bio for a plant-derived recombinant human serum albumin injection, which has been accepted for priority review by NMPA, showcasing its commitment to ecosystem partnerships [5] Group 3 - The company has adjusted its earnings forecasts upward due to lower-than-expected R&D expense ratios and the commercialization of new products, projecting EPS of 1.71, 2.42, and 3.07 yuan for 2025-2027 [6] - The projected PE ratio for 2025 is 29 times based on the closing price on April 24, 2025, maintaining a "buy" rating [6]

Investment Rating - The investment rating for the company is "Buy" (maintained) [7] Core Views - The company is expected to enter a multi-product commercialization phase in 2025, with key products like Ensartinib and others anticipated to drive significant revenue and profit growth from 2025 to 2027 [2][5] - The international approval of Ensartinib in the US and its ongoing EMA approval process are seen as major catalysts for performance [3] - The company is focusing on building an ecosystem through strategic partnerships, which is expected to enhance its competitive edge and drive performance [4] Financial Performance - In Q1 2025, the company achieved a record revenue of 918 million yuan, representing a year-over-year increase of 24.71%, and a net profit of 100 million yuan, with a non-GAAP net profit of 164 million yuan, reflecting an 83.59% increase year-over-year [11] - The non-GAAP net profit margin reached 17.86%, up 5.64 percentage points year-over-year, indicating strong operational performance [11] - The company forecasts revenues of 3.75 billion yuan in 2025, with a year-over-year growth of 29.75%, and expects EPS to rise to 1.71 yuan [12] Valuation and Earnings Forecast - The earnings per share (EPS) estimates for 2025, 2026, and 2027 are projected to be 1.71 yuan, 2.42 yuan, and 3.07 yuan respectively, reflecting significant growth compared to previous forecasts [5][12] - The price-to-earnings (P/E) ratio for 2025 is estimated at 29 times, indicating a favorable valuation relative to expected earnings growth [5][12]

Core Viewpoint - Beida Pharmaceutical reported a revenue growth of 17.74% year-on-year to 2.892 billion yuan in 2024, with a net profit of 403 million yuan, marking a 15.67% increase, and a significant turnaround in profitability with a 55.92% rise in non-net profit [1][2] Financial Performance - The company achieved a revenue of 2.892 billion yuan in 2024, approaching the 3 billion yuan mark, with a net profit of 403 million yuan [1] - The non-net profit reached 410 million yuan, indicating a strong recovery from previous years where revenue growth did not translate into profit [1] - Historical revenue figures from 2021 to 2023 were 2.246 billion yuan, 2.377 billion yuan, and 2.456 billion yuan, with net profits fluctuating significantly [1] Product Portfolio - Beida Pharmaceutical currently has five new drugs in the oncology treatment field, including the first-generation EGFR inhibitor, Alectinib (Kaimena®), and the ALK inhibitor, Ensartinib (Beimina®) [1][2] - The company has expanded its product lineup from a single product to five through independent research and strategic partnerships [2] - Alectinib has generated over 1 billion yuan in annual revenue since its inclusion in the national medical insurance directory in 2017 [2] Market Expansion and Pipeline - The company has one innovative drug under review for market approval and over 20 projects in development, indicating potential for future growth [2][6] - The sales forecast for Beimina in 2024 is expected to approach 800 million yuan, while Kaimena's sales are projected to be between 1.2 billion and 1.4 billion yuan [4][5] - Beida's research and development investment has consistently been high, with R&D expenditures from 2020 to 2024 being 742 million yuan, 861 million yuan, 977 million yuan, 1 billion yuan, and 717 million yuan, respectively [7] Leadership and Strategic Moves - The return of Professor Mao Li as the Chief R&D Officer is a significant development for the company, as he previously held key positions within Beida and has extensive experience in the industry [8][9]

