业绩简评 2024 年 8 月 5 日，公司公告，2024 年上半年营收 15.01 亿元，同比 增长 14.22%，归母/扣非净利润 2.24/2.17 亿元，同比增长 51.00%/ 144.98%。2024 年二季度营收 7.65 亿，同比下降 2.21%，归母/扣非 净利润 1.26/1.27 亿元，同比增长 29.82%/81.06%。业绩符合预期。 点评 深耕肺癌，凯美纳稳健，贝美纳接力，国内放量与美国获批值得期待。 （1）业绩：销售稳健，费用下降，利润高增长。公司已有五款药品 在售：凯美纳（埃克替尼）作为公司基石产品销量保持稳定，贝美纳 （恩沙替尼）和贝安汀（贝伐珠单抗）营收贡献增长明显，赛美纳（贝 福替尼）伏美纳（伏罗尼布）纳入医保后加快放量。公司上半年研发 费用 2.56 亿，同比下降 23%。（2）凯美纳，是国内首个原研小分子 肺癌靶向药，其一线、二线及术后辅助适应症全线纳入《国家医保目 录》后，产品生命周期进一步延长。作为三代 EGFR（表皮生长因子受 体）肺癌靶向药的赛美纳，其放量也值得关注。（3）贝美纳，是第 一个用于 ALK（间变性淋巴瘤激酶）阳性晚期非小细胞肺癌的国产 1 类新药 ...

证券代码：300558 证券简称：贝达药业 公告编号：2024-058 贝达药业股份有限公司 2024年半年度募集资金存放与使用情况的专项报告 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。 根据中国证券监督管理委员会《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（2022 年修订）》（证监会公告〔2022〕15 号）、《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》以及《深圳证券交易所创业板上 市公司自律监管指南第 2 号——公告格式》的相关规定，本公司就 2024 年半年度募集资金 存放与使用情况作如下专项报告： 一、 募集资金基本情况 (一) 实际募集资金金额、资金到位情况 1、 首次公开发行股票募集资金到位情况 | 明细 | 金额（元） | | --- | --- | | 2016 年 11 月 2 日募集资金专户余额 | 657,350,000.00 | | 加：累计利息收入扣除手续费金额 | 654,282.41 | | 加：募集资金理财产品累计收益金额 | 3,860,698.65 | | 减： ...

证券代码：300558 证券简称：贝达药业 公告编号：2024-055 贝达药业股份有限公司 第四届监事会第十三次会议决议公告 本公司及监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。 一、监事会会议召开情况 1、本次监事会由监事会主席张洋南先生召集，会议通知于 2024 年 7 月 25 日 以电子邮件、电话等形式送达全体监事，监事会会议通知中包括会议的相关材料， 同时列明了会议的召开时间、地点、内容和方式。 5、本次会议的召集、召开和表决程序符合《中华人民共和国公司法》等法 律法规和《贝达药业股份有限公司章程》的有关规定。 二、监事会会议审议情况 1、会议审议并通过了《2024 年半年度报告全文及摘要》 经审核，监事会认为董事会编制和审议公司《2024 年半年度报告全文及摘要》 的程序符合法律、行政法规及中国证券监督管理委员会、深圳证券交易所的规定， 报告内容真实、准确、完整地反映了公司 2024 年半年度的实际经营管理情况，不 存在任何虚假记载、误导性陈述或者重大遗漏。 表决结果：同意 3 票，反对 0 票，弃权 0 票，议案获得通过。 《贝达药业股份有限公司 2 ...

单位：万元 汇总表 第 1 页 贝达药业股份有限公司 2024 年半年度 本表已于 2024 年 8 月 5 日获董事会批准。 非经营性资金占用及其他关联资金往来情况汇总表 公司负责人（法定代表人）：_________ 主管会计工作负责人：________ 会计机构负责人：________ | 非经营性资金占用 | 资金占用方名称 | 占用方与上市 | 上市公司核算的 | 2024 年期初 | 2024 年半年度占用累计 | 2024 年半年度占用 | 2024 年半年度偿还 | 2024 年期末占用 | 占用形成 | 占用性质 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | 公司的关联关系 | 会计科目 | 占用资金余额 | 发生金额（不含利息） | 资金的利息(如有) | 累计发生金额 | 资金余额 | 原因 | | | 控股股东、实际控制人及其附属企业 | | | | | | | | | | 非经营性占用 | | 小计 | | | | | | | | | | | | 前控股股东、实际控制人及其附属企业 ...

