中信证券股份有限公司 关于四川百利天恒药业股份有限公司 2025 年度向特定对象发行 A 股股票 之 发行保荐书 保荐人（主承销商） 广东省深圳市福田区中心三路 8 号卓越时代广场（二期）北座 二〇二五年四月 四川百利天恒药业股份有限公司 发行保荐书 | 声 | 明 | 1 | | --- | --- | --- | | 目 | 录 | 2 | | 第一节 | | 本次证券发行基本情况 3 | | | | 一、保荐人名称 3 | | | | 二、保荐代表人、项目协办人及其它项目组成员情况 3 | | | | 三、发行人情况 3 | | | | 四、保荐人及其关联方与发行人及其关联方之间的利害关系及主要业务往来 | | | | 情况 8 | | | | 五、保荐人内核程序和内核意见 10 | | 第二节 | | 保荐人承诺事项 11 | | 第三节 | | 对本次证券发行的推荐意见 12 | | | | 一、对本次证券发行的推荐结论 12 | | | | 二、对发行人本次发行是否履行决策程序的核查 12 | | | | 三、发行人符合《公司法》及《证券法》规定的发行条件和程序 13 | | | | 四、本次发行 ...

证券代码：688506 证券简称：百利天恒 公告编号：2025-030 四川百利天恒药业股份有限公司 自愿披露关于注射用 BL-M09D1（ADC）治疗晚期实体瘤获得 药物临床试验批准通知书的公告 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。 四川百利天恒药业股份有限公司（以下简称"公司"）近日收到国家药品监督 管理局(NMPA)正式批准签发的《药物临床试验批准通知书》,公司自主研发的创新 生物药注射用 BL-M09D1（ADC）的药物临床试验获得批准。现将相关情况公告如 下： 一、《药物临床试验批准通知书》基本情况 产品名称：注射用 BL-M09D1 受理号：CXSL2500103 通知书编号：2025LP01070 申请事项：境内生产药品注册临床试验 申请人：成都百利多特生物药业有限责任公司；四川百利药业有限责任公司 结论：根据《中华人民共和国药品管理法》及有关规定，经审查，注射用 BL-M09D1 符合药品注册的有关要求，同意本品单药在晚期实体瘤患者中开展临床 试验。 二、药品的其他情况 BL-M09D1 是与 B ...

百利天恒：2025年度向特定对象发行A股股票申请获得上交所受理 金十数据4月16日讯，百利天恒公告称，公司于2025年4月16日收到上交所出具的《关于受理四川百利天 恒药业股份有限公司科创板上市公司发行证券申请的通知》，上交所决定予以受理并依法进行审核。 ...

每经记者 林姿辰 每经编辑 杨夏 丨 2025年4月16日 星期三 丨 点评：健帆生物2024年业绩表现极为亮眼。公司核心产品血液灌流器、吸附器销售收入同比增长 59.58%，推动整体业绩强劲增长，显示出公司强大的盈利能力和业务拓展能力。公司整体毛利率高达 80.78%，血液灌流器产品毛利率更是达到85.01%，表明其在市场中拥有显著的竞争优势。这一业绩表 现有望增强投资者信心，进一步提升公司在资本市场的估值。 NO.3 达仁堂发布关于转让参股公司股权的交易公告 4月15日，达仁堂发布公告，称拟分别向赫力昂（中国）有限公司、Haleon CH SARL转让所持有的中美 天津史克制药有限公司4.6%股权、7.4%股权，交易价格分别为6.22亿元、10.01亿元。经初步测算，该 项交易预计影响公司当期投资收益约15.4亿元。公司认为本次交易价格符合市场水平且相比于资产评估 价值有35%的溢价，有利于增加公司现金流入，且符合公司聚焦主业的发展思路。 点评：本次交易中，公司处置资产获得了较为理想的价格，有助于提升股东价值。从资金流向来看，这 笔现金流入将增强公司的流动性，为后续业务发展提供资金支持。同时，聚焦主业的发 ...

