证 券 研 究 报 告 百利天恒-U（688506）重大事项点评 强推（维持） BL-B01D1 新瘤种数据读出，潜力进一步扩展 目标价：204.4 元 事项： 2024 年 9 月 13 日到 16 日，百利天恒在 2024 ESMO 大会公布 3 项 I 期临床数 据，分别为 BL-B01D1 单药用于经治的 UC、BTC 以及 ESCC 患者。 评论： 全球首创双靶点 ADC，多癌种疗效优异。BL-B01D1 是全球首创的 EGFR× HER3 ADC，在多个癌种中展现治疗潜力。2024 ESMO 年会公布了 3 项 BLB01D1 单药治疗数据，疗效积极。在 32 例中位前线系统性治疗线数为 2 线的 la/m UC 患者中，23 例接受 2.2 mg/kg Q3W 剂量的患者疗效可评估，ORR 为 43.5%，其中 cORR 为 34.8%，DCR 达到 91.3%，mPFS 为 5.5 个月；在 10 名 接受过一线化疗的患者中，ORR 高达 90%，其中 cORR 为 80%，mPFS 未成 熟。在 39 例中位前线系统性治疗线数为 2 线的 la/m BTC 患者中，21 例接受 2.5 mg ...

[Table_Page] 跟踪研究|化学制药 [Table_Title] 百利天恒-U（688506.SH） B01D1 闪耀 ESMO，全球注册临床可期 [Table_Summary] 核心观点： ⚫ 公 司 在 2024ESMO 首 次 公 布 核 心 产 品 BL-B01D1 在尿路上皮癌、食管鳞癌及胆道癌中的数据，其中 UC 数据尤为亮眼。 2.2mg/kg 组 27 例疗效可评估，大多数患者均经受抗 PD-(L)1 和含铂 化疗，14 例经受 ADC 治疗，实现 ORR 40.7%，confirmed 33.3%。 在 12 例化疗经治线数仅为 1 的患者中实现 ORR 75%，6 个月 PFS 率 100%。在 EGFR 和 HER3 各表达水平下均观察到抗肿瘤活性。安全 性方面，≥G3 TRAE 发生率 52.9%，治疗相关 SAE 35.3%，大部分血 液学毒性为 1-2 级，未观察到治疗相关死亡及 ILD（来源：公司官网）。 ⚫ BMS 表达对开展 B01D1 全球注册临床的信心。BMS 召开 ESMO2024 投资者交流会议，BMS 认为 B01D1 在胃肠道和生殖泌尿系统癌症中 表现出可 ...

证券代码：688506 证券简称：百利天恒 四川百利天恒药业股份有限公司 投资者关系活动记录表 | --- | --- | --- | --- | --- | |----------------|-------------------------|-------|-------|-------------------------------------------------------------------| | | | | | | | | □ | | | 特定对象调研 □分析师会议 | | 投资者关系活动 | □ 媒体采访 √业绩说明会 | | | | | 类别 | □ 新闻发布会 □路演活动 | | | | | | □ | | | 现场参观 □其他（电话会议） | | 参与单位名称 | 参加 2024 | | | 年半年度科创板制药及生物制品专场集体业绩说明会的 | | | 线上投资者 | | | | | 时间 | 2024 年 9 月 18 | 日 | | 14:00-16:00 | | 地点 | roadshow.sseinfo.com/ | | | 上 海 证 券 交 易 所 上 证 路 演 中 ...