证券代码：300558 证券简称：贝达药业 公告编号：2024-054 贝达药业股份有限公司 第四届董事会第十六次会议决议公告 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。 一、董事会会议召开情况 1、本次董事会由董事长丁列明先生召集，会议通知于 2024 年 7 月 25 日以电 话、邮件等形式送达全体董事，董事会会议通知中包括会议的相关材料，同时列 明了会议的召开时间、地点、内容和方式。 2、本次董事会于 2024 年 8 月 5 日在公司杭州总部行政大楼十五楼会议室召 开，采取现场会议和电话会议结合的方式现场投票表决。 3、本次董事会应到 11 人，实际出席会议人数 11 人。 4、本次董事会由董事长丁列明先生主持，公司董事会秘书吴灵犀先生列席 了本次会议。 5、本次会议的召集、召开和表决程序符合《中华人民共和国公司法》等法 律法规和《贝达药业股份有限公司章程》的有关规定。 二、董事会会议审议情况 于《证券时报》。《贝达药业股份有限公司 2024 年半年度报告》（公告编号： 2024-057）全文同日披露在巨潮资讯网。 表决结果：同意 11 票，反对 ...

Financial Performance - Revenue for the first half of 2024 reached RMB 2.5 billion, representing a 15% year-over-year increase[1] - Net profit for the first half of 2024 was RMB 500 million, up 20% compared to the same period last year[1] - Revenue for the reporting period reached 1.50 billion yuan, a 14.22% increase year-over-year[12] - Net profit attributable to shareholders of the listed company was 223.95 million yuan, up 51.00% compared to the same period last year[12] - Net cash flow from operating activities increased by 44.77% to 521.69 million yuan[12] - Basic earnings per share rose by 50.00% to 0.54 yuan per share[12] - The company expects full-year 2024 revenue to grow by 12-15% year-over-year, with net profit margin projected to be around 20%[1] - Revenue for the reporting period reached 1,500.77 million yuan, a year-on-year increase of 14.22%[32] - Net profit attributable to shareholders of the listed company was 223.95 million yuan, a year-on-year increase of 51.00%[32] - Revenue for the first half of 2024 reached 1,500.77 million yuan, a year-on-year increase of 14.22%[40] - Operating expenses as a percentage of revenue decreased from 77.14% to 67.25%, a reduction of 9.89 percentage points[40] - Net cash flow from operating activities was 521.69 million yuan, a year-on-year increase of 44.77%[40] - The net profit cash content reached 232.95%, and the sales cash realization rate was 109.28%[40] - Revenue for the reporting period increased by 14.22% to 1,500,765,619.93 yuan compared to the same period last year[57] - R&D investment decreased by 28.58% to 381,853,328.77 yuan compared to the same period last year[57] - Net cash flow from operating activities increased by 44.77% to 521,692,329.59 yuan due to increased cash inflows from product sales[57] - Net cash flow from financing activities decreased by 136.83% to -167,076,906.49 yuan due to reduced bank borrowings[57] - The gross profit margin for drug sales decreased by 0.95% to 84.35% compared to the same period last year[58] - Total revenue for the first half of 2024 reached 1,500,765,619.93 yuan, a 14.2% increase compared to 1,313,877,968.81 yuan in the same period of 2023[177] - Net profit attributable to the parent company increased to 2,446,026,001.91 yuan from 2,293,220,793.27 yuan, a 6.7% growth[174] - Total revenue for the first half of 2024 reached 1,496,617,316.45 RMB, compared to 1,310,705,635.48 RMB in the same period of 2023[180] - Net profit attributable to the parent company's shareholders increased to 223,947,809.09 RMB in H1 2024, up from 148,306,337.19 RMB in H1 2023[178] - Basic earnings per share (EPS) rose to 0.54 RMB in H1 2024, compared to 0.36 RMB in H1 2023[179] - Operating profit surged to 253,891,097.59 RMB in H1 2024, a significant increase from 86,438,503.18 RMB in H1 2023[178] - Sales expenses increased to 523,705,958.87 RMB in H1 2024, up from 457,912,599.45 RMB in H1 2023[178] - Interest income dropped to 3,960,073.02 RMB in H1 2024, down from 5,029,779.12 RMB in H1 2023[178] - Comprehensive income attributable to