证券代码：688506 证券简称：百利天恒 公告编号：2025-029 四川百利天恒药业股份有限公司（以下简称"公司"）近日收到国家药品监督 管理局(NMPA)正式批准签发的 4 个《药物临床试验批准通知书》，公司自主研发的 创新生物药注射用 BL-B01D1（EGFR×HER3 双抗 ADC）的 4 个联合用药的 II 期 临床试验获得批准。现将相关情况公告如下： 一、《药物临床试验批准通知书》基本情况 四川百利天恒药业股份有限公司 自愿披露关于 BL-B01D1（EGFR×HER3 双抗 ADC）联合用 药治疗多种晚期实体瘤获得4个II期药物临床试验批准通知书 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。 产品名称：注射用 BL-B01D1 受理号：CXSL2500115、CXSL2500116、CXSL2500118、CXSL2500120 通知书编号：2025LP01063、2025LP01064、2025LP01065、2025LP01066 申请事项：境内生产药品注册临床试验 申请人：四川百利药业有限 ...

Group 1 - The Shanghai Stock Exchange Sci-Tech Innovation Board Composite Index (000680) increased by 0.61% as of April 14, 2025, with notable gains from stocks such as Yuyuan Pharmaceutical (688658) up 19.91%, and Kexing Pharmaceutical (688136) up 16.90% [1] - The Penghua Sci-Tech Innovation Index ETF (589680) rose by 0.76%, marking its fifth consecutive increase, indicating a strong performance in the AI industry chain [2] - The top ten weighted stocks in the Sci-Tech Innovation Board Composite Index as of March 31, 2025, include Haiguang Information (688041) and Cambrian (688256), collectively accounting for 22.34% of the index [3] Group 2 - The AI industry chain is experiencing breakthroughs, with expectations for major product releases from companies like Alibaba and Tencent around May to June [2] - The Chinese government is likely to enhance policy support and funding for the technology sector, particularly in AI, as part of its strategy to counterbalance the U.S. in the ongoing trade disputes [2]

公司以化学仿制药和中成药业务起步，成功转型创新 差异化ADC 平台+全球领先多抗平台FIC 及BIC 管线 公司经过过去十年努力，已构建起了全球领先的ADC 药物研发平台（HIRE-ADC平台）、创新多特异 性抗体药物研发平台（GNC 平台）、特异性增强双特异性抗体平台（SEBA 平台）及创新ARC（核 药）研发平台（HIRE-ARC 平台）。 BL-B01D1（EGFR/HER3 ADC）已成功验证HIRE-ADC 平台的实力。全球多抗药物研发处于早研阶 段，尚无产品获批上市。公司已有多款双/多特异性T 细胞衔接器进入临床，全球领先。 风险提示：药物临床研发失败、药物安全性风险、核心成员流失、行业竞争格局恶化等。 百利天恒成立于1996 年，是以化学仿制药和中成药业务起步的第一批民营医药企业。2010 年公司开始 创新转型，尝试小分子创新药物和生物药的研发。2023年公司与BMS 就BL-B01D1 达成全球重磅合作 协议（首付8 亿美元、近期或有付款5 亿美元及潜在里程碑付款71 亿美元），研发能力得到MNC 认 可，开启国际化新纪元。公司核心产品BL-B0ID1 有望于2025 年向NMPA 申报NDA ...

Investment Rating - The investment rating for the company is "Buy" (首次) [1] Core Insights - The company, Baili Tianheng, has successfully transformed from a traditional chemical generic and traditional Chinese medicine business to focus on innovative drug development, particularly in the field of ADCs (Antibody-Drug Conjugates) [4][15] - The company has entered a significant global collaboration with BMS for its lead product BL-B01D1, which includes an upfront payment of $800 million, with potential milestone payments totaling $7.1 billion, marking a new era of internationalization for the company [4][24] - BL-B01D1 is expected to submit its NDA to the NMPA in 2025, with commercialization anticipated in 2026, indicating a strong pipeline and growth potential [4][27] Summary by Sections Company Overview - Baili Tianheng was established in 1996, initially focusing on chemical generics and traditional Chinese medicine, and has since evolved through three stages: generic drug development, innovative transformation, and development as a biopharmaceutical company [15][16] - The company has established R&D centers in both the US and China, enhancing its capabilities in developing small molecule drugs, biologics, and ADCs [17][23] Financial Performance - The company reported a significant increase in revenue for 2024, primarily due to the large upfront payment from BMS, despite a decline in sales from chemical and traditional Chinese medicine products [20][21] - R&D investment reached 1.443 billion yuan in 2024, a 93.34% increase year-on-year, reflecting the company's commitment to innovative drug development [20][22] Product Pipeline - BL-B01D1 is the world's first EGFRxHER3 ADC, currently undergoing nine Phase III clinical trials in China, targeting multiple cancers including non-small cell lung cancer and breast cancer [5][30] - The product has shown promising early clinical data and is expected to be a cornerstone treatment for various tumor types, with potential submissions for additional indications in the coming years [5][27][30] R&D Platforms - The company has developed a leading ADC research platform (HIRE-ADC) and multiple innovative multi-specific antibody platforms, positioning itself at the forefront of ADC and multi-target drug development [6][30] - The ongoing development of several dual and multi-specific T-cell engagers indicates a robust pipeline with significant potential for future growth [6][30]

