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]

Investment Rating - The investment rating for the company is "Buy" and the rating has been maintained [4][9] Core Views - The company achieved a revenue of 2.892 billion yuan in 2024, representing a year-on-year growth of 17.74%. The net profit attributable to the parent company was 403 million yuan, up 15.67% year-on-year, while the non-recurring net profit reached 410 million yuan, marking a significant increase of 55.92% [4][11] - The company is expanding the clinical value and evidence of its products, Kai Mei Na and Sai Mei Na, and has successfully included them in the national medical insurance catalog, enhancing patient accessibility [5][6] - The successful overseas launch of Bei Mei Na, which received FDA approval for first-line treatment indications, is expected to further open up market opportunities for the company [5][6] - The company is continuously enriching its pipeline with ongoing research and development, including the acceptance of NDA for its self-developed CDK4/6 inhibitor BPI-16350 [6][7] - The company is actively expanding its innovative ecosystem and has made significant progress in strategic collaborations, including projects related to plant-derived recombinant human serum albumin and stem cell therapy for diabetes [7] Financial Data and Forecast - The company forecasts net profits attributable to the parent company for 2025, 2026, and 2027 to be 534 million, 604 million, and 739 million yuan respectively, with corresponding EPS of 1.28, 1.44, and 1.77 yuan [8][11] - The current stock price corresponds to a PE ratio of 39, 35, and 28 times for the years 2025, 2026, and 2027 respectively [8][11]

Investment Rating - The investment rating for the company is "Buy" and the rating has been maintained [4][9] Core Views - The company achieved a revenue of 2.892 billion yuan in 2024, representing a year-on-year growth of 17.74%. The net profit attributable to the parent company was 403 million yuan, up 15.67% year-on-year, while the non-recurring net profit reached 410 million yuan, marking a significant increase of 55.92% [4][11] - The company is expanding the clinical value and evidence of its products, particularly focusing on the domestic market for EGFR-TKI. Both Kai Mei Na and Sai Mei Na have been included in the national medical insurance directory, enhancing patient accessibility [5][6] - The successful overseas launch of Bei Mei Na, which received FDA approval for first-line treatment indications, is expected to further open up market opportunities for the product [5][6] - The company is continuously enriching its pipeline with ongoing research and development, including the acceptance of NDA for its self-developed CDK4/6 inhibitor BPI-16350 [6][7] - The company is actively expanding its innovation ecosystem and strategic partnerships, achieving significant progress in projects such as plant-derived recombinant human serum albumin and stem cell therapy for diabetes [7] Financial Data and Forecast - The company forecasts net profits attributable to the parent company for 2025, 2026, and 2027 to be 534 million, 604 million, and 739 million yuan respectively, with corresponding EPS of 1.28, 1.44, and 1.77 yuan [8][11] - The projected revenue growth rates for 2025, 2026, and 2027 are 20.61%, 17.06%, and 18.22% respectively, indicating a robust growth trajectory [11]

Investment Rating - The report maintains a "Strong Buy" rating for the company, with a target price of 66.1 CNY [2][9]. Core Insights - The company achieved a revenue of 2.892 billion CNY in 2024, representing a year-on-year growth of 17.74%. The net profit attributable to shareholders was 403 million CNY, up 15.67%, while the net profit excluding non-recurring items reached 410 million CNY, marking a significant increase of 55.92% [2][5]. - The company has multiple new products set to launch, which are expected to drive future growth. The R&D investment for 2024 was 717 million CNY, accounting for 24.80% of total revenue [2][5]. - The company is expanding its product pipeline with promising candidates in various clinical stages, including a CDK4/6 inhibitor and a plant-derived recombinant human serum albumin [9]. Financial Performance Summary - **2024 Actuals and Future Estimates**: - Total revenue for 2024 was 2.892 billion CNY, with projections of 3.562 billion CNY for 2025, 4.198 billion CNY for 2026, and 5.345 billion CNY for 2027, reflecting growth rates of 23.2%, 17.9%, and 27.3% respectively [5][10]. - Net profit attributable to shareholders for 2024 was 403 million CNY, with estimates of 496 million CNY for 2025, 689 million CNY for 2026, and 945 million CNY for 2027, indicating growth rates of 23.2% and 38.9% for the following years [5][10]. - **Valuation Metrics**: - The company’s price-to-earnings (P/E) ratio is projected to decrease from 52 in 2024 to 22 by 2027, while the price-to-book (P/B) ratio is expected to decline from 3.7 to 2.8 over the same period [5][10]. Product Pipeline and Market Expansion - The company is set to launch several innovative products, including a third-generation EGFR-TKI and a long-acting ophthalmic formulation, which have shown promising results in clinical trials [9]. - The company is also focusing on expanding its early-stage pipeline with multiple new molecular entities that are currently in Phase I clinical trials [9].

A股创新药板块上扬，润都股份、江苏吴中涨停，健友股份涨超6%，康辰药业、贝达药业等跟涨。 ...

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Core Viewpoint - Beida Pharmaceutical reported a revenue of 2.892 billion yuan for 2024, representing a year-on-year increase of 17.74%, and a net profit attributable to shareholders of 403 million yuan, up 15.67% year-on-year [1] Financial Performance - The overall gross margin for the company was 81.38%, a decrease of 2.15 percentage points year-on-year; the period expense ratio was 65.72%, down 7.37 percentage points year-on-year [2] - The operating cash flow net amount was 911 million yuan, a decrease of 0.33% year-on-year [2] - The company achieved a net profit of -14 million yuan in Q4 2024, a decline of 131.51% year-on-year [1] R&D Progress - The company expanded its pipeline with five products currently on sale, and received FDA approval for its first overseas product, Bemetan (Ensartinib), in December 2024 [3] - R&D investment for the year was 717.78 million yuan, accounting for 24.80% of revenue, with multiple innovative drug IND approvals during the reporting period [4] Strategic Collaborations - The company has established strategic partnerships with various organizations to enhance its R&D pipeline, including a commercialization agreement for a plant-derived recombinant human serum albumin injection [5] - In November 2024, the company invested 20 million yuan in Ruipuchen to collaborate on stem cell therapy business [5] Investment Outlook - Revenue forecasts for 2025-2027 are adjusted to 3.69 billion, 4.46 billion, and 5.24 billion yuan, with expected year-on-year growth rates of 27.7%, 20.6%, and 17.5% respectively [6] - The net profit forecasts for the same period are 610 million, 910 million, and 1.21 billion yuan, with growth rates of 51.6%, 48.2%, and 33.4% respectively [6]

Group 1: Beida Pharmaceutical - In 2024, Beida Pharmaceutical achieved operating revenue of 2,891.95 million yuan, a year-on-year increase of 17.74%, and a net profit attributable to shareholders of 402.57 million yuan, up 15.67% year-on-year [1] - The company has launched five new drugs, including Acetylcysteine, Ensartinib capsules, Bevacizumab, and others, with Beimu approved by the FDA and included in the NCCN guidelines [1] - R&D investment for 2024 is 717 million yuan, accounting for 24.80% of revenue, with multiple new drug developments progressing smoothly [1] Group 2: East China Pharmaceutical - East China Pharmaceutical is actively advancing product R&D and market layout across multiple fields, with GLP-1 series products entering Phase III clinical trials, expecting significant results by 2025 [2] - The company has several innovative products in the ADC and PROTAC fields, with some already in clinical stages [2] - East China Pharmaceutical is confident in the overseas medical beauty market and is actively pursuing overseas registration for its medical beauty products [2]