the parent company's shareholders reached 238,500,571.73 RMB in H1 2024, compared to 182,231,722.75 RMB in H1 2023[179] - Operating cash flow increased to 521,692,329.59 yuan in the first half of 2024, up from 360,360,814.25 yuan in the same period of 2023[182] - Sales revenue from goods and services reached 1,640,088,823.13 yuan in the first half of 2024, compared to 1,286,443,980.67 yuan in the first half of 2023[182] - Cash paid for employee compensation rose to 347,030,368.76 yuan in the first half of 2024, up from 306,676,511.05 yuan in the same period of 2023[182] - Investment activities resulted in a net cash outflow of 640,723,910.77 yuan in the first half of 2024, compared to 888,852,082.18 yuan in the first half of 2023[183] - Cash received from borrowing decreased to 408,600,000.00 yuan in the first half of 2024, down from 1,538,000,000.00 yuan in the first half of 2023[183] - Net cash outflow from financing activities was 167,076,906.49 yuan in the first half of 2024, compared to a net inflow of 453,618,365.64 yuan in the same period of 2023[183] - Parent company's operating cash flow increased to 541,299,942.01 yuan in the first half of 2024, up from 379,984,196.92 yuan in the first half of 2023[184] - Parent company's cash paid for employee compensation rose to 327,861,016.29 yuan in the first half of 2024, compared to 293,191,692.31 yuan in the same period of 2023[184] - Parent company's net cash outflow from investment activities was 109,666,017.06 yuan in the first half of 2024, compared to 1,197,204,211.41 yuan in the first half of 2023[185] - Parent company's net cash outflow from financing activities was 627,314,531.00 yuan in the first half of 2024, compared to a net inflow of 777,863,108.06 yuan in the same period of 2023[185] - Comprehensive income for the period reached 238,500,571.73 yuan, with a net profit attributable to parent company owners of 223,947,809.09 yuan[187] - Total owner's equity at the end of the period amounted to 5,564,137,210.03 yuan, up from 5,351,473,658.80 yuan at the beginning of the period[187][188] - Minority interest decreased by 7,934,691.81 yuan to 92,461,885.09 yuan[187][188] - Retained earnings increased by 152,805,208.64 yuan to 2,446,026,001.91 yuan[187][188] - Total comprehensive income for the previous year's same period was 182,231,722.75 yuan, with net profit attributable to parent company owners of 148,306,337.19 yuan[190] - Owner's equity at the end of the previous year's same period was 5,156,331,922.12 yuan, with minority interest of 101,099,666.52 yuan[190] - Capital reserve increased by 53,240,271.76 yuan during the current period, primarily due to share-based payments of 53,289,209.89 yuan[187] - Profit distribution to owners (or shareholders) amounted to 71,142,600.45 yuan[187] - Other comprehensive income for the current period was 14,552,762.64 yuan[187] - Comprehensive income for the period reached 284,714,798.18 yuan, driven by a net profit increase of 284,494,298.18 yuan[192] - Total owner's equity at the end of the period stood at 6,436,319,822.22 yuan, up from 6,169,507,352.73 yuan at the beginning of the period[192][193] - Profit distribution to owners (or shareholders) amounted to -71,142,600.45 yuan, indicating a significant payout[192] - The company's total equity increased by 266,812,469.49 yuan during the period, primarily due to comprehensive income and capital injections[192] - In the previous year, the company's total equity was 5,621,873,001.86 yuan, showing a year-over-year growth[194] Product Performance and Market Penetration - The company's