公 司 研 究 [Table_Reportdate] 2024年08月07日 [Table_invest] 买入（维持） 报告原因：业绩点评 [证券分析师 Table_Authors] 杜永宏 S0630522040001 dyh@longone.com.cn 证券分析师 伍可心 S0630522120001 wkx@longone.com.cn 联系人 付婷 futing@longone.com.cn | --- | --- | |-------------------------|-------------| | 数据日期 Table_cominfo] | 2024/08/06 | | 收盘价 | 36.22 | | 总股本(万股) | 41,849 | | 流通A股/B股(万股) | 41,718/0 | | 资产负债率(%) | 39.14% | | 市净率(倍) | 2.72 | | 净资产收益率(加权) | 4.16 | | 12个月内最高/最低价 | 63.09/30.43 | [Table_QuotePic] -44% -30% -16% -2% 12% 26% 40% 54% 23-08 2 ...

2024 年 08 月 06 日 证券研究报告/公司研究 贝达药业 300558.SZ 基础数据： 总股本 4.18 亿股 流通股本 4.17 亿股 分分析析师师：XXX huchenxi@gwgsc.com 执业证书编号：S0200518090001 联系电话：010-68085205 化学制剂/化学制药/医药生物 业绩符合预期，商业化产品持续放量 事件：公司发布2024年半年报：2024年上半年公司实现营收15.01亿元， 截至 2024 年 8 月 06 日 同比增长14.22%；归母净利润2.24亿元，同比增长51.00%；扣非归母净 当前股价 36.22 元 利润2.17亿元，同比增长144.98%；经营活动产生的现金流量净额5.22 亿元，同比增长44.77%。 投资评级 买入 评级变动 维持 事件点评： 总市值 151.40 亿元 流动市值 151.10 亿元 ◆利润端保持快速增长，运营效率持续提升。2024年上半年公司实现营 业收入15.01亿元；扣非归母净利润为2.17亿元，约为2023全年的83%， 相对市场表现： 同比增长144.98%，延续快速增长态势。公司注重投入产出效率，重视 研发 ...

证券研究报告 非金融公司|公司点评|贝达药业（300558） 收入稳健增长，利润表现亮眼 请务必阅读报告末页的重要声明 glzqdatemark1 2024年08月06日 证券研究报告 |报告要点 贝达药业发布 2024 年半年报，上半年实现收入 15.01 亿元（同比+14.22%），实现归母净利润 2.24 亿元（同比+51.00%），实现扣非归母净利 2.17 亿元（同比+144.98%）。业绩符合预期。 |分析师及联系人 夏禹 郑薇 SAC：S0590518070004 SAC：S0590521070002 请务必阅读报告末页的重要声明 1 / 5 非金融公司|公司点评 glzqdatemark2 2024年08月06日 贝达药业(300558) 收入稳健增长，利润表现亮眼 | --- | --- | |------------|-------------------| | 行 业： | 医药生物/化学制药 | | 投资评级： | 增持（维持） | | 当前价格： | 34.44 元 | 基本数据 总股本/流通股本(百万股) 418.49/417.16 流通 A 股市值(百万元) 14,366.85 ...

本报告仅供 Choice 东方财富 使用，请勿传阅。 公司快报 2024 年 08 月 06 日 贝达药业(300558.SZ) 24H2 存在贝福替尼一线适应症医保谈 判催化，多个产品有序推进中 事件：公司发布 2024 年中报，报告期内实现营业收入 15.01 亿 元，同比增长 14.22%；实现归母净利润 2.24 亿元，同比增长 51.00%；实现扣非归母净利润 2.17 亿元，同比增长 144.98%。 2024H2 存在贝福替尼 NSCLC 一线适应症医保谈判催化，2025 年 放量值得期待。公司三代 EGFR TKI 贝福替尼 NSCLC 二线适应症 于 2023 年 5 月获批上市，已纳入 2023 年医保目录中，正处于积 极入院的阶段；其 NSCLC 一线适应症于 2023 年 10 月获批上市， 预计将于年底参与 2024 年医保谈判，考虑到公司在今年充分的入 院准备工作，预计一线适应症纳入医保后有望带动 2025 年销售额 的快速增长。 恩沙替尼海外、CDK4/6 抑制剂国内上市工作有序推进中，其他 多个重点产品临床研究进展值得关注。 处在上市申请阶段的产品及适应症方面：恩沙替尼 ALK ...