证券代码：688506 证券简称：百利天恒 公告编号：2024-052 四川百利天恒药业股份有限公司 关于参加 2024 年半年度科创板制药及生物制品专场集体 业绩说明会的公告 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： 投资者可于 2024 年 9 月 13 日(星期五)16:00 前通过四川百利天恒药业股 份有限公司（以下简称"公司"）邮箱 ir@baili-pharm.com 进行提问，公司将在 业绩说明会上对投资者普遍关注的问题进行回答。 公司已于 2024 年 8 月 24 日在上海证券交易所网站（www.sse.com.cn）披露 公司 2024 年半年度报告，为便于广大投资者更全面深入地了解公司 2024 年半年 度的经营成果、财务状况及发展战略，公司计划于 2024 年 9 月 18 日（星期三） 14:00-16:00 参加由上海证券交易所主办的 2024 年半年度科创板制药及生物制品 专场集体业绩说明会，就投资者关心的问题进行交流。 一、说明会类型 本次业绩说明会以网络文字互动形式召 ...

国投证券股份有限公司 关于四川百利天恒药业股份有限公司 1 序号 工作内容 持续督导情况 1 建立健全并有效执行持续督导工作制度，并 针对具体的持续督导工作制定相应的工作 计划。 保荐机构已建立健全并有效执行了持续督导工作 制度，并制定了相应的工作计划。 2 根据中国证监会相关规定，在持续督导工作 开始前，与上市公司或相关当事人签署持续 督导协议，明确双方在持续督导期间的权利 义务，并报上海证券交易所备案。 保荐机构已与百利天恒签订保荐协议，协议明确 了双方在持续督导期间的权利和义务，并报上海 证券交易所备案。 3 持续督导期间，按照有关规定对上市公司违 法违规事项公开发表声明的，应于披露前向 上海证券交易所报告，并经上海证券交易所 审核后在指定媒体上公告。 百利天恒在 2024 年 1 月 1 日至 2024 年 6 月 30 日 期间（以下简称"本持续督导期间"）未发生按 有关规定需保荐机构公开发表声明的违法违规情 况。 4 持续督导期间，上市公司或相关当事人出现 违法违规、违背承诺等事项的，应自发现或 应当发现之日起五个工作日内向上海证券 交易所报告，报告内容包括上市公司或相关 当事人出现违法违规、违背 ...

2024 年 08 月 31 日 昨收盘:169.29 厚积薄发的 ADC 和多抗龙头，携手 BMS 掘金全球市场 走势比较 (20%) 10% 40% 70% 100% 130% 23/8/31 23/11/1224/1/2424/4/624/6/1824/8/30 股票数据 总股本/流通(亿股) 4.01/0.90 总市值/流通(亿元) 678.85/153.12 12 个月内最高/最低价 (元) 215.71/76.32 证券分析师：周豫 E-MAIL：zhouyua@tpyzq.com 分析师登记编号：S1190523060002 证券分析师：霍亮 E-MAIL：huoliang@tpyzq.com 分析师登记编号：S1190523070002 研究助理：戎晓婕 E-MAIL：rongxj@tpyzq.com 一般证券业务登记编号：S1190123070050 报告摘要 创新转型的典范，成功打造行业领先的 ADC 和多抗平台。 1） 百利天恒（688506）是国内第一批转型创新的制药企业。公司于 2010 年涉足生物药研发并于 2014 年在美国设立研发子公司 SystImmune，搭建工程化抗体技术 ...