flagship product, Camena (Icotinib Hydrochloride Tablets), generated sales of RMB 1.2 billion, accounting for 48% of total revenue[1] - The company's core product, Icotinib Hydrochloride Tablets (Conmana®), continues to maintain stable sales[17] - Enzotinib Capsules (Bemena®) and Bevacizumab Injection (MIL60, Beiantin®) showed significant revenue growth[17] - The company has five marketed drugs, with two recently included in the national medical insurance, accelerating market penetration[17] - Key products like Kaimeina, Beimeina, and Saimeina showed significant market growth, contributing to revenue[39] - The company achieved a 100% product qualification rate in the first half of 2024[37] - The company has successfully commercialized China's first self-developed small molecule lung cancer targeted drug, Kaimeina, and other innovative drugs[47] - The company's drug BPI-16350 (Tabecciclib Tartrate Capsules) has received NMPA acceptance for registration[47] - The company's drug Enzastaurin Capsules has received FDA acceptance for the treatment of ALK-positive NSCLC[47] - The company's drug Enzastaurin Capsules has a compound patent protection period until 2031-2037[49] - BPI-16350, a CDK4/6 inhibitor, has reached the NDA stage and is expected to contribute to future revenue growth[50] - Bemnara's first-line indication for ALK-positive NSCLC has been accepted by the US FDA, potentially becoming the first globally marketed lung cancer targeted innovative drug led by a Chinese pharmaceutical company[21] - Bemnara's Phase II-IIIB clinical trial for postoperative adjuvant treatment of ALK-positive NSCLC has completed patient enrollment[21] - Bemnara has published 69 articles with a total impact factor of 405.33, demonstrating its efficacy and safety in multiple studies[21] - In the eXalt 3 study, Bemnara showed a median PFS of 47.1 months in baseline brain metastasis-free patients and 23.9 months in baseline brain metastasis patients[21] - Bemnara's second-line clinical study updated results show a median OS of 42.8 months in patients with crizotinib-resistant NSCLC[21] - Bemnara's first-line and second-line indications have been included in the national medical insurance, significantly improving product accessibility[22] - Betta's Phase III clinical study for Bemnara showed a 12-week ORR of 48.6% vs 43.1% in the control group, proving bioequivalence[23] - Betta has acquired full sales royalties for Bemnara for 25 million RMB[23] - Bemnara's five major indications have been approved by the NMPA, making it a cornerstone drug in combination therapy[23] - MCLA-129 clinical trial for EGFR-mutated NSCLC patients approved by NMPA, with exclusive rights for BPI-D0316 in mainland China, Hong Kong, and Taiwan secured through a partnership with InventisBio in December 2018[25] - IBIOS-103 study published in The Lancet Respiratory Medicine shows median PFS of 22.1 months for Befotertinib vs. 13.8 months for Icotinib in EGFR-mutated NSCLC patients, with consistent benefits in patients with or without brain metastases[25] - Befotertinib (Saimena) included in 2024 CSCO guidelines as a Grade I recommendation for first-line treatment of EGFR-mutated NSCLC and for T790M-positive patients after first/second-generation TKI failure[25] - Fumetinib (Vometinib) approved for advanced RCC in June 2023, with median PFS of 10.0 months in combination with Everolimus vs. 6.4 months for Everolimus alone, and ORR of 24.8% vs. 8.3%[26] - EYP-1901, a sustained-release formulation of Vorolanib for ophthalmic indications, shows 65% and 64% of patients in 2mg and 3mg