Investment Rating - The report assigns a "Buy" rating for the company for the first time [1]. Core Insights - Baili Tianheng has successfully transformed from a traditional chemical generic and traditional Chinese medicine company to an innovative biopharmaceutical enterprise, with a focus on anti-tumor antibody drugs and a strong pipeline of innovative drugs [4][15]. - The company has entered into a significant global collaboration with BMS for its lead product BL-B01D1, which is expected to submit its NDA to the NMPA in 2025, marking the beginning of its commercialization phase [4][24]. - The financial projections indicate a substantial increase in revenue in 2024, primarily due to the upfront payment from BMS, despite a decline in sales from chemical and traditional Chinese medicine products [20][21]. Summary by Sections Company Overview - Baili Tianheng was established in 1996 and has evolved through three stages: development as a generic drug company, exploration of innovative transformation, and growth as an innovative biopharmaceutical enterprise [15][16]. - The company has built a comprehensive R&D capability across small molecule drugs, biologics, and ADCs, with R&D centers in both the U.S. and China [17][18]. Product Pipeline - BL-B01D1 is the world's first EGFRxHER3 ADC drug, currently undergoing nine Phase III clinical trials in China, targeting multiple cancers including lung, breast, and esophageal cancers [30][31]. - The drug has shown promising early clinical data and is expected to be a cornerstone treatment for various tumor types [27][30]. Financial Performance - The company forecasts a significant increase in revenue for 2024, driven by a large upfront payment from BMS, while traditional product lines are expected to see a decline [20][21]. - R&D investment has increased significantly, reaching 1.443 billion yuan in 2024, reflecting the company's commitment to innovation [21][22]. Market Position - Baili Tianheng's innovative platforms, including HIRE-ADC and GNC, position it as a leader in the ADC space, with multiple candidates in clinical development [6][30]. - The company aims to leverage its strong R&D capabilities and strategic partnerships to enhance its market presence and drive future growth [4][24].

Group 1 - The Shanghai Stock Exchange Science and Technology Innovation Board Composite Index (000680) has shown a strong increase of 2.66% as of April 11, 2025, with notable individual stocks such as Jinghua Micro (688130), Meixin Sheng (688458), and Naxin Micro (688052) each rising by 20% [1] - The Huaxia Science and Technology Innovation Index ETF (589000) has experienced a 2.22% increase, marking its fourth consecutive rise, with the latest price reported at 0.92 yuan and a transaction volume of 21.67 million yuan [1] - Over the past month, the Huaxia Science and Technology Innovation Index ETF has seen a significant growth in scale, increasing by 7.13 million yuan, with the latest share count reaching 884 million, a new high for the month [2] Group 2 - The net inflow of funds into the Huaxia Science and Technology Innovation Index ETF has reached 28.90 million yuan, with a total of 43.39 million yuan accumulated over the last five trading days [2] - The Ministry of Industry and Information Technology has emphasized the need to accelerate the development of specialized and innovative small and medium-sized enterprises, focusing on innovation, digital empowerment, talent development, ecological support, and service enhancement [2] - Guosen Securities highlights that under the current trade tensions, technological self-reliance and autonomy are crucial for breaking through challenges, with China's established industrial ecosystem and advancing engineering talent providing a significant comparative advantage in the electronics industry [2] Group 3 - The Huaxia Science and Technology Innovation Index ETF closely tracks the performance of the Shanghai Stock Exchange Science and Technology Innovation Board Composite Index, which includes stocks from eligible companies listed on the Science and Technology Innovation Board [3] - As of March 31, 2025, the top ten weighted stocks in the index include Haiguang Information (688041), Cambricon (688256), and SMIC (688981), collectively accounting for 22.34% of the index [3] - The Huaxia Science and Technology Innovation Index ETF has associated fund products, including the Huaxia Shanghai Science and Technology Innovation Board Composite ETF Connect A (023719) and C (023720) [3]