Clinical Progress of BL-B01D1 - BL-B01D1 is currently undergoing 7 Phase III clinical trials for various cancer types, including non-small cell lung cancer, small cell lung cancer, breast cancer, esophageal squamous cell carcinoma, and nasopharyngeal carcinoma [5] - 8 Phase II trials are evaluating BL-B01D1 in combination with PD-(L)1 therapies for first-line treatment of 9 cancer types [5] - 2 Phase II trials are assessing BL-B01D1 in combination with TKIs for first-line lung cancer treatment [5] - 6 Phase Ib trials are ongoing for BL-B01D1 [5] Overseas Development of BL-B01D1 - BL-B01D1 is progressing well in Phase I dose escalation in the US [6] - The drug is expanding its indications from non-small cell lung cancer to small cell lung cancer, breast cancer, esophageal cancer, and nasopharyngeal cancer [6] - Future clinical studies in the US will focus on combination therapies with PD-(L)1 and TKIs for first-line patients [6] Future Clinical Plans for BL-B01D1 - The company plans to advance BL-B01D1 into Phase III trials for urothelial carcinoma, biliary tract malignancies, and ovarian cancer based on current research data [7] CD33 ADC (BL-M11D1) Development - BL-M11D1 has shown strong efficacy signals in Phase I dose escalation studies [8] - The drug demonstrates low hepatotoxicity and manageable side effects [8] - BL-M11D1 has potential to become a best-in-class drug with high clinical and market value [8] GNC Antibody Development - The company's GNC-077, a fourth-generation GNC antibody, has shown significant tumor-killing activity in various solid tumors [9] - GNC-077 can effectively activate, differentiate, and proliferate naïve T cells, targeting tumor antigen-positive cells [9] - The company submitted an IND for GNC-077 to the NMPA in June 2024 [9] HER2 ADC (BL-M07D1) Development - BL-M07D1 shows potential to outperform ENHERTU in efficacy with lower incidence of interstitial lung disease [10] - The drug is currently in 9 Phase I/II/III clinical trials in China and the US, evaluating its use in various HER2-expressing solid tumors [10] IPO Progress - The company's Hong Kong IPO application is progressing smoothly [11]

证券代码：688506 证券简称：百利天恒 公告编号：2024-051 四川百利天恒药业股份有限公司 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。 根据《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》《上海证券交易所科创板上市公司自律监管指引第 1 号——规范运作》等有 关规定，四川百利天恒药业股份有限公司（以下简称"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、资金到账时间 根据中国证券监督管理委员会（以下简称"中国证监会"）出具的《关于同 意四川百利天恒药业股份有限公司首次公开发行股票注册的批复》（证监许可 〔2022〕2969 号）以及上海证券交易所出具的《关于四川百利天恒药业股份有限 公司人民币普通股股票科创板上市交易的通知》（〔2023〕1 号），公司已向社会公 众首次公开发行人民币普通股（A 股）4,010.00 万股（以下简称"本次发行"）， 每股发行价为人民币 ...

证券代码：688506 证券简称：百利天恒 公告编号：2024-050 四川百利天恒药业股份有限公司 第四届监事会第十四次会议决议公告 本公司监事会及全体监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。 一、监事会会议召开情况 2024 年 8 月 23 日，四川百利天恒药业股份有限公司（以下简称"公司"） 第四届监事会第十四次会议在公司会议室召开。本次会议以现场及通讯表决方式 召开，应出席监事 3 名，实际出席监事 3 名，会议由监事会主席汪捷女士主持。 本次会议的通知于 2024 年 8 月 13 日通过书面形式送达全体监事。本次会议的召 集和召开程序符合《中华人民共和国公司法》和《公司章程》的规定，会议决议 合法、有效。 二、监事会会议审议情况 全体监事对本次监事会会议议案进行了审议，经表决形成如下决议： 1、《关于公司<2024 年半年度报告>及其摘要的议案》 监事会认为：公司《2024 年半年度报告》的编制和审议程序符合相关法律 法规及《公司章程》等规章制度的规定。公司 2024 年半年度报告披露的信息真 实、准确、完整，不存在任何 ...