dose groups, respectively, requiring no anti-VEGF rescue therapy for 6 months in DAVIO 2 trial[26] - EYP-1901 achieves 12-month results in DAVIO 2 trial, with approximately half of patients requiring no anti-VEGF rescue therapy after a single injection, demonstrating good disease control[27] - Saimena strengthens the company's EGFR pathway product pipeline, with rapid market expansion post-NRDL inclusion, offering new treatment options for patients[25] - Fumetinib expands the company's oncology portfolio, with improved accessibility post-NRDL inclusion, and shows promising clinical and commercial potential in ophthalmic indications[27] - The company has published 6 SCI papers on Saimena with a total impact factor of 83.96, and 19 SCI papers on Fumetinib with a total impact factor of 81.26, presented at major international conferences[25][26] - The company focuses on unmet clinical needs, leveraging its R&D centers in Beijing and Hangzhou, and has built a product matrix with five marketed drugs, seeking breakthroughs in new targets and therapies[29] - BPI-16350, a CDK4/6 inhibitor, received NMPA acceptance for its marketing application in May 2024[34] - BPI-520105 and BPI-221351, targeting EGFR and IDH1/IDH2 mutations, had their clinical trial applications approved in March 2024[34] - EYP-1901, a treatment for wet AMD, received clinical trial approval in July 2024[34] - The company has 5 approved drugs, with 4 included in the National Reimbursement Drug List[38] - Strategic investments, such as in Wuhan Heyuan Biotechnology, are progressing with Phase III clinical studies completed[36] - The company is advancing multiple projects in NSCLC treatment, including postoperative adjuvant therapies for EGFR-mutated NSCLC[53] - Academic brand activities, such as the "Beda Speaker" and "Success Innovation Pharma Experience Sharing Conference," reinforce the company's market differentiation[54] - The company is exploring diverse cancer treatments, including targeted therapies, immunotherapies, and combination therapies, to provide new options for cancer patients[53] R&D and Innovation - R&D expenditure for the first half of 2024 amounted to RMB 600 million, representing 24% of total revenue[1] - The company plans to launch two new drugs, BPI-D0316 and CM082, in the second half of 2024, targeting NSCLC and RCC markets respectively[5] - The company's pipeline includes 15 innovative drugs in various stages of clinical trials, with 3 in Phase III[5] - International expansion efforts are underway, with plans to submit regulatory filings for Ensartinib in the US and EU by the end of 2024[5] - The company has initiated a strategic partnership with a leading global pharmaceutical company to co-develop and commercialize a novel oncology drug[5] - R&D investment in the first half of 2024 amounted to 381.85 million yuan, driving pipeline growth[33] - The company's R&D investment accounted for 38.32%, 41.12%, and 40.80% of its revenue over the past three years, supporting a robust pipeline of innovative drugs[52] - Balstilimab and Zalifrelimab, both monoclonal antibodies, are in Phase II trials for cervical cancer treatment, expanding the company's R&D pipeline[50] - MCLA-129, an EGFR/c-Met bispecific antibody, is in Phase I trials for treating EGFR-mutated advanced NSCLC, further diversifying the pipeline[50] - BPI-21668, a PI3Kα selective inhibitor, is in Phase I trials for advanced solid tumors, enhancing the company's oncology portfolio[51] - The company has successfully transitioned from a single product (Kaimeina) to five marketed products, demonstrating