Financial Performance - The company's revenue for Q1 2025 reached ¥917,554,506.92, representing a 24.71% increase compared to ¥735,775,468.80 in the same period last year[6] - Net profit attributable to shareholders was ¥100,089,181.47, a slight increase of 1.99% from ¥98,140,741.56 year-on-year[6] - The net profit after deducting non-recurring gains and losses surged by 83.59% to ¥164,430,292.77 from ¥89,562,834.38 in the previous year[6] - The net cash flow from operating activities improved by 20.35%, amounting to ¥297,535,688.01 compared to ¥247,235,603.12 in the prior year[6] - The company's basic earnings per share increased by 4.35% to ¥0.24 from ¥0.23 in the same period last year[6] - Total operating revenue for the current period reached ¥917,554,506.92, an increase of 24.7% compared to ¥735,775,468.80 in the previous period[25] - Net profit for the current period was ¥95,463,516.48, a slight increase from ¥93,790,802.53 in the previous period, representing a growth of 1.8%[26] - The company reported a net cash flow from operating activities of ¥297,535,688.01, an increase of 20.3% compared to ¥247,235,603.12 in the previous period[28] - Basic and diluted earnings per share were both ¥0.24, up from ¥0.23 in the previous period[26] Assets and Liabilities - Total assets at the end of the reporting period were ¥9,125,518,301.96, down 2.31% from ¥9,341,677,723.81 at the end of the previous year[6] - The total current assets as of March 31, 2025, amounted to CNY 1,301,717,893.56, an increase from CNY 1,224,330,599.97 at the beginning of the period[22] - The total liabilities as of March 31, 2025, were CNY 3,494,218,702.83, down from CNY 3,675,567,489.25 at the beginning of the period[23] - The total assets decreased to CNY 9,125,518,301.96 from CNY 9,341,677,723.81[24] - The total owner's equity as of March 31, 2025, was CNY 5,631,299,599.13, a decrease from CNY 5,666,110,234.56[24] Operating Costs and Expenses - Operating costs increased by 33.65% to ¥171,801,799.66, primarily driven by higher sales volumes of pharmaceuticals[9] - Total operating costs increased to ¥730,520,724.15, up 14% from ¥641,561,760.14 in the previous period[25] - Research and development expenses decreased to ¥113,293,329.82, down 26% from ¥152,750,433.40 in the previous period[25] - The company incurred financial expenses of ¥20,838,891.73, which is an increase of 109.5% compared to ¥9,947,530.44 in the previous period[25] Clinical Developments - The company received FDA approval for its drug, Beimingna (恩沙替尼胶囊), in December 2024, and it was recommended in the NCCN guidelines for NSCLC in January 2025[16] - Xcovery Holdings, Inc. submitted a marketing application to the European Medicines Agency for Beimingna, aiming to provide new treatment options for ALK-positive NSCLC patients[16] - The company’s oral small molecule HIF-2α inhibitor, BPI-452080, has received approval for clinical trials targeting tumors related to von Hippel-Lindau syndrome[16] - DURAVYU™, developed in collaboration with EyePoint Pharmaceuticals, showed significant efficacy in a Phase II trial for diabetic macular edema, with a +7.1 letter improvement in best-corrected visual acuity[17] - In the DURAVYU™ trial, 73% of patients did not require supplemental treatment, compared to 50% in the control group[17] - The company is advancing its clinical trials for DURAVYU™ in both diabetic macular edema and wet age-related macular degeneration[17] - The objective response rate (ORR) for the new MET inhibitor, Bemcentinib, reached 53.3% in patients with advanced NSCLC carrying MET exon 14 skipping mutations[19] - The disease control rate (DCR) for Bemcentinib was reported at 86.7%, with a median progression-free survival (PFS) of 6.0 months and a median duration of response (DoR) of 7.9 months[19] - In patients with ctDNA clearance after 4 weeks, the ORR was 80%, and the median PFS extended to 9.5 months, significantly better than the non-clearance group, which had a median PFS of 2.2 months[19] Non-Recurring Items - The company recorded a total of ¥64,341,111.30 in non-recurring losses, mainly due to fair value changes in financial assets and liabilities[7] - The company recorded a total comprehensive income of -¥42,417,477.67, a significant decline from ¥241,283,970.75 in the previous period[26] Cash and Cash Equivalents - Cash and cash equivalents increased to CNY 548,136,702.10 from CNY 471,682,855.12[22] - Cash and cash equivalents at the end of the period totaled ¥548,136,702.10, a slight decrease from ¥554,020,499.69 at the end of the previous period[28]

证券代码：300558 证券简称：贝达药业 公告编号：2025-034 贝达药业股份有限公司 2025 年第一季度报告披露提示性公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 贝达药业股份有限公司（以下简称"公司"）于 2025 年 4 月 24 日召开第四 届董事会第二十三次会议和第四届监事会第二十次会议，会议审议通过了《2025 年第一季度报告》的议案。 为使投资者全面了解公司 2025 年第一季度的经营成果和财务状况，公司 《2025 年第一季度报告》于 2025 年 4 月 25 日在中国证监会指定的创业板信息披 露网站巨潮资讯网（http://www.cninfo.com.cn）上披露，敬请投资者注意查阅。 特此公告。 贝达药业股份有限公司董事会 2025 年 4 月 24 日 1 ...

Group 1: Company Overview and Performance - The company achieved a revenue of 2.892 billion CNY in 2024, representing a year-on-year growth of 17.74% [12] - The net profit attributable to shareholders was 403 million CNY, an increase of 15.67% year-on-year [17] - The net profit excluding non-recurring items was 409 million CNY, reflecting a significant growth of 55.92% [17] Group 2: Clinical Development and Product Pipeline - BPI-16350, a CDK4/6 inhibitor, is currently undergoing drug registration review, with promising clinical data for treating HR-positive, HER2-negative breast cancer [42] - The RGB-5088 stem cell injection for diabetes has received IND approval and is in clinical trials, marking a significant breakthrough in treatment options [11] - The company has multiple projects in the pipeline, including BPI-520105 and BPI-221351, which have recently received IND approvals [12] Group 3: Market Position and Strategic Initiatives - The company is positioned as a leading player in China's innovative drug sector, with a market capitalization around 20 billion CNY [5] - Strategic collaborations with companies like C4T and EyePoint are aimed at enhancing the product pipeline and market reach [9] - The company emphasizes building an innovative ecosystem through partnerships and investments, which is expected to enrich its product offerings [16] Group 4: Financial Management and Market Challenges - The company reported a 35% quarter-on-quarter decline in revenue for Q4 2024, attributed to various factors affecting sales [18] - The gross margin decreased by 2.15 percentage points due to price reductions after products were included in the national medical insurance [29] - The company is actively managing costs and optimizing its operational efficiency to counteract the impact of reduced margins [11] Group 5: Future Outlook and Growth Drivers - Future growth drivers include expanding market sales of proprietary and collaborative products, focusing on core R&D pipelines, and implementing cost management strategies [11] - The company plans to leverage its innovative capabilities to explore new treatment areas beyond oncology, such as diabetes and cardiovascular diseases [23] - The overall outlook for the pharmaceutical industry remains positive, driven by policy support and advancements in research and development [10]