Financial Performance - The company reported a half-year performance summary for the period from January 1, 2024, to June 30, 2024[1]. - The company's revenue for the first half of 2024 reached approximately ¥5.55 billion, a significant increase of 1,685.19% compared to ¥311 million in the same period last year[19]. - Net profit attributable to shareholders was approximately ¥4.67 billion, compared to a loss of ¥328 million in the previous year[19]. - The basic earnings per share for the reporting period was ¥11.64, a substantial improvement from a loss of ¥0.82 per share in the same period last year[19]. - The weighted average return on net assets was 187.78%, a significant increase from -42.65% in the previous year[19]. - The net cash flow from operating activities was approximately ¥5.03 billion, compared to a negative cash flow of ¥323 million in the previous year[19]. - Total assets increased to approximately ¥7.19 billion, up 404.22% from ¥1.43 billion at the end of the previous year[19]. - Net assets attributable to shareholders rose to approximately ¥4.83 billion, a dramatic increase of 3,079.34% from ¥151 million at the end of the previous year[19]. Research and Development - Research and development expenses accounted for 9.81% of operating revenue, a decrease of 97.19 percentage points compared to the previous year[19]. - The total R&D investment for the period was approximately ¥544.53 million, a 63.61% increase compared to ¥332.83 million in the same period last year[60]. - The increase in R&D investment was primarily due to higher costs in testing, employee salaries, and materials[61]. - The R&D team has grown to 879 members, representing 38.83% of the total workforce, compared to 30.06% in the previous year[68]. - The company has established R&D centers in both the US and China, enhancing its capability to develop innovative therapies[26]. - The company has developed a leading ADC drug research platform (HIRE-ADC) and has successfully developed 3 Phase III clinical assets, including 2 ADC drugs and 1 bispecific antibody drug[48]. - The company is actively advancing its core innovative biopharmaceutical pipeline, with several products in clinical research or IND application stages[28]. Market Overview - The global oncology drug market grew from $129 billion in 2018 to $223.2 billion in 2023, with a compound annual growth rate (CAGR) of 11.6%[40]. - The oncology drug market is projected to grow at a CAGR of 9.9% from 2023 to 2033, reaching $575 billion by 2033[40]. - The bispecific and multispecific tumor drug market was valued at $2 billion in 2023 and is projected to reach $70 billion by 2033[43]. - The Chinese anesthetic drug market grew from RMB 14.9 billion in 2018 to RMB 20.4 billion in 2023, with a CAGR of 6.5%, and is forecasted to reach RMB 34.1 billion by 2033[44]. - The Chinese traditional Chinese medicine market increased from RMB 395.2 billion in 2018 to RMB 422.5 billion in 2023, with a CAGR of 1.3%, and is projected to reach RMB 563.8 billion by 2033[46]. Corporate Governance - The report outlines the company's governance structure and compliance with decision-making procedures[6]. - The company has not disclosed any special arrangements regarding corporate governance during this reporting period[6]. - The company confirmed that there were no non-operating fund occupations by controlling shareholders or related parties[6]. - The financial report has not been audited, but the responsible personnel have declared its authenticity and completeness[4]. - The company has established long-term commitments to address related party transactions and competition issues[141]. Environmental Responsibility - The company invested CNY 526.85 million in environmental protection during the reporting period, demonstrating its commitment to environmental responsibility[127]. - The company has established an environmental protection mechanism and strictly adheres to national environmental laws and regulations[127]. - The wastewater treatment facility at Baili Pharmaceutical has a processing capacity of 800 cubic meters per day, while the actual pollution generation was 600 cubic meters per day[127]. - The company has implemented annual self-monitoring plans for environmental management, with no exceedances in pollutant emissions reported[135]. - There were no administrative penalties due to environmental issues during the reporting period[136]. Shareholder Commitments - The actual controller and major shareholders have made commitments to reduce and regulate related party transactions to protect the interests of minority shareholders[167]. - The controlling shareholder Zhu Yi has committed to not transferring or managing shares for 36 months post-IPO[142]. - The company has outlined strict compliance with relevant laws and regulations regarding share reductions by major shareholders[145]. - The company will take responsibility for any losses incurred by investors due to its failure to meet commitments[174]. - The company has committed to ensuring that any share reductions by OAP III (HK) Limited will not be below the IPO price[145]. Financial Risks - The company faces significant financial risks as all innovative drug candidates are still in clinical and preclinical development stages, with future R&D expenditures expected to rise[105]. - The company is exposed to foreign exchange risks due to its international operations, which may impact its financial performance[105]. - The company’s business performance is heavily reliant on the successful development and commercialization of its drug candidates, including BL-B01D1[105].