strong drug development capabilities[52] - BPI-16350's Phase III drug registration application has been accepted by the NMPA, highlighting the company's continuous innovation efforts[52] - The company is closely tracking industry innovation technologies, exploring new drugs and indications, and enhancing its R&D pipeline to manage new drug R&D and market risks[77] - The company has established strategic partnerships with companies like TianGuangShi, Yifang Biologics, EYPT, and C4T, leading to the approval of new drugs such as Beianting, Saimena, and Fumeina[55] - The company's investment in C4 Therapeutics, Inc. increased by 2.02% to 1,190,654,307.59 yuan, accounting for 13.02% of total assets[59] - The company's overseas assets, including Xcovery Holdings, Inc. and C4 Therapeutics, Inc., account for 26.21% and 3.29% of the company's net assets, respectively[60][61] - The company's construction-in-progress increased by 1.51% to 2,174,352,080.65 yuan due to increased investment in projects like the DreamWorks Phase II project and the Shengzhou Innovative Drug Industrialization Base project[59] - The company's investment in C4 Therapeutics, Inc. amounted to RMB 177,492,476.71, representing an 8.09% stake, with a profit of RMB 5,836,096.12 during the reporting period[65] - The total investment in the Menggongchang Phase II project reached RMB 1,419,098,225.96, with a progress rate of 78.84%[66] - The total investment in the Shengzhou Innovative Drug Industrialization Base project was RMB 730,235,762.78, with a progress rate of 74.51%[66] - The company's financial assets measured at

证券代码：300558 证券简称：贝达药业 公告编号：2024-053 贝达药业股份有限公司 关于股东股份质押变动的公告 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"）今日接到股东宁波凯铭投资管理合伙企业 （有限合伙）（以下简称"凯铭投资"）函告，获悉凯铭投资持有本公司的部分股份发生质 押变动，现将具体情况公告如下： 一、股东股份质押基本情况 1、凯铭投资股份补充质押情况 | 股东 | 是否为控 股股东或 第一大股 | 本次质押 数量 | 占其所 持股份 | 占公司 总股本 | 是否为 | 是否为 | 质押 | 质押 | 质权人 | 质押 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 名称 | | | | | 限售股 | 补充质押 | 起始日 | 到期日 | | 用途 | | | 东及其一 | （股） | 比例 | 比例 | | | | | | | | | 致行动人 | | | | | | | | | | | 凯铭 | 是 ...

证券代码：300558 证券简称：贝达药业 公告编号：2024-052 1、凯铭投资股份补充质押情况 | | 是否为控 | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 股东 | 股股东或 | 本次质押 | 占其所 | 占公司 | 是否为 | 是否为 | 质押 | 质押 | | 质押 | | 名称 | 第一大股 | 数量 | 持股份 | 总股本 | 限售股 | 补充质押 | 起始日 | 到期日 | 质权人 | 用途 | | | 东及其一 | （股） | 比例 | 比例 | | | | | | | | | 致行动人 | | | | | | | | | | | 凯铭 | | | | | | | | | 浙商证券 | 补充 | | | 是 | 50,000 | 0.06% | 0.01% | 否 | 是 | 2024/7/24 | 2024/10/23 | 股份有限 | | | 投资 | | | | | | | | | 公司 | 质押 | 2、股东股份累计质押情况 截至公告披露日，凯铭投 ...

关于股东股份质押变动的公告 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"）今日接到股东宁波凯铭投资管理合伙企业 （有限合伙）（以下简称"凯铭投资"）函告，获悉凯铭投资持有本公司的部分股份发生质 押变动，现将具体情况公告如下： 证券代码：300558 证券简称：贝达药业 公告编号：2024-051 贝达药业股份有限公司 一、股东股份质押基本情况 1、凯铭投资股份延期购回情况 | 是否为控股股东或 | 本次延期 | 占其所持 | 占公司总 | 是否为 | | | 延期后质押 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 第一大股东及其 | 购回数量 | 股份比例 | 股本比例 | 限售股 | 质押起始日 质押到期日 | | 到期日 | 质权人 | 质押用途 | | 一致行动人 | （股） | | | | | | | | | | 是 | 3,000,000 | 3.75% | 0.72% | 否 | 2021/6/25 | 2024 ...

注：本公告中的"元"均指人民币元。 1 证券代码：300558 证券简称：贝达药业 公告编号：2024-050 贝达药业股份有限公司 2024 年半年度业绩预告 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。 一、本期业绩预计情况 （一）业绩预告期间 2024 年 1 月 1 日至 2024 年 6 月 30 日 （二）业绩预告情况 1、预计净利润为正值且同向上升 | --- | --- | --- | --- | |----------------|-------------------------------------------|--------|------------------| | 项 目 | 本报告期 | | 上年同期 | | 归属于上市公司 | 盈利： 20,762.88 万元– 23,729.01 万元 | | | | 股东的净利润 | 比上年同期增长： 40.00% - 60.00% | 盈利： | 14,830.63 万元 | | 扣除非经常性 | 盈利： 21,214.78 万元– 22,982.67 万元 | | | | 损益后的 ...