2024 ￥ 08 月 06 日 证 养坏 充报者•2024 羊 牛报点评 则 达 药 业（300558）底 药生物 持有 （维持） 当 前 价：34.44 无 目标价：一一无（６个月） 净利润快速增长，创新成果持续兑现 投资夫点 ● 业绩总站: 公司发布 2024 年半年报, 2024 上半年实现营业救入 15 亿元 (+14.2%)，归득净利润 2.2 亿元 (+51%)，标非后归득净利润 2.2 亿元 (+145%)。 ● 利润高增主美系公司加强期间食用开支管理，降本增效。公司注重投入产出效 率，查視研发项目质量，通过预算管理、招投标管理、食用考核、系统控制等 机制，各理答理期间象用开支，稳步实现降本增效。报告期内期间象用占容业 收入比例从 77.14%降低到 67.25%，下降 9.89pp。公司办强经销商管理、信 用答理，扩大销量同时积极增办现全回笼。报告期内经营活动产生的现全流量 净领 52,169.23 万元，同比增长 44.77%，净利润现金仓量达 232.95%，销售 创 现率达 109.28%。 ● 思莎斧尼有雙牟底子 FDA 获ঝ，查组人自正在徐进上市市市。上半年，关国 FDA 完成思莎 ...

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 ...

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

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 ...

各位订阅者大家上午好我是国人正事的超商编辑师陈清明然后呢今天下午我们也是非常荣幸荣幸的邀请到了贝达LEA董事吴总然后来给大家对公司近期的一个整体的一些进展做一个介绍然后整个贝达的话目前在不管是在销售层面还是说在整个这个研发端他们的一个推进其实都是非常的一个向好包括在前段时间ESCO会议上面的一个整个双团ABC的一个 整个双抗EJ8CMI的双抗的一个数据也是非常好,而且也是一个非常大的一个仪器的硬仓,然后数据也是非常扎实。对,所以然后下面的话我也是把时间那个交给吴总,给大家做一个进一步一个详细的一个介绍,欢迎吴总。 哎 吴总我看您现在是那个静音的状态可能需要那个那个上点一下上麦或者解除一下静音吴总目前直播间听不到您的声音需要点击一下上麦发言哦 吴总可以听到吗可以刚才声音有点问题 抱歉没有麻烦您就先介绍一下公司的一个整体进展然后后面我们再开放Q&A的环节 好的最近因为也不是季报的季节所以其实整体的进展不算很多财务数据上总体而言二季度数字还可以然后具体的产品细分可能等到我们半年报出来之后再给大家做一个相对详细的拆分二季度总体而言可能nsha的进度还不错然后三代也有一定程度的增长其他产品总体比较 正常的这样一个状态其 ...

公司报告 | 年报点评报告 贝达药业（300558） 证券研究报告 2024年05月 25日 投资评级 2023 年利润端符合预期，商业化品种持续拓展 行业 医药生物/化学制药 6个月评级 增持（维持评级） 当前价格 38.03元 事件 目标价格 元 公司发布2023年年度报告及2024年一季报：2023年收入24.56亿元，同 比增长3.35%，归母净利润3.48 亿元，同比增长 139.33%，扣非归母净利 基本数据 润2.63亿元，同比增长768.85%；2024Q1收入7.36亿元，同比增长38.4%， A股总股本(百万股) 418.49 归母净利润0.98亿元，同比增长90.95%，扣非归母净利润0.9亿元，同比 增长390.39%。 流通A股股本(百万股) 417.16 A股总市值(百万元) 15,915.02 2023年经营基本稳定，管理费用下降较多 流通A股市值(百万元) 15,864.44 2023 年销售费用率为 34.76%，同比增长 1.98pt；管理费用率为 10.66%， 每股净资产(元) 13.20 同比下降8.49pt；研发费用率26.06%，同比下降3.39pt。管理